Catalyst Pharmaceuticals
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2002-01-01
- Employees
- 167
- Market Cap
- $2.4B
- Introduction
Catalyst Pharmaceuticals, Inc. is a commercial-stage, patient-centric biopharmaceutical company, which focuses on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult to treat diseases. The company was founded by Hubert E. Huckel and Patrick J. McEnany in January 2002 and is headquartered in Coral Gables, FL.
Clinical Trials
13
Trial Phases
3 Phases
Drug Approvals
3
Clinical Trials
Distribution across different clinical trial phases (11 trials with phase data)• Click on a phase to view related trials
Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.
- Conditions
- Duchenne Muscular Dystrophy
- First Posted Date
- 2024-08-21
- Last Posted Date
- 2025-08-05
- Lead Sponsor
- Catalyst Pharmