Ozmosi | Losmapimod Drug Profile
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Losmapimod

Alternative Names: losmapimod, gw856553, gw856553x, gs856553
Clinical Status: Active
Latest Update: 2024-12-02
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: MAPK Inhibitor, Immunomodulator

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Fast Track - Muscular Dystrophies|Muscular Dystrophy, Facioscapulohumeral
Orphan Drug - Muscular Dystrophies|Muscular Dystrophy, Facioscapulohumeral *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: GSK
Company Location: Europe
Company CEO: Emma Walmsley
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Losmapimod

Countries in Clinic: Denmark, France, Germany, Italy, Netherlands, Spain

Active Clinical Trial Count: 3

Recent & Upcoming Milestones

  • Clinical Outcomes Reported - Fulcrum Therapeutics presented P3 Muscular Dystrophy, Facioscapulohumeral results on 2024-09-12 for Losmapimod

Highest Development Phases

Phase 3: Muscular Dystrophy, Facioscapulohumeral

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2024-512732-30-00

 FIS-002-2019

P2

Completed

Muscular Dystrophy, Facioscapulohumeral

2024-11-07

2025-05-02

Treatments

2024-512736-29-00

 FIS-001-2019

P2

Completed

Muscular Dystrophy, Facioscapulohumeral

2024-10-31

2025-05-02

Treatments

2024-512737-33-00

 1821-FSH-301

P3

Completed

Muscular Dystrophy, Facioscapulohumeral

2024-10-28

2025-05-02

Treatments

Recent News Events

Date

Type

Title

09/13/2024

News Article

 Fulcrum Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

09/12/2024

News Article

 FULC Investors Have Opportunity to Join Fulcrum Therapeutics, Inc. Fraud Investigation with the Schall Law Firm

09/12/2024

News Article

 Fulcrum Therapeutics Announces Topline Results from Phase 3 REACH Clinical Trial of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

08/27/2024

News Article

 Fulcrum Therapeutics to Participate in Upcoming September Conferences

05/01/2024

PubMed

 Safety and efficacy of losmapimod in facioscapulohumeral muscular dystrophy (ReDUX4): a randomised, double-blind, placebo-controlled phase 2b trial.

04/01/2024

PubMed

 Vitamin D3 inhibits p38 MAPK and senescence-associated inflammatory mediator secretion by senescent fibroblasts that impacts immune responses during ageing.

09/30/2023

PubMed

 Apabetalone, a Clinical-Stage, Selective BET Inhibitor, Opposes DUX4 Target Gene Expression in Primary Human FSHD Muscle Cells.

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