Longevity network
Longevity Centers of America (Netzwerk)
- Hormone therapy (HRT / BHRT)
- Peptide therapy
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§ — Substance profile
D
Melanotan II
MT-II · Synthetic melanocortin receptor agonist
01 — Regulatory status
Regulatory status · United States · as of September 2026
Not FDA-approved; FDA has issued consumer warnings. Previously withdrawn from review; FDA has announced a further PCAC meeting before the end of February 2027 to reconsider it.
Source: FDA 503A Bulks List · PCAC meeting records · verified September 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 September 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?
Providers offering peptide therapy
Listing in the registry is not an endorsement of any substance or protocol, and it is not a statement that a treatment is approved.
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.