Peptency Academy · Compound
TB-500: two molecules, one name
slug tb-500: sequenceLength 43, sequence Ac-SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES, cas 77591-33-41 Peptency catalog record, TB-500 Thymosin beta 4 is also called timbetasin and weighs about 4963 Da. Source sentence
Synonyms include 'Timbetasin'; MolecularWeight 49632 PubChem CID 16132341 Most analytical and regulatory sources use TB-500 for the 7 residue fragment Ac-LKKTETQ. Source sentence
detection and the identification of the N-terminal acetylated 17-23 fragment of human thymosin beta 4 (Ac-LKKTETQ) in TB-5003 Drug Test Anal 20124 J Chromatogr B Analyt Technol Biomed Life Sci 20245 J Chromatogr A 20126 FDA, bulk drug substances Category 2 page, content current as of 22 April 20267 ClinicalTrials.gov NCT07487363 The fragment weighs about 889 Da. Source sentence
MolecularWeight 889.0; MolecularFormula C38H68N10O148 PubChem CID 62707662
Regulatory content shown for: United States and the Americas.
Two molecules, one name
- Catalog recordThymosin beta 443 residuesabout 4963 DaSource sentence
Synonyms include 'Timbetasin'; MolecularWeight 4963
2 PubChem CID 16132341 - Most analytical and regulatory sourcesAc-LKKTETQ7 residuesabout 889 DaSource sentence
MolecularWeight 889.0; MolecularFormula C38H68N10O14
8 PubChem CID 62707662
Known, not known, contested
Known
- The catalog record lists the 43 residue sequence of thymosin beta 4, CAS 77591-33-4, PubChem CID 16132341. Source sentence
sequenceLength 43; cas 77591-33-4; pubchem.cid 16132341; casConfirmedByPubChem true
1 Peptency catalog record, TB-5002 PubChem CID 16132341 - Ac-LKKTETQ is residues 17 to 23 of thymosin beta 4 with an acetyl group added to its N terminus. Source sentence
the N-terminal acetylated 17-23 fragment of human thymosin beta 4 (Ac-LKKTETQ)
3 Drug Test Anal 20125 J Chromatogr A 2012 - In the full protein, residue 17 carries no acetyl group; doping control chemists describe the fragment's acetylation as artificial. Source sentence
The key ingredient of TB-500 is the peptide LKKTETQ with artificial acetylation of the N-terminus.
5 J Chromatogr A 20122 PubChem CID 16132341 - The two molecules differ by about 4074 Da in average mass, so an intact mass measurement separates them. Source sentence
MolecularWeight 4963 (CID 16132341) against 889.0 (CID 62707662); difference computed
2 PubChem CID 161323418 PubChem CID 62707662 - Published randomised human studies of synthetic thymosin beta 4 exist in eye surface, skin ulcer and healthy volunteer settings. Source sentence
8 records with publication type randomized controlled trial, incl. 25826322, 36613994, 20536470, 20536472
9 PubMed search for randomised trials of thymosin beta 4, 12 October 202610 Cornea 201511 Int J Mol Sci 202212 Ann N Y Acad Sci 201013 Ann N Y Acad Sci 2010
Not known
- No published human study of the fragment Ac-LKKTETQ was found in PubMed as of 12 Oct 2026; one registered trial (NCT07487363) is recruiting. Source sentence
38 records screened on 12 Oct 2026; none reports a human study of the fragment
14 PubMed search for TB-500, TB500 or LKKTETQ, 12 October 20267 ClinicalTrials.gov NCT07487363 - Whether the fragment shares the activities studied for the full protein is not documented: a 2024 metabolism paper states "the biological effects of TB-500, however, have not been documented". Source sentence
The biological effects of TB-500, however, have not been documented.
