Thymosin beta-4: FDA status and clinical evidence

Not FDA-approved, in clinical research

Thymosin beta-4 is not approved by the FDA for any use. It appears in the clinical trial registry, so it is under study, which is not the same as being shown to work. 18 studies are registered on ClinicalTrials.gov, reaching Phase 3.

FDA-approved

Registered studies

Phase 3

Highest phase

FDA applications

FDA approval status

Status

No approved application

Clinical evidence

Registered studies

Interventional

Completed

Currently active

Studies with posted results

Highest phase reached

Phase 3

Total enrolment across studies

2,460

By phase

Phase 212

Phase 34

Phase 14

Full trial breakdown for Thymosin beta-4 →

Molecular identity

Substance class

Protein

FDA UNII

549LM7U24W

CAS number

77642-24-1

Amino acid sequence

SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES

Sequence length

43 residues

Recorded synonyms

From the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.

How to read this. This page reports what federal records say about Thymosin beta-4, nothing more. An FDA approval covers specific uses and doses on a reviewed label. A registered trial records that research was declared, not that it succeeded. A listed patent governs who may sell a drug, not whether it works. None of this is medical advice, and none of it means a compound is safe to use outside a prescription.

Frequently asked questions

Is Thymosin beta-4 FDA-approved?

No. Thymosin beta-4 has no approved FDA application. It appears in registered clinical trials, which means it is being studied, not that it has been shown to work or to be safe.

How much clinical research is there on Thymosin beta-4?

18 studies are registered on ClinicalTrials.gov with Thymosin beta-4 as an intervention, 11 of them completed. The highest phase reached is Phase 3. Registration counts research activity, not proven benefit.

Where does the information on this page come from?

Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.

Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.