FDA tracker
Thymosin Alpha-1: FDA regulatory status
InvestigationalUpdated Apr 23, 2026
Approved in 30+ countries; US investigational
Editorially reviewedThe Peptide Examiner editorial team, Editorial review · Reviewed Apr 23, 2026
Regulatory timeline
Feb 27, 2026 · Reclassification
HHS proposes removal from Category 2
HHS Secretary RFK Jr. announced proposed removal of 14 peptides from Category 2. Final FDA determination pending PCAC review (July 2026 hearing).
Sep 7, 2023 · Reclassification
FDA places on Category 2 list
Listed among 19 peptide bulk substances potentially raising significant safety risks for compounding. Prohibits compounding under Section 503A or 503B pending review.
What this means for patients
Thymosin Alpha-1 is investigational. Access is through clinical trial enrollment only. Research-peptide vendors selling it face FDA enforcement risk.