Chemical structure of Thymosin Beta-4 (full-length)

Thymosin Beta-4 (full-length)

The endogenous 43-amino-acid actin-sequestering protein — an investigational drug (eye drops, injectable) with an unconvincing Phase 3 record so far.

Thymosin Beta-4 (full-length) at a Glance

Thymosin β4 is a real endogenous protein — 43 amino acids, present in most human cells, where it sequesters actin monomers and regulates cytoskeletal assembly during tissue repair. Unlike most compounds in this category it entered genuine clinical development, reaching trials as eye drops for corneal injury and as an injectable for cardiac and wound repair. It is investigational rather than approved, and it is the parent molecule that the widely sold fragment TB-500 is derived from and frequently confused with.

History & Development

Thymosin beta 4 is one of the few compounds in this category that entered genuine clinical development - three Phase 3 trials in eye disease. It is also one of the few where those trials have largely not delivered.

First describedEndogenous protein; clinical development as the ophthalmic solution RGN-259 25Reference 25ClinicalTrials.govNCT03937882 - Assessment of the safety and efficacy of RGN-259 ophthalmic solutions for dry eye syndrome: ARISE-3View study →
Discovered / synthesised byNot established in the sources consulted for this section
InstitutionNot established in the sources consulted for this section
OriginEndogenous 43-amino-acid regulatory protein (~4.9 kDa, N-terminally acetylated), present in essentially every human cell and in circulating plasma
Key patentNot established in the sources consulted for this section
AssigneeNot established in the sources consulted for this section
Development statusInvestigational - Phase 3 completed in dry eye (ARISE-3, NCT03937882); not approved 25Reference 25ClinicalTrials.govNCT03937882 - Assessment of the safety and efficacy of RGN-259 ophthalmic solutions for dry eye syndrome: ARISE-3View study →

Discovery

Thymosin beta 4 is not a designed drug. It is a protein the body already makes, in nearly every cell, whose primary job is to bind and sequester monomeric G-actin - controlling the pool of actin available for building the cytoskeleton. Because cell migration depends on actin remodelling, that single function touches wound healing, corneal repair and tissue regeneration.

The endogenous protein and the peptide sold as TB-500 are not the same thing, and the distinction matters commercially: TB-500 is a synthetic fragment, not full-length thymosin beta 4. Claims made for one are routinely transferred to the other.

Development & ownership

Clinical development has centred on the eye, as the 0.1% ophthalmic solution RGN-259, and it is the most substantial trial programme of any compound on this hub.

Two positive small Phase 2 trials in dry eye disease - reporting a 35.1% reduction in ocular discomfort and a 59.1% reduction in total corneal fluorescein staining against vehicle 2Reference 2Sosne G et al. · 2015RCTThymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model — human (RCT, Phase 2, n=72, topical)View study → - led to three large Phase 3 trials: ARISE-1, ARISE-2 and ARISE-3 (n=317, 601 and 700). ARISE-3 (NCT03937882) completed in October 2021 25Reference 25ClinicalTrials.govNCT03937882 - Assessment of the safety and efficacy of RGN-259 ophthalmic solutions for dry eye syndrome: ARISE-3View study →. The programme has not produced an approval.

A parallel Phase 3 in neurotrophic keratopathy reported a genuinely positive result - 6 of 10 healed against 1 of 8 on placebo - but from a trial of only 18 patients, which the registry lists as terminated 26Reference 26Sosne et al. · 2022RCTSosne, G., Kleinman, H. K., Springs, C., et al. (2022). 0.1% RGN-259 (thymosin beta4) ophthalmic solution promotes healing and improves comfort in neurotrophic keratopathy patients in a randomized, placebo-controlled, double-masked Phase III clinical trial. International Journal of Molecular Sciences. https://pmc.ncbi.nlm.nih.gov/articles/PMC9820614/View study →.

How it reached the market

Thymosin beta 4 has not been approved anywhere. Meanwhile the injectable peptide market sells it, and more often TB-500, for injury repair and recovery - applications supported by rodent work rather than by the human programme, which tested eye drops and reported mixed results.

