Atlas/ Regenerative & Tissue Repair/ Cytoprotective Peptides · Body-Protection Signals/ TB-500 (Thymosin β4)
Reading depth · audience layer
Class 07 · Regenerative & tissue repair · β-thymosin actin-sequestering peptide · cell-migration signal

TB-500thymosin β4 · the G-actin migration signal

TB-500 is a lab-made version of a natural healing protein your body already makes — thymosin beta-4 (Tβ4) — sold most often as its short active fragment, Ac-LKKTETQ. Its job is to help cells move quickly to an injury, sprout new blood vessels into damaged tissue, and quiet down inflammation, which is why it is one of the most-studied "recovery" peptides in animal science. The honest picture: the human evidence is concentrated in eye drops and the heart (where the full protein has reached Phase II/III trials), while the popular injectable use for muscles, tendons and general recovery has no completed human efficacy trial at all. It is not approved as a drug anywhere and is banned in sport by WADA, in and out of competition. Everything below the clinical-trial evidence line is a hypothesis built on rodent data, equine practice and clinic protocols — not validated prescribing.

TB-500 is the commercial name for synthetic Thymosin Beta-4 (Tβ4) — a 43-amino-acid, N-acetylated β-thymosin (MW ≈ 4,963 Da) — and, in most research-grade product, for its central WH2-domain heptapeptide Ac-LKKTETQ (residues 17–23; MW 889 Da). Its defining pharmacology is 1:1 G-actin sequestration via the conserved WH2 motif, which maintains a polymerization-ready actin pool and enables rapid directional cell migration into wounds. Downstream, Tβ4 activates integrin-linked kinase → PI3K/Akt (cell survival), upregulates VEGF (angiogenesis), and suppresses NF-κB (anti-inflammation). Human evidence clusters in ophthalmology (Phase III RGN-259/timbetasin) and cardiac repair (a 2025 Phase II/III STEMI RCT); systemic subcutaneous use — the dominant real-world pattern — has no powered human RCT. All SC dose ladders are extrapolations.

Thymosin β4 (gene TMSB4X; CAS 77591-33-4; C₂₁₂H₃₅₀N₅₆O₇₈S; MW 4,963.44 Da) is the principal G-actin-sequestering protein in mammalian cells, present intracellularly up to ~0.5 mM in selected lineages. The commercial TB-500 fragment (Ac-LKKTETQ; CAS 885340-08-9; MW 889.02 Da; PubChem CID 62707662; UNII QHK6Z47GTG) corresponds to the actin-binding WH2 domain and binds G-actin at ~1:1 with Kd ≈ 0.5–2.0 µM. The cardioprotective arm proceeds ILK → PI3K/Akt(Ser473) → BAD/GSK-3β, demonstrated in the foundational 2004 Nature paper and re-confirmed via an ErbB2/Raf1 axis in the 2025 human STEMI RCT (Cardiovascular Research, cvaf223). Plasma t½ is short (~2 h) but biological effect persists days–weeks via intracellular actin-pool binding and sustained gene programs (the "plasma/effect disconnect"). Overall GRADE for systemic SC repair indications: LOW to VERY LOW; ophthalmic topical reaches MODERATE.

60% vs 12.5% Complete corneal healing · Phase III ophthalmic (RGN-259) vs placebo
~2 h Plasma half-life · effect persists days–weeks (disconnect)
0 RCT Powered human trials for the popular SC musculoskeletal use
43 / 7 AA Full Tβ4 (4,963 Da) · WH2 fragment Ac-LKKTETQ (889 Da)
Status
Unapproved · investigational · off 503A Cat-2 (Apr 2026)
Open dose calculator
Routes
SC (primary) · IM · IV (trial) · topical ophthalmic · IA
Originator
Goldstein & White · Albert Einstein · 1966
WADA status
Prohibited · S2 + S0 · in & out of competition
01 · At a glance

Key facts & headline data.

TB-500 occupies an unusual position: a deep, multi-species preclinical dataset and two genuinely clinical human programs (eye and heart) sitting beside a near-total absence of controlled evidence for its most popular real-world use — systemic subcutaneous injection for musculoskeletal recovery. The efficacy numbers worth weighing are the ophthalmic Phase III and the cardiac trials; the dosing numbers are practice-pattern; and the regulatory facts should weigh heaviest for anyone considering use.

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Origin · discovery
Thymus · 1966
Isolated by Allan Goldstein and Abraham White from calf-thymus "fraction 5" in 1966; the full 43-residue sequence was synthesized in 1981. Thymosin β4 is now recognized as the dominant G-actin-sequestering protein across most mammalian cell types. TB-500 is the synthetic actin-binding fragment (Ac-LKKTETQ) of that protein.
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Best human evidence
Phase III · eye
In the SEER-1 Phase III neurotrophic-keratopathy RCT, 0.1% RGN-259 (synthetic Tβ4) achieved complete corneal healing in 60% of treated eyes vs 12.5% on placebo at day 29 (p=0.0656; significant at day 43, p=0.0359), with no significant adverse effects. This is the strongest controlled human evidence for any Tβ4 form — but it is topical ophthalmic, not systemic SC.
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Plasma half-life
~2 h
A randomized Phase I IV study in healthy volunteers (42–1,260 mg) showed dose-proportional PK with a short terminal phase and increasing t½ at higher doses. The widely-cited ~2 h plasma figure contrasts with a 7–10 day functional window — explained by intracellular actin-pool binding and sustained downstream signaling after the peptide has cleared.
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Cardiac signal (2025)
Infarct ↓ (subgroup)
A 2025 Phase II/III STEMI RCT (Cardiovascular Research, n=96, doi 10.1093/cvr/cvaf223) found significantly reduced infarct area in patients given IV rhTB4 within 8 h of PCI, via an ErbB2/Raf1-dependent mechanism confirmed in mice — though the overall between-group endpoint was not significant.
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Practice SC dose
2–5 mg/wk
Practice-pattern subcutaneous use centers on 2.0–2.5 mg 1–2× weekly (loading 4–6 weeks), with up to 5 mg twice weekly for acute high-demand situations and weekly-to-monthly maintenance. None of these SC regimens has been tested in a powered human efficacy trial — they are extrapolated from animal, equine and clinic data.
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Regulatory status (May 2026)
Unapproved · WADA S2+S0
Not FDA-approved for any indication. Removed from FDA 503A Category 2 in April 2026 (with CJC-1295 and others) but not moved to Category 1 — a regulatory gray zone pending the PCAC review on July 23–24, 2026 (Docket FDA-2025-N-6895). Prohibited in sport under WADA S2 + S0, in and out of competition (4-year sanction).
02 · Mechanism of action

How an actin-sequestering peptide works.

