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
- 9 sources
- Status as of
- How we source
- Ellum doesn't sell peptides.
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.
- 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- No category (nomination withdrawn; removed from Cat 2 2024-09-27); not on 216.23 as of 2026-10-07; not an approved-drug component; 503B Category 3 (as of October 7, 2026)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
| Date | What happened | Source |
|---|---|---|
| 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
- FDA: api.fda.gov/drug/drugsfda.json
- FDA: www.fda.gov/media/185642/download
- FDA: www.fda.gov/media/183820/download
- FDA: www.fda.gov/media/94155/download
- FDA: www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- FDA: www.fda.gov/media/94164/download
- Internet Archive: web.archive.org/web/20241107074712id_/https://www.fda.gov/media/94155/download
- AIFA: api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1361/farmaci/28364/stampati
- eCFR: www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23