Setmelanotide
Also referenced as: Imcivree
A melanocortin-4 receptor agonist for narrowly defined causes of obesity.
- Evidence grade
- BModerate Human Evidence
Moderate Human Evidence
- Regulatory status
- FDA Approved for Specific Indication
The March 2026 FDA label includes acquired hypothalamic obesity from age 4 and qualifying BBS or POMC/PCSK1/LEPR deficiency from age 2, subject to label criteria.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A melanocortin-4 receptor agonist for narrowly defined causes of obesity.
The March 2026 FDA label includes acquired hypothalamic obesity from age 4 and qualifying BBS or POMC/PCSK1/LEPR deficiency from age 2, subject to label criteria.
Genetic and diagnostic eligibility matter; results cannot be transferred to common obesity or cosmetic use.
Why It's Being Studied
- Genetic obesity
- Acquired hypothalamic obesity
- Central appetite signalling
Mechanism of Action
Central MC4-receptor activation acts on appetite pathways disrupted in particular genetic or hypothalamic disorders.
Central MC4-receptor activation acts on appetite pathways disrupted in particular genetic or hypothalamic disorders. Genetic and diagnostic eligibility matter; results cannot be transferred to common obesity or cosmetic use.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Genetic obesity
- Acquired hypothalamic obesity
- Central appetite signalling
- Subcutaneous approved medicine
Evidence Summary
Clinical studies support weight and hunger responses in the specifically approved populations, not routine obesity treatment.
Higher tiers carry more weight. Filled tiers have evidence for Setmelanotide; tap to read it.
- Clinical studies support weight and hunger responses in the specifically approved populations, not routine obesity treatment.
1 cited sources.
- Prescribing label1
Human clinical evidence
- Clinical studies support weight and hunger responses in the specifically approved populations, not routine obesity treatment.
Reported Adverse Events in Research
- Pigmentation and nevus changes, sexual-arousal effects, depression and suicidal ideation require attention.
Limitations of Current Evidence
- Genetic and diagnostic eligibility matter; results cannot be transferred to common obesity or cosmetic use.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Setmelanotide | Trofinetide | |
|---|---|---|
| Evidence grade | B — Moderate Human Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Subcutaneous approved medicine | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Prescribing label
Setmelanotide — prescribing label