What It's Used For

Thymosin β4 (Tβ4) is an endogenous, 43-amino-acid regulatory protein (~4.9 kDa, N-terminally acetylated) present in essentially every human cell and in circulating plasma, whose primary job is to bind and sequester monomeric G-actin — giving it broad, upstream roles in cytoskeletal dynamics, cell migration, angiogenesis and tissue repair. It is not the same molecule as the peptide sold to consumers. The gray-market product marketed as TB-500 is a synthetic seven-residue fragment (Ac-LKKTETQ, residues 17–23) of Tβ4’s actin-binding site; the subject here is the full-length protein, and it is the full-length side that has genuinely reached human clinical trials. That distinction runs both ways: the trial data below do not transfer to the fragment, and the fragment’s unregulated-vendor reputation does not attach to the protein. Route is load-bearing — Tβ4 has negligible oral bioavailability, so the ophthalmic drug RGN-259 (timbetasin) is a 0.1% topical eye drop, wound trials applied it topically to the ulcer bed, and systemic work is intravenous or (in rodents) intraperitoneal. Its clinical record is the honest headline: three Phase 3 dry-eye trials and a European Phase 3 in neurotrophic keratopathy have read out without meeting their primary endpoints, so despite a decade of development Tβ4 remains investigational and unapproved in every market, and is prohibited in sport under WADA’s S2 growth-factor category.

The largest human dataset, and it has not delivered:dry eye disease. Two positive small Phase 2 RCTs of 0.1% RGN-259 1,2Reference 1Sosne G et al. · 2015RCTThymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial — human (RCT, Phase 2, n=9, topical)View study →Reference 2Sosne G et al. · 2015RCTThymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model — human (RCT, Phase 2, n=72, topical)View study → were followed by three large Phase 3 trials (ARISE-1/-2/-3, n=317/601/700). ARISE-3 missed its primary endpoints; the positives that sponsor ReGenTree reported were a pre-specified secondary (ocular grittiness) and a post-hoc pooled corneal-staining analysis. Consistently safe, not yet convincingly effective.
Same pattern, smaller numbers:neurotrophic keratopathy. One genuinely positive Phase 3 read-out — 6/10 healed vs 1/8 on placebo — but from a trial of only 18 patients that the registry lists as terminated 3Reference 3Sosne G et al. · 2022RCTSosne G, et al. (2022). 0.1% RGN-259 (thymosin β4) ophthalmic solution promotes healing and improves comfort in neurotrophic keratopathy patients in a randomized, placebo-controlled, double-masked Phase III clinical trial — human (RCT, Phase 3, n=18, topical). International Journal of Molecular Sciences. https://pubmed.ncbi.nlm.nih.gov/36613994/View study →. A European Phase 3 (SEER-3) then missed its primary endpoint on complete corneal healing at 4 weeks; a further Phase 3 (SEER-2) is still recruiting.
Emerging / early human signal:chronic dermal wounds. A deep, replicated rodent base 5,7Reference 5Treadwell T et al. · 2012Clinical trialThe regenerative peptide thymosin β4 accelerates the rate of dermal healing in preclinical animal models and in patients — review (animal + Phase 2 human)View study →Reference 7Yang WS et al. · 2019ReviewThymosin β4: potential to treat epidermolysis bullosa and other severe dermal injuries — reviewView study → plus Phase 2 venous-stasis and pressure-ulcer RCTs showing acceptable safety and faster healing only in the subset of patients who healed at all 5,6Reference 5Treadwell T et al. · 2012Clinical trialThe regenerative peptide thymosin β4 accelerates the rate of dermal healing in preclinical animal models and in patients — review (animal + Phase 2 human)View study →Reference 6Guarnera G et al. · 2010RCTThe effect of thymosin treatment of venous ulcers — human (RCT, Phase 2, n=73, topical)View study →. Modest, inconsistent, never taken to a pivotal trial.
Deep animal signal, one ambiguous human trial:cardiac repair after MI. Strong replicated mouse infarction models 8,9Reference 8Peng H et al. · 2014AnimalThymosin-β4 prevents cardiac rupture and improves cardiac function in mice with myocardial infarction — animal (mouse)View study →Reference 9Hinkel R et al. · 2018ReviewThymosin β4-mediated protective effects in the heart — reviewView study →; the one human RCT (recombinant Tβ4, n=96 STEMI) was overall non-significant, positive only in a pre-specified early-dosing subgroup 10Reference 10Zhang Y et al. · 2025RCTRecombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion — animal (mouse) + human (RCT, n=96; overall endpoint not significant)View study →.
Rodent-only:acute stroke 12,13Reference 12Morris DC et al. · 2014AnimalA dose-response study of thymosin β4 for the treatment of acute stroke — animal (rat)View study →Reference 13Morris DC et al. · 2017AnimalThymosin β4 for the treatment of acute stroke in aged rats — animal (rat)View study →, traumatic brain injury 14Reference 14Xiong Y et al. · 2012AnimalNeuroprotective and neurorestorative effects of thymosin β4 treatment initiated 6 hours after traumatic brain injury in rats — animal (rat)View study →, organ fibrosis 15,16,17Reference 15Tian Z et al. · 2022AnimalThymosin β4 suppresses LPS-induced murine lung fibrosis by attenuating oxidative injury and alleviating inflammation — animal (mouse)View study →Reference 16Kleinman HK et al. · 2023ReviewThymosin β4 and the anti-fibrotic switch — review (mechanism)View study →Reference 17Di H et al. · 2026ReviewThymosin beta 4: an emerging therapeutic candidate for kidney diseases (Tβ4–Ac-SDKP axis) — reviewView study →. Hair growth is rodent plus a single human ex-vivo follicle study with a mixed effect 18,19,20Reference 18Philp D et al. · 2004AnimalThymosin beta4 increases hair growth by activation of hair follicle stem cells — animal (rat)View study →Reference 19Gao X et al. · 2015AnimalThymosin beta-4 induces mouse hair growth — animal (mouse)View study →Reference 20Meier N et al. · 2012Thymic peptides differentially modulate human hair follicle growth — human tissue (ex-vivo organ culture)View study →.
Not scored at all:the tendon/ligament/muscle “recovery” and anti-aging uses this molecule is marketed for. There is no human musculoskeletal trial of Tβ4 in any form; a 2026 sports-medicine review cites it as an unapproved gray-market peptide rather than a therapy 22Reference 22Mendias CL et al. · 2026ReviewSafety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance — reviewView study →. Community and vendor claims are not evidence and are not scored here.
The honest read:a real drug-development program with real human data — which is more than almost any peptide on this hub can say — that has repeatedly failed to convert Phase 2 promise into Phase 3 proof. Investigational, unapproved, WADA-banned, and a long way from the regenerative claims made for it.
Evidence by IndicationStrength of support · Beta

