Imcivree FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 29, 2024.

FDA Approved: Yes (First approved November 25, 2020)
Brand name: Imcivree
Generic name: setmelanotide
Dosage form: Injection
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Weight Loss (Obesity/Overweight)

Imcivree (setmelanotide) is a melanocortin-4 receptor agonist used for weight management in patients with rare, genetic diseases of obesity.

Imcivree is indicated to reduce excess body weight and maintain weight reduction long term by reducing hunger and food intake and increasing energy expenditure in adults and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to:
- Bardet-Biedl syndrome (BBS).
- Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
Variants in certain genes may impair the functioning of the melanocortin-4 (MC4) receptor pathway, which can lead to hyperphagia (a feeling of extreme, insatiable and early-onset, severe obesity.
Imcivree works as an MC4 receptor agonist to reduce hunger and weight in patients with obesity due to genetic disease by restoring the functioning of the MC4 receptor pathway, a key biological pathway that regulates hunger, caloric intake and energy expenditure.
Imcivree is administered subcutaneously once daily.
Imcivree warnings and precautions include disturbances in sexual arousal; depression and suicidal ideation; hypersensitivity reactions; and skin hyperpigmentation, darkening of pre-existing nevi, and development of new melanocytic nevi.
Common adverse reactions include skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

Development timeline for Imcivree

Date	Article
Dec 20, 2024	Approval Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Patients as Young as 2 Years Old
Jun 16, 2022	Approval Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Use in Patients with Bardet-Biedl Syndrome
Nov 27, 2020	Approval FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
Jul 1, 2020	Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
May 13, 2020	Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities
Mar 30, 2020	Rhythm Pharmaceuticals Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Setmelanotide in POMC and LEPR Deficiency Obesities
Mar 18, 2020	Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome
Dec 13, 2018	Rhythm Pharmaceuticals Announces First Patient Enrolled in Pivotal Phase 3 Clinical Trial Evaluating Setmelanotide in Bardet-Biedl and Alström Syndromes
Jun 14, 2018	Rhythm Pharmaceuticals Completes Pivotal Enrollment in Two Ongoing Phase 3 Clinical Trials Evaluating Setmelanotide in Rare Genetic Disorders of Obesity

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Imcivree FDA Approval History

Development timeline for Imcivree

See also

Further information