Status checked on October 6, 2026 dailymed.nlm.nih.gov
Imcivree (setmelanotide): FDA-approved only for acquired hypothalamic obesity, Bardet-Biedl syndrome and POMC, PCSK1 or LEPR deficiency; how it works, trial results, side effects and access.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key facts
- Class
- MC4R agonist
- Route
- Injection
- How often
- Daily
- Manufacturer
- Rhythm Pharmaceuticals
- Approved for weight
- Yes
- First approved
- 2020
- Generic available
- No
- Controlled substance
- No
- Official label
- Prescribing information
Key takeaways
- Imcivree (setmelanotide) is FDA approved only for acquired hypothalamic obesity, Bardet-Biedl syndrome and genetically confirmed POMC, PCSK1 or LEPR deficiency, not for general obesity.[1]
- In acquired hypothalamic obesity, BMI changed by -15.84% with Imcivree vs +2.55% with placebo after 52 weeks, a placebo-adjusted difference of -18.40%.[1]
- In one-year trials, 80% of people with POMC or PCSK1 deficiency and 46% with LEPR deficiency lost at least 10% of their weight.[1]
- Skin darkening is very common (58% to 78% across trials) and reversible; the label asks for full-body skin exams before and during treatment.[1]
- Imcivree has no boxed warning; its warnings cover sexual side effects, depression, allergic reactions, moles, and adrenal and sodium problems in hypothalamic obesity.[1]
In short: Imcivree (setmelanotide) is a once-daily injection from Rhythm Pharmaceuticals for a small group of rare causes of obesity, not for common obesity. The FDA label covers people with acquired hypothalamic obesity (age 4 and older), Bardet-Biedl syndrome, and obesity caused by POMC, PCSK1 or LEPR deficiency confirmed by genetic testing (age 2 and older). The label says it is not expected to work for general obesity (status checked on the FDA label on 2026-10-06).
This page explains what the official prescribing information says about Imcivree: which rare conditions it is approved for, how it works on the brain’s hunger pathway, what the trials found, the side effects (including skin darkening, which is very common), and how families usually get access. It is general information to prepare you for a conversation with a specialist, not medical advice. Only a clinician who knows the person’s history, test results and other medicines can decide whether a treatment fits.
Imcivree at a glance
- 2020first FDA approval (November 25, 2020)Drugs@FDA, NDA 213793
- 4labeled conditions: acquired hypothalamic obesity, Bardet-Biedl syndrome, POMC or PCSK1 deficiency, LEPR deficiencyFDA label (DailyMed)
- -18.4%placebo-adjusted change in BMI after 52 weeks in acquired hypothalamic obesity (Trial 1)FDA label (DailyMed)
- Dailyone injection under the skin at the start of each dayFDA label (DailyMed)
Checked on October 6, 2026
What Imcivree is
Imcivree contains setmelanotide, a small ring-shaped peptide made of 8 amino acids. It is built to resemble alpha-MSH, a natural hormone the brain uses to signal fullness. The label classifies it as a melanocortin 4 (MC4) receptor agonist: it switches on the MC4 receptor, a “brake” on hunger in the hypothalamus, the part of the brain that balances hunger, fullness and energy use.
It is a different kind of medicine from the GLP-1 drugs most people hear about, such as Wegovy or Zepbound. GLP-1 medicines act like a gut hormone released after meals; setmelanotide acts further along the brain’s signaling chain, at a point that is broken or under-active in the specific conditions it is approved for. Our GLP-1 medications guide explains how the more common class works, and the weight-loss medications hub lists every option with its FDA status badge.
Why a rare-disease medicine: the MC4R pathway
After eating, fat tissue releases leptin. Leptin acts on the leptin receptor (made from the LEPR gene) in the hypothalamus, which leads cells to make POMC, a precursor protein. An enzyme made from the PCSK1 gene cuts POMC into smaller hormones, including alpha-MSH, which then turns on the MC4 receptor and reduces hunger. When one link in this chain does not work, the “full” signal never arrives. People with these conditions typically have constant, intense hunger (called hyperphagia) and severe obesity from early childhood.