Support is an experimental score I’m building — a composite weighted by study type (human > animal > in vitro > review) and study volume. It’s a beta: a fast way to rank strength of evidence at a glance, not a validated metric. Each application links down to its write-up. Note that scores here reflect evidence volume and quality, not success: dry eye scores highest because it has by far the most human data, even though that data is largely negative on its primary endpoints.

Mechanisms

Target / pathwayEffectRelevant to
G-actin sequestration (LKKTETQ motif, residues 17–23)Buffers monomeric actin; regulates cytoskeletal dynamics and cell migration
The core mechanism — underlies keratinocyteendothelialcorneal and cardiac cell migration
Angiogenesis (endothelial migration, VEGF-associated signaling)↑ new vessel formation
Wound healingcardiac repairstroke/TBI recovery
Inflammatory signaling (NF-κB-linked)↓ inflammatory infiltrate and cytokine drive
Ocular-surface repaircardiac rupture preventionlung fibrosis
Apoptosis / cell survival (incl. ErbB2–Raf1 in the heart)↓ apoptosis, ↑ survival
Cardiac repair (effect abolished by ErbB2 inhibition in mice)neurorestoration
Ac-SDKP N-terminal tetrapeptide fragmentAnti-fibrotic, anti-inflammatory
Cardiac remodelingrenal and hepatic fibrosis — a distinct fragmentnot present in TB-500
Stem/progenitor cell mobilization & differentiation↑ migration and differentiation
Dermal repairepicardial cardiac repairhair-follicle bulge cells

