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№ 060

Setmelanotide (Imcivree)

MC4R agonist. FDA-approved 2020 for obesity due to POMC, PCSK1, or LEPR deficiency, and 2022 for Bardet-Biedl syndrome. Educational anchor for melanocortin-pathway weight regulation.

Fat Loss
Evidence: Strong
Half-life
~11 hours
Route
Subcutaneous
Cycle
Long-term in approved indications
Schedule
Once daily
In plain English

Setmelanotide (sold as Imcivree) is an FDA-approved drug for a very specific kind of obesity — caused by rare genetic mutations in the leptin/melanocortin pathway. It activates MC4R, the same melanocortin receptor MT-1, MT-2 and PT-141 hit. Educational reference for how the melanocortin pathway controls weight.

Status & legality
Natty?
Not natty
FDA
Approved

Approved as Imcivree (2020) for obesity due to POMC, PCSK1, or LEPR deficiency. 2022 expansion: Bardet-Biedl syndrome.

Compounding
Approved drug

Available as an FDA-approved drug, not a compounded peptide.

WADA
Not listed
Prescribed

Yes — pediatric endocrinology and metabolic-disease specialists prescribe for the genetic-obesity indications.

Who it's for

  • →Patients with diagnosed monogenic obesity (POMC, PCSK1, LEPR, BBS)
  • →Educational reference for the MC4R pathway
  • →Researchers studying the melanocortin / hypothalamic appetite axis

What to expect

  1. Week 1

    Appetite drops noticeably in monogenic-obesity patients. Skin pigmentation begins to shift.

  2. Week 4

    Weight loss tracking established.

  3. Week 8

    Cumulative weight loss; pigmentation visible.

How it works (mechanism)

Selective MC4R agonist. Activates the melanocortin-4 receptor in the hypothalamus, the appetite-control hub. In patients with rare loss-of-function mutations in this pathway, restoring the signal restores appetite regulation.

Dosing protocol

1-3 mg sub-q daily (titrated). Adult max 3 mg, pediatric weight-based.

Stacks well with

Standalone in approved indications

Side effects

01Skin hyperpigmentation (universal — MC4R activates melanocortin receptors)
02Injection-site reaction
03Nausea, vomiting, diarrhea
04Spontaneous penile erections (males)
05Depression / suicidal ideation (boxed warning)

When NOT to use

  • ⚠Active depression or suicidal ideation
  • ⚠Pregnancy / nursing

Bloodwork to monitor

  • • Skin / mole monitoring (dermatology)
  • • Mental-health screening

Common mistakes

  • • Using it for general obesity (it's specific to monogenic obesity)
  • • Skipping the mole-map baseline (pigmentation drift is real)
  • • Underestimating the depression black-box warning

Drug & supplement interactions

  • ⚠MAO inhibitors: theoretical interaction (not contraindicated, but disclose)
  • ⚠Drugs causing depression: caution — Imcivree carries depression black-box
  • ⚠MC4R activation: spontaneous erections in male patients

Educational only. User-specific dosing is between you and a qualified provider.

Frequently asked

What is Setmelanotide (Imcivree)?+
Setmelanotide (sold as Imcivree) is an FDA-approved drug for a very specific kind of obesity — caused by rare genetic mutations in the leptin/melanocortin pathway. It activates MC4R, the same melanocortin receptor MT-1, MT-2 and PT-141 hit. Educational reference for how the melanocortin pathway controls weight.
Is Setmelanotide (Imcivree) FDA approved?+
Approved as Imcivree (2020) for obesity due to POMC, PCSK1, or LEPR deficiency. 2022 expansion: Bardet-Biedl syndrome.
Is Setmelanotide (Imcivree) banned by WADA?+
Setmelanotide (Imcivree) is not currently on the WADA prohibited list.
Are you still natty after taking Setmelanotide (Imcivree)?+
No. Setmelanotide (Imcivree) is a performance-enhancing peptide and would disqualify a strict natty claim.
Do doctors prescribe Setmelanotide (Imcivree)?+
Yes — pediatric endocrinology and metabolic-disease specialists prescribe for the genetic-obesity indications.
What's the typical dose of Setmelanotide (Imcivree)?+
1-3 mg sub-q daily (titrated). Adult max 3 mg, pediatric weight-based.
What are the side effects of Setmelanotide (Imcivree)?+
Common side effects include: Skin hyperpigmentation (universal — MC4R activates melanocortin receptors); Injection-site reaction; Nausea, vomiting, diarrhea; Spontaneous penile erections (males). Less common effects and full safety details are on the entry page.
How long until Setmelanotide (Imcivree) starts working?+
Appetite drops noticeably in monogenic-obesity patients. Skin pigmentation begins to shift.

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