How much water do I add to Setmelanotide (Imcivree)?

You can reconstitute Setmelanotide (Imcivree) with 0.5, 1, or 2 mL of bacteriostatic water. Each option produces a different concentration and syringe draw for the same dose. Use the calculator to see which is easiest to measure.

What does Setmelanotide (Imcivree) cost per dose?

Cost per dose depends on vial size, price paid, and your dose. Enter your vendor's price in the Setmelanotide (Imcivree) calculator to see cost per dose and monthly cost.

What is the reference dose for Setmelanotide (Imcivree)?

The commonly referenced range is 2 up to 3 mg per day (start low, increase slowly), taken daily. This is reference information, not a recommendation. Talk to a licensed clinician.

What are the side effects of Setmelanotide (Imcivree)?

Reported side effects of Setmelanotide (Imcivree) include: It can darken skin and moles, cause nausea, and irritate the injection site.; It is only appropriate for diagnosed genetic obesity.. Severity and frequency vary by person and dose.

Who should not take Setmelanotide (Imcivree)?

Setmelanotide (Imcivree) is generally not appropriate for: Pregnancy; Only appropriate for specific diagnosed conditions, so it is not a general weight-loss option. Talk to a licensed clinician before starting.

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Decoding

Setmelanotide (Imcivree)_Dosage, benefits & legal status

Also known as Imcivree, RM-493, Setmelanotide

By the Peptide Decoding Editorial Team

Published July 22, 2026 · Updated August 14, 2026

An approved daily shot for rare genetic forms of obesity.

Weight loss (genetic)MC4R agonistFDA-approved

InFat loss without GLP-1

Common vial size10 mg

Dose2 up to 3 mg per day (start low, increase slowly)

FrequencyDaily

RouteUnder the skin (subcutaneous)

StatusFDA-approved

MixYour choice, calculate it

CycledNot cycled

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.

The technical version

Setmelanotide is an MC4R agonist that switches on the brain's melanocortin-4 receptor, a master control for hunger.

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.

01
It switches on MC4R in the brain
The melanocortin-4 receptor, the master switch for hunger, sitting at the end of a signalling chain.
02
It replaces a signal that never arrives
In people with rare genetic faults upstream of MC4R, the fullness message is never sent. This supplies it directly at the receptor.
03
Approved only for those genetic conditions
POMC, 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.

Where it acts

Brain

Where this compound is thought to act.

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

Research index

251

Records indexed for Setmelanotide (Imcivree)

144 in humans, 68 of them original studies.

27 registered trials, 14 with posted results.

Browse the records

In animalsPro

In the labPro

ReviewsPro

Senior author sharePro

Counted from Europe PMC indexing, not read by a person. Human means indexed under humans, which includes reviews and work on human cells. Original studies exclude reviews and lab work on human cells.Last updated 12 September 2026.

Compound field notes

At a glance

Four things to know about Setmelanotide (Imcivree)

Evidence

FDA-approved

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 cycledFDA label

Taken continuously for as long as it is working. Neither the label nor clinical practice describes an on/off schedule.

Compare this against the whole library →

How long does it stay in the body?

The half-life, and where the figure comes from.

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.

Your vial size (mg)

Printed on the vial.

What you paid per vial

Used for cost per dose only.

Your dose (mg)

Commonly referenced range: 2 up to 3 mg per day (start low, increase slowly)FDA label

Choose your mix

0.5 mL water10units · 20 mg/mL

Half a 100-unit syringe

1 mL water20units · 10 mg/mL

One full 100-unit syringe

Easiest

2 mL water40units · 5 mg/mL

Two full 100-unit syringes

your own mL

units · —

Enter your own volume

Measuring the water1 mL = one full 100-unit syringe.

Your draw

40 / 100 units

Full calculator with reorder date →Read a syringe →

How do you store it?

Before mixing, and after.

Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.