4 J Chromatogr B Analyt Technol Biomed Life Sci 2024 - Which molecule a vial labelled TB-500 contains cannot be read from the name. The molecule line for Peptency lots is pending the lot results. Source sentence
VR23: TB-500 catalog molecule line from the lab results already held per lot, state open
15 Drug Test Anal 2023
Contested
- Most analytical and regulatory sources use "TB-500" for the 7 residue fragment, while the catalog record uses it for the 43 residue protein. Source sentence
TB-500 (Ac-LKKTETQ), derived from the active site of thymosin β4 (Tβ4)
4 J Chromatogr B Analyt Technol Biomed Life Sci 20243 Drug Test Anal 20125 J Chromatogr A 20121 Peptency catalog record, TB-500 - Some papers use the same name for the full protein: a 2026 rat study calls its material "synthetic thymosin beta-4 (TB-500)" and its abstract gives no sequence or mass. Source sentence
synthetic thymosin beta-4 (TB-500)
16 Jt Dis Relat Surg 2026 - A 2025 materials paper uses "TB500" for a peptide with the sequence LKKTETQ inside a larger conjugate. Source sentence
incorporates TB500, a biologically active peptide with the amino acid sequence LKKTETQ
17 ACS Appl Mater Interfaces 2025 - Products sold online as TB500 and TB1000 were found "not systematically consistent" with their descriptions. Source sentence
We confirm that the content of TB500/TB1000 products is not systematically consistent with it's former descriptions
15 Drug Test Anal 2023
Chemistry: thymosin beta 4, the catalog record
- Sequence
Ac-SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES- Length
- 43 residues
- Modifications
- N-terminal acetylation (Ser1)
- Formula
- C212H350N56O78S
- Monoisotopic mass
- 4960.4863 Da
- Average mass
- 4963 Da
- CAS
- 77591-33-4
- PubChem CID
- 16132341
- InChIKey
UGPMCIBIHRSCBV-XNBOLLIBSA-N- Synonyms
- thymosin beta 4, thymosin beta-4, Tβ4, Tbeta4, timbetasin
- Salt form
- No salt form stated in the record
Chemistry: the fragment Ac-LKKTETQ
- Ac-LKKTETQ, the 7 residue fragment: formula C38H68N10O14, monoisotopic mass 888.4916 Da, average mass 889.0 Da, PubChem CID 62707662, InChIKey ADKDNDYYIZUVCZ-ZQNQAVPYSA-N. PubChem lists CAS 885340-08-9 among its synonyms; that number is not confirmed against the CAS Registry for this page. Source sentence
MolecularFormula C38H68N10O14; MonoisotopicMass 888.49164688; MolecularWeight 889.0; InChIKey ADKDNDYYIZUVCZ-ZQNQAVPYSA-N; synonyms include 885340-08-9
8 PubChem CID 62707662 - PubChem lists "Thymosin beta4 Acetate" and "TB 500 acetate" as synonyms. The masses on this page are for the peptides without a counterion. Source sentence
Synonyms: 'Thymosin beta4 Acetate' (CID 16132341); 'TB 500 acetate' (CID 62707662)
2 PubChem CID 161323418 PubChem CID 62707662
Sequence
Ac-SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES
- Residues 17 to 23 of thymosin beta 4 are LKKTETQ; only the fragment carries an acetyl group on Leu17. Source sentence
The key ingredient of TB-500 is the peptide LKKTETQ with artificial acetylation of the N-terminus.
5 J Chromatogr A 20122 PubChem CID 161323413 Drug Test Anal 2012
Which molecule is in a vial labelled TB-500?
- Read the mass result on the certificate of analysis. A deconvoluted intact mass near 4960.5 Da (monoisotopic) fits thymosin beta 4. A singly protonated ion near m/z 889.50 fits Ac-LKKTETQ. A label that says only "TB-500" fits either. Source sentence
MonoisotopicMass 4960.4863169 (CID 16132341); 888.49164688 (CID 62707662); [M+H]+ computed as monoisotopic mass plus 1.00728
2 PubChem CID 161323418 PubChem CID 62707662 - Monoisotopic masses: 4960.49 Da for thymosin beta 4 and 888.49 Da for Ac-LKKTETQ. Source sentence
MonoisotopicMass 4960.4863169 (CID 16132341); 888.49164688 (CID 62707662)
2 PubChem CID 161323418 PubChem CID 62707662 - The fragment was identified in a product sold as TB-500 by liquid chromatography with high resolution mass spectrometry (Orbitrap), and a reference standard was synthesised. Source sentence
This work describes the detection and the identification of the N-terminal acetylated 17-23 fragment of human thymosin beta 4 (Ac-LKKTETQ) in TB-500 by means of high-performance liquid chromatography/high resolution mass spectrometry using an Orbitrap Exactive benchtop mass spectrometer.
