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IMCIVREE (setmelanotide acetate)

TherapyRhythm Pharmaceuticals

IMCIVREE (setmelanotide acetate) from Rhythm Pharmaceuticals treats rare genetic forms of obesity driven by MC4R pathway deficiencies.

Approvals

Indications

Biomarkers

Mapped tests

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and IMCIVREE. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where IMCIVREE is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria	Notes
Obesity Non-cancer · Metabolic	LEPR Variants (Pathogenic/Likely Pathogenic) and Variants of Uncertain Significance		View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for IMCIVREE.

No tumor-agnostic companion diagnostic approvals are currently mapped for this therapy.

Tests used in these approvals

These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering IMCIVREE for eligible patients.

Test

POMC/PCSK1/LEPR CDx Panel

Prevention Genetics

Method

NGS

Specimen

Whole blood

1 approvalView test profile →

This view is scoped to IMCIVREE (setmelanotide acetate). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.