What is Thymosin alpha-1?

The short answer

Thymosin alpha-1 is a lab-made copy of a peptide that the thymus gland makes.

  • What it is

    Thymus peptide studied as an immune modulator.

  • What people look into

    Aging

Get updates on Thymosin alpha-1

What it is

Type
Thymic peptide (28-aa)
Also known as
ta1, thymalfasin, zadaxin
How it works
Thymus peptide studied as an immune modulator.

Regulatory status

Approved outside the US How we label status

As of October 4, 2026, Thymosin alpha-1 is not FDA-approved for any use and is not on FDA's 503A bulks list. It is approved in Italy.

See Thymosin alpha-1 in the Index →

Federal (FDA)
Not FDA-approved (openFDA thymalfasin: no records)
503A compounding
No category (nomination withdrawn; removed from Cat 2 2024-09-27); not on 216.23 as of 2026-10-07; not an approved-drug component; 503B Category 3 (as of October 7, 2026)
PCAC history
2024-12-04: against 4-17-0 (free base and acetate; uses reviewed incl. hepatitis B/C, HIV, cancers); FDA staff: against

Timeline

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Timeline table
DateWhat happenedSource
FDA warning letter to a compounding pharmacy states that thymosin alpha was not nominated for inclusion on the 503A bulks list.FDA, event of November 10, 2021, on fda.gov
Federal Register notice of an FDA Pharmacy Compounding Advisory Committee meeting lists thymosin alpha-1 among bulk drug substances under consideration for the 503A bulks list.Federal Register, event of October 25, 2024, on federalregister.gov

References

Sources as of October 4, 2026

  1. FDA: api.fda.gov/drug/drugsfda.json
  2. FDA: www.fda.gov/media/185642/download
  3. FDA: www.fda.gov/media/183820/download
  4. FDA: www.fda.gov/media/94155/download
  5. FDA: www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  6. FDA: www.fda.gov/media/94164/download
  7. Internet Archive: web.archive.org/web/20241107074712id_/https://www.fda.gov/media/94155/download
  8. AIFA: api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1361/farmaci/28364/stampati
  9. eCFR: www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23