3 Drug Test Anal 2012 - Doping control laboratories have published LC-MS methods for the fragment and its metabolites in equine urine and plasma, and in rat urine. Source sentence
describes a method for the simultaneous detection of N-acetylated LKKTETQ and its metabolites in equine urine and plasma samples
5 J Chromatogr A 20124 J Chromatogr B Analyt Technol Biomed Life Sci 2024 - Ac-LK and Ac-LKK are reported metabolites of the fragment in rats. Source sentence
Ac-LK was the primary metabolite with the highest concentration in rats at 0-6 h intervals. Also, the metabolite Ac-LKK was a long-term metabolite of TB-500
4 J Chromatogr B Analyt Technol Biomed Life Sci 2024 - Products bought online as TB500 and TB1000 were not consistent with their descriptions (analytical finding, 2023). Source sentence
the content of TB500/TB1000 products is not systematically consistent with it's former descriptions
15 Drug Test Anal 2023 - Equine doping laboratories report products online that claim either the acetylated fragment or the full protein (2024). Source sentence
products available online claiming to contain a synthetic acetylated fragment of TB4 or TB4 itself
18 Drug Test Anal 2025 - Thymosin beta 4 measured in stored horse plasma rises when plasma is not separated from blood cells, which matters for detection methods. Source sentence
the TB4 concentration increases significantly and rapidly in plasma stored at 4°C when not separated from blood cells due to cell lysis
18 Drug Test Anal 2025
Is TB-500 the same molecule as thymosin beta 4?
detection and the identification of the N-terminal acetylated 17-23 fragment of human thymosin beta 4 (Ac-LKKTETQ) in TB-5003 Drug Test Anal 20124 J Chromatogr B Analyt Technol Biomed Life Sci 20245 J Chromatogr A 20126 FDA, bulk drug substances Category 2 page, content current as of 22 April 20267 ClinicalTrials.gov NCT074873631 Peptency catalog record, TB-5002 PubChem CID 16132341
What is the molecular weight of TB-500?
MonoisotopicMass 4960.4863169 (CID 16132341); 888.49164688 (CID 62707662)2 PubChem CID 161323418 PubChem CID 62707662
What is Ac-LKKTETQ?
the N-terminal acetylated 17-23 fragment of human thymosin beta 4 (Ac-LKKTETQ)3 Drug Test Anal 20125 J Chromatogr A 20124 J Chromatogr B Analyt Technol Biomed Life Sci 20241 Peptency catalog record, TB-500
How does a lab tell the two TB-500 molecules apart?
MolecularWeight 4963 (CID 16132341) against 889.0 (CID 62707662); difference computed2 PubChem CID 161323418 PubChem CID 627076625 J Chromatogr A 20124 J Chromatogr B Analyt Technol Biomed Life Sci 2024
Evidence map: thymosin beta 4 (1 to 43)
| Model | Chemistry and analytical | Pharmacokinetics | Receptor binding and signalling | Tissue histology | Biomarkers | Clinical endpoint | |
|---|---|---|---|---|---|---|---|
| Analytical only (no biological model) | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet |
| In vitro or ex vivo | Not mapped yet | Not mapped yet | Receptor binding and signalling2 | Not mapped yet | Not mapped yet | Not mapped yet | |
| Rodent | Not mapped yet | Not mapped yet | Not mapped yet | Tissue histology1 | Not mapped yet | Not mapped yet | |
| Other animal | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet |
| Human, uncontrolled | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet | Not mapped yet |
| Human, randomised | Not mapped yet | Pharmacokinetics1 | Not mapped yet | Not mapped yet | Not mapped yet | Clinical endpoint3 |
6 studies countedEvidence level facet: L4. A design scale, not a measure of strength or quality.
Counts only the exact match studies reviewed for this page on 12 October 2026. Empty cells were not searched exhaustively and are marked not mapped yet. Related forms (recombinant protein, endogenous equine protein, material without a stated sequence) are in the study list and are not counted.
