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Setmelanotide - Rhythm

Drug Profile

Setmelanotide - Rhythm

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

Latest Information Update: 12 Dec 2018

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At a glance

  • Originator Ipsen
  • Developer Charite - Universitatsmedizin Berlin; Ipsen; Rhythm
  • Class Amides; Antihyperglycaemics; 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 - Prader-Willi syndrome; Obesity
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Obesity
  • No development reported Diabetes mellitus

Most Recent Events

  • 04 Jan 2019 Rhythm plans to submit NDA for pro-opiomelanocortin (POMC) deficient and leptin receptor (LepR) deficiency Obesity in early 2020
  • 19 Nov 2018 Phase-III clinical trials in Obesity (In adolescents, In the elderly, In adults, In children) in USA (SC) (NCT03746522)
  • 15 Nov 2018 The US FDA expands a granted Breakthrough Therapy designation for setmelanotide, to include Alström Syndrome, for the treatment of Obesity associated with genetic defects upstream of the MC4R in the central melanocortin pathway
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