TB-500 doesn't bind a classic receptor — it works from inside the cell on the cytoskeleton, the scaffolding cells use to move. Its core trick is holding a ready supply of "actin building blocks" so injured tissue can rapidly send repair cells to the wound. From there it switches on a survival signal (so stressed cells don't die), tells the body to grow new blood vessels (better supply lines), and calms inflammation. In animals it also wakes hair-follicle stem cells and helps repair nerve tissue. Almost all of this is shown in rats, mice and cell cultures — so read it as a strong mechanism story with two real human footholds (eye and heart), not proven human biology for muscles and tendons.

Six mechanistically linked arms. First — the defining mechanism: 1:1 G-actin sequestration through the conserved WH2 domain (Ac-LKKTETQ), suppressing barbed-end elongation while maintaining a polymerization-ready pool that powers lamellipodial extension and directional migration into wounds. Second — ILK → PI3K/Akt(Ser473) → BAD/GSK-3β survival signaling, reducing infarct size in MI models. Third — VEGF-A upregulation and endothelial tube formation (angiogenesis), with MMP-2-mediated matrix remodeling. Fourth — NF-κB suppression lowering TNF-α / IL-1β / IL-6, distinct from glucocorticoid action. Fifth — hair-follicle stem-cell activation (bulge keratinocyte migration, MMP-2, telogen→anagen). Sixth — neural repair: progenitor and oligodendrocyte recruitment in TBI, stroke, MS and optic-nerve models.

Thymosin β4 is a multifunctional, receptor-independent cytoskeletal regulator rather than a single-target ligand. The WH2 heptapeptide binds G-actin with Kd ≈ 0.5–2.0 µM; at physiological intracellular Tβ4 (0.1–0.5 mM) roughly half the G-actin pool is sequestered, poising the cell for rapid remodeling on a wounding cue. The cardioprotective axis was established in the 2004 Nature ILK paper (Bock-Marquette et al.) and re-demonstrated through ErbB2/Raf1 signaling in the 2025 human STEMI RCT, where RNA-seq of I/R heart tissue showed ErbB-pathway modulation and in-vitro H/R models confirmed ErbB2/Raf1 activation. The N-terminal cleavage product Ac-SDKP contributes independent, ACE-regulated anti-fibrotic activity via TGF-β1/Smad2/3 suppression. The plasma/effect disconnect (t½ ~2 h vs. weekly functional dosing) is attributed to intracellular sequestration and sustained transcriptional programs — plausible but not formally modeled in humans.

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G-actin sequestration · WH2 domain

The signature mechanism. The Ac-LKKTETQ heptapeptide binds monomeric (G-)actin 1:1 via the Wiskott-Homology-2 motif (residues 17–23), suppressing barbed-end filament elongation while preserving a large cytoplasmic G-actin reservoir. On a wounding signal, that reservoir feeds rapid lamellipodial extension and directional migration — the rate-limiting cell behavior in wound closure and re-epithelialization.
Clinical significance: Cell migration is upstream of nearly every claimed TB-500 indication — corneal epithelial healing, dermal wound closure, tendon/muscle repair, and cardiac cell repopulation all depend on getting reparative cells to the injury fast. It is also the mechanistic root of the angiogenesis and neural-repair arms (endothelial and progenitor cells must migrate to act).
Molecular detail: Kd ≈ 0.5–2.0 µM; the WH2 motif is among the most evolutionarily conserved eukaryotic domains, explaining Tβ4's near-ubiquitous expression. At 0.1–0.5 mM intracellular Tβ4, ~50% of the G-actin pool is sequestered. No cell-surface receptor or human EC50 exists, so a classical target-engagement PK/PD model cannot be built — the mechanism is biochemically defined but quantitatively open in vivo.
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ILK → PI3K/Akt · cell survival

Tβ4 upregulates integrin-linked kinase (ILK), activating PI3K/Akt and promoting cardiomyocyte and endothelial survival after ischemic insult. In murine MI models this cascade reduces infarct size; the 2004 Nature paper first tied Tβ4 to ILK/Akt-mediated cardiac cell migration, survival and repair.
Clinical significance: This is the arm with the most direct human translation — it underwrites the cardiac trial program (EPC pre-treatment pilot, the NL005 Phase I/IIb line, and the 2025 STEMI RCT). The "survival" framing (anti-apoptosis under oxidative/ischemic stress) is also the rationale for neuroprotection and for protecting grafted/transplanted cells.
Molecular detail: ILK → Akt phosphorylation at Ser473 → BAD phosphorylation (anti-apoptotic) and GSK-3β inactivation (pro-survival), delaying mitochondrial permeability-transition-pore opening under oxidative stress. The 2025 human STEMI RCT demonstrated an ErbB2/Raf1-dependent route in H/R cardiomyocyte models with corroborating cardiac RNA-seq — adding receptor-level specificity to the previously "receptor-independent" survival story.
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Angiogenesis · VEGF-A & MMP-2

Tβ4 upregulates VEGF-A and drives endothelial migration and tube formation. It was first identified as a gene upregulated four- to six-fold during early endothelial tube formation; in aged rodents it restores impaired wound vascularization toward young-animal levels — relevant for hypovascular tissues like tendon and cartilage.
Clinical significance: Angiogenesis links repair to oxygen/nutrient delivery and is the unifying rationale for wound, tendon and cardiac claims. It is also the basis for the principal theoretical safety concern — pro-angiogenic signaling could, in principle, support existing tumor vasculature (see Safety).
Molecular detail: The angiogenic effect is both VEGF-dependent (VEGF mRNA, VEGFR2 signaling) and VEGF-independent (direct endothelial actin remodeling). MMP-2 secretion increases, enabling the ECM proteolysis required for neovascular sprouting — the same MMP-2 axis that appears in the hair-follicle arm, making matrix remodeling a shared convergence point.
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Anti-inflammation · NF-κB & Ac-SDKP

Tβ4 suppresses NF-κB activation, lowering TNF-α, IL-1β and IL-6 and reducing neutrophil-mediated tissue damage — without suppressing the productive (M2) macrophage phase of healing. The effect is distinct from glucocorticoid mechanisms.
Clinical significance: Controlled inflammation supports the broad "recovery" use case and the rationale for combining TB-500 with other repair peptides. As with most anti-inflammatory peptides, this arm provides mechanistic plausibility rather than indication-specific human proof.
Molecular detail: A large part of the anti-inflammatory/anti-fibrotic effect is carried by the N-terminal cleavage product Ac-SDKP, which has ACE-regulated activity and suppresses TGF-β1, Smad2, Smad3 and myofibroblast differentiation across cardiac, hepatic and pulmonary fibrosis models. Reduced ROS (oxidative-stress lowering) contributes to cytoprotection and intersects the ILK/Akt survival node.
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Hair-follicle stem-cell activation

