Imcivree
What Imcivree is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
Key facts
- Brand
- Imcivree
- Active substance
- setmelanotide
- Disease area
- Obesity
- Medicine group
- Antiobesity preparations, excl. diet products
- ATC code
- A08AA
- Marketing authorisation holder
- Rhythm Pharmaceuticals Netherlands B.V.
- Authorised in the EU since
- 2021
Official information
In the USA
Same active substance: Imcivree
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Imcivree used for?
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 o…
What is the active substance in Imcivree?
Imcivree contains setmelanotide.
Who makes Imcivree?
The EU marketing authorisation holder is Rhythm Pharmaceuticals Netherlands B.V..
Is Imcivree an orphan medicine?
Yes. Imcivree is designated an orphan medicine in the EU, for a rare disease (Obesity).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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