TB-500 Benefits: Claims vs What Studies Show
Benefits people claim for TB-500, set against what published studies measured, and where no study exists.
- Strongest evidence
- Human RCT
- Human / animal studies
- 7 / 7
- in our evidence file (PubMed search, 11 Oct 2026)
- FDA status
- Not approved
- Off Category 2, 15 Apr 2026
Claimed benefits and what studies show
Each row is an area where people claim a benefit, with the strongest study we summarise behind it. Animal and cell results are labelled and are not human results. User reports are not counted as evidence here.
| Claim | Best evidence | Studies (human / animal) | What was measured | Page |
|---|---|---|---|---|
| Healing | Human RCT evidence, 4 of 4 | 1 / 5 | Wound healing; Phase 2 wound trials; Maximum load to failure (TB-500) | Evidence for healing |
| Eyes and vision | Human RCT evidence, 4 of 4 | 2 / 1 | Ocular discomfort and corneal staining; Primary endpoints; Secondary endpoints | Evidence for eyes and vision |
| Skin | Human RCT evidence, 4 of 4 | 2 / 0 | Scalp seborrheic dermatitis; Wound healing; Phase 2 wound trials | Evidence for skin |
| Inflammation | Human RCT evidence, 4 of 4 | 1 / 1 | Scalp seborrheic dermatitis; Corneal alkali burn | Evidence for inflammation |
| Heart health | Human RCT evidence, 4 of 4 | 1 / 0 | Infarct area in STEMI patients | Evidence for heart health |
| Strength | Animal evidence, 2 of 4 | 0 / 1 | Maximum load to failure (TB-500) | Evidence for strength |
| Hair growth | Animal evidence, 2 of 4 | 0 / 1 | Hair regrowth after depilation | Evidence for hair growth |
| Joint pain | Animal evidence, 2 of 4 | 0 / 1 | Ligament healing | Evidence for joint pain |
Strongest study per claim: Healing, Annals of the New York Academy of Sciences 2010, PMID 20536470; Eyes and vision, Cornea 2015, PMID 25826322; Skin, Microbial biotechnology 2021, PMID 34318587.
What the studies measured
| Outcome | Result | Study type | Source |
|---|---|---|---|
| Infarct area in STEMI patients | In the human trial, the overall difference in infarct area between the recombinant thymosin beta-4 and placebo groups was not significant; a reduction was reported only in the subgroup dosed early after PCI. | Human RCTn = 96 | Cardiovascular research 2025, PMID 41229390 |
| Safety and tolerability | The recombinant thymosin product was reported well tolerated and safe in healthy volunteers across the single and multiple dose ranges (phase I). | Human RCT | Journal of cellular and molecular medicine 2021, PMID 34346165 |
| Scalp seborrheic dermatitis | The thymosin beta-4 gel was reported more effective than ketoconazole lotion for scalp seborrheic dermatitis (randomization not stated in abstract). | Human controlled trialn = 71 | Microbial biotechnology 2021, PMID 34318587 |
| Ocular discomfort and corneal staining | At day 56, the treated group had a 35.1% greater reduction in ocular discomfort and a 59.1% greater reduction in total corneal fluorescein staining than vehicle (very small trial). | Human RCTn = 9 | Cornea 2015, PMID 25826322 |
| Primary endpoints | Neither primary endpoint (ocular discomfort, inferior corneal staining) differed significantly between groups. | Human RCTn = 72 | Clinical ophthalmology 2015, PMID 26056426 |
| Secondary endpoints | Discomfort scores in the challenge environment on day 28 were 27% lower than placebo (P=0.0244), a secondary endpoint. | Human RCTn = 72 | Clinical ophthalmology 2015, PMID 26056426 |
| Tolerability | Intravenous synthetic thymosin beta-4 over 42-1260 mg, single or daily for 14 days, was well tolerated with no dose-limiting toxicity. | Human RCTn = 40 | Annals of the New York Academy of Sciences 2010, PMID 20536472 |
| Wound healing | Phase 2 findings suggest a 0.03% dose may accelerate healing, with complete healing within 3 months in about 25% of patients, mainly those with smaller or milder ulcers. | Human RCTn = 73 | Annals of the New York Academy of Sciences 2010, PMID 20536470 |
| Phase 2 wound trials | The review reports accelerated repair in phase 2 trials of pressure ulcers, stasis ulcers and epidermolysis bullosa wounds. | Review | Vitamins and hormones 2016, PMID 27450738 |
| Maximum load to failure (TB-500) | Maximum load to failure was higher in both the BPC-157 and TB-500 groups than controls; the difference reached significance only for TB-500 (p < 0.05). | Animal · rat (not a human result)n = 32 | Joint diseases and related surgery 2026, PMID 42542926 |
| Combination vs single agent | Combining BPC-157 and TB-500 gave no additional benefit over either alone. | Animal · rat (not a human result)n = 32 | Joint diseases and related surgery 2026, PMID 42542926 |