Evidence map: Ac-LKKTETQ (thymosin beta 4, 17 to 23)
| Model | Chemistry and analytical | Pharmacokinetics | Receptor binding and signalling | Tissue histology | Biomarkers | Clinical endpoint | |
|---|---|---|---|---|---|---|---|
| Analytical only (no biological model) | Chemistry and analytical1 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | |
| In vitro or ex vivo | Chemistry and analytical2 | Pharmacokinetics2 | Receptor binding and signalling1 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | |
| Rodent | No published study found as of 12 October 2026 | Pharmacokinetics1 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | |
| Other animal | Chemistry and analytical1 | Pharmacokinetics1 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | |
| Human, uncontrolled | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found |
| Human, randomised | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found as of 12 October 2026 | No published study found |
3 studies countedEvidence level facet: L2. A design scale, not a measure of strength or quality.
Built from a screen of all 38 PubMed records naming TB-500, TB500 or LKKTETQ in title or abstract on 12 October 2026. One registered trial of the fragment, NCT07487363, is recruiting and has no published results.
Who produced this evidence
- All 3 exact match fragment studies found come from doping control laboratories: Ghent (Belgium), the Korea Institute of Science and Technology (South Korea) and the Hong Kong Jockey Club racing laboratory. Source sentence
Affiliations: DoCoLab Ghent University (22962027); Doping Control Center KIST (38382158); Hong Kong Jockey Club (23084823)
3 Drug Test Anal 20124 J Chromatogr B Analyt Technol Biomed Life Sci 20245 J Chromatogr A 2012 - The exact match human randomised studies on this page come from the RGN-259 eye programme (US sites), a RegeneRx sponsored skin ulcer trial in Italy and Poland, and a US healthy volunteer study. The SEER-1 paper declares author employment at the developer, ReGenTree. Source sentence
Lead sponsor RegeneRx Biopharmaceuticals; countries Italy, Poland
21 ClinicalTrials.gov NCT0083209110 Cornea 201511 Int J Mol Sci 202213 Ann N Y Acad Sci 201022 ClinicalTrials.gov NCT02600429 - The two early laboratory studies on this page come from the same NIH institute group (Kleinman, NIDCR). Source sentence
Institute of Dental and Craniofacial Research, NIH, Bethesda
19 J Invest Dermatol 199920 FASEB J 2003
Studies
Analytical only (no biological model)Drug Test Anal 2012
Identity of the peptide in a product sold as TB-500 by LC-HRMS (Orbitrap); synthesis of a reference standard
- Design
- Analytical chemistry: synthesis by solid phase peptide synthesis, identification in a commercial product
- Population or model
- none (chemistry and analytical)
- Molecule
- Ac-LKKTETQ (thymosin beta 4, 17 to 23) different molecule
RodentJ Chromatogr B Analyt Technol Biomed Life Sci 2024
Metabolites of Ac-LKKTETQ in human serum in vitro, enzyme systems and rat urine; cytotoxicity and scratch assays in fibroblasts
- Design
- Analytical method development plus in vitro metabolism and rat urine metabolite study
- Population or model
- human serum and enzyme systems in vitro; rat; fibroblast cell assays
- Molecule
- Ac-LKKTETQ (thymosin beta 4, 17 to 23) different molecule
Authors declare no competing interests
Other animalJ Chromatogr A 2012
Detection of N-acetylated LKKTETQ and its metabolites in equine urine and plasma by LC-MS
- Design
- Analytical method development with in vitro metabolite identification and equine samples collected after a TB-500 product was given
- Population or model
- horse (other animal); in vitro metabolism
- Molecule
- Ac-LKKTETQ (thymosin beta 4, 17 to 23) different molecule
RodentJ Invest Dermatol 1999
Re-epithelialisation, contraction, collagen deposition and vessel formation in rat skin wounds; keratinocyte migration (Boyden chamber)
- Design
- Animal study plus cell migration assay
- Population or model
- rat full thickness skin wound model; keratinocytes in vitro
- Molecule
- thymosin beta 4 (1 to 43) exact
In vitro or ex vivoFASEB J 2003
Endothelial cell migration, adhesion and vessel sprouting for the full protein and for peptides containing or lacking the seven residue actin binding motif
- Design
- In vitro and ex vivo comparison of the full protein, proteolytic fragments and synthetic peptides
- Population or model
- human umbilical vein endothelial cells; chick aortic arch explants
- Molecule
- thymosin beta 4 (1 to 43) exact
Molecule note: Full protein exact; the synthetic motif peptides are a related form of the fragment (acetylation not stated).
