Drug Profile

Losmapimod - Fulcrum Therapeutics

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

Latest Information Update: 02 Jul 2025

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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

Suspended Facioscapulohumeral muscular dystrophy
Discontinued Acute coronary syndromes; Atherosclerosis; Chronic obstructive pulmonary disease; COVID 2019 infections; Dyslipidaemias; Focal segmental glomerulosclerosis; Inflammation; Major depressive disorder; Neuropathic pain; Rheumatoid arthritis

17 Apr 2025 Sanofi terminates licensing agreement for losmapimod with Fulcrum Therapeutics due to convenience reasons
27 Nov 2024 Fulcrum Therapeutics terminates phase-III clinical trials in Facioscapulohumeral muscular dystrophy in US, Canada, Denmark, Netherlands, Spain, France, Germany, Italy and in the UK due to sponsor decision (PO) (NCT05397470)
27 Nov 2024 Fulcrum Therapeutics terminates phase II trial in Facioscapulohumeral muscular dystrophy in US, Canada, France and Spain (PO), due to sponsor decision(NCT04264442)

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