According to the label, setmelanotide may re-establish activity in this pathway, reducing food intake and promoting weight loss through less calorie intake and, based on non-clinical evidence, higher energy use. Because it skips past the broken steps and acts directly on the receptor, it can help where the problem sits upstream. It also explains the label’s limitation: in general (polygenic) obesity this pathway usually works, so Imcivree is not expected to be effective and is not approved for it.
How rare are these conditions? MedlinePlus Genetics, from the U.S. National Library of Medicine, says Bardet-Biedl syndrome affects about 1 in 120,000 to 160,000 newborns in most of North America and Europe, that only about 50 cases of POMC deficiency have been reported in the medical literature, and that the prevalence of leptin receptor deficiency is unknown. Acquired hypothalamic obesity is different: it is not inherited, but follows injury or damage to the hypothalamus, which the label describes as “hypothalamic injury or dysfunction”.
FDA status and approved uses
Drugs@FDA lists Imcivree under NDA 213793 as a new molecular entity with priority review and orphan status. The approvals came in steps:
| Date | What the FDA approved |
|---|---|
| November 25, 2020 | First approval: chronic weight management in people 6 and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing |
| June 16, 2022 | Added adults and children 6 and older with Bardet-Biedl syndrome (BBS) |
| December 20, 2024 | Extended the BBS and POMC, PCSK1 or LEPR indications to children 2 to under 6 years old |
| March 19, 2026 | Added adults and children 4 and older with acquired hypothalamic obesity |
The current label states the indication as: to reduce excess body weight and maintain weight reduction long term in adults and children aged 4 and older with acquired hypothalamic obesity, and aged 2 and older with syndromic or monogenic obesity due to BBS or due to POMC, PCSK1 or LEPR deficiency, where genetic testing shows variants interpreted as pathogenic, likely pathogenic or of uncertain significance (VUS). On our site it carries the “FDA approved for weight management” badge, limited to these populations. Our status badges guide explains what each badge means.
Who it is labeled for, and how the diagnosis is made
The label’s “patient selection” section describes three routes. For acquired hypothalamic obesity, the person has that diagnosis. For BBS, the person has a clinical diagnosis of BBS, and the label suggests considering genetic confirmation in children under 6. For POMC, PCSK1 or LEPR deficiency, the deficiency is genetically determined or suspected, and the result is interpreted in the person’s clinical context. The label also notes that no FDA-approved test exists for variants in these genes, so testing is done by clinical genetics laboratories and read by specialists.
In practice this usually means care from a pediatric or adult endocrinologist, a geneticist or an obesity medicine specialist. Signs that lead clinicians to consider these conditions, according to MedlinePlus Genetics, include severe obesity that starts in the first months or years of life together with constant hunger; in BBS, vision loss from retinal changes is also a major feature. If you are exploring whether a rare cause could apply in your family, our obesity medicine provider directory and the conditions hub are places to start; only a specialist can diagnose these conditions.
The usual path to a decision about Imcivree
- Notice the patternSevere obesity from early childhood with constant hunger, or weight gain after hypothalamic injury, is worth raising with a doctor.
- See a specialistAn endocrinologist, geneticist or obesity medicine clinician reviews the history and examines the person.
- Genetic or clinical diagnosisGenetic testing for POMC, PCSK1 or LEPR, or a clinical diagnosis of BBS or acquired hypothalamic obesity.
- Skin check and baseline testsThe label asks for a full-body skin exam before starting; kidney function affects dosing.
- Training and follow-upThe person or caregiver learns daily injections; mood, skin, sexual side effects and, in HO, adrenal and sodium levels are watched.