Pharmacokinetics

Tβ4 is a small (~4.9 kDa), highly water-soluble 43-residue peptide with negligible oral bioavailability — it is degraded in the gastrointestinal tract like any peptide of its size, and no oral formulation exists clinically or could work if it did. All dosing is therefore local or parenteral, and matched to the indication: the ophthalmic drug RGN-259 is a 0.1% topical solution applied to the eye surface (six times daily in the Phase 2 trials), wound studies applied it topically to the ulcer bed, and systemic studies used intravenous (human) or intraperitoneal (rodent) injection. The first-in-human study of recombinant human Tβ4 (NL005) gave single and multiple IV doses of 0.05–25 µg/kg to healthy volunteers, reporting good tolerability and dose-proportional exposure 11Reference 11Wang X et al. · 2021RCTA first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy volunteers (NL005) — human (RCT, Phase 1, IV PK)View study →. Circulating Tβ4 has a short plasma half-life — on the order of a couple of hours after systemic dosing — which is the acknowledged limitation driving work on longer-acting engineered analogues such as a tandem dual-domain Tβ4 23Reference 23Nguyen J et al. · 2025In vitroEngineered tandem thymosin peptide promotes corneal wound healing — in vitro + animalView study →. Two dedicated Phase 1a/1b PK studies (NCT04555824, n=54; NCT04555850, n=30) are listed as completed, but detailed human half-life and clearance parameters have not been publicly posted — a genuine and slightly surprising PK gap for a molecule this far into development. Reconstituted peptide is chemically labile in solution and requires refrigeration.

Clinical & regulatory status

Full-length thymosin β4 is an unapproved, investigational drug — not an approved medicine or dietary supplement in the US, EU, UK, Japan, Australia or any other major market. Its most advanced program is the ophthalmic formulation RGN-259 (timbetasin), developed by RegeneRx Biopharmaceuticals and its joint venture ReGenTree with HLB Therapeutics. That program has completed three Phase 3 dry-eye trials (ARISE-1/-2/-3) without meeting primary endpoints, produced one positive but terminated Phase 3 in neurotrophic keratopathy (SEER-1) and one European Phase 3 that missed its primary endpoint (SEER-3), and has a third NK Phase 3 (SEER-2) still recruiting. Orphan-drug interest attaches to some ocular indications; no approval or BLA clearance has been granted. Injectable Tβ4 has completed Phase 1 safety/PK studies in healthy volunteers and Phase 2 trials in chronic wounds and acute MI — the latter completed without posting results — while earlier injectable cardiac trials were withdrawn. There are no completed registered human trials for the musculoskeletal, tendon, “recovery” or anti-aging uses the molecule is marketed for. Tβ4 and its active fragments are prohibited in sport under the World Anti-Doping Agency’s S2 (growth factors) category, banned at all times, in and out of competition.

One caution for anyone searching the registry: a recruiting record titled “TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD” (NCT07487363) states in its own brief summary that it is a fictional example record. I verified this directly against the ClinicalTrials.gov API in July 2026. It is excluded from every count below and carries no evidentiary weight.

CompletedOngoingTerminated / WithdrawnPreclinical
1125~50+

Last checked: July 2026.

Regulatory status. Full-length thymosin β4 has no marketing approval from any major regulator — FDA, EMA, MHRA, TGA, PMDA — as either a drug or a dietary supplement, and it is not a lawful dietary-supplement ingredient in the US, UK or EU. It is a genuine investigational pharmaceutical (RGN-259 topical, NL005 recombinant injectable) that has not cleared its confirmatory trials. “Investigational” is not a softer word for “nearly approved”: three Phase 3 dry-eye trials and a Phase 3 neurotrophic-keratopathy trial have read out without meeting primary endpoints. It is not a scheduled or controlled substance in the US, but marketing it for human use is unlawful in most Western jurisdictions.

Banned in sport. Tβ4 sits on the WADA Prohibited List under S2, growth factors affecting tissue repair, angiogenesis and muscle/tendon/ligament regeneration — prohibited at all times, in and out of competition, and detectable: validated LC-MS anti-doping methods exist for both the protein and its fragments. A 2026 sports-medicine review of peptide therapies for musculoskeletal injury classes Tβ4 and “TB-500” among unapproved gray-market peptides with no efficacy data, citing them as a clinical problem rather than a treatment 22Reference 22Mendias CL et al. · 2026ReviewSafety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance — reviewView study →.

How it’s supplied & administered. The clinical drug is formulated by route to the indication: a 0.1% topical ophthalmic solution for the eye, direct topical application for ulcers, and intravenous injection in systemic studies. Oral products cannot deliver intact peptide and are pharmacologically inert regardless of the label. The consumer market is a different supply chain entirely — lyophilized powder in vials, reconstituted by the user with bacteriostatic water and self-injected subcutaneously or intramuscularly.