A bulge-region keratinocyte subset expresses high Tβ4 during the anagen (growth) phase. Tβ4 promotes migration of these follicle stem cells and their transit-amplifying daughters toward the hair-shaft-producing base, and accelerates the telogen→anagen transition in rodents.
Clinical significance: This explains the commonly reported (and sometimes unwanted) hair-growth effect during TB-500 use, and underlies speculative interest in hair-loss applications. There is no human RCT for a hair-growth indication — the data are rodent and in-vitro only.
Molecular detail: Tβ4 increases clonogenic keratinocyte migration and MMP-2 secretion in rat vibrissa follicle stem-cell cultures at nanomolar concentrations. The pathway is largely independent of the VEGF/angiogenesis arm and is mediated through actin-dependent cell motility — a direct downstream consequence of the WH2/G-actin node rather than a separate signaling system.
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Neuroprotection · CNS / PNS repair

In rodent models of traumatic brain injury, stroke, multiple sclerosis and spinal-cord injury, systemic Tβ4 promotes functional recovery by recruiting neural progenitor cells and oligodendrocyte precursors. In optic-nerve-crush models it roughly tripled retinal-ganglion-cell survival vs. untreated animals.
Clinical significance: CNS repair is the least clinically substantiated arm — entirely animal-model based, with no human neurological RCT. The SEER ophthalmic investigators noted potential nerve-repair relevance given Tβ4's documented CNS activity, but clinician counseling should treat neurological claims as the most speculative.
Molecular detail: The mechanism combines ILK/Akt-mediated survival with upregulation of endogenous repair signaling and axon regeneration. Oligodendrocyte-driven remyelination is hypothesized (from progenitor-recruitment data) but not directly confirmed. As with the cardiac arm, the survival cascade is the shared engine — here applied to neurons and glia rather than cardiomyocytes.
L3 · Downstream pathway
Administration → Tβ4 / Ac-LKKTETQ → Cytoskeletal & Signaling Targets → Effector Program → Tissue Phenotype
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Dose
t½ ~2 h
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Tβ4 /
Ac-LKKTETQ
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G-actin · ILK
VEGF · NF-κB
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Akt survival ·
VEGF · Ac-SDKP
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Migration +
angiogenesis
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Anti-inflamm +
anti-fibrosis
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Healed, low-scar
vascularized tissue
03 · Dosing protocols & models

Route-specific dosing architecture.

This is the engine's centerpiece — a speculative, hypothesis-driven dosing layer. Every ladder, band, threshold and titration rule is built on (1) the human IV Phase I PK envelope, (2) the cardiac and ophthalmic trial doses, (3) equine veterinary practice, and (4) human practice-pattern ranges (~2–5 mg/week SC) that are not evidence-based. No standardized, trial-validated human SC dose ladder exists for any TB-500 musculoskeletal or wellness indication as of 2026. The structure mirrors how clinicians titrate biologics and is meant as a base for protocol critique and research design — not validated prescribing. Each route is built to the same skeleton: starting dose, escalation cadence, dose ladder, maintenance target, cycle structure, reconstitution math, monitoring overlay, and explicit evidence grade.