| Corneal alkali burn | The peptide-containing hydrogel accelerated corneal epithelial regeneration and reduced inflammation in an alkali burn model; this is a formulation study. | Animal · human corneal cells in vitro plus an animal alkali burn model (species not stated in abstract) (not a human result) | ACS applied materials & interfaces 2025, PMID 41359360 |
| Hair regrowth after depilation | Hair regrowth was faster in mice overexpressing Tbeta4 and slower in knockout mice (genetic models, not injected peptide). | Animal · mouse (transgenic overexpression and knockout) (not a human result) | PloS one 2015, PMID 26083021 |
| Neurological recovery after stroke | Neurological outcome improved significantly at 2 and 12 mg/kg from day 14, extending to day 56. | Animal · rat (not a human result)n = 10 | Journal of the neurological sciences 2014, PMID 25060418 |
| Highest dose | The higher dose (18 mg/kg) did not show significant improvement, so the dose response was not linear. | Animal · rat (not a human result)n = 10 | Journal of the neurological sciences 2014, PMID 25060418 |
| Ligament healing | Local thymosin beta-4 improved ligament healing histologically and mechanically in rats. | Animal · rat (not a human result) | Regulatory peptides 2013, PMID 23523891 |
| Detection after administration | An analytical method detected the TB-500 peptide and its metabolites in horse urine and plasma after a single dose. This is a doping-control method paper with no efficacy outcome. | Animal · horse (not a human result) | Journal of chromatography. A 2012, PMID 23084823 |
| Serum levels after injection | Serum thymosin beta-4 rose within 2 minutes of intraperitoneal injection and stayed elevated for 40 minutes in mice. | Animal · mouse (not a human result) | International journal of immunopharmacology 1997, PMID 9226473 |
| Myoblast migration | Thymosin beta-4 and its sulphoxide form accelerated wound closure and increased chemotaxis of cultured myoblasts. | In vitro (not a human result) | Journal of biochemistry 2011, PMID 20880960 |
Claimed: faster tendon and ligament repair
The one study that tested TB-500 itself for repair was an exploratory study in rats with a cut Achilles tendon, which linked TB-500 to a biomechanical advantage during early repair. It is animal data.[9]
A rat ligament study of full-length thymosin beta-4 (not TB-500) reported better healing of a cut ligament, histologically and mechanically, when the protein was placed locally.[13]
Claimed: skin and wound healing
In a 73-patient phase 2 trial of topical full-length thymosin beta-4 (not TB-500) on venous ulcers, the authors said a 0.03% dose may accelerate healing, with about 25% of patients fully healed within 3 months.[7]
In seborrheic dermatitis of the scalp, a recombinant full-length thymosin beta-4 gel (not TB-500) beat ketoconazole lotion in a 71-patient study.[3]
Claimed: eye and heart benefits
In a 72-subject phase II dry-eye trial of full-length thymosin beta-4 eye drops (not TB-500), neither primary endpoint showed a significant difference from placebo.[5]
In a 96-patient heart-attack trial of recombinant full-length thymosin beta-4 (not TB-500), the overall difference in infarcted area was not significant.[1]
Claimed: hair growth and muscle repair
Hair regrowth was faster in mice genetically engineered to overexpress thymosin beta-4 and slower in knockout mice. These are genetic mouse models, not injected TB-500.[11]
For muscle, cultured mouse myoblast cells moved faster toward thymosin beta-4. This is a cell-culture finding about the full-length protein, not a result in people.[16]
Claims with no study behind them
A PubMed search for TB-500 or its acetylated LKKTETQ sequence on 2 October 2026 returned 33 records, and the evidence file records no human trial of the TB-500 fragment among them.
Calculated from evidence file web/src/data/evidence/tb-500.json; query "TB-500"[tiab] OR TB500[tiab] OR "Ac-LKKTETQ"[tiab]; date 2026-10-02; records 33; human trials of fragment 0. Formula: records = 33; human trials of the TB-500 fragment among them = 0
The evidence file found no study of any thymosin beta-4 form for joint pain beyond the rat ligament paper, so a joint-pain benefit has no human study here.
Calculated from evidence file web/src/data/evidence/tb-500.json; joint pain human studies 0; rat ligament studies 1. Formula: human joint-pain studies = 0; rat ligament studies = 1
More on TB-500
Common questions
Is TB-500 proven to work?
