Setmelanotide (Imcivree)

An FDA-approved daily shot for rare genetic forms of obesity caused by problems in the brain's MC4R hunger pathway.

Evidence: Extensive clinical research
Half-life: ~11 hours
Sources: 3 cited

Is setmelanotide FDA-approved?

FDA-approved (2020 for POMC, PCSK1 and LEPR deficiency; 2022 for Bardet-Biedl syndrome).

Overview

Setmelanotide switches on MC4R, a key "I'm full" switch in the brain. It's approved for obesity caused by POMC, PCSK1 or LEPR deficiency and for Bardet-Biedl syndrome. It isn't meant for common obesity; a genetic test confirms who it can help.

How it works

In these conditions the brain's fullness signal is broken upstream of MC4R. Setmelanotide switches MC4R on directly, restoring the signal and lowering hunger.

How long does setmelanotide stay in the body?

About 11 hours; taken once daily.

What it's studied for

Genetic obesity (POMC, PCSK1, LEPR deficiency)
Bardet-Biedl syndrome
Hypothalamic obesity

Reported side effects

Darkening of skin and moles
Injection-site reactions, nausea
Spontaneous erections in males
Depression or suicidal thoughts (warning)

Sources

The studies and prescribing labels this page is written from.