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Setmelanotide 2 mg

Phase 3
RHYTHM PHARMACEUTICALS, INC. (RYTM)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Bardet-Biedl Syndrome

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Drug Information

Target Indication

Bardet-Biedl Syndrome

Clinical Trial

NCT05194124

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA7/16/2021

Imcivree

Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.

OrphanPRIME
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Drug Science
Mechanism of action & safety profile
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