Important · regulatory status & evidence ceiling TB-500 / thymosin β4 is not FDA-approved for any human indication in any jurisdiction. It was removed from the FDA 503A Category 2 bulks list in April 2026 but not added to Category 1 — leaving it in a regulatory gray zone pending the Pharmacy Compounding Advisory Committee (PCAC) review on July 23–24, 2026 (Docket FDA-2025-N-6895; TB-500 free base and acetate forms). It is prohibited in sport under WADA S2 (peptide hormones / growth factors) and S0 (non-approved substances), in and out of competition, with a 4-year first-offense sanction. All dose ladders, biomarker thresholds and titration rules below carry evidence grade D (practice-pattern) or P (preclinical) and must not be read as clinical guidelines. Use only under IRB-approved research protocols or physician-supervised informed-consent settings, with verified product source.
PK note · why these dosing patterns are heuristic Plasma half-life is short (~2 h terminal phase; dose-proportional in the IV Phase I across 42–1,260 mg), yet the functional window appears to run 7–10 days — the basis for weekly dosing. This plasma/effect disconnect means TB-500 is administered as a repeated pulse signal, not titrated to a steady-state plasma level. There is no validated clinical assay, no established therapeutic range, and no meaningful peak/trough concept for routine use — drawing a "level" days post-dose is currently uninformative. Twice-weekly-to-weekly SC dosing reflects practice-pattern "exposure cover," anchored to the intracellular actin-pool-binding hypothesis, not to measured human kinetics. Note the orders-of-magnitude gap between the IV trial doses (mg/kg-scale) and SC practice doses (single-digit mg total) — they are different pharmacokinetic worlds.
Subcutaneous Protocol — Primary Route (Hypothetical)
SC · 2.0–5.0 mg/injection · 1–2× weekly · 4–6 wk loading · practice-pattern
Grade D
Indication framing
Systemic tissue repair: musculoskeletal injury recovery, tendon/ligament, general recovery, anti-aging. Practice guides converge on 2.0–2.5 mg 1–2× weekly with a 4–6 week loading phase, all extrapolated from animal and equine data — none human-validated for SC use.
Starting dose
2.0–2.5 mg SC per injection. Abdomen or lateral thigh, ~2 inches from the umbilicus; 29–31 G insulin syringe at 45°; inject slowly and rotate sites.
Escalation cadence (loading ladder)
Week 1–2: 2.0 mg twice weekly (tolerance) → Week 3–6: 2.5 mg twice weekly (loading target). For acute high-demand situations some protocols use 5 mg twice weekly. Reassess symptomatic response at week 2; escalate only with no adverse events.
Dose ladder
2.0 mg → 2.5 mg → (acute) 5.0 mg per injection, 1–2× weekly. Weekly totals: ~4–5 mg standard; up to 10 mg in acute high-band protocols. Above 10 mg/week is off-protocol "experimental mode."
Maintenance / taper
After loading, step to 2.0–2.5 mg once weekly, then optionally to every 2 weeks or monthly. Taper rather than stop abruptly; no data supports indefinite continuous use.
Cycle structure
4–6 weeks loading; up to 12 weeks for chronic conditions, then a 4–8 week washout (practice varies). No human data defines optimal cycle length; cycling is a conservative default.
Reconstitution & injection
Typical 5 mg vial + 2 mL bacteriostatic water → 2.5 mg/mL. 2.5 mg = 1.0 mL = 100 units (U-100); 2.0 mg = 0.8 mL = 80 units. Roll — don't shake; refrigerate reconstituted product 2–8 °C, use within ~21 days, protect from light, discard if turbid or particulate. Use the calculator below for exact draw volumes for any vial/dose.
Monitoring overlay (borrowed)
Baseline + week 2/6: pain VAS/WOMAC + function/ROM (musculoskeletal), hsCRP/ESR (inflammation proxy), CBC + CMP for safety, injection-site assessment. None of these is validated as a TB-500 marker — a heuristic overlay only.
PK heuristic note
Given ~2 h plasma t½ and a presumed 7–10 day tissue window, weekly SC dosing is "exposure cover," not level-guided. Estimated SC bioavailability ~85–90% (unvalidated). The standard-band internal reference is ≈ 0.067 mg/kg/week (≈ 7–10 µg/kg/day equivalent) for adult weights.
⚠ Evidence & source checkpoint No human RCT has validated any SC dose, route comparison, or dose–response curve for musculoskeletal repair. The dominant real-world hazard is product quality: research-grade RUO material is not manufactured to pharmaceutical sterility/potency/endotoxin standards. Minimum standards for any injectable use: HPLC ≥98% purity, sterility certification, endotoxin limits, and mass-spectrometry identity confirmation from a verified source.
Intramuscular Protocol (Hypothetical)
IM · 2.0–2.5 mg/injection · alternate-day → weekly · 6–8 wk · practice-pattern
Grade D
Indication framing
Same systemic-repair targets as SC, occasionally favored for localized muscle injury. No comparative human efficacy data exists for IM vs SC; IM is not preferred in practice due to greater injection-site discomfort.
Starting dose
2.0 mg IM per injection. IM may tolerate slightly larger volumes (up to ~2 mL per site) than SC.
Escalation cadence
2.0 mg IM every other day × 2 weeks2.5 mg IM twice weekly × 4 weeks2.0 mg IM weekly maintenance.
Dose ladder
2.0 mg → 2.5 mg per injection; weekly total ~4–5 mg. Acute high-band escalation is borrowed from the SC protocol where used.
Maintenance target
2.0 mg IM weekly through the active block, optional step-down.
Cycle structure
6–8 weeks on, then washout. Same cautions as SC.
Reconstitution & injection
Same math as SC (5 mg + 2 mL → 2.5 mg/mL). Deeper injection; rotate large muscle groups. Greater injection-site pain reported vs SC.
Monitoring overlay (borrowed)
Injection-site pain assessment; consider myoglobin only if heavy IM dosing; baseline CBC/CMP. Same unvalidated caveat as SC.
⚠ Evidence & source checkpoint IM literature specific to TB-500 is sparse; the protocol is a practice-pattern variant of the SC route with no comparative efficacy data. Higher injection-site discomfort is the main practical downside. Same product-quality requirements as SC apply.
Intravenous Protocol — Clinical-Trial Context Only
IV · 0.5–1.0 µg/kg (cardiac) to 42–1,260 mg (Phase I) · monitored only
Grade B / D
Indication framing
IV is the route of the human cardiac and PK trials — not a self-administration route. Listed here because it carries the strongest human PK/safety data, which anchors the engine's safety envelope.
Phase I dose range (healthy volunteers)
42, 140, 420, 1,260 mg single dose, then the same dose daily × 14 days; well-tolerated at all doses with no dose-limiting toxicities and dose-proportional PK. These are orders of magnitude above SC practice doses.
Cardiac-trial dose (STEMI)
0.5 µg/kg and 1.0 µg/kg IV within 8 h of PCI plus days 2–7 in the 2025 NL005/rhTB4 STEMI RCT. The NL005 first-in-human Phase I used IV ascending doses 0.05–25 µg/kg (single) and 0.5–5 µg/kg daily × 10 days.
Dose ladder
Not established for routine use. IV at therapeutic doses occurs only inside controlled cardiac trials under full monitoring.
Reconstitution
Sterile physiological saline, prepared under aseptic pharmaceutical conditions — not a home-reconstitution scenario.
Monitoring overlay
Full cardiovascular monitoring, ECG, echocardiography (LVEF) for cardiac indications, hepatic/renal function, and hematology — i.e. a clinical-trial monitoring bundle, not a wellness panel.
PK note
The IV Phase I established dose-proportional exposure with increasing terminal t½ at higher doses — the operative human PK dataset. Do not extrapolate IV mg/kg trial doses to SC self-dosing; the contexts are not interchangeable.
⚠ Not for unmonitored self-administration IV TB-500 belongs to the controlled cardiac and PK trial setting only. The very high Phase I doses (up to 1,260 mg) describe a tolerability envelope in monitored healthy volunteers — they are not a license for high-dose home use by any route.
Topical Ophthalmic — Clinical-Trial Context Only
0.1% RGN-259 (Tβ4 1 mg/mL) · 5× daily × 4 wk · the strongest human evidence
Grade B
Indication framing
Neurotrophic keratopathy and dry-eye disease, using full-length synthetic Tβ4 as eye drops (RGN-259 / timbetasin). This is the only Tβ4 form with controlled Phase III human efficacy data.
Preparation & dosing
0.1% solution (1 mg/mL), 5× per day for 4 weeks in the SEER-1 Phase III neurotrophic-keratopathy protocol.
Efficacy
Phase III RCT: 60% complete corneal healing at day 29 vs 12.5% placebo (p=0.0656; significant at day 43, p=0.0359); improved ocular comfort. A Phase II dry-eye RCT (n=72) missed its primary endpoints but showed favorable secondary trends.
Safety
No significant adverse effects; only 1 treatment-related AE among 16 total in the Phase III trial.
Monitoring overlay (validated)
Corneal fluorescein staining is a validated ophthalmic endpoint (the SEER trials' primary measure). This is the one place where a TB-500/Tβ4 efficacy marker is genuinely validated — within ophthalmology.
Program status
Not FDA-approved; investigational. ReGenTree (successor to RegeneRx) holds the IND; SEER-2 and SEER-3 trials ongoing. Topical ophthalmic delivery is mechanistically distinct from systemic SC — do not read across.
⚠ Strongest evidence ≠ systemic evidence The ophthalmic Phase III is the best controlled human data for any Tβ4 form, but it is topical, full-length Tβ4, for an eye-surface indication. It does not validate the systemic SC fragment use that dominates the market.
Intra-Articular Protocol (Hypothetical)
IA · 1.0–2.5 mg/injection · weekly × 4–6 · practice-pattern only
Grade D
Indication framing
Local delivery into avascular joint spaces (e.g. knee), where systemic distribution may be suboptimal, on the theory of improving local VEGF/migration signaling. No clinical-trial data exist for the IA route.
Dose used
1.0–2.5 mg per injection directly into the affected joint.
Frequency
Once weekly × 4–6 injections (practice-pattern).
Reconstitution
Same math as SC; clinician-administered under strict sterile technique only.
Monitoring overlay
Joint exam, effusion/ROM, pain VAS/WOMAC; vigilance for septic arthritis. No validated TB-500 joint marker.
⚠ Highest procedural risk, lowest evidence The IA route has no clinical-trial data or validated protocol. Joint-infection risk demands strict sterile technique and clinician administration. Treat as the most speculative of all routes.
Global dose bands · practice-pattern + trial bridge

Weekly dose tiers & weight-band interpolation.

