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Setmelanotide - Rhythm

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Drug Profile

Setmelanotide - Rhythm

Alternative Names: BIM-22493; CAM 4072; IMCIVREE; RM-493

Latest Information Update: 28 Aug 2024

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At a glance

  • Originator Ipsen
  • Developer Ipsen; Rhythm
  • Class Amides; Cyclic peptides; Cysteines; Disulfides; Obesity therapies
  • Mechanism of Action Melanocortin type 4 receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Obesity
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Obesity

Most Recent Events

  • 26 Aug 2024 FDA assigns PDUFA action date of 26/12/2024 for Setmelanotide for Obesity
  • 06 Aug 2024 Rhythm submits sNDA to US FDA for Obesity (In children) seeking to expand US label of Setmelanotide for pediatric patients as young as 2 years old
  • 31 Jul 2024 European Commission approves expanded MAA for Obesity of Setmelanotide for pediatric patients as young as 2 years old in European Union, Iceland, Norway, Liechtenstein (SC)

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