360 MD Austin
Austin, TX
Physician credentials on file
§ — Substance profile
D
Melanotan II
MT-II · Synthetic melanocortin receptor agonist
01 — Regulatory status
Regulatory status · United States · as of October 2026
Not FDA-approved; FDA has issued consumer warnings. Removed from 503A Category 2 on April 15, 2026, and scheduled for review by the advisory committee before the end of February 2027. It is not on the 503A Bulks List.
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.
Skin tanning, erectile dysfunction (abandoned development).
03 — What the evidence shows
The published record.
Early trials in the 1990s were discontinued. The approved successor compounds are afamelanotide (Scenesse, for erythropoietic protoporphyria) and bremelanotide (Vyleesi). Melanotan II itself has no approved use anywhere.
04 — What is claimed but not shown
Claimed, not demonstrated.
Safe tanning; libido benefit; fat loss.
05 — Known risks
Documented risks.
Documented reports of new or changing moles, melanoma concern, nausea, blood pressure changes; contaminated product from illegal sales.
06 — Researched for these goals
Where Melanotan II 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.
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Ahvie Herskowitz, MD · Ann Lee, MD
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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.