The engine anchors SC/IM protocols to weekly dose tiers. Weight bands default to a standard reference of ≈ 0.067 mg/kg/week (≈ 5 mg/week at 75 kg, split as 2.5 mg × 2). All values are evidence grade D. The equine reference is included because much of the practice-pattern dosing was back-derived from equine veterinary use.

BandPer injectionFrequencyWeekly totalBasisGrade
Low1.5–2.0 mgOnce weekly1.5–2.0 mgConservative / sensitive individuals; maintenance.D
Standard2.0–2.5 mgTwice weekly4.0–5.0 mgTypical loading protocol; default working band.D
High (acute)5.0 mgTwice weekly10 mgAcute high-demand / equine-derived; flag >10 mg/wk as experimental.D
Equine reference10 mgOnce weekly × 610 mgEquine practice (RMTC) — not a human recommendation.D

Weight-band interpolation (speculative)

Standard band at ≈ 0.033 mg/kg per injection × 2 injections/week. Round to practical vial-friendly doses.

Body weightPer injection (0.033 mg/kg)Twice-weekly totalPractical rounding
~55 kg (120 lb)1.8 mg3.6 mg/week2.0 mg × 2
~65 kg (143 lb)2.1 mg4.3 mg/week2.0–2.5 mg × 2
~75 kg (165 lb)2.5 mg5.0 mg/week2.5 mg × 2 (nominal standard)
~85 kg (187 lb)2.8 mg5.6 mg/week2.5–3.0 mg × 2
~95 kg (209 lb)3.1 mg6.3 mg/week3.0 mg × 2
~105 kg (231 lb)3.5 mg6.9 mg/week3.5 mg × 2

Weight-based dosing for TB-500 is not validated in human trials — these figures are interpolated from practice-pattern protocols. The clinical STEMI trial used 0.5–1.0 µg/kg IV, a different dose context entirely. No pediatric dosing trials or structured pediatric protocols exist — pediatric use is off-protocol by default.

Titration logic · engine-ready decision rules

Escalation, hold & stop logic.

Generic heuristics mirroring how clinicians titrate biologics — clearly marked unvalidated for TB-500. Escalation requires both a response floor and a safety floor before stepping the dose. Hard stops are non-editable and reflect regulatory/ethical caution rather than observed TB-500 events.

Trigger / conditionActionRationaleGrade
No symptomatic response after 2 wk at standard bandEscalate to high band (5 mg × 2/wk) if no AEsMay require higher exposure for clinical effect; gated on a safety floor.D
Injection-site reaction (erythema >2 cm, induration)De-escalate / hold; assess for infectionLocal response may indicate sensitivity or contaminated preparation.D
Persistent fatigue >48 h post-injectionDe-escalate to once-weekly dosingDose-related systemic response; may normalize with adaptation.D
Active infection (any site)Hold until resolvedPro-migratory / angiogenic effects may theoretically worsen spread.D
Active malignancy (any type)Permanent stop (hard) — discontinue immediatelyPro-angiogenic VEGF mechanism could support tumor vascularization. Absolute contraindication.P/D
Pregnancy confirmed or suspectedPermanent stop (hard)No pregnancy safety data; growth-promoting activity contraindicated in development.D
Uncontrolled diabetes (HbA1c >9%) / active diabetic retinopathyHold; optimize firstImpaired healing environment; theoretical retinal-VEGF neovascularization concern.D
LFTs >3× ULN or significant CBC/CMP abnormalityHold; evaluate etiologyNo established hepatotoxic mechanism; conservative monitoring borrowed from biologic practice.D
Goals achieved (pain/function restored)Taper to maintenance (2.0 mg weekly→monthly)Prevent unnecessary exposure; no data on long-term continuous use.D
12-wk cycle complete, no further improvementStop; re-evaluate after 6-wk off-periodNo evidence supports indefinite dosing; prevents cumulative exposure without benefit.D

Special populations — renal, hepatic, elderly, pregnancy: no PK/PD data stratified by eGFR or Child-Pugh exists for TB-500. Conservative default: avoid use in these groups outside IRB-approved protocols.

Biomarker scaffold · borrowed, mostly not validated

Response & safety monitoring bundles.

Critical flag: no biomarker below is validated as a specific TB-500 efficacy or toxicity marker in humans except within the ophthalmic and wound contexts. Each item is stored with a validated_for_TB500 boolean — currently false for systemic use across the board.

Biomarker / testCategoryRationaleValidated for TB-500?
CBC (incl. platelets)SafetyBaseline hematology (Tβ4 is platelet-released).No
CMP (LFTs, renal, glucose)SafetyHepatic/renal function; glycemic context.No
hsCRP / ESREfficacy proxySystemic inflammation; may fall with anti-inflammatory effect.No
Echocardiography (LVEF)Efficacy (cardiac only)Functional recovery endpoint in cardiac trials.Cardiac trials only (B)
Corneal fluorescein stainingEfficacy (ophthalmic)Primary endpoint in SEER trials.Yes — ophthalmic (B)
Wound area (photo + ruler)Efficacy (wound)Standard wound-trial methodology.Yes — wound method (B)
Pain / function (VAS, WOMAC, ROM)Efficacy proxyPatient-reported musculoskeletal outcomes.No
Tumor markers (PSA/CEA/CA-125/AFP)Safety (pre-screen)Screen for occult malignancy before use, given the angiogenic concern.No (baseline screen only)

Architecture note: store each biomarker with a source_context tag (ophthalmic / wound / cardiac / borrowed) and a validated_for_TB500 boolean. Only the ophthalmic and wound endpoints flip to true — and only within those contexts, not for systemic musculoskeletal use.

SC loading ladder · practice-pattern · grade D

Visual titration: from loading to washout.

Week 1–2 2.0mg × 2/wk SC · tolerance + response floor
Week 3–6 2.5mg × 2/wk Loading target · reassess at wk 2
Acute 5.0mg × 2/wk High band · acute injury only · cap 10 mg/wk
Maint. 2.0–2.5mg/week Step to weekly, then every-2-weeks/monthly
Then Washout4–8 wk off After ≤12-wk cycle · reassess before resuming
L2 · Reconstitution & dose math

Reconstitution & Dose Calculator

For reference only. Not medical dosing advice. TB-500 is dosed in milligrams (mg). Verify peptide purity (≥98% HPLC), sterility, endotoxin limits, identity (MS), and storage. Only use product from a licensed / verified source for any injection protocol.