Sourcing reality (this is a safety issue, not a footnote). Any Tβ4 bought online comes from unregulated research-chemical vendors with no manufacturing oversight, and the single most common problem is identity: the 43-residue protein and the 7-residue TB-500 fragment are routinely sold under each other’s names, so a vial labeled “thymosin beta-4” may contain either, both, or neither. Beyond mislabeling, the documented risks across this market are under- and over-potency, bacterial endotoxin contamination (serious for an injectable), residual synthesis solvents and non-sterile fill — every one of them amplified because the product is injected rather than swallowed. Third-party certificates of analysis (independent HPLC identity/purity plus endotoxin testing) are the minimum a buyer would look for, cannot substitute for GMP manufacturing, and can themselves be falsified. No independent assay of marketed product was located in this pass. This page does not recommend, rank or link any vendor.

Safety

Short-term trial tolerability has been good, but almost all of that record is topical, weeks long, and in eye or wound patients — chronic systemic injection, the way the molecule is actually used off-label, has no safety dataset at all.

Safety at a Glance
Toxicity unknown
  • Good short-term tolerability in trials. No serious adverse events in the ophthalmic program and no dose-limiting toxicity in the wound and IV studies.
  • Pregnancy and lactation not assessed. No reproductive data of any kind; treated as contraindicated by default — see the box below.
  • Cancer-history caution. Tβ4 is pro-angiogenic and pro-migratory, and over-expressed in several human cancers.
  • Chronic systemic injection is unstudied. No safety dataset exists for repeated off-label injection, or for use in healthy people.
  • Gray-market product is its own hazard. Non-sterile or endotoxin-contaminated vials, injection-site infection, and dosing error from self-reconstitution.
  • Interactions not assessed. No controlled drug-interaction studies exist for any formulation.
Full Safety & Interactions Detail

Short-term tolerability in trials has been good; that is not the same as an established safety profile. In the ophthalmic Phase 2 and Phase 3 studies, topical RGN-259 was well tolerated, with no serious adverse events and only mild-to-moderate events reported in both active and placebo arms across the full ARISE program 1,3Reference 1Sosne G et al. · 2015RCTThymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial — human (RCT, Phase 2, n=9, topical)View study →Reference 3Sosne G et al. · 2022RCTSosne G, et al. (2022). 0.1% RGN-259 (thymosin β4) ophthalmic solution promotes healing and improves comfort in neurotrophic keratopathy patients in a randomized, placebo-controlled, double-masked Phase III clinical trial — human (RCT, Phase 3, n=18, topical). International Journal of Molecular Sciences. https://pubmed.ncbi.nlm.nih.gov/36613994/View study →. In the Phase 2 venous-ulcer dose-escalation trial, the safety profile of all topical doses was judged acceptable with no dose-limiting toxicity 6Reference 6Guarnera G et al. · 2010RCTThe effect of thymosin treatment of venous ulcers — human (RCT, Phase 2, n=73, topical)View study →, and the first-in-human study of recombinant Tβ4 found no dose-limiting toxicity across single and multiple IV doses of 0.05–25 µg/kg 11Reference 11Wang X et al. · 2021RCTA first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy volunteers (NL005) — human (RCT, Phase 1, IV PK)View study →. That is a reassuring but narrow record: mostly topical exposure, mostly weeks long, in eye and wound populations.

What has not been assessed. Chronic and repeated systemic injection — the way the molecule is actually used off-label — has no safety dataset at all. Neither does use in any healthy person for “recovery” or anti-aging.

Theoretical mechanism-based caution. Tβ4 is pro-angiogenic and pro-migratory, and it is over-expressed in several human cancers, including hepatocellular and colorectal carcinoma, where expression has been examined alongside thymosin β10 24Reference 24Theunissen W et al. · 2014Thymosin beta 4 and thymosin beta 10 expression in hepatocellular carcinoma — human tissue (expression study)View study →. No causal human harm has been demonstrated, and expression in a tumor is not the same as a drug causing one — but the biology that supports wound repair is the biology tumors co-opt, which is why anyone with a personal history of malignancy is routinely cautioned against this class.

Route-specific risks. For injected gray-market material, the dominant real-world hazard is not the peptide but the product and the technique: non-sterile or endotoxin-contaminated vials, injection-site infection or abscess, and dosing error from self-reconstituted solutions of unverified potency.

Interactions. Not assessed. No controlled drug-interaction studies exist for any formulation.

