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Research / Unapproved

Thymosin Beta-4: Research Status and Trial Data

Molecular formulaC212H350N56O78S
Molecular weight4963 g/mol
Registered trials18
PubChem CID45382195

Thymosin beta-4 is often searched for its role in tissue-related research, but it holds no FDA-approved indication. This monograph summarizes only what is documented in trial registries.

Regulatory status

Thymosin beta-4 is classified as an unapproved, investigational compound. No FDA label, approved brand name, or approved indication exists for it.

What thymosin beta-4 is

Thymosin beta-4 is a peptide compound (molecular formula C212H350N56O78S) identified in chemical databases under PubChem CID 45382195. Because no FDA label has been issued, there is no official description of its mechanism of action or drug class.

Trial footprint

Eighteen studies involving thymosin beta-4 have been registered in clinical trial databases. Sampled studies illustrate the range of conditions explored, without indicating that any use is established or effective. One completed Phase 2 study examined thymosin beta-4 in patients with venous stasis ulcers. A separate Phase 2 study on injectable thymosin beta-4 for acute myocardial infarction was withdrawn. A combined Phase 2/Phase 3 study evaluated an ophthalmic solution formulation, RGN-259, for dry eye syndrome, and this study was completed.

FAQ

Is thymosin beta-4 FDA-approved?
No. Thymosin beta-4 has no FDA-approved label, indication, or brand name. It remains classified as an investigational compound.
What conditions has thymosin beta-4 been studied for?
Registered trials have examined thymosin beta-4 in contexts such as venous stasis ulcers, acute myocardial infarction, and dry eye syndrome using an ophthalmic formulation called RGN-259. These studies do not establish that the compound is safe or effective for any use.
How many clinical trials involve thymosin beta-4?
Eighteen studies involving thymosin beta-4 have been registered in clinical trial databases as of the most recent data pull. Trial statuses among the sampled studies range from completed to withdrawn.
What is the chemical identity of thymosin beta-4?
Thymosin beta-4 has the molecular formula C212H350N56O78S and is catalogued under PubChem CID 45382195. No official mechanism of action has been published because it lacks an approved label.
Was the acute myocardial infarction trial completed?
No. The Phase 2 study of injectable thymosin beta-4 for acute myocardial infarction was withdrawn, according to the trial registry record.
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Sources: PubChem CID 45382195 ClinicalTrials.gov registry (NCT00832091, NCT01311518, NCT02597803)

Updated 2026-09-19