Human, randomisedCornea 2015
Adverse events (registry primary outcome); corneal fluorescein staining and a symptom questionnaire (registry secondary outcomes)
- Design
- Randomised, double masked, vehicle controlled, phase 2
- Population or model
- adults with severe dry eye
- Molecule
- thymosin beta 4 (1 to 43) exact
- n
- 9
- Comparator
- vehicle
- Blinding
- double masked (registry: triple)
- Duration
- 56 days including 28 day follow up
- Funding
- PubMed publication type: Research Support, Non-U.S. Gov't; registry sponsor Michigan Cornea Consultants
- Registration
- ClinicalTrials.gov NCT01393132
Molecule note: Eye drop formulation RGN-259 containing thymosin beta 4.
Human, randomisedInt J Mol Sci 2022
Closure of persistent epithelial defects at day 29 (registry primary outcome); comfort scores
- Design
- Randomised, placebo controlled, double masked, phase 3 (SEER-1)
- Population or model
- adults with stage 2 or 3 neurotrophic keratopathy
- Molecule
- thymosin beta 4 (1 to 43) exact
- n
- 18
- Comparator
- placebo
- Blinding
- double masked (registry: quadruple)
- Funding
- Sponsor ReGenTree LLC (registry)
- Registration
- ClinicalTrials.gov NCT02600429
Two authors employed by ReGenTree LLC, which develops RGN-259; one by its parent company (declared). Molecule note: RGN-259 eye drop formulation containing thymosin beta 4.
Human, randomisedAnn N Y Acad Sci 2010
Safety and tolerability (registry primary outcome); ulcer closure
- Design
- Randomised, double blind, placebo controlled, sequential cohorts, phase 2
- Population or model
- adults with venous stasis ulcers
- Molecule
- thymosin beta 4 (1 to 43) exact
- n
- 73
- Comparator
- placebo
- Blinding
- double blind (registry: quadruple)
- Duration
- 84 days (registry title)
- Funding
- Registry sponsor RegeneRx Biopharmaceuticals
- Registration
- ClinicalTrials.gov NCT00832091
Molecule note: Abstract describes a synthetic copy of the naturally occurring 43 amino acid peptide.
Human, randomisedAnn N Y Acad Sci 2010
Adverse events and pharmacokinetic parameters
- Design
- Randomised, placebo controlled, single and multiple ascending cohorts, phase 1
- Population or model
- healthy volunteers
- Molecule
- thymosin beta 4 (1 to 43) exact
- n
- 40
- Comparator
- placebo
- Duration
- single exposure, then 14 days
Molecule note: Abstract states synthetic thymosin beta 4.
Human, randomisedCardiovasc Res 2025
Infarct area by imaging at 90 days in the trial
- Design
- Mouse and cell work plus a randomised, placebo controlled, double blind trial
- Population or model
- mouse; cardiomyocyte lines; human randomised: adults after ST elevation myocardial infarction
- Molecule
- recombinant thymosin beta 4 (NL005) related form
- n
- 96
- Comparator
- placebo
- Blinding
- double blind
Three authors employed by Beijing Northland Biotechnology (declared). Molecule note: Recombinant human thymosin beta 4 (NL005); N terminal acetylation not stated in abstract.
Human, randomisedJ Cell Mol Med 2021
Safety, tolerability, pharmacokinetics and anti drug antibodies
- Design
- Randomised, double blind, phase 1
- Population or model
- healthy volunteers
- Molecule
- recombinant thymosin beta 4 (NL005) related form
- n
- 84
Three authors are employees of the sponsor (declared). Molecule note: Recombinant human thymosin beta 4 (NL005).
RodentJt Dis Relat Surg 2026
Load to failure, histology scores and collagen type I and III staining
- Design
- Randomised animal study, four groups
- Population or model
- rat (Sprague-Dawley), Achilles tendon transection model
- Molecule
- not stated in the abstract (no sequence or mass given) related form
- n
- 32
Molecule note: Abstract calls the material synthetic thymosin beta-4 (TB-500) and gives no sequence or mass, so the molecule cannot be assigned.
In vitro or ex vivoACS Appl Mater Interfaces 2025
Gelation, cell migration and corneal epithelium in a hydrogel built from a Nap-YpYY-TB500 precursor
- Design
- Materials study with cell assays and an animal model
- Population or model
- human corneal cells in vitro; alkali burn model
- Molecule
- a peptide with the sequence LKKTETQ inside a larger conjugate related form
Molecule note: Uses the name TB500 for a peptide with the sequence LKKTETQ inside a larger conjugate.
