Evidence strength for the context described on this page.
PEPTIDE ATLAS / METABOLIC & FAT LOSS / SETMELANOTIDE
FDA-approvedHigh for approved indication
Setmelanotide
ALSO KNOWN ASImcivree
A precision therapy for obesity caused by specific rare genetic pathway disorders.
01CATEGORYMetabolic & fat loss
02REGULATORY STATUSFDA-approved
03COMMON ROUTESubcutaneous injection once daily
04DOSE BASISFDA-approved label
HOW TO USE THIS PAGE
Read the profile in the order that protects the decision.
- 01Verify what it is
Confirm the exact molecule, route, regulatory lane and actual human evidence.
- 02Read limits before dose
Unsupported claims, contraindications and uncertainty come before any protocol.
- 03Build the monitoring plan
Define the target, baseline checks, reassessment point and stop rules with a qualified clinician.
RESEARCH PASSPORT
The five facts to know first.
REVIEWED
JULY 2026
Status is product-, formulation- and indication-specific.
Trial, label or reported-practice basis is always named.
Official labels, regulators, trials and indexed literature where available.
Peptide hormones, growth factors and related substances may be prohibited.
Check Global DRO ↗OVERVIEW
What Setmelanotide is.
A melanocortin-4 receptor agonist for genetically or clinically defined rare disorders that impair MC4R-pathway signaling. It is not a treatment for common polygenic obesity.
HOW IT IS THOUGHT TO WORK
Activates MC4 receptors in the hypothalamic appetite pathway, reducing hunger and supporting energy expenditure when the pathway defect is upstream and responsive.
EFFECTS & EVIDENCE
What the evidence supports—and what it does not.
- Reduced hunger and weight in eligible rare-disease populations
- Targets a defined biological pathway rather than general appetite alone
- Use for ordinary obesity
- Use without genetic or specialist evaluation
- Cosmetic weight loss
Evidence grade: High for approved indication. For an approved drug, “high” refers only to its labeled indication—not every off-label or wellness claim.
DOSAGE CONTEXT
Best available dosing range.
FDA-approved labelCurrent U.S. labeling is diagnosis-specific. For BBS or POMC, PCSK1 or LEPR deficiency in adults and patients age 12 or older, start 2 mg subcutaneously once daily for 2 weeks and increase to a 3 mg once-daily maintenance dose if tolerated. Acquired hypothalamic obesity uses a slower 0.5 mg to 1 mg to 2 mg to 3 mg escalation over 6 weeks. Pediatric and severe-renal-impairment schedules differ.
- Route
- Subcutaneous injection once daily
- Duration
- Chronic; response criteria determine continuation
- Men & women
- No routine sex-based dose; pregnancy and reproductive plans require specialist review.
Clinician verification required. Always double-check the exact molecule or salt, concentration, route, volume, schedule, indication, patient-specific contraindications, interactions and applicable law with the prescribing clinician and dispensing pharmacy. A disclaimer does not make an unapproved product FDA-approved, and a reported-use range is not a prescription.
MONITORING
What should be tracked.
- Hunger and weight response
- Skin and hair pigmentation changes
- Sexual adverse effects
- Mood and depression symptoms
SAFETY
Risks, red flags and reasons to avoid it.
- Skin hyperpigmentation and darkening of existing nevi
- Spontaneous erections or sexual adverse reactions
- Depression or suicidal ideation warning
- Injection-site reactions
- Use without a qualifying diagnosis
- Unexamined changing skin lesions
- Continuing without label-defined response
Stop and seek careGet urgent medical help for trouble breathing, facial or throat swelling, chest pain, fainting, severe persistent abdominal pain, neurologic changes, severe hypoglycemia, uncontrolled vomiting or a prolonged painful erection.
CLINICIAN VISIT CHECKLIST
Six questions worth bringing with you.
Molecule or analog, salt, concentration, route, manufacturer or compounder, lot and beyond-use date.
Name the diagnosis or target, how it will be measured and the realistic time to reassess.
Ask how it compares with FDA-approved, lower-risk or better-studied alternatives.
Label, human trial, specialty guideline or clinic convention—and whether that route and formulation match.
Baseline checks, follow-up measures, interactions, pregnancy considerations and symptoms that mean stop.
Pharmacy license, prescription, identity/potency testing, sterility controls and who handles a product complaint.
Do not improvise reconstitution or convert “units” without the exact concentration. Mixing, storage and beyond-use instructions are product-specific; confirm them with the dispensing pharmacy.
PRIMARY SOURCES
Read the record yourself.
We prioritize official prescribing information, FDA regulatory material, registered trials and indexed biomedical literature. A source supports the specific statement beside it—not every claim made about the molecule.
PRODUCTS & TREATMENT ACCESS
Use a verified prescription pathway.
Specialty prescription product for specific rare conditions.
It belongs in a peptide atlas because it shows what true precision peptide medicine looks like: biomarker-defined indication, specialist selection and a regulated product.
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Coming soon: indication-matched clinicians, transparent pricing, required monitoring and verified prescription sourcing.
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