Unmixed lyophilized Setmelanotide (Imcivree) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.

What are the side effects and cautions?

Known cautions and warnings for this compound.

Who should avoid it

Check these before anything else.

Pregnancy
Only appropriate for specific diagnosed conditions, so it is not a general weight-loss option

Stop and get help

These are emergencies. Seek care.

A mole that changes in size, shape, or color
Signs of an allergic reaction
A prolonged erection

Common effects

Expected, and usually mild.

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 status
FDA-approved
Route
Under the skin (subcutaneous)
Checked
July 2026

What has happened recently

FDA-approved in November 2020 for chronic weight management in people aged six and over whose obesity is caused by POMC, PCSK1 or LEPR deficiency, confirmed by genetic testing. 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. It was later extended to Bardet-Biedl syndrome, another rare genetic condition.

You can compare this against the whole library, or read how to check a seller.

DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
Vial sizeFrom what vendors typically list; not a recommendation.
Sources
FDA, first approval for rare genetic obesity Rhythm Pharmaceuticals, hypothalamic obesity approval (Mar 2026)FDA prescribing information, IMCIVREE (setmelanotide) injection for subcutaneous use, revised March 2025
Reviewed22 July 2026

What else is like Setmelanotide (Imcivree)?

Others in Fat loss without GLP-1, side by side.

If you're weighing Setmelanotide (Imcivree), it's worth reading GHRP-6, Humanin, and Melanotan II in the same class.

YOU ARE HERE

Setmelanotide (Imcivree)

An approved daily shot for rare genetic forms of obesity.

FDA-approved

Dose: 2 up to 3 mg per day (start low, increase slowly)
How often: Daily

GHRP-6

A growth-hormone shot that also triggers strong hunger, used for bulking.

Research only

Dose: 0.1 up to 0.3 mg per dose (start low, increase slowly)
How often: 1-3x daily

HUM

Humanin

A natural longevity peptide studied for cell protection and aging.

Research only

Dose: Research only
How often: As studied

MT-2

Melanotan II

A shot for a fast, deep tan, plus libido and appetite effects.

Research only

Dose: 0.25 up to 1 mg per dose (start low, increase slowly)
How often: Daily loading, then maintenance

See other fat loss without glp-1

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, IMCIVREE (setmelanotide) injection for subcutaneous use, revised March 2025(2025)
The prescribing information, and it opens with the sentence anyone reading this page most needs. Under Limitations of Use, FDA states that IMCIVREE is not indicated for obesity unrelated to Bardet-Biedl syndrome or to POMC, PCSK1 or LEPR deficiency, including general polygenic obesity, because it would not be expected to be effective. This is a drug for rare genetic conditions in which one specific brain pathway is broken, not a weight-loss peptide. The efficacy numbers reflect that. In the 44-patient Bardet-Biedl trial the placebo-adjusted BMI difference at 14 weeks was 4.5%, and over 52 weeks mean BMI fell 7.9%, with 61% losing at least 5% and 39% at least 10%. In the genetic deficiency studies the results split sharply by gene: 80% of the ten POMC or PCSK1 patients lost at least 10% of body weight in a year, against 46% of the eleven with LEPR deficiency, with mean weight changes of 23.1% and 9.7%. When the drug was withdrawn for four weeks, patients regained about 5 kg. The warnings are substantial and specific. Depression occurred in 26% of patients aged six and over and suicidal ideation in 11%, with a labelled instruction to monitor and consider stopping. Spontaneous erections occurred in 24% of males. Skin darkening occurred in 67% of patients aged six and over and 83% of younger children, new or darkening moles in 16% and 33%, and the label requires a full body skin examination before starting and periodically after. Anaphylaxis has been reported. Half-life is about 11 hours, and in one small study 43% of LEPR patients developed antibodies against their own alpha-MSH.

Last reviewed 22 July 2026

Beyond these, 251 records are indexed. Browse the records