How it is taken, in general
Imcivree comes as a 10 mg/mL solution in a 1 mL multiple-dose vial and is drawn up with a 1-mL syringe and a fine needle. It is injected under the skin of the abdomen, thigh or arm once a day at the beginning of the day, with or without food, rotating the site each day. Before the first dose, the label asks the care team to train the patient and caregivers in injection technique.
The label describes starting at a low dose for about two weeks and stepping up if the person tolerates it; the starting dose and pace depend on age and on which condition is treated, and for the youngest children the maintenance dose is based on body weight. The dose is reduced in severe kidney disease, and Imcivree is not recommended for people with end-stage kidney disease or for people with acquired hypothalamic obesity and severe kidney impairment. If a dose is missed, the label says to resume with the next scheduled dose. The prescriber decides every dose; never change it on your own.
What the studies showed
Acquired hypothalamic obesity (Trial 1, TRANSCEND, NCT05774756). This was a randomized, double-blind, placebo-controlled trial of 56 to 60 weeks with 142 patients aged 4 and older (47% adults). After 52 weeks at the treatment dose, average BMI changed by -15.84% with Imcivree and +2.55% with placebo, a placebo-adjusted difference of -18.40%. About 76% of people on Imcivree lost at least 5% of their BMI, compared with about 10% on placebo. In the 110 people 12 and older who could rate their hunger, hunger scores on a 0-10 scale fell by 2.27 points with Imcivree and 1.44 points with placebo. The peer-reviewed report in the New England Journal of Medicine (2026) analyzed 120 participants aged 4 to 66 and reported a BMI change of -16.5% with setmelanotide and +3.3% with placebo.
| Item | Imcivree | Placebo |
|---|---|---|
| 5% or more BMI loss | 75.79% | 9.73% |
| 10% or more | 60.99% | 4.69% |
| 15% or more | 50.12% | 2.15% |
142 patients aged 4 and older; randomized, double-blind, placebo-controlled. BMI is used because many participants were children and still growing.
Source: Imcivree prescribing information, Table 9 (Trial 1) (checked on October 6, 2026)
Bardet-Biedl syndrome (Trial 2, NCT03746522). 44 patients aged 6 and older with a clinical diagnosis of BBS took part in a 66-week trial: 14 weeks double-blind against placebo, then 52 weeks in which everyone received Imcivree. In the placebo-controlled part, BMI fell 4.6% with Imcivree and 0.1% with placebo. Over 52 weeks of treatment (31 patients analyzed), average BMI fell 7.9%; 61.3% reached at least a 5% BMI reduction and 38.7% at least 10%. In the 14 patients 12 and older who rated hunger, scores fell by about 2.1 points. Because there was no control group after week 14, the label notes the effects on blood pressure, lipids and waist could not be measured accurately.
POMC, PCSK1 or LEPR deficiency (Trials 3 and 4, NCT02896192 and NCT03287960). Two one-year, open-label trials included 21 patients in the efficacy analysis. In Trial 3 (POMC or PCSK1 deficiency), 8 of 10 patients (80%) lost at least 10% of their weight, and average weight change was -23.1%. In Trial 4 (LEPR deficiency), 5 of 11 patients (46%) lost at least 10%, with an average change of -9.7%. During a planned 4-week switch to placebo, patients regained an average of 5.5 kg (Trial 3) and 5.0 kg (Trial 4), and lost weight again when Imcivree restarted. A fifth open-label trial in 12 children aged 2 to under 6 supported the youngest age group.
| Item | Value |
|---|---|
| POMC or PCSK1 (weight, Trial 3) | 23.1% |
| Acquired HO (BMI vs placebo, Trial 1) | 18.4% |
| LEPR (weight, Trial 4) | 9.7% |
| BBS (BMI, Trial 2) | 7.9% |
Shown as reductions. Different trials, designs and measures (weight vs BMI, with or without placebo): do not compare the bars as if they were one study. Trials 2-4 were small and mostly open label.
