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FDA-approvedMetabolic Imcivree

Setmelanotide

An approved melanocortin peptide — but only for specific genetic obesity syndromes.

Class
MC4 receptor agonist
Molar mass
1,117 g/mol
Half-life
~11 h
Human PK
Fully characterised
Regulatory
FDA-approved (rare genetic obesity)
Sport
Not prohibited

What it is claimed to help

These are the uses attached to Setmelanotide in research, clinical practice, or marketing. Listing a claim is not endorsing it — tap any of them to see every other compound carrying the same claim.

What the human evidence actually is

Grade: FDA-approved

Approved by the FDA with randomised human trial data behind the label.

Pivotal trials in POMC and LEPR deficiency and in Bardet-Biedl syndrome showed substantial weight and hunger reduction. Approval is narrow and genetics-gated: it is not a general obesity drug and does not work like one.

How it is supposed to work

Restores signalling through the MC4 receptor in the hypothalamic melanocortin pathway, which is broken in these specific genetic conditions.

Safety

Skin hyperpigmentation, injection site reactions, nausea, spontaneous penile erections, depression and suicidal ideation have been reported.

Storage and handling

Lyophilised peptide is generally stored at 2–8 °C, or below −20 °C for long-term storage. Reconstituted in bacteriostatic water (0.9% benzyl alcohol) a solution is typically treated as usable for about 28 days refrigerated, versus roughly 24 hours for plain sterile water, which has no preservative. Add the water slowly down the vial wall and swirl — never shake, which shears peptide chains and foams the solution.

The arithmetic is the dangerous part

Whatever number a protocol or a prescriber gave you, converting it into syringe units is where a misplaced decimal becomes a tenfold error. Our calculators do that conversion and nothing else — they never invent a dose.

Open the calculators

Sources

  1. FDA prescribing information, Imcivree
  2. Clément K et al. NEJM / Lancet D&E pivotal trials

Verified against primary sources on 27 August 2026. Regulatory status in this field changes several times a year. See How We Rate Evidence.

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