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Fulcrum Therapeutics (FULC)
NASDAQ:FULC
Losmapimod
Facioscapulohumeral Muscular Dystrophy (Fshd)
Phase III
Terminated
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
May 04, 2022
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Pociredir Oral Capsule(S)
Sickle Cell Disease, Sickle Cell Anemia
Phase I
Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pociredir
Dec 14, 2021
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Losmapimod 15 Mg Oral Tablet, Losmapimod Two 7.5 Mg Oral Tablets, Losmapimod One 15 Mg Oral Tablet
Healthy Adult Subjects
Phase I
Completed
Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets
Aug 04, 2021
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Ftx-6058 - Two Dosing Periods, Ftx-6058 / Midazolam Syrup
Sickle Cell Disease, Healthy Adult Subjects
Phase I
Completed
Safety, Tolerability and Pharmacokinetics of FTX-6058
Oct 05, 2020
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Losmapimod Oral Tablet
Covid-19
Phase III
Terminated
Losmapimod Safety and Efficacy in COVID-19
Aug 08, 2020
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Losmapimod
Facioscapulohumeral Muscular Dystrophy (Fshd)
Phase II
Terminated
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
Jan 30, 2020
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Losmapimod Oral Tablet
Facioscapulohumeral Muscular Dystrophy (Fshd)
Phase II
Completed
Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)
Jun 25, 2019
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Losmapimod
Facioscapulohumeral Muscular Dystrophy 1
Phase II
Terminated
Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension
Jun 25, 2019
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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
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
FULC is currently developing the following drugs: Losmapimod, Pociredir Oral Capsule(S), Losmapimod 15 Mg Oral Tablet, Losmapimod Two 7.5 Mg Oral Tablets, Losmapimod One 15 Mg Oral Tablet. These drug candidates are in various stages of clinical development as the company works toward FDA approval.