Concentration
Draw volume
Units (U-100)
Doses per vial
Cadence basis
04 · Combination protocols

Stacking TB-500.

TB-500 is the canonical "systemic" half of regenerative peptide stacks. No published controlled study has evaluated TB-500 in combination with any other peptide in humans — every stack below is a community-derived concept based on mechanistic complementarity, not clinical-trial data. No co-administration PK/PD data exist. The default engine rule is to keep each component in its mid-range band and avoid simultaneous high-end dosing of multiple pro-angiogenic agents.

TB-500 + BPC-157 · "Wolverine Stack"
Moderate (mechanistic)
TB-500 2–2.5 mg × 2/wk BPC-157 200–500 µg/day SC · cycled
The most popular regenerative stack. The complementarity is real at the single-compound level — TB-500 sequesters G-actin to drive systemic cell migration and MMP-mediated remodeling, while BPC-157 acts more locally via VEGFR2 angiogenesis, nitric-oxide balance and growth-hormone-receptor modulation. The only human "combination" evidence is a retrospective intra-articular knee pilot (n=16) comparing BPC-157 alone vs BPC-157 + Tβ4, with no control and no statistics. Engine default: when TB-500 is ≥4–5 mg/week, cap BPC-157 at its standard band.
ComponentPrimary mechanismEvidence
TB-500G-actin sequestration · migration (systemic)Preclinical · no SC RCT (P)
BPC-157VEGFR2 angiogenesis · FAK-paxillin (local)Preclinical (P)
CombinationSystemic + local repair1 retrospective pilot (D)
TB-500 + GHK-Cu · "Glow / repair-remodel"
Exploratory
TB-500 2.0 mg × 2/wk GHK-Cu (topical / low-dose SC) skin / scar / recovery
Sequential-logic pairing for skin, scar and post-procedure recovery: TB-500 drives migration and angiogenesis (early repair) while GHK-Cu supports collagen/elastin synthesis and matrix remodeling (consolidation). Sometimes sold pre-blended (e.g. a "Glow Blend" of GHK-Cu / BPC-157 / TB-500). No combination clinical data exist. Of note, GHK-Cu sits on a different regulatory track (non-injectable cosmetic-approved); the injectable combination remains legally uncertain.
ComponentRoleStatus
TB-500Migration · angiogenesis (early)Preclinical · no SC RCT (P)
GHK-CuCollagen / elastin · remodelingCosmetic-approved · small clinical (B/C)
CombinationRepair → remodeling sequenceNo combination data (D)
TB-500 + KPV · "Wolverine +"
Exploratory
TB-500 2–2.5 mg × 2/wk KPV 500 µg–10 mg gut / systemic anti-inflammatory
KPV — the C-terminal α-MSH tripeptide (Lys-Pro-Val) — adds melanocortin-receptor (MC1R/MC3R) anti-inflammatory and mucosal-healing activity, complementing TB-500's NF-κB-mediated anti-inflammation. Used in community gut/systemic-inflammation protocols. No co-administration studies. Mechanistically plausible but speculative; KPV's melanocortin activity may theoretically affect pigmentation, and the added component raises monitoring burden.
ComponentRoleStatus
TB-500Migration · NF-κB anti-inflammationPreclinical · no SC RCT (P)
KPVα-MSH-derived mucosal anti-inflammatoryPreclinical (P)
CombinationAdditive anti-inflammatory / mucosal healingNo data (D)
TB-500 + Thymosin α1 · "thymic pair"
Exploratory · monitor
TB-500 2–2.5 mg × 2/wk Tα1 (immunomodulatory) immune + repair
Tα1 and Tβ4 are both thymic peptides with divergent functions — Tα1 modulates T-cell and NK-cell activity (immunostimulant), Tβ4 drives tissue repair. The pairing is proposed for immunocompromised states needing simultaneous immune support and healing. No co-administration data. Mechanistically non-overlapping, with a regulatory asymmetry: Tα1 is on a different compounding track from TB-500. Treat as exploratory; monitor for any immune-activation symptoms.
ComponentMechanismAdded monitoring
TB-500Tissue repair · migrationStandard panel
Thymosin α1T-cell / NK immunomodulationImmune-symptom review
Hard constraint · absolute contraindication for stacking

Active or recent malignancy is an absolute contraindication for TB-500 — alone or in any stack. TB-500's pro-angiogenic mechanism (VEGF upregulation, endothelial migration) carries a theoretical risk of supporting tumor vascularization. BPC-157 carries a similar pro-angiogenic concern, so the Wolverine stack compounds that theoretical risk. No clinical data show that TB-500 causes or accelerates human cancer — but the mechanism-derived concern is sufficient to classify this as an absolute stop until definitive safety data exist. If a user profile flags active malignancy, the engine should suppress all pro-angiogenic stacks — not just TB-500 — and label the combination "discouraged." Screen for malignancy before initiating any TB-500 protocol, particularly in patients >50 or with a family history of cancer. All such flags are mechanistic/pathway-based, with no human outcome data.

05 · Safety profile & contraindications

Clean where tested; thin for systemic use.

TB-500 / Tβ4 has a reassuring profile in the contexts that were actually studied — high-dose IV in healthy volunteers and topical use in the eye — but almost no systematically collected human safety data for the popular subcutaneous use. The Phase I IV study (n=40, 42–1,260 mg daily × 14 days) reported only infrequent mild-to-moderate AEs and no dose-limiting toxicities or SAEs. The SEER-1 Phase III (n=18) recorded 16 AEs across 7 subjects, just 1 treatment-related, no deaths or withdrawals. No standard preclinical toxicology has flagged organ toxicity, mutagenicity or carcinogenicity. But there is no long-term human safety dataset for systemic SC use, and the dominant practical hazard is product quality in the research-chemical market.

