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setmelanotide

Imcivree · ATC code A08AA

Also known as: Setmelanotid

Key facts
Active substance
setmelanotide
Drug class
Anorectic
ATC code
A08AA
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
IMCIVREE 10 mg/ml solution for injection
Marketing authorisation holder
Rhythm Pharmaceuticals Netherlands B.V.
Information as of
2026-10-28

Key facts

Setmelanotide (Imcivree) is a melanocortin-4 receptor agonist given by subcutaneous injection. It is used for weight and hunger control in rare genetic or hypothalamic forms of obesity.

What it is used for

  • Obesity and control of hunger in acquired hypothalamic obesity (adults and children 4 years and above).
  • Obesity and control of hunger with genetically confirmed Bardet-Biedl syndrome (2 years and above).
  • Obesity and control of hunger with genetically confirmed biallelic POMC (including PCSK1) or LEPR deficiency (2 years and above).

Dosing

  • Once-daily subcutaneous injection with stepwise titration by tolerability and response; schemes differ by indication, age and weight.
  • POMC/LEPR deficiency, 12 years and above: 1 mg once daily for 2 weeks, then 2 mg; if needed 2.5 mg up to a maximum of 3 mg once daily.
  • Bardet-Biedl syndrome, 16 years and above: 2 mg once daily in weeks 1-2, then 3 mg.
  • Acquired hypothalamic obesity, 6 years and above: start at 0.5 mg, increasing weekly to 2 mg or 3 mg.
  • Younger children and severe renal impairment: separate schemes, see the full text.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Generalised increased skin pigmentation and darkening of pre-existing nevi; full body skin examination annually.
  • Monitor heart rate and blood pressure at each visit (at least every 6 months).
  • Spontaneous penile erections; seek emergency care for an erection lasting longer than 4 hours.
  • Depression has been reported; consider stopping if suicidal thoughts occur.

Side effects

  • Very common: hyperpigmentation disorders (66%), injection site reactions (45%), nausea (36%), headache (19%), vomiting, melanocytic naevus.
  • Common: dizziness, depression, insomnia, hot flush, yawning.

Interactions

  • No interaction studies; low potential for pharmacokinetic interactions.

Pregnancy and breastfeeding

  • As a precaution, do not start during pregnancy or while trying to conceive, as weight loss in pregnancy may harm the foetus.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ImcivreeRhythm Pharmaceuticals Netherlands B.V. · EMEA/H/C/005089

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Imcivree
Liechtenstein
Imcivree
Norway
Imcivree

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Imcivree – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/imcivree-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC A08AA.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.