Imcivree (setmelanotide): label, dosing, who it treats

Key takeaways

• Imcivree (setmelanotide) is an MC4 receptor agonist given as a once-daily injection under the skin. It treats a short list of rare obesity conditions, not general weight loss .
• The approved conditions are acquired hypothalamic obesity (age 4 and up), Bardet-Biedl syndrome (age 2 and up), and POMC, PCSK1, or leptin-receptor (LEPR) deficiency confirmed by genetic testing (age 2 and up) .
• The hypothalamic obesity use is new. The FDA added it in March 2026, making Imcivree the first approved treatment for that condition .
• The dose depends on age and condition. Starting doses run from 0.5 mg to 2 mg once daily for two weeks, then the prescriber adjusts up to a usual maximum of 3 mg once daily for patients 6 and older .
• The most common effect is skin and mole darkening, which happens in the majority of patients, along with injection-site reactions and nausea .

Who Imcivree is actually for

All of these are conditions where the body's appetite control is broken, so people feel intense, hard-to-override hunger and gain weight in a way ordinary diet advice does not touch. Imcivree is approved to reduce that excess weight and help keep it off long term .

The dose: by age and condition, then titrate

Imcivree is injected under the skin once a day. Every group starts low for the first two weeks, then the prescriber adjusts the dose based on how the person responds and tolerates it .

After the first two weeks, the dose is increased as needed. The usual maximum is 3 mg once daily for patients 6 and older; for the youngest group (2 to 5 years) the maximum is lower and set by the label .

• Where to inject: the abdomen, thigh, or arm, rotating to a different spot each day .
• The product: a 10 mg/mL solution in a small 1 mL multiple-dose vial .
• Missed a dose? Do not double up. Just resume the once-daily schedule with the next scheduled dose .

What it is: the brain's appetite switch, turned back on

Setmelanotide is an MC4 receptor agonist . The MC4 receptor is a control point in the brain's melanocortin pathway that helps set appetite and energy balance .

In the conditions Imcivree treats, that pathway is broken, by a genetic fault or by hypothalamic injury, so the off-switch for hunger never really fires. Setmelanotide steps in downstream and activates MC4R directly, which is why it can work even when the upstream signal is missing . For the full mechanism, how setmelanotide works on the MC4R pathway and the melanocortin system explained go deeper.

It first reached the market in 2020, approved for POMC, PCSK1, and LEPR deficiency, then expanded to Bardet-Biedl syndrome, and most recently to acquired hypothalamic obesity in March 2026 .

The warnings that actually come up

• Sexual effects: spontaneous erections in males and changes in sexual arousal in females are listed effects .
• Mood: depression and suicidal ideation have occurred, so mood is monitored .
• Allergic reactions: serious hypersensitivity, including anaphylaxis, has been reported; a prior serious reaction to setmelanotide is the one contraindication .

Hypothalamic obesity comes with two extra cautions, because that population can have other hormone problems. About 5% of treated patients had acute adrenal insufficiency, and sodium imbalance showed up too (about 6% low sodium, 5% high sodium), so those are watched closely in HO patients .

The most common adverse reactions overall, each at 20% or more in at least one approved use, are skin hyperpigmentation, injection-site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection .

What Imcivree is not

It helps to be clear about the edges, because setmelanotide gets talked about loosely online. Imcivree is prescription-only, and for the genetic deficiencies the approved use includes a confirmed genetic test, not a self-diagnosis .

It is also not a general obesity or GLP-1-style weight drug. The label is deliberately narrow: acquired hypothalamic obesity, Bardet-Biedl syndrome, and the three named deficiencies . If your interest is everyday weight management, that is a different conversation and a different class of drug. And the skin darkening is not a bug you can dose around; it is a built-in effect of activating this pathway, and it affects most users .

For research and educational purposes only. Not medical advice.

pepSmart has not commissioned independent clinical review of this article.

More on how we write and source these pieces: Editorial process and contributor disclosure and Sourcing posture.

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Sources: 4 entries, three primary canon (the FDA IMCIVREE label, the 2020 FDA approval announcement, and a peer-reviewed MC4R pathway review) plus one reputable secondary source (a WebMD drug update for the March 2026 approval date), acknowledged inline. Last reviewed 2026-06-26.

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