360 MD Austin
Austin, TX
Physician credentials on file
§ — Substance profile
B
Thymosin alpha-1
Tα1 · Thymalfasin · Zadaxin · Thymic peptide immunomodulator
01 — Regulatory status
Regulatory status · United States · as of October 2026
Not FDA-approved in the United States. The advisory committee reviewed it on December 4, 2024, and did not recommend it for the 503A Bulks List. It is not on the list and cannot be compounded under section 503A.
Source: FDA 503A Bulks List · PCAC meeting records · verified October 2026
- Approved drug with randomized controlled trials for the approved indication
- Human clinical data exists, but no approval for the researched use
- Animal or in-vitro data only, no controlled human trials
- No published clinical data; use rests on anecdote
A
B
C
D
Reviewed October 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.
- 01What is your primary board certification, and in what year did you obtain it?
- 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?
- 03Which human trials support this use, and what were their size and duration?
- 04Where does the product come from, and can you show me a certificate of analysis for this batch?
- 05What outcome will we measure, when, and what happens if it does not improve?
- 06What is the total cost for the first three months, in writing?
Practices near you that offer peptide therapy
Every practice in the registry that lists peptide therapy, sorted by distance and nothing else. You contact the practice directly.
AgeReversalMD
La Jolla, CA
No physician listed on the practice website
Amped MD Chandler
Chandler, AZ
Physician credentials on file
Ana Casas M.D. Anti-Aging and Regenerative Medicine
Alpharetta, GA
Physician credentials on file
Anatara Medicine
San Francisco, CA
Ahvie Herskowitz, MD · Ann Lee, MD
Anazao MD
Steamboat Springs, CO
Physician credentials on file
Listed for transparency, not as an endorsement of any practice, substance or protocol. Most peptides are not FDA-approved for the uses they are offered for.
Reviewed October 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.