Imcivree
Imcivree ingredients
| Active ingredient | Strength |
|---|---|
| Setmelanotide | 10 mg/mL |
What Imcivree is used for
The FDA lists the approved uses on the official label (below). In the EU, setmelanotide is approved as Imcivree 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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Imcivree
- Generic name
- Setmelanotide
- Made by
- Rhythm Pharmaceuticals, Inc
- Forms
- Solution
- Given
- Subcutaneous
- Drug class
- Melanocortin 4 Receptor Agonist
- FDA approval
- New drug application (NDA) NDA213793
- On the US market since
- 2020
Official information
- Imcivree prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Setmelanotide)
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?
Imcivree (Setmelanotide) is a specialist medicine made by Rhythm Pharmaceuticals, Inc, approved by the US FDA.
What are the ingredients of Imcivree?
Imcivree contains Setmelanotide (10 mg/mL).
Is Imcivree approved in Europe?
The same active substance is approved in the EU as Imcivree.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA