Metabolic · Dosing reference

Setmelanotide dosage

Dosing as the FDA label states it, how long trials ran, and the arithmetic for working with vials.

FDA-approvedAHuman trial evidenceFDA label

Full research page Cycle-length evidence Compare Prefer Amiravo on Google

Regulatory status: FDA-approved
Human amounts: Maintenance 3 mg once daily for patients aged 6 and older (all indications), after a 2-week starting dosage of 0.5 mg (acquired HO) or 2 mg (BBS/POMC/PCSK1/LEPR, age 12+); weight-based maintenance under age 6 (IMCIVREE label)
Route studied: Subcutaneous injection
Frequency: Once daily
Half-life: About 11 hours
Evidence grade: Grade A · Human trial evidence
Vial sizes on the market: Not recorded
Other forms seen: —

What Setmelanotide is

Setmelanotide is a cyclic eight-residue melanocortin-4 receptor agonist that the FDA approved in 2020 as Imcivree for obesity caused by specific genetic MC4R-pathway disorders, with acquired hypothalamic obesity added to the label by 2026.

Setmelanotide activates the melanocortin 4 (MC4) receptor, which is involved in regulating hunger, satiety and energy expenditure in the brain; it has about 20-fold less activity at MC3 and MC1 receptors ^1. Why it targets specific disorders The label states that, based on nonclinical evidence, it may re-establish MC4 receptor pathway signaling when obesity stems from insufficient MC4 receptor activation, as in… How it works →

Key evidence

Clément et al., Lancet Diabetes Endocrinol · 2020 · Humans (10 with POMC/PCSK1 deficiency, 11 with LEPR deficiency)
80% (POMC) and 45% (LEPR) reached at least 10% body-weight reduction at about 1 year; no serious treatment-related adverse events ^3. ³
Haqq et al., Lancet Diabetes Endocrinol · 2022 · Humans (38 with Bardet-Biedl or Alström syndrome)
32.3% of patients aged 12 or older with Bardet-Biedl syndrome reached at least 10% body-weight reduction at 52 weeks; hyperpigmentation in 61% ^4. ⁴
Miller et al., N Engl J Med (TRANSCEND, NCT05774756) · 2026 · Humans (120 aged 4-66 with acquired hypothalamic obesity)
BMI change -16.5% versus +3.3% with placebo; hunger scores fell more; serious adverse events 28% versus 8% ^5. ⁵

All studies on the research page

Dosing as stated on the FDA label

Acquired hypothalamic obesity, age 4 and older (IMCIVREE): starting dosage 0.5 mg subcutaneously once daily for 2 weeks, then titrated per the label's tables ^1.
BBS or POMC, PCSK1 or LEPR deficiency: starting dosage 2 mg once daily for 2 weeks (age 12 and older), 1 mg (age 6 to under 12) or 0.5 mg (age 2 to under 6) ^1.
Recommended maintenance dosage for adults and children aged 6 and older for all indications is 3 mg subcutaneously once daily; for younger children the maintenance dosage is based on body weight ^1.
The label specifies dose reductions if starting or escalated dosages are not tolerated, dosing in renal impairment, and patient selection by clinical or genetic diagnosis; those details are in the prescribing information and not reproduced here ^1.

How long did human studies run?

No human study durations are recorded for Setmelanotide.

Cycle-length evidence for Setmelanotide

Side effects reported in studies

Skin hyperpigmentation
Majority of treated patients; 67% versus 0% placebo in the 14-week BBS placebo period · Label clinical trials ¹
Spontaneous or increased penile erections
7% versus 4% placebo (acquired HO trial); 8% (BBS trial) · Males in label trials ¹
Acute adrenal insufficiency (serious)
5% versus 0% placebo · Acquired HO with secondary adrenal insufficiency ¹
Hyponatremia / hypernatremia
6% versus 2% / 5% versus 4% · Acquired HO with central diabetes insipidus ¹
Vomiting
11% versus 0% placebo · BBS trial, 14-week placebo period ¹
Serious adverse events (any)
28% versus 8% placebo · TRANSCEND, acquired hypothalamic obesity ⁵

Full adverse-event data

Supplies and handling

Lyophilized vial
Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
Sterile diluent
The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
Graduated syringes
Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
Alcohol prep pads
For wiping vial stoppers before each puncture.
Nitrile gloves
Clean gloves for aseptic handling.
Sharps container
Puncture-resistant container for used needles.