Who should avoid it. Anyone with a current or prior cancer diagnosis or strong family history; anyone pregnant, breastfeeding or trying to conceive; children and adolescents; anyone subject to anti-doping testing (this is a bannable substance); and anyone unwilling to inject a product whose identity and sterility cannot be verified.

Scope disclosure (honesty, not a claim):

  • Human data? Yes, and unusually so for this hub — small positive Phase 2 RCTs and three large Phase 3 trials in dry eye, a Phase 3 in neurotrophic keratopathy, Phase 2 trials in venous-stasis and pressure ulcers, one Phase 2 cardiac RCT, and Phase 1 systemic PK studies. But almost all of it is topical, and the Phase 3 endpoints were not met. No human data exist for musculoskeletal “recovery,” anti-aging, stroke, TBI, fibrosis or hair growth.
  • Interactions assessed? No — none, for any drug class.
  • Pregnancy/lactation assessed? No — no human or animal reproductive data located.
  • Long-term safety established? No. Only short-term, mostly topical trial tolerability is documented; chronic and repeated-injection safety is unstudied.

Never imply safety from silence. Where Tβ4 has not been studied, the correct statement is “not assessed,” not “safe.”

Pregnancy & Lactation
Not established in pregnancy Not established in lactation

Not assessed / not established. No human pregnancy or lactation data and no reproductive-toxicity data for Tβ4 in any formulation were located. Treat as contraindicated by default in pregnancy and breastfeeding.

Dosage

There is no established human dose for thymosin β4, and none is recommended here. It is an investigational drug with no approved indication, so there is no label, no maintenance schedule and no over-the-counter dose to report.

For context only, and explicitly not as a substitute for medical direction: the doses that exist in the literature are formulation- and indication-specific. The ophthalmic trials used a 0.1% topical solution instilled in the eye, six times daily in the Phase 2 studies 1,2Reference 1Sosne G et al. · 2015RCTThymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial — human (RCT, Phase 2, n=9, topical)View study →Reference 2Sosne G et al. · 2015RCTThymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model — human (RCT, Phase 2, n=72, topical)View study → and on comparable schedules through Phase 3. The venous-ulcer trial applied topical Tβ4 to the wound bed at escalating concentrations up to 0.03% 6Reference 6Guarnera G et al. · 2010RCTThe effect of thymosin treatment of venous ulcers — human (RCT, Phase 2, n=73, topical)View study →. The first-in-human systemic study gave recombinant Tβ4 intravenously at 0.05–25 µg/kg 11Reference 11Wang X et al. · 2021RCTA first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy volunteers (NL005) — human (RCT, Phase 1, IV PK)View study →. None of these transfers to self-injected subcutaneous use: different formulation, different route, different target tissue, and a completely different quality of product. Milligram-per-week injection protocols circulating in vendor copy and forums have no experimental basis and are not reproduced here. Oral products cannot deliver intact peptide at all. This entry is informational only and is not an endorsement of use.