Analytical only (no biological model)Drug Test Anal 2023
Content of products sold online as TB500, TB1000 and SGF1000
- Design
- Analytical study of products bought online (short communication)
- Population or model
- none (product analysis)
- Molecule
- product sold as TB-500 (content not confirmed) related form
Molecule note: Products named TB500 and TB1000; content found inconsistent with descriptions, so not counted for either molecule.
Other animalDrug Test Anal 2025
Endogenous thymosin beta 4 concentration in racing horse blood; effect of sample storage; a synthesis impurity marker
- Design
- Population study of endogenous levels plus detection strategy
- Population or model
- horse (other animal)
- Molecule
- endogenous equine thymosin beta 4 related form
Molecule note: Endogenous equine thymosin beta 4; sequence identity with the catalog molecule not checked for this page.
Mechanism studied
- Thymosin beta 4 is described as the main G-actin sequestering peptide, and a seven amino acid actin binding motif was studied in cell assays. Source sentence
It is the most abundant member of the beta-thymosin family in mammalian tissue and is regarded as the main G-actin sequestering peptide.
20 FASEB J 2003
Status matrix
FDA
No authorisation found 25 openFDA Drugs@FDA query for thymosin, 12 October 2026No Drugs@FDA record for thymosin or timbetasin
503A
Nominated, then withdrawn by the nominator 6 FDA, bulk drug substances Category 2 page, content current as of 22 April 2026Listed as "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500". Applies to the fragment, not to the catalog molecule
503A
Full length thymosin beta 4 does not appear on the Category 2 page
WADA
Named in a prohibited class 26 WADA Prohibited List 2026S2.3: "Thymosin-ß4 and its derivatives e.g. TB-500", prohibited at all times
United States: FDA records
US
- The FDA compounding entries below name the fragment Ac-LKKTETQ. They do not describe the 43 residue thymosin beta 4 in the catalog record. Source sentence
Thymosin beta-4, fragment (LKKTETQ), also known as TB-500
6 FDA, bulk drug substances Category 2 page, content current as of 22 April 20261 Peptency catalog record, TB-500 - FDA lists "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" under bulk drug substances nominated but withdrawn on its Category 2 page (content current as of 22 Apr 2026). Withdrawn by the nominator is not approval and not listing. Source sentence
Bulk drug substances nominated but withdrawn ... | Thymosin beta-4, fragment (LKKTETQ), also known as TB-500 | ... Content current as of: 04/22/2026
6 FDA, bulk drug substances Category 2 page, content current as of 22 April 2026 - On the same page FDA states that it has not identified human exposure data for drug products containing the fragment and that it lacks important information about its safety. Source sentence
FDA has not identified any human exposure data drug products containing Thymosin Beta-4, Fragment. FDA lacks important information regarding any safety issues raised by this drug
6 FDA, bulk drug substances Category 2 page, content current as of 22 April 2026 - A Federal Register notice listed "TB-500-related bulk drug substances (TB-500 (free base)/TB-500 acetate)" for discussion by the Pharmacy Compounding Advisory Committee on 23 Jul 2026 (docket FDA-2025-N-6895). Source sentence
On July 23, 2026, the Committee will discuss ... TB-500-related bulk drug substances (TB-500 (free base)/TB-500 acetate)
27 Federal Register 2026-07361, 16 April 2026 - No FDA approved drug containing thymosin beta 4 or its fragment was found in openFDA on 12 Oct 2026. Source sentence
NOT_FOUND: No matches found!
