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Is Thymosin Alpha-1 legal? FDA status and US regulatory standing
Current status
Compounding nomination withdrawn. Thymosin Alpha-1 was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists.
Primary source: www.fda.gov
Federal legal status
FDA approval status
Thymosin Alpha-1 was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Approved as Zadaxin in China, Italy, and other countries but NOT FDA-approved. Not on FDA 503A Category 1 bulks list. Research use only in US. Immunomodulatory thymic peptide.
Also known as
Tα1 · Zadaxin
Frequently asked questions
- Is Thymosin Alpha-1 FDA approved?
- Thymosin Alpha-1 was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Primary source linked on this page.
- Is Thymosin Alpha-1 legal to buy?
- Thymosin Alpha-1 is available in the U.S. as a research-use-only compound. It was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Sale for human consumption is not permitted.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .