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Research / Unapproved

Thymosin Beta-4: Research Status And Trial Data

Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.

Molecular formulaC212H350N56O78S
Molecular weight4963 g/mol
Registered trials18
PubChem CID45382195

Key takeaways

  • Thymosin beta-4 is classified as unapproved and investigational, with no FDA-approved label or indication.
  • It is a large peptide with the molecular formula C212H350N56O78S and a molecular weight near 4,963 (PubChem CID 45382195).
  • At least 18 trials referencing thymosin beta-4 are registered in clinical trial databases.
  • Sampled trials span ophthalmic and cardiac research, including completed and recruiting studies.

What thymosin beta-4 is

Thymosin beta-4 is a naturally occurring peptide composed of 43 amino acids, giving it a large molecular weight compared to typical small-molecule drugs. It has not been reviewed or approved by regulatory agencies as a marketed drug, and no official prescribing label exists for it. Any use outside of registered clinical research falls outside its current regulatory status.

Trial footprint

Registries list 18 trials referencing thymosin beta-4. Sampled studies include a completed Phase 2/Phase 3 trial of an ophthalmic solution (RGN-259) for dry eye syndrome, a completed Phase 2 study evaluating safety and efficacy in patients with acute myocardial infarction, and a recruiting Phase 3 trial of a 0.1% RGN-259 ophthalmic solution for neurotrophic keratopathy. These studies illustrate the range of conditions under active investigation but do not establish approved efficacy for any indication.

FAQ

Is thymosin beta-4 FDA approved?
No. Thymosin beta-4 does not have an FDA-approved label or indication. It remains classified as an investigational compound studied through clinical research.
What is thymosin beta-4?
It is a naturally occurring peptide made up of 43 amino acids, with a molecular formula of C212H350N56O78S and a molecular weight near 4,963. Its PubChem entry is listed under CID 45382195.
What conditions is thymosin beta-4 being studied for?
Registered trials have examined ophthalmic formulations for dry eye syndrome and neurotrophic keratopathy, as well as use in patients with acute myocardial infarction. These are research studies and do not reflect an approved use.
How many clinical trials involve thymosin beta-4?
At least 18 trials in clinical trial registries reference thymosin beta-4, ranging across different phases and study designs. Some are completed and others are still recruiting participants.
Are there known side effects of thymosin beta-4?
Available data for this compound does not include a summary of reported adverse event reports. Safety information is instead found within the individual clinical trial results as they are published.
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Sources: ClinicalTrials.gov PubChem

Updated 2026-08-03