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Losmapimod - Fulcrum Therapeutics

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Drug Profile

Losmapimod - Fulcrum Therapeutics

Alternative Names: 856553; FTX-1821; GS856553; GSK 856553; GW 856553; GW856553X

Latest Information Update: 02 Aug 2024

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At a glance

  • Originator GlaxoSmithKline
  • Developer Fulcrum Therapeutics; GlaxoSmithKline; GSK
  • Class Amides; Analgesics; Anti-inflammatories; Antidepressants; Antihyperlipidaemics; Antirheumatics; Antivirals; Cardiovascular therapies; Cyclopropanes; Fluorobenzenes; Pyridines; Small molecules; Vascular disorder therapies
  • Mechanism of Action DUX4 protein inhibitors; P38 mitogen-activated protein kinase inhibitors
  • Orphan Drug Status

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

    Yes - Facioscapulohumeral muscular dystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Acute coronary syndromes; COVID 2019 infections; Facioscapulohumeral muscular dystrophy
  • Phase II Chronic obstructive pulmonary disease; Focal segmental glomerulosclerosis
  • No development reported Inflammation
  • Discontinued Atherosclerosis; Dyslipidaemias; Major depressive disorder; Neuropathic pain; Rheumatoid arthritis

Most Recent Events

  • 31 Jul 2024 Fulcrum Therapeutics and Sanofi intend to file regulatory submissions and launch losmapimod outside of the US
  • 31 Jul 2024 Fulcrum Therapeutics plans to launch Losmapimod for Facioscapulohumeral muscular dystrophy in the US
  • 14 May 2024 Fulcrum Therapeutics announces intention to submit NDA to US FDA for Facioscapulohumeral muscular dystrophy in the US

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