Observed / Reported AE Profile (trial + practice-pattern)
IV Phase I · well toleratedAcross 42–1,260 mg IV daily × 14 days in 40 healthy volunteers, AEs were infrequent, mild-to-moderate, with no dose-limiting toxicities and no SAEs.
Ophthalmic Phase III · minimal AEsOnly 1 treatment-related AE of 16 total; no significant adverse effects; no deaths or withdrawals (n=18).
Transient injection effects (SC, anecdotal)Lightheadedness/head-rush during injection, mild headache, and fatigue/lethargy 24–48 h post-injection are commonly reported in practice; usually self-limited.
Injection-site reactionsSwelling, redness, itching, or pain at SC sites; occasional nausea. Rotate sites; reduce concentration if recurrent.
Hair-growth stimulationA mechanism-consistent effect (follicle stem-cell activation) — sometimes reported as a side effect, sometimes as a desired one.
No organ toxicity / carcinogenicity reportedNo serious systemic toxicity, organ damage, mutagenicity or carcinogenicity has been reported in available human or standard animal data.
Theoretical & Unresolved Risks
Tumor vascularizationPro-angiogenic VEGF upregulation could, in principle, support an existing tumor's blood supply — the basis for the absolute malignancy contraindication. No human data demonstrate that TB-500 causes or accelerates cancer; the concern is mechanism-derived.
Pathologic neovascularizationTheoretical worsening of retinal neovascularization in active diabetic retinopathy or wet AMD via the same VEGF axis. Avoid in active retinal neovascular disease.
Autoimmune exacerbationImmune-modulatory activity might theoretically trigger autoimmune flares; no evidence reported. Caution in uncontrolled autoimmune disease.
Long-term tissue remodeling (unknown)Sustained anti-fibrotic and pro-migratory signaling — the effect of multi-year continuous use is entirely uncharacterized.
Drug interactions (unknown)No human PK drug–drug interaction studies. Caution with anti-angiogenic/anti-VEGF cancer therapy (theoretical pathway interference).
Product quality / contaminationResearch-grade RUO preparations lack FDA oversight for sterility, purity and potency — likely the dominant real-world hazard. Require HPLC ≥98%, sterility, endotoxin limits, and MS identity.

Contraindication reference (precautionary)

Given the absence of systemic human data, most contraindications are precautionary — based on theoretical mechanism and regulatory caution, not observed TB-500 events.

Condition / factor Risk level Applies to Rationale
Active malignancy (any type)AbsoluteAll routesPro-angiogenic VEGF mechanism may support tumor vascularization. Discontinue/avoid outside trials.
Recent malignancy (<5 years)AbsoluteAll routesResidual tumor cells theoretically supported by VEGF upregulation.
PregnancyAbsoluteAll routesNo safety data; growth-promoting mechanisms contraindicated in development.
BreastfeedingAbsoluteAll routesNo lactation/infant-exposure data.
Active systemic infectionContraindicatedSystemicPro-migratory cell activity may theoretically disseminate pathogen. Hold until resolved.
Active diabetic retinopathy / wet AMDContraindicatedSystemicVEGF upregulation may worsen retinal neovascularization.
Uncontrolled diabetes (HbA1c >9%)High cautionSystemicImpaired healing environment; retinal-VEGF concern.
Uncontrolled autoimmune diseaseHigh cautionSystemicImmune-modulatory activity may exacerbate disease.
Competitive athlete / WADA testing poolAbsolute (regulatory)All routesProhibited under WADA S2 + S0, in and out of competition; 4-year sanction. Use is a doping violation regardless of safety.
Pediatric useNot establishedAll routesNo safety data in children/adolescents. Off-protocol by default.
Unverified "research-chemical" productAvoidAll routesSequence-error and endotoxin contamination are the dominant practical risk; require HPLC ≥98%, sterility, endotoxin, MS identity.

Suggested monitoring for TB-500 research protocols

Baseline

CBC, CMP (LFTs, renal, glucose); pregnancy test if reproductive potential; malignancy screen / history review (± tumor markers per age/sex risk). Indication-specific endpoint baseline: pain VAS + WOMAC/ROM (musculoskeletal); wound photo + ruler (wound); echocardiography (cardiac, trial only); corneal staining (ophthalmic, trial only).

Week 2

Tolerability review (injection-site, head-rush, headache, fatigue). Response check vs the borrowed surrogate → escalation gate. Safety labs only if a symptom flag appears.

Mid-cycle (week 6)

Repeat indication endpoint + targeted safety labs (CBC, CMP, hsCRP). Decision: continue, escalate, hold, or step back per the titration logic.

End of cycle (≤12 wk)

Repeat endpoint + safety panel. Document objective and subjective outcomes for cycle-to-cycle comparison. Decision: washout, resume, modify, or discontinue.

Washout / reassess (4–8 wk post)

Confirm symptom trajectory off-drug; reassess whether a further cycle is justified by clear prior benefit.

Stop / hold criteria (hard)

New malignancy diagnosis or progression, pregnancy, severe injection-site or systemic reaction, active infection, LFTs >3× ULN, significant cytopenia, or any new diagnosis changing the risk/benefit calculus.

06 · Key studies & research program

Real human trials — in the eye and the heart.

Unlike most repair peptides, Tβ4 has reached genuine clinical phases — but in indications and routes far from the popular SC use. The controlled human record is concentrated in ophthalmology (Phase II/III topical) and cardiac repair (Phase I PK + a 2025 Phase II/III STEMI RCT), plus a wound pilot and a biomarker correlation. The animal base is broad and replicated across labs and species. The critical gap remains: no adequately powered human RCT for subcutaneous musculoskeletal or anti-aging use.

Phase III · ophthalmic
n=18
SEER-1 neurotrophic keratopathy (0.1% RGN-259); 60% complete healing vs 12.5% placebo (sig. at day 43). Strongest controlled Tβ4 evidence.
Phase II/III · cardiac · 2025
n=96
IV rhTB4 post-PCI STEMI; infarct reduction in the early-treatment subgroup via ErbB2/Raf1; overall endpoint not significant.
Phase I · IV PK/safety
n=40
42–1,260 mg IV daily × 14 days in healthy volunteers; well tolerated, no DLTs, dose-proportional PK. Safety/PK, not efficacy.
SC musculoskeletal RCT
0
No adequately powered human RCT exists for the popular subcutaneous repair / anti-aging use. The central evidence gap.
B Human Phase I · IV anchor

Ruff et al. 2010 — IV Tβ4 Phase I safety / PK

Randomized, placebo-controlled single- and multiple-dose Phase I in 40 healthy volunteers (IV 42, 140, 420, 1,260 mg, then daily × 14 days). Well tolerated at all doses; no dose-limiting toxicities or SAEs; dose-proportional PK with increasing terminal t½ at higher doses (PMID 20536472). The operative human PK/safety dataset — but doses are orders of magnitude above SC practice and it is not an efficacy study.

B Human Phase III · ophthalmic

SEER-1 — 0.1% RGN-259 for neurotrophic keratopathy

Randomized, double-masked, placebo-controlled Phase III (NCT02600429, n=18): 60% complete corneal healing at day 29 vs 12.5% placebo (p=0.0656), significant at day 43 (p=0.0359), with improved comfort and no significant AEs (PMID 36613994). Underpowered due to rare-disease enrollment, and topical ophthalmic ≠ systemic SC — but the strongest controlled human evidence for any Tβ4 form.

