Setmelanotide (Imcivree)_Dosage, benefits & legal status
Also known as Imcivree, RM-493, Setmelanotide
An approved daily shot for rare genetic forms of obesity.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Setmelanotide (Imcivree)?
Plain language first. The technical label stays, but it never stands alone.Overview
For people with rare genetic defects in this exact hunger pathway, it restores the missing 'I'm full' signal. It is FDA-approved only for those specific conditions.
What it's used for
An approved daily shot for rare genetic forms of obesity. It flips a fullness switch in the brain to cut relentless hunger, but it is only for specific diagnosed conditions.
How does Setmelanotide (Imcivree) work?
What it does in the body, and where.Setmelanotide is the clearest example of a drug built for a specific broken mechanism rather than for a symptom.
- 01It switches on MC4R in the brainThe melanocortin-4 receptor, the master switch for hunger, sitting at the end of a signaling chain.
- 02It replaces a signal that never arrivesIn people with rare genetic faults upstream of MC4R, the fullness message is never sent. This supplies it directly at the receptor.
- 03Approved only for those genetic conditionsPOMC, PCSK1, and LEPR deficiency, and Bardet-Biedl syndrome. In people without those faults the pathway is already working, and the drug has little to add.
What else is it used for?
Each use below carries its own evidence level. Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
- Severe obesity and constant hunger caused by certain rare genetic conditions (POMC, PCSK1 and LEPR deficiency, and Bardet-Biedl syndrome)FDA-approved
- Obesity caused by injury or damage to the hypothalamus, the part of the brain that controls hunger, approved in March 2026FDA-approved
The published record
Papers and trials about Setmelanotide (Imcivree)
Searched: Setmelanotide, Imcivree, RM-493.
149 papers tagged human · 71 not reviews or lab · 17 clinical trial publications
27 registered trials · 14 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Setmelanotide (Imcivree)
Evidence
FDA-approved
Category
Weight loss and metabolic
Common vial
10 mg
Half-life
About 11 hours
How much, and do you cycle it?
The range, and whether you take breaks.2 up to 3 mg per day (start low, increase slowly), daily. Not cycled FDA label
Taken continuously for as long as it is working. Neither the label nor clinical practice describes an on/off schedule.
About 11 hoursFDA label
The label calls it the effective elimination half-life. Exposure runs considerably higher in children than in adults at the same dose.
Source: Imcivree label section 12.3, DailyMed setid 70c3ccf7-4df0-4c75-ba07-fede9970c8d9
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
Setmelanotide (Imcivree) starts at $60.00 across 1 vendor.
1 listing, last read Oct 24, 2026. Shipping and card fees are not included.
How do you store it?
Before mixing, and after.Follow the label that came with it.
This is an approved product, and its own label sets how long it keeps once mixed. Those windows vary enormously between products, from use-immediately to about a month, so the label is the only thing worth following here. Vials of the same compound sold by peptide vendors arrive with no label and no established holding time.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 50% charged residues, 62% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Pregnancy
- Only appropriate for specific diagnosed conditions, so it is not a general weight-loss option
Stop and get help
- A mole that changes in size, shape, or color
- Signs of an allergic reaction
- A prolonged erection
Common effects
- Darkening of skin and moles, which is expected
- Injection-site reactions
- Nausea
- Spontaneous erections in men
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Setmelanotide (Imcivree) approved?
And where the numbers on this page come from.Yes. Setmelanotide (Imcivree) is FDA approved and available on prescription in the United States.
- Approval statusFDA-approved
- RouteUnder the skin (subcutaneous)
- Checked22 July 2026
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- Sources
What has happened recently
First approved in November 2020, setmelanotide now carries three indications with three different minimum ages. For obesity caused by POMC, PCSK1 or LEPR deficiency, confirmed by genetic testing, and for obesity caused by Bardet-Biedl syndrome, it is approved from age 2. For acquired hypothalamic obesity, added in March 2026, it is approved from age 4. The genetic confirmation is part of the indication rather than a formality: the drug replaces a missing signal in one specific pathway, so an approval for that pathway says nothing about obesity with any other cause. The label states it is not indicated for ordinary obesity unrelated to those three conditions.
You can compare this against the whole library, or read how to check a seller.
If you're weighing Setmelanotide (Imcivree), it's worth reading 710GO, Adropin, and AT-7687 in the same class.
An approved daily shot for rare genetic forms of obesity.
- Dose
- 2 up to 3 mg per day (start low, increase slowly)
- How often
- Daily
An experimental weight-loss pill aimed at two melanocortin receptors instead of one, so far tested only in animals.
- Dose
- No human dose disclosed
- How often
- Not established (daily in monkeys)
A metabolic hormone measured in blood, sold as though the measurement were a treatment.
- Dose
- Research only
- How often
- Not established
An experimental weekly shot that blocks the GIP receptor, the opposite of what tirzepatide does.
- Dose
- 25 or 50 mg weekly (phase 2 doses)
- How often
- Weekly
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- Semaglutide vs Tirzepatide vs Retatrutide
One receptor, two, or three. Mechanism, trial weight loss, side effects, and real cost.
Sources
- FDA, first approval for rare genetic obesity(2020)First FDA approval for obesity caused by specific rare genetic conditions.
- Rhythm Pharmaceuticals, hypothalamic obesity approval (Mar 2026)(2026)FDA approval for acquired hypothalamic obesity.
- FDA prescribing information for IMCIVREE (setmelanotide), revised March 2026, sections 1, 3 and 16(2026)The current label. Three indications with their minimum ages, and a ready-to-use 10 mg/mL solution in a 1 mL multiple-dose vial.
Beyond these, 263 records are indexed. Browse the records