Prescription medicine
Setmelanotide Brand names: Imcivree
Setmelanotide (Imcivree) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the setmelanotide FDA label on DailyMed (effective April 1, 2026, Rhythm Pharmaceuticals, Inc); the NDA 213793 record on Drugs@FDA; every setmelanotide label on DailyMed.
Highlights of the record
FDA label of April 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin rece
Forms and strengths
- 10 mg/ml
Solution.
On the market
- Earliest approval on file
- November 25, 2020 Imcivree, Rhythm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 4, 2034 Imcivree injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 270 through July 30, 2026
What is setmelanotide used for?
From the label: indications and usageIMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). […]
Conditions named in the indications of setmelanotide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Melanocortin 4 Receptor Agonist.
Source: FDA drug label (Imcivree), Rhythm Pharmaceuticals, Inc, effective April 1, 2026 (SPL set 70c3ccf7-4df0-4c75-ba07-fede9970c8d9), via openFDA; the full label on DailyMed
Is there a generic for setmelanotide (Imcivree)?
No generic setmelanotide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Imcivree injection: the compound patent runs to August 21, 2032, and the last listed entry to July 4, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the setmelanotide label say about other medicines?
The setmelanotide label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Arginine | warnings and precautions | Imbalance in Patients with Acquired HO and Central Diabetes Insipidus In a clinical trial of adults and pediatric patients aged 4 years and older with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency, hyponatremia was reported in 6% of IMCIVREE-treated patients and 2% … |
Source: FDA drug label (Imcivree), Rhythm Pharmaceuticals, Inc, effective April 1, 2026 (SPL set 70c3ccf7-4df0-4c75-ba07-fede9970c8d9), via openFDA; the full label on DailyMed
What do FAERS reports show for setmelanotide?
The FDA Adverse Event Reporting System holds 270 reports that list setmelanotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 96 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Setmelanotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other