25 openFDA Drugs@FDA query for thymosin, 12 October 2026
Sport anti-doping lists
International
- The WADA 2026 Prohibited List names "Thymosin-ß4 and its derivatives e.g. TB-500" in class S2.3, so the class covers both molecules. Source sentence
S2.3. GROWTH FACTORS AND GROWTH FACTOR MODULATORS ... Thymosin-ß4 and its derivatives e.g. TB-500
26 WADA Prohibited List 2026 - An equine doping study states that thymosin beta 4 is forbidden by the IFHA, the FEI and WADA. Source sentence
forbidden by the IFHA, the FEI, and the WADA
18 Drug Test Anal 2025
Elsewhere: New Zealand
New Zealand
- New Zealand's Medsafe advisory of 21 May 2026 lists TB-500 and thymosin among products advertised by online sellers. Source sentence
TB‑500 and thymosin
28 Medsafe, 21 May 2026
Registered trials
NCT07487363Phase 1/2
- Status
- Recruiting (start 5 Feb 2026, estimated primary completion 14 Feb 2027)
- Sponsor
- Hudson Biotech
- Site countries
- China (global context)
- Primary endpoint
- safety: adverse events
- Primary endpoint met
- not reported
- Last synced
- 12 October 2026
NCT01393132Phase 2
- Status
- Completed (Dec 2012), results posted
- Sponsor
- Michigan Cornea Consultants
- Site countries
- US
- Primary endpoint
- safety
- Primary endpoint met
- not reported
- Last synced
- 12 October 2026
NCT02600429Phase 3
- Status
- Terminated (business decision)
- Sponsor
- ReGenTree
- Site countries
- US
- Primary endpoint
- epithelial defect closure at day 29
- Primary endpoint met
- not met
- Last synced
- 12 October 2026
NCT05555589Phase 3
- Status
- Recruiting per registry (last update 23 Dec 2025; estimated completion 30 May 2026 has passed)
- Sponsor
- ReGenTree
- Site countries
- Italy, Poland, Spain, US
- Primary endpoint
- epithelial defect closure at day 29
- Primary endpoint met
- not reported
- Last synced
- 12 October 2026
- ClinicalTrials.gov on 12 Oct 2026: 18 records for "thymosin beta 4" (one of them the fragment trial) and 1 record for "TB-500". Source sentence
totalCount 18; totalCount 1 (NCT07487363)
31 ClinicalTrials.gov search, 12 October 2026
Timeline
- Rat skin wound model and keratinocyte migration study of thymosin beta 4 Source sentence
J Invest Dermatol 1999: Re-epithelialisation, contraction, collagen deposition and vessel formation in rat skin wounds; keratinocyte migration (Boyden chamber)
19 J Invest Dermatol 1999 - Seven residue actin binding motif compared with the full protein in endothelial assays Source sentence
FASEB J 2003: Endothelial cell migration, adhesion and vessel sprouting for the full protein and for peptides containing or lacking the seven residue actin binding motif
20 FASEB J 2003 - Healthy volunteer randomised study of synthetic thymosin beta 4 published Source sentence
Ann N Y Acad Sci 2010: Adverse events and pharmacokinetic parameters
13 Ann N Y Acad Sci 2010 - Ac-LKKTETQ identified in a product sold as TB-500 by LC-HRMS Source sentence
Drug Test Anal 2012: Identity of the peptide in a product sold as TB-500 by LC-HRMS (Orbitrap); synthesis of a reference standard
3 Drug Test Anal 2012 - LC-MS method for the fragment in horse urine and plasma Source sentence
J Chromatogr A 2012: Detection of N-acetylated LKKTETQ and its metabolites in equine urine and plasma by LC-MS
5 J Chromatogr A 2012 - Online TB500 and TB1000 products analysed Source sentence
Drug Test Anal 2023: Content of products sold online as TB500, TB1000 and SGF1000
15 Drug Test Anal 2023 - SEER-2 phase 3 starts at sites in the US, Italy, Poland and Spain Source sentence
Study start 2023-04; locations United States, Italy, Poland, Spain
30 ClinicalTrials.gov NCT05555589 - Metabolism of Ac-LKKTETQ in human serum in vitro and in rats Source sentence
J Chromatogr B Analyt Technol Biomed Life Sci 2024: Metabolites of Ac-LKKTETQ in human serum in vitro, enzyme systems and rat urine; cytotoxicity and scratch assays in fibroblasts