Source: Imcivree prescribing information, sections 14.1-14.3 (checked on October 6, 2026)
These trials are small, as expected for rare diseases, and three of the four had no placebo group for most of their length. Results varied a lot between people: in the BBS trial, individual BMI changes ranged from -25.4% to +5.3%. The withdrawal phase of Trials 3 and 4 also showed that the benefit lasts only while the medicine is taken.
Side effects
The label lists the most common side effects (20% or more in at least one indication) as skin darkening (hyperpigmentation), injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression and spontaneous penile erections. Frequencies differ by condition because the trials differed in design and age groups.
| Item | Imcivree (94 patients) | Placebo (48 patients) |
|---|---|---|
| Skin darkening | 58% | 10% |
| Nausea | 55% | 25% |
| Vomiting | 38% | 19% |
| Headache | 37% | 31% |
| New or darker moles | 15% | 6% |
| Constipation | 12% | 6% |
| Dizziness | 12% | 4% |
| Throat pain | 11% | 4% |
| Gastroenteritis | 9% | 2% |
| Ear infection | 5% | 0% |
Reactions in 5% or more of Imcivree patients and more often than with placebo. Skin darkening includes discoloration, nail pigmentation and freckles.
Source: Imcivree prescribing information, Table 5 (checked on October 6, 2026)
In the open-label POMC, PCSK1 and LEPR trials (27 patients, no placebo group), the label reports injection site reactions in 96%, skin darkening in 78%, nausea in 56%, headache in 41%, diarrhea in 37%, abdominal pain and back pain in 33% each, fatigue and vomiting in 30% each, depression in 26%, and spontaneous penile erections in 23% of the 13 male patients. In the BBS trial (43 treated patients), skin darkening was reported in 63%, injection site reactions in 51%, nausea in 26%, spontaneous erections in 25% of male patients, vomiting in 19%, and diarrhea and new or darker moles in 14% each.
Warnings and serious risks
Imcivree has no boxed warning. Its label lists six warnings and precautions:
- Sexual arousal changes. Spontaneous or more frequent erections in males and sexual side effects in females occurred in trials (7% vs 4% with placebo in the hypothalamic obesity trial). An erection lasting longer than 4 hours needs emergency care.
- Depression and suicidal thoughts. These have occurred. The label asks for monitoring of new or worsening depression or unusual mood changes; people with a history of depression may be at higher risk. If you or someone you love is in crisis, call or text 988.
- Serious allergic reactions, including anaphylaxis, generally within minutes to hours after an injection.
- Skin darkening and moles. Generalized or patchy skin darkening happened in most trial patients and reverses after stopping. New moles or darker existing moles can appear, so the label asks for a full-body skin exam before starting and regularly during treatment.
- Acute adrenal insufficiency in acquired hypothalamic obesity. In people who also had secondary adrenal insufficiency, serious adrenal events were reported in 5% of Imcivree patients and none on placebo.
- Sodium imbalance in acquired hypothalamic obesity with central diabetes insipidus. Low sodium occurred in 6% vs 2% on placebo, high sodium in 5% vs 4%; sodium levels need watching when fluid intake changes.
Who should not use it
The only contraindication on the label is a prior serious allergic reaction (hypersensitivity) to setmelanotide or any ingredient in Imcivree. Beyond that, the label does not recommend it for end-stage kidney disease, or for people with acquired hypothalamic obesity and severe kidney impairment, and it was not studied in adults 65 and older. Each vial also contains the preservative benzyl alcohol.
Interactions
According to the label, laboratory studies suggest setmelanotide has a low potential for drug interactions through liver enzymes, transporters or protein binding, but no clinical interaction studies have been done. In acquired hypothalamic obesity, where many people also take hormone replacement (for example for adrenal insufficiency or diabetes insipidus), the label asks the care team to adjust those treatments as needed. Bring a full list of medicines and supplements to every visit.