References

  1. Sosne G, et al. (2015). Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial — human (RCT, Phase 2, n=9, topical). Cornea. https://pubmed.ncbi.nlm.nih.gov/25826322/
  2. Sosne G, et al. (2015). Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model — human (RCT, Phase 2, n=72, topical). Clinical Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/26056426/
  3. Sosne G, et al. (2022). 0.1% RGN-259 (thymosin β4) ophthalmic solution promotes healing and improves comfort in neurotrophic keratopathy patients in a randomized, placebo-controlled, double-masked Phase III clinical trial — human (RCT, Phase 3, n=18, topical). International Journal of Molecular Sciences. https://pubmed.ncbi.nlm.nih.gov/36613994/
  4. Sosne G (2018). Thymosin beta 4 and the eye: the journey from bench to bedside — review. Expert Opinion on Biological Therapy. https://pubmed.ncbi.nlm.nih.gov/30063853/
  5. Treadwell T, et al. (2012). The regenerative peptide thymosin β4 accelerates the rate of dermal healing in preclinical animal models and in patients — review (animal + Phase 2 human). Annals of the New York Academy of Sciences. https://pubmed.ncbi.nlm.nih.gov/23050815/
  6. Guarnera G, et al. (2010). The effect of thymosin treatment of venous ulcers — human (RCT, Phase 2, n=73, topical). Annals of the New York Academy of Sciences. https://pubmed.ncbi.nlm.nih.gov/20536470/
  7. Yang WS, et al. (2019). Thymosin β4: potential to treat epidermolysis bullosa and other severe dermal injuries — review. European Journal of Dermatology. https://pubmed.ncbi.nlm.nih.gov/31649007/
  8. Peng H, et al. (2014). Thymosin-β4 prevents cardiac rupture and improves cardiac function in mice with myocardial infarction — animal (mouse). American Journal of Physiology — Heart and Circulatory Physiology. https://pubmed.ncbi.nlm.nih.gov/25015963/
  9. Hinkel R, et al. (2018). Thymosin β4-mediated protective effects in the heart — review. Expert Opinion on Biological Therapy. https://pubmed.ncbi.nlm.nih.gov/30063857/
  10. Zhang Y, et al. (2025). Recombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion — animal (mouse) + human (RCT, n=96; overall endpoint not significant). Cardiovascular Research. https://pubmed.ncbi.nlm.nih.gov/41229390/
  11. Wang X, et al. (2021). A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy volunteers (NL005) — human (RCT, Phase 1, IV PK). Journal of Cellular and Molecular Medicine. https://pubmed.ncbi.nlm.nih.gov/34346165/
  12. Morris DC, et al. (2014). A dose-response study of thymosin β4 for the treatment of acute stroke — animal (rat). Journal of the Neurological Sciences. https://pubmed.ncbi.nlm.nih.gov/25060418/
  13. Morris DC, et al. (2017). Thymosin β4 for the treatment of acute stroke in aged rats — animal (rat). Neuroscience Letters. https://pubmed.ncbi.nlm.nih.gov/28864242/
  14. Xiong Y, et al. (2012). Neuroprotective and neurorestorative effects of thymosin β4 treatment initiated 6 hours after traumatic brain injury in rats — animal (rat). Journal of Neurosurgery. https://pubmed.ncbi.nlm.nih.gov/22324420/
  15. Tian Z, et al. (2022). Thymosin β4 suppresses LPS-induced murine lung fibrosis by attenuating oxidative injury and alleviating inflammation — animal (mouse). Inflammation. https://pubmed.ncbi.nlm.nih.gov/34414534/
  16. Kleinman HK, et al. (2023). Thymosin β4 and the anti-fibrotic switch — review (mechanism). International Immunopharmacology. https://pubmed.ncbi.nlm.nih.gov/36580759/
  17. Di H, et al. (2026). Thymosin beta 4: an emerging therapeutic candidate for kidney diseases (Tβ4–Ac-SDKP axis) — review. Peptides. https://pubmed.ncbi.nlm.nih.gov/41570941/
  18. Philp D, et al. (2004). Thymosin beta4 increases hair growth by activation of hair follicle stem cells — animal (rat). FASEB Journal. https://pubmed.ncbi.nlm.nih.gov/14657002/
  19. Gao X, et al. (2015). Thymosin beta-4 induces mouse hair growth — animal (mouse). PLoS One. https://pubmed.ncbi.nlm.nih.gov/26083021/
  20. Meier N, et al. (2012). Thymic peptides differentially modulate human hair follicle growth — human tissue (ex-vivo organ culture). Journal of Investigative Dermatology. https://pubmed.ncbi.nlm.nih.gov/22402437/
  21. Bock-Marquette I, et al. (2023). Thymosin beta-4 denotes new directions towards developing prosperous anti-aging regenerative therapies — review. International Immunopharmacology. https://pubmed.ncbi.nlm.nih.gov/36709593/
  22. Mendias CL, et al. (2026). Safety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance — review. Sports Medicine. https://pubmed.ncbi.nlm.nih.gov/41966639/
  23. Nguyen J, et al. (2025). Engineered tandem thymosin peptide promotes corneal wound healing — in vitro + animal. Investigative Ophthalmology & Visual Science. https://pubmed.ncbi.nlm.nih.gov/41235866/
  24. Theunissen W, et al. (2014). Thymosin beta 4 and thymosin beta 10 expression in hepatocellular carcinoma — human tissue (expression study). European Journal of Histochemistry. https://pubmed.ncbi.nlm.nih.gov/24704991/
  25. ClinicalTrials.gov. NCT03937882 - Assessment of the safety and efficacy of RGN-259 ophthalmic solutions for dry eye syndrome: ARISE-3. https://clinicaltrials.gov/study/NCT03937882
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