Imcivree (setmelanotide)

An FDA-approved weight-loss shot, but only for people with certain rare genetic or brain-related types of obesity. It is not for regular weight loss.

AI illustration of a vial labeled Setmelanotide — AI illustration

FDA statusFDA approved

The FDA approved it as a prescription medicine for certain uses.

Proof it works in people for weight in certain rare kinds of obesitySome

A small trial in a rare disease met its goal.

Safety data in peopleLimited

Small groups, because the diseases are rare.

These are 3 different questions. FDA status is about the law. Proof is about whether it works. Safety data is about how much we know about its risks. A lack of safety data does not mean it does not work, and "not approved" does not mean "illegal."

By the Peptide Science Desk Editorial TeamFact-checked against FDA and official sources · Oct 18, 2026Not yet reviewed by a licensed clinician. How we check facts

What is it?

Setmelanotide is a lab-made peptide medicine. It turns on a hunger switch in the brain called MC4R. The brand is Imcivree. You need a prescription.

Why do people use it?

Imcivree helps lower extra weight in people with certain rare causes of obesity. These include Bardet-Biedl syndrome, some gene problems (POMC, PCSK1, or LEPR) confirmed by a gene test, and obesity caused by damage to a brain area called the hypothalamus.

Does it really work?

It is proven and FDA-approved (first in 2020) for those rare conditions. The label says it is not expected to work for obesity that does not have one of those causes.

Studies in people

Study	People	What they found	Limits
Randomized trial (phase 3)	38	32% of people 12 and older with Bardet-Biedl syndrome lost at least 10% of weight in 52 weeks.	Rare disease, small. Darker skin was common.

We only list studies we read on PubMed or ClinicalTrials.gov. Checked October 18, 2026.

The numbers in a chart

Setmelanotide (Imcivree) in Bardet-Biedl syndrome

38 people with a rare genetic obesity, 1 year on the drug

Lost at least 10% of their weightPeople age 12 and up with Bardet-Biedl syndrome

32.3%

Skin got darkerAll 38 people

61%

Only for rare gene-related obesity, not regular weight loss.

Show the numbers as a table

Setmelanotide (Imcivree) in Bardet-Biedl syndrome: 38 people with a rare genetic obesity, 1 year on the drug
Result	% of people
Lost at least 10% of their weight People age 12 and up with Bardet-Biedl syndrome	32.3%
Skin got darker All 38 people	61%

The placebo part lasted only 14 weeks. After that everyone got the drug, so the 1-year result has no placebo group. Paid for by Rhythm Pharmaceuticals, which makes it. Sources: Haqq et al., Lancet Diabetes Endocrinol 2022 (PMID 36356613).

More charts: Peptides by the numbers

Is it safe? Side effects

Common side effects on the label include darker skin, shot-site reactions, feeling sick, headache, diarrhea, belly pain, throwing up, depression, and erections that happen on their own.
The label warns about depression and thoughts of suicide. Tell a doctor right away about mood changes.
Get emergency help for an erection that lasts more than 4 hours.

Is it legal in the US?

Yes. Imcivree is FDA-approved for its labeled uses. (The FDA is the US agency that checks if medicines are safe and work.) Using it for regular weight loss is not an approved use.

What "not approved" does and does not mean

With a prescription, it is legal to use for the uses on its FDA label.
Doctors may also prescribe an approved drug for other uses ("off-label") when they think it is right for you. (FDA)
Copies made by a pharmacy (compounded) are not FDA approved. The FDA does not check them before they are sold. State boards of pharmacy oversee most pharmacies. (FDA)
Products sold online "for research" or "not for human use" are not the approved medicine. The FDA has warned companies that sold them to people. (FDA)

Banned in sports? Drug tests

Not named on the banned list.

Setmelanotide (Imcivree) is not named on WADA's 2026 list. It is an approved medicine, so the "not approved" rule (S0) does not fit. But WADA says its list is not complete. Check it on GlobalDRO.com or ask USADA.

Check work, NCAA, and military rules for Imcivree

Talk to your doctor

Do not start any peptide on your own. Ask a doctor first. We never share doses or tell you where to buy. Print our doctor questions sheet.

Check any peptide in 1 secondFree FDA Status Checker: approved, being tested, or not proven.

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Not medical advice. Medical disclaimer.