B Human Phase II · dry eye

RGN-259 Phase II dry-eye RCT (CAE™ model)

Single-center, double-masked, placebo-controlled Phase II (n=72) of 0.1% Tβ4 ophthalmic solution over 28 days. Primary endpoints (ocular discomfort, inferior corneal staining) were not statistically significant; several secondary endpoints showed favorable trends (PMC4445951). Primary-endpoint miss tempers the ophthalmic story, though the signal direction was consistent.

B Human Phase II/III · cardiac · 2025

Zhang et al. 2025 — rhTB4 in STEMI post-PCI (ErbB2)

Randomized, double-blind, placebo-controlled (NCT05984134; Cardiovascular Research 2025, vol 121(17):2747–2758, doi 10.1093/cvr/cvaf223). In 96 STEMI patients, IV rhTB4 (0.5 / 1.0 µg/kg) within 8 h of PCI significantly reduced infarct area in the early-treatment cohort; the overall between-group endpoint was not significant. Murine I/R and H/R cardiomyocyte models showed cardioprotection via ErbB2/Raf1 signaling, with cardiac RNA-seq confirming ErbB-pathway modulation.

B Human Phase I · cardiac (NL005)

Wang et al. 2021 — first-in-human rhTβ4 (NL005) Phase I

Randomized, double-blind single- and multiple-dose Phase I in healthy Chinese volunteers (J Cell Mol Med, doi 10.1111/jcmm.16693; PMID 34346165). 54 subjects received single ascending IV doses 0.05–25 µg/kg; 30 received 0.5–5 µg/kg daily × 10 days. AEs mild-to-moderate; no dose-limiting toxicities or SAEs; dose-proportional Cmax/AUC, no accumulation, manageable anti-drug-antibody profile — the basis for advancing NL005 into the AMI program.

B Human pilot · cardiac (EPC)

RegeneRx 2016 — Tβ4-pretreated EPC transplant (STEMI)

Randomized pilot (n=10, 5 per arm) of endothelial progenitor cells pre-treated with Tβ4 24 h before transplantation vs EPC alone. LVEF improved >50%, stroke volume +50% (p<0.05), and 6-minute walk +14% (p<0.01) at 6 months, with no severe complications. Extremely small n and an indirect design (pre-treating cells, not direct Tβ4 dosing) — cannot be extrapolated to SC use.

B Human correlation · cardiac biomarker

REGENERATIVE-IHD — endogenous Tβ4 & cardiac repair

A biomarker sub-study of the largest UK randomized placebo-controlled bone-marrow stem-cell cardiac trial measured endogenous plasma Tβ4 after intracardiac stem-cell injection. Circulating Tβ4 rose significantly at 24 h in responders and correlated with improved cardiac symptoms at 6 months. Observational/correlational — indirect evidence for a Tβ4 role in human cardiac repair, not an intervention.

D Human pilot · wound

Venous stasis ulcer pilot (NCT00832091)

A Phase II pilot of Tβ4 for venous stasis ulcers (completed 2010; abstract-level data, Ann NY Acad Sci 2010, PMID 20536470) reported positive wound-healing effects. Minimal published detail — efficacy conclusions cannot be confirmed from available data. Wound-area photography/ruler measurement is a validated methodology here, even if not TB-500-specific.

C Preclinical base · multi-lab

The animal foundation — MI, wound, hair, cornea, neuro, fibrosis

The mechanistic foundation is robust and multi-lab: Tβ4 reduces infarct size and promotes cardiomyocyte survival via ILK/Akt (the 2004 Nature paper); accelerates wound closure and angiogenesis even in aged animals; stimulates the anagen hair transition via MMP-2; promotes corneal and neural repair across TBI/stroke/MS/optic-nerve models. Replicated across species and labs — placing mechanistic confidence at MODERATE while human SC efficacy stays unproven.

GRADE summary

Evidence strength is route- and indication-dependent. MODERATE for topical ophthalmic use (Phase III RCT, though underpowered). LOW–MODERATE for cardiac indications (small pilots plus a 2025 RCT significant only in an early-treatment subgroup). LOW–VERY LOW for the dominant real-world use — subcutaneous administration for musculoskeletal recovery, wound healing or anti-aging, where no adequately powered human RCT exists. Animal data are robust and replicated, putting mechanistic confidence at MODERATE. The human IV Phase I is a PK/safety study, not an efficacy trial, and its mg/kg doses are a different pharmacokinetic world from low-dose SC. This is precisely why the dosing engine above is framed as a speculative hypothesis layer, not a guideline.

TB-500 vs. the repair-peptide family

ParameterTB-500 (Tβ4 / fragment)BPC-157GHK-Cu (copper tripeptide)
Structure43-AA thymosin β4 (4,963 Da) / 7-AA WH2 fragment Ac-LKKTETQ (889 Da)15-AA synthetic pentadecapeptide; gastric origin (~1,419 Da)Tripeptide (Gly-His-Lys) · Cu²⁺ complex (~340 Da)
Primary mechanismG-actin sequestration → migration; ILK/Akt survival; VEGF angiogenesis; NF-κB↓VEGFR2-Akt-eNOS angiogenesis; FAK-paxillin; NO; GHREpigenetic gene modulation; collagen/elastin/GAG; copper shuttle
Target scopeSystemic (broad cell migration) + cardiac/ocularLocal (tendon, gut) + systemicSkin, connective tissue (primarily topical)
Best human evidencePhase III ophthalmic; Phase II/III cardiac; no SC RCT3 uncontrolled pilots (n=30 total)One RCT-method study + cosmetic/wound studies
Best evidence gradeB (ophthalmic RCT)C (animal models; small pilots)C (preclinical / in vitro; small clinical)
Half-life~2 h plasma; 7–10 day functional window~5–30 min plasma; effects persist weeksShort; topical depot effect
WADA statusProhibited (S2 + S0), in & out of competitionProhibited (S0) since 2022Non-injectable not prohibited; injectable under review
FDA compounding (May 2026)Off Cat-2 Apr 2026; PCAC Jul 2026Off Cat-2 Apr 2026; PCAC Jul 2026Cosmetic-approved (INCI); injectable PCAC ~Feb 2027
Cancer concernYes — pro-angiogenic VEGF upregulationYes — pro-angiogenicLower — collagen/matrix focus; weak VEGF effect
Typical use caseSystemic tissue repair · cardiac · ocular surfaceTendon / ligament / gut / CNS recoverySkin wound healing · anti-aging
07 · Compare & contrast

Adjacent peptides.

08 · Evidence & references

Every claim, graded and sourced.

A · RCT / meta-analysis
B · Large cohort / consistent trial set
C · Small trial / mechanistic
P · Preclinical / animal
D · Expert / textbook / regulatory
Explore the ATLAS index

More Repair / Immune peptides & tools.