Is thymosin alpha 1 FDA approved?
Not fully. In the US it has orphan drug status, which helps a drug get developed for a rare disease. That is not the same as full approval. It is not licensed in the UK, Australia, or Canada. It is approved as Zadaxin in more than 30 other countries, mainly for hepatitis. That is why its status looks mixed depending on where you look.
Every FDA-approved compound in the archive, as a list
Studies in people from the compound pages this answer belongs to
- Thymosin Alpha-1
- Efficacy of thymosin alpha1 in patients with chronic hepatitis B: a randomized, controlled trial 1998 PMID 9581695
- The efficacy and safety of thymosin alpha 1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial 2025 PMID 39814420
- The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial 2013 PMID 23327199
Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use.
Part of immune and longevity peptides. Thymosin alpha-1, thymalin, epitalon, MOTS-c, humanin, and the bioregulator family.