Pregnancy and breastfeeding
There are no data on Imcivree in pregnant women. The label advises stopping it when a pregnancy is recognized unless the benefits outweigh the possible risks to the fetus, and notes that weight loss offers no benefit during pregnancy and may harm the fetus. It is not recommended during breastfeeding; setmelanotide passes into rat milk. Anyone planning a pregnancy should talk with their specialist and obstetric clinician first.
Cost, insurance and access
Rhythm Pharmaceuticals does not publish a list or cash price on the patient pages we checked on 2026-10-06. Access usually runs through insurance with prior authorization, supported by the diagnosis and, where relevant, genetic test results. Rhythm’s support program, Rhythm InTune, offers patient education managers who give “personalized ongoing support” to patients and families. For general help with coverage, denials and appeals, see our insurance guide and the cost hub. Prices for rare-disease medicines are usually far higher than for common weight medicines, so confirm coverage before starting.
Stopping treatment
Imcivree treats the effect of a lifelong condition, not its cause. In the withdrawal phase of Trials 3 and 4, weight came back within 4 weeks of switching to placebo, and the skin darkening reverses after stopping. Any decision to stop or pause should be planned with the specialist, together with a plan for nutrition and activity. Our guide to keeping weight off covers the general habits that help.
Alternatives and related reading
For people without one of these rare conditions, Imcivree is not an option, and the usual medicines are the GLP-1 and related drugs, such as Wegovy, Zepbound and Saxenda, alongside the basics in how to lose weight. New drugs in development, including other approaches to hunger signaling, are tracked on our emerging medications page. Our medical weight loss guide explains what a supervised program looks like, and the BMI calculator shows where an adult stands (for children, clinicians use BMI-for-age percentiles).
FDA status and approved uses
| Indication | Labeled population | For weight | Approved | Source |
|---|---|---|---|---|
| Reduce excess body weight and maintain weight reduction long term (obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing) | Adults and pediatric patients 6 years and older at first approval; extended to 2 years and older on 2024-12-20 | Yes | November 25, 2020 | Source |
| Reduce excess body weight and maintain weight reduction long term (Bardet-Biedl syndrome) | Adults and pediatric patients 6 years and older; extended to 2 years and older on 2024-12-20 | Yes | June 16, 2022 | Source |
| Expansion of the BBS and POMC, PCSK1 or LEPR deficiency indications | Pediatric patients 2 to less than 6 years of age | Yes | December 20, 2024 | Source |
| Reduce excess body weight and maintain weight reduction long term (acquired hypothalamic obesity) | Adults and pediatric patients 4 years and older | Yes | March 19, 2026 | Source |
From the FDA label. Who a medicine is labeled for is not the same as whether it fits you; only a clinician can decide that.
How it is taken (in general)
Once daily at the beginning of the day, injected under the skin of the abdomen, thigh or arm with a 1-mL syringe, rotating sites; with or without meals. The label describes a low starting dose for about 2 weeks, then step-ups if tolerated; the schedule depends on age, condition and kidney function, and for young children the maintenance dose is based on body weight. Patients and caregivers are trained before the first dose. Follow the prescriber; never change the dose on your own.
This is what the label describes in general, never a personal dose or schedule. Follow your prescriber.
What studies showed
| Trial | Population | Duration | Outcome as reported |
|---|---|---|---|
| Trial 1 (TRANSCEND), acquired hypothalamic obesity NCT05774756 | 142 patients aged 4 and older with acquired HO (47% adults) | 56-60 weeks (52 weeks at the therapeutic dose) | BMI change -15.84% vs +2.55% with placebo (placebo-adjusted -18.40%); 5% or more BMI loss in 75.79% vs 9.73%.[1] |
| Trial 2, Bardet-Biedl syndrome NCT03746522 | 44 patients aged 6 and older with a clinical diagnosis of BBS | 14 weeks placebo-controlled + 52 weeks open label | BMI -4.6% vs -0.1% at 14 weeks; -7.9% after 52 weeks of treatment (31 patients); 61.3% reached a 5% or greater BMI decrease.[1] |
| Trial 3, POMC or PCSK1 deficiency NCT02896192 | 10 patients aged 6 and older in the efficacy analysis | 1 year, open label, with an 8-week blinded withdrawal | 80% lost 10% or more of body weight; mean weight change -23.1%.[1] |
| Trial 4, LEPR deficiency NCT03287960 | 11 patients aged 6 and older in the efficacy analysis | 1 year, open label, with an 8-week blinded withdrawal | 46% lost 10% or more of body weight; mean weight change -9.7%.[1] |
Average results from trials; individual results vary. Results from different trials cannot be compared directly.
