Setmelanotide
Also known as: Imcivree
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, setmelanotide is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity due to hypothalamic injury or impairment. It is also indicated in the European Union for adults and children 2 years of age and above with genetically confirmed Bardet Biedl syndrome, or with genetically confirmed loss-of-function biallelic pro-opiomelanocortin, including PCSK1, deficiency or biallelic leptin receptor deficiency. In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients 4 years and older with acquired hypothalamic obesity. It is also indicated in the United States for patients 2 years and older with Bardet-Biedl syndrome, or with pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency confirmed by genetic testing.
From: Source: European Medicines Agency (EMA), Imcivree — EPAR, 27/05/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 2469247 setmelanotide
- EMA
- EMEA/H/C/005089
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Imcivree
Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.
Source: European Medicines Agency (EMA), Imcivree — EPAR, 27/05/2026. © European Medicines Agency.
Document date: 27/05/2026 · Official document →
FDA (USA) Imcivree
1 INDICATIONS AND USAGE IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged (1): 4 years and older with acquired hypothalamic obsesity (HO). 2 years and older with Bardet-Biedl syndrome (BBS). 2 years and older with pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by an genetic test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). Limitations of Use: IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective: Obesity due to suspected POMC, PCSK1, or LEPR-deficiency with POMC , PCSK1 , or LEPR variants classified as benign or likely benign. ( 1 ) Other types of obesity not related to acquired HO, BBS or POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity. ( 1 ) 1.1 Limitations of Use: IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective: • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign. • Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity
Data provided by the U.S. Food and Drug Administration.
Document date: 20260401 · Official document →
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Setmelanotide approved for in the European Union?
Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above. (Source: European Medicines Agency (EMA), Imcivree — EPAR, 27/05/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Imcivree — EPAR, 27/05/2026. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
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