The Longevity Registry

§ — Substance profile

B

Thymosin alpha-1

Tα1 · Thymalfasin · Zadaxin · Thymic peptide immunomodulator

01 — Regulatory status

Regulatory status · United States · as of September 2026

Not FDA-approved. Placed in 503A Category 2 in 2023. Current category must be verified against the FDA bulks list before publication.

Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026

A
Approved drug with randomized controlled trials for the approved indication
B
Human clinical data exists, but no approval for the researched use
C
Animal or in-vitro data only, no controlled human trials
D
No published clinical data; use rests on anecdote

Reviewed September 2026 · Sources: FDA, EMA

02 — Researched for

What is being studied.

Hepatitis B and C adjunct, sepsis, vaccine response, cancer adjunct, COVID-19.

03 — What the evidence shows

The published record.

Randomized trials in hepatitis and sepsis show modest immunological effects with mixed clinical outcomes. Approved in over 30 countries for hepatitis B; never approved by FDA or EMA.

04 — What is claimed but not shown

Claimed, not demonstrated.

General immune 'boosting' in healthy adults; anti-aging immune restoration; autoimmune benefit.

05 — Known risks

Documented risks.

Generally well tolerated in trials; theoretical risk in autoimmune disease; grey-market purity unknown.

06 — Researched for these goals

Where Thymosin alpha-1 appears.

07 — Questions for your physician

Six questions worth printing.

  1. 01What is your primary board certification, and in what year did you obtain it?
  2. 02Is this peptide approved for what you are prescribing it for — and if not, what is the legal basis on which you are supplying it?
  3. 03Which human trials support this use, and what were their size and duration?
  4. 04Where does the product come from, and can you show me a certificate of analysis for this batch?
  5. 05What outcome will we measure, when, and what happens if it does not improve?
  6. 06What is the total cost for the first three months, in writing?

Reviewed September 2026 · Sources: FDA, EMA

This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.