Setmelanotide
Centrally Acting Antiobesity Products
Sold as IMCIVREE
- Drug class
- Centrally Acting Antiobesity Products
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 3
- Products on record
- 4
Overview
Setmelanotide is an active pharmaceutical ingredient in the Centrally Acting Antiobesity Products group (A08AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 2 | March 13, 2026 |
| EU European Union | EMA | 1 | May 27, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
2 products
Uses
IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), 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.
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
CACanada· Health Canada
1 product
Uses
1 Pediatrics Pediatrics (<6 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients below 6 years of age.
Pediatrics (6 to 17 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of IMCIVREE in pediatric patients (6 to 17 years of age) have been established. Therefore, Health Canada has authorized an indication for pediatric use (see 1 INDICATIONS).
IMCIVREE contains the preservative benzyl alcohol, which has been associated with serious and fatal adverse reactions including “gasping syndrome” in neonates and low birth weight infants (see 7 WARNINGS AND PRECAUTIONS). 2 Geriatrics Geriatrics: Clinical studies of IMCIVREE did not include patients aged 65 and over.
It is not known whether geriatric patients would respond differently than younger adult patients.
Sources & citations
- [1]MHRA (UK) · PLGB555870001 · revised March 13, 2026
- [2]European Medicines Agency · EMEA/H/C/005089 · revised May 27, 2026
- [3]Health Canada (DPD) · 02537745 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.