The strongest study we summarise for TB-500 is human rct evidence, among 16 studies. A trial result is not an approval; see the legal status.
What does TB-500 do?
Its only direct test in the cited studies is the exploratory rat tendon study; everything else is full-length thymosin beta-4, which is a different molecule.
Calculated from studies testing tb500 itself 1; studies of full length tb4 9. Formula: 1 TB-500 study (rat tendon) among the cited; the rest test the longer protein
More on TB-500
Sources
- 1Recombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion.Cardiovascular research · 2025PMID 41229390Accessed 2 Oct 2026
- 2A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers.Journal of cellular and molecular medicine · 2021PMID 34346165Accessed 2 Oct 2026
- 3Recombinant human thymosin beta-4 (rhTβ4) improved scalp condition and microbiome homeostasis in seborrheic dermatitis.Microbial biotechnology · 2021PMID 34318587Accessed 2 Oct 2026
- 4Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial.Cornea · 2015PMID 25826322Accessed 2 Oct 2026
- 5Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model.Clinical ophthalmology (Auckland, N.Z.) · 2015PMID 26056426Accessed 2 Oct 2026
- 6A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers.Annals of the New York Academy of Sciences · 2010PMID 20536472Accessed 2 Oct 2026
- 7The effect of thymosin treatment of venous ulcers.Annals of the New York Academy of Sciences · 2010PMID 20536470Accessed 2 Oct 2026
- 8Thymosin β4 Promotes Dermal Healing.Vitamins and hormones · 2016PMID 27450738Accessed 2 Oct 2026
- 9Effects of BPC-157 and TB-500 on Achilles tendon healing in rats: A histopathological and biomechanical study.Joint diseases and related surgery · 2026PMID 42542926Accessed 2 Oct 2026
- 10Alkaline Phosphatase-Triggered Spatiotemporal Repair of Corneal Injury with TB500 Peptide Hydrogel.ACS applied materials & interfaces · 2025PMID 41359360Accessed 2 Oct 2026
- 11Thymosin Beta-4 Induces Mouse Hair Growth.PloS one · 2015PMID 26083021Accessed 2 Oct 2026
- 12A dose-response study of thymosin β4 for the treatment of acute stroke.Journal of the neurological sciences · 2014PMID 25060418Accessed 2 Oct 2026
- 13Thymosin β4 enhances the healing of medial collateral ligament injury in rat.Regulatory peptides · 2013PMID 23523891Accessed 2 Oct 2026
- 14Doping control analysis of TB-500, a synthetic version of an active region of thymosin β₄, in equine urine and plasma by liquid chromatography-mass spectrometry.Journal of chromatography. A · 2012PMID 23084823Accessed 2 Oct 2026
- 15Biodistribution of synthetic thymosin beta 4 in the serum, urine, and major organs of mice.International journal of immunopharmacology · 1997PMID 9226473Accessed 2 Oct 2026
- 16Muscle injury-induced thymosin β4 acts as a chemoattractant for myoblasts.Journal of biochemistry · 2011PMID 20880960Accessed 2 Oct 2026
- 17PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab]) (1199 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 18PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab]) AND (humans[mh] OR patients[tiab]) (678 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 19PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab]) AND (randomized[tiab] OR clinical trial[pt]) (18 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 20PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab]) AND (half-life[tiab] OR pharmacokinetic*[tiab]) (16 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 21PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab]) AND (wound[tiab] OR dermal[tiab] OR skin[tiab] OR hair[tiab]) (212 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 22PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab]) AND (tendon[tiab] OR muscle[tiab] OR cardiac[tiab] OR myocardial[tiab] OR heart[tiab]) (246 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 23PubMed search: "TB-500"[tiab] OR TB500[tiab] OR "Ac-LKKTETQ"[tiab] (33 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 24PubMed search: ("TB-500"[tiab] OR TB500[tiab] OR "thymosin beta-4"[tiab] OR "thymosin beta4"[tiab] OR Tbeta4[tiab] OR RGN-259[tiab] OR RGN-137[tiab]) AND (adverse[tiab] OR "side effect*"[tiab] OR safety[tiab] OR tolerab*[tiab] OR toxicity[tiab] OR "case report"[pt]) (61 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 11 Oct 2026
- 25PubMed search: ("RGN-259"[tiab] OR "RGN-137"[tiab] OR "thymosin beta 4"[tiab]) AND (eye[tiab] OR ophthalmic[tiab] OR neurotrophic[tiab] OR cornea*[tiab]) AND (patients[tiab] OR trial[tiab]) (15 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 11 Oct 2026
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