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Fulcrum Therapeutics (FULC) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
PociredirSickle Cell DiseasePhase ITerminatedSingle-dose Pharmacokinetics of Pociredir in Participants With Sickle Cell DiseaseFeb 18, 2026―
PociredirSickle Cell DiseasePhase IIEnrolling By InvitationOpen-Label Extension Study to Pioneer Study 6058-SCD-101Jan 28, 2026
LosmapimodFacioscapulohumeral Muscular Dystrophy (Fshd)Phase IIITerminatedEfficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)May 04, 2022―
Pociredir Oral CapsuleSickle Cell Anemia, Sickle Cell DiseasePhase ICompletedSafety, Tolerability, Pharmacokinetics and Pharmacodynamics of PociredirDec 14, 2021
Losmapimod 15 Mg Oral Tablet, Losmapimod Two 7.5 Mg Oral Tablets, Losmapimod One 15 Mg Oral TabletHealthy Adult SubjectsPhase ICompletedRelative Bioavailability and Food Effect Study of Losmapimod 15 mg TabletsAug 04, 2021―
Ftx-6058 - Two Dosing Periods, Ftx-6058 / Midazolam SyrupHealthy Adult Subjects, Sickle Cell DiseasePhase ICompletedSafety, Tolerability and Pharmacokinetics of FTX-6058Oct 05, 2020―
Losmapimod Oral TabletCovid-19Phase IIITerminatedLosmapimod Safety and Efficacy in COVID-19Aug 08, 2020―
LosmapimodFacioscapulohumeral Muscular Dystrophy (Fshd)Phase IITerminatedEfficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)Jan 30, 2020―
Losmapimod Oral TabletFacioscapulohumeral Muscular Dystrophy (Fshd)Phase IICompletedEfficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)Jun 25, 2019―
LosmapimodFacioscapulohumeral Muscular Dystrophy 1Phase IITerminatedEvaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With ExtensionJun 25, 2019―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Fulcrum Therapeutics (FULC) have in its pipeline
Fulcrum Therapeutics FULC is currently developing the following drugs: Pociredir, Losmapimod, Pociredir Oral Capsule, Losmapimod 15 Mg Oral Tablet, Losmapimod Two 7.5 Mg Oral Tablets, Losmapimod One 15 Mg Oral Tablet, Ftx-6058 - Two Dosing Periods, Ftx-6058 / Midazolam Syrup, Losmapimod Oral Tablet. These drug candidates are in various stages of clinical development as the company works toward FDA approval.