Step-by-step reconstitution guide Storage and transport accessories

Storage

Follow the current IMCIVREE label for storage of vials; research material per supplier documentation.

Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent: The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed: Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles: Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution: This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed: Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status: FDA-approved as IMCIVREE (NDA 213793, original approval November 25, 2020) ^2. The April 2, 2026 label covers people aged 4 years and older with acquired hypothalamic obesity and aged 2 years and older with Bardet-Biedl syndrome or POMC, PCSK1 or LEPR deficiency; it is not indicated for other genetic syndromes or general (polygenic) obesity ^1.
United States (FDA): FDA-approved under NDA 213793 (IMCIVREE, Rhythm), original approval November 25, 2020 per Drugs@FDA ^2; indications per the April 2, 2026 DailyMed label include acquired hypothalamic obesity, Bardet-Biedl syndrome and POMC, PCSK1 or LEPR deficiency ^1.
Sport (WADA): Setmelanotide is not named in the 2026 Prohibited List text reviewed; as an approved drug it falls outside S0, so status should be confirmed with the relevant anti-doping organization ^6.

Status varies by country and changes over time. How we describe regulatory status.

Setmelanotide compared with related compounds

Compound	Status	Evidence	Human amounts	Half-life
Setmelanotide	FDA-approved	A	FDA label	About 11 hours
Tesofensine	Investigational	B	Trial doses	About 234 hours (M1 metabolite about 374
Mazdutide	Approved outside the US	A	Trial doses	150.9 to 403.5 hours (phase 1b in overwe
Cagrilintide	Investigational	A	Trial doses	159 to 195 hours (phase 1b, co-administe
SLU-PP-332	Not approved — research use only	C	None established	Unknown in humans
MariTide (maridebart cafraglutide)	Investigational	A	Trial doses	Not reported numerically in the sources

Frequently asked questions

What doses of Setmelanotide have been studied in humans?

Setmelanotide is FDA-approved, so the label states the dosing for the approved product. This page quotes it, with citations. It does not apply to research-grade material.

Is there an established Setmelanotide cycle length?

No. We found no human studies that report treatment duration for Setmelanotide.

How much bacteriostatic water should be added to a Setmelanotide vial?

There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.

How many units is a given amount on an insulin syringe?

On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.

What is the half-life of Setmelanotide?

About 11 hours

Is Setmelanotide FDA-approved?

FDA-approved. FDA-approved as IMCIVREE (NDA 213793, original approval November 25, 2020) ^2. The April 2, 2026 label covers people aged 4 years and older with acquired hypothalamic obesity and aged 2 years and older with Bardet-Biedl syndrome or POMC, PCSK1 or LEPR deficiency; it is not indicated for other genetic syndromes or general (polygenic) obesity ^1.

References

IMCIVREE (setmelanotide) injection, prescribing information (DailyMed SPL version 14, published Apr 02, 2026) FDA label (DailyMed). 2026
Drugs@FDA application NDA 213793 (IMCIVREE, Rhythm; original approval 2020-11-25) via openFDA FDA (openFDA Drugs@FDA). 2026
Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials Lancet Diabetes Endocrinol. 2020
Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period Lancet Diabetes Endocrinol. 2022
Setmelanotide for the Treatment of Acquired Hypothalamic Obesity N Engl J Med. 2026
Tractatenblad 2026 Nr. 25: Anti-doping convention (ETS No. 135), amendment to the appendix - The 2026 Prohibited List, World Anti-Doping Code (English text; entry into force 1 January 2026) Tractatenblad van het Koninkrijk der Nederlanden (official government publication). 2026
PubChem compound record for setmelanotide (CID 11993702) PubChem. 2026

Last reviewed October 24, 2026 by the Amiravo editorial team. Editorial policy · Report an error