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Thymosin alpha-1: FDA status and clinical evidence
Thymosin alpha-1 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. 65 studies are registered on ClinicalTrials.gov, reaching Phase 4.
FDA approval status
A search of Drugs@FDA by active ingredient returns no application for Thymosin alpha-1. No company has taken it through FDA review, so there is no approved use, no approved dose and no FDA-reviewed label.
Clinical evidence
By phase
Molecular identity
W0B22ISQ1CSDAAVDTSSEITTKDLKEKKEVVEEAENFrom the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.
Frequently asked questions
Is Thymosin alpha-1 FDA-approved?
No. Thymosin alpha-1 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 alpha-1?
65 studies are registered on ClinicalTrials.gov with Thymosin alpha-1 as an intervention, 23 of them completed. The highest phase reached is Phase 4. 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.