4 J Chromatogr B Analyt Technol Biomed Life Sci 2024 - Endogenous thymosin beta 4 population study in racing horses Source sentence
Drug Test Anal 2025: Endogenous thymosin beta 4 concentration in racing horse blood; effect of sample storage; a synthesis impurity marker
18 Drug Test Anal 2025 - WADA 2026 list in force, S2.3 names thymosin beta 4 and derivatives Source sentence
S2.3 ... Thymosin-ß4 and its derivatives e.g. TB-500
26 WADA Prohibited List 2026 - A registered human trial of the fragment starts recruiting in China Source sentence
Study start 2026-02-05; overall status Recruiting
7 ClinicalTrials.gov NCT07487363 - Medsafe advisory names TB-500 Source sentence
21 May 2026 ... TB‑500 and thymosin
28 Medsafe, 21 May 2026
Integrity notes
- PubMed CommentsCorrections and Crossref update-to checked on 12 Oct 2026 for the core identity and trial papers: no retraction, correction or expression of concern found. Source sentence
PubMed CommentsCorrections and Crossref update-to: no entries on 12 Oct 2026
3 Drug Test Anal 20124 J Chromatogr B Analyt Technol Biomed Life Sci 202415 Drug Test Anal 202318 Drug Test Anal 202510 Cornea 201512 Ann N Y Acad Sci 2010 - Enrolment differs between the skin ulcer trial publication (73 randomised) and its registry record (72 enrolled). Source sentence
Publication abstract: 73 randomised; registry NCT00832091 actual enrolment: 72
12 Ann N Y Acad Sci 201021 ClinicalTrials.gov NCT00832091 - NCT07487363 is titled double blind, while its structured masking field lists the participant only. Source sentence
Official title: double blind; design masking: Participant
7 ClinicalTrials.gov NCT07487363
Chemistry and records
TB-500: sequence, mass, CAS and regulatory record in the research library →
Sources
- 1Peptency catalog record, TB-500 accessed 12 Oct 2026
- 2PubChem CID 16132341 accessed 12 Oct 2026
- 3Drug Test Anal 2012 accessed 12 Oct 2026
- 4J Chromatogr B Analyt Technol Biomed Life Sci 2024 accessed 12 Oct 2026
- 5J Chromatogr A 2012 accessed 12 Oct 2026
- 6FDA, bulk drug substances Category 2 page, content current as of 22 April 2026 accessed 12 Oct 2026
- 7ClinicalTrials.gov NCT07487363 accessed 12 Oct 2026
- 8PubChem CID 62707662 accessed 12 Oct 2026
- 9PubMed search for randomised trials of thymosin beta 4, 12 October 2026 accessed 12 Oct 2026
- 10Cornea 2015 accessed 12 Oct 2026
- 11Int J Mol Sci 2022 accessed 12 Oct 2026
- 12Ann N Y Acad Sci 2010 accessed 12 Oct 2026
- 13Ann N Y Acad Sci 2010 accessed 12 Oct 2026
- 14PubMed search for TB-500, TB500 or LKKTETQ, 12 October 2026 accessed 12 Oct 2026
- 15Drug Test Anal 2023 accessed 12 Oct 2026
- 16Jt Dis Relat Surg 2026 accessed 12 Oct 2026
- 17ACS Appl Mater Interfaces 2025 accessed 12 Oct 2026
- 18Drug Test Anal 2025 accessed 12 Oct 2026
- 19J Invest Dermatol 1999 accessed 12 Oct 2026
- 20FASEB J 2003 accessed 12 Oct 2026
- 21ClinicalTrials.gov NCT00832091 accessed 12 Oct 2026
- 22ClinicalTrials.gov NCT02600429 accessed 12 Oct 2026
- 23Cardiovasc Res 2025 accessed 12 Oct 2026
- 24J Cell Mol Med 2021 accessed 12 Oct 2026
- 25openFDA Drugs@FDA query for thymosin, 12 October 2026 accessed 12 Oct 2026
- 26WADA Prohibited List 2026 accessed 12 Oct 2026
- 27Federal Register 2026-07361, 16 April 2026 accessed 12 Oct 2026
- 28Medsafe, 21 May 2026 accessed 12 Oct 2026
- 29ClinicalTrials.gov NCT01393132 accessed 12 Oct 2026
- 30ClinicalTrials.gov NCT05555589 accessed 12 Oct 2026
- 31ClinicalTrials.gov search, 12 October 2026 accessed 12 Oct 2026
About this page
Research-use information. This library summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.
Reviewed by the Peptency editorial process. Version 1, last edited 12 October 2026, 31 sources.
Cite this page: Peptency Academy. TB-500: two molecules, one name. Version 1./us/academy/compounds/tb-500/