Side effects
| Common side effect | How often (label) |
|---|---|
| Skin hyperpigmentation | 58% vs 10% placebo (acquired HO); 63% (BBS); 78% (POMC/PCSK1/LEPR, open label) |
| Nausea | 55% vs 25% placebo (acquired HO); 26% (BBS); 56% (POMC/PCSK1/LEPR) |
| Vomiting | 38% vs 19% placebo (acquired HO); 19% (BBS); 30% (POMC/PCSK1/LEPR) |
| Headache | 37% vs 31% placebo (acquired HO); 41% (POMC/PCSK1/LEPR) |
| Injection site reactions | 51% (BBS); 96% (POMC/PCSK1/LEPR, open label) |
| New or darker melanocytic nevi (moles) | 15% vs 6% placebo (acquired HO); 14% (BBS); 19% (POMC/PCSK1/LEPR) |
| Spontaneous penile erection | 7% vs 4% placebo (acquired HO); 25% of males (BBS); 23% of males (POMC/PCSK1/LEPR) |
| Depression | 26% (POMC/PCSK1/LEPR, open label); depressed mood 8% (ages 2 to under 6) |
Serious risks
- Disturbance in sexual arousal (erection lasting more than 4 hours needs emergency care)
- Depression and suicidal ideation
- Serious hypersensitivity reactions, including anaphylaxis
- Skin hyperpigmentation, darkening of existing moles and new moles (skin exams before and during treatment)
- Acute adrenal insufficiency in acquired hypothalamic obesity (5% vs 0% placebo)
- Sodium imbalance in acquired hypothalamic obesity with central diabetes insipidus
Warnings and who should not use it
Who should not use it (per the label)
- Prior serious hypersensitivity reaction to setmelanotide or any of the excipients in Imcivree (serious reactions have included anaphylaxis)
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| Other medicines in general | Low potential for interactions in laboratory studies; no clinical interaction studies have been done. |
| Treatments for diabetes insipidus / AVP deficiency | In acquired hypothalamic obesity, sodium levels are monitored and these treatments adjusted as needed. |
Pregnancy and breastfeeding
No data in pregnant women. The label advises discontinuing Imcivree when pregnancy is recognized unless the benefits outweigh the potential risks to the fetus; weight loss offers no benefit during pregnancy and may cause fetal harm. Not recommended while breastfeeding (setmelanotide is present in rat milk). Contains benzyl alcohol.
Cost, insurance and savings
Savings programs
- Rhythm InTune (patient education managers): Patients and families starting or taking Imcivree; contact through the intake form (checked October 6, 2026)
Non-drug approaches
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FDA approved for weight managementPrescriptionInjectionSaxenda (liraglutide 3 mg): uses, side effects and costLiraglutide: the daily GLP-1 (Saxenda, Victoza) and generics · Injection · Daily
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Questions to ask your doctor or pharmacist
- Could a rare genetic or hypothalamic cause explain the weight and hunger in our family, and which tests would show it?
- If a test shows a variant of uncertain significance, what does that mean for treatment?
- How will we monitor skin, mood, and, for hypothalamic obesity, adrenal function and sodium levels?
- How should my other hormone treatments be adjusted while on Imcivree?
- What will insurance need from us, and who helps with prior authorization?
- What is our plan for nutrition, activity and family support alongside the medicine?
Frequently asked questions
Can Imcivree be used for regular weight loss?
No. The label says it is not indicated, and would not be expected to work, for general (polygenic) obesity or for obesity linked to other genetic syndromes. It is approved only for acquired hypothalamic obesity, Bardet-Biedl syndrome and confirmed POMC, PCSK1 or LEPR deficiency.
Is a genetic test needed?
For POMC, PCSK1 or LEPR deficiency, yes: the label requires variants interpreted as pathogenic, likely pathogenic or of uncertain significance. BBS can be diagnosed clinically (genetic confirmation is suggested for children under 6), and acquired hypothalamic obesity is a clinical diagnosis. No FDA-approved test exists for these genes.
How young can a child start Imcivree?
The label covers children from 2 years of age for BBS and POMC, PCSK1 or LEPR deficiency, and from 4 years for acquired hypothalamic obesity. A pediatric specialist decides whether it fits.
Why does Imcivree darken the skin?
Setmelanotide also activates the MC1 receptor on pigment cells, which increases melanin. The label says this skin darkening happened in most patients and reverses after stopping. It can also darken moles or cause new ones, so regular skin exams are part of treatment.
How is Imcivree taken?
As one injection under the skin each morning, drawn from a vial with a small syringe. The dose starts low and is increased step by step depending on age, condition and kidney function; the prescriber sets every dose.
Does Imcivree have a boxed warning?
No. Unlike GLP-1 medicines such as Wegovy and Zepbound, which carry a boxed warning about thyroid tumors in rodents, the Imcivree label has no boxed warning. It does list six warnings, including depression and suicidal thoughts.
What happens if Imcivree is stopped?
In the trials, weight came back quickly: during a 4-week switch to placebo, patients regained an average of about 5 kg. Skin darkening also fades after stopping. Plans to stop should be made with the specialist.
Can Imcivree be used in pregnancy?
The label advises stopping it when pregnancy is recognized unless the benefits outweigh the possible risks to the fetus, and does not recommend it while breastfeeding.
How much does Imcivree cost?
Rhythm Pharmaceuticals did not publish a price on the patient pages we checked on 2026-10-06. Access usually goes through insurance with prior authorization, with help from the Rhythm InTune support program.
Official sources
References
- IMCIVREE (setmelanotide) injection: prescribing information. Rhythm Pharmaceuticals, via DailyMed, 2026. (accessed October 6, 2026) Drug label
- Drugs@FDA: Imcivree, NDA 213793 (original approval 2020-11-25). U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
- NDA 213793/S-001 approval letter (Bardet-Biedl syndrome). U.S. Food and Drug Administration, 2022. (accessed October 7, 2026) Government page
- NDA 213793/S-007 approval letter (children 2 to under 6 years). U.S. Food and Drug Administration, 2024. (accessed October 6, 2026) Government page
- NDA 213793/S-009 approval letter (acquired hypothalamic obesity). U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
- Miller JL, van Santen HM, Phillips SA, et al.. Setmelanotide for the Treatment of Acquired Hypothalamic Obesity (TRANSCEND). New England Journal of Medicine, 2026. doi:10.1056/NEJMoa2512275 · PMID 42418774 · NCT05774756 (accessed October 6, 2026) Randomized trial
- Bardet-Biedl syndrome. MedlinePlus Genetics (National Library of Medicine). (accessed October 6, 2026) Government page
- Proopiomelanocortin deficiency. MedlinePlus Genetics (National Library of Medicine). (accessed October 6, 2026) Government page
- Leptin receptor deficiency. MedlinePlus Genetics (National Library of Medicine). (accessed October 6, 2026) Government page
- Imcivree for Bardet-Biedl syndrome: Rhythm InTune support. Rhythm Pharmaceuticals. (accessed October 6, 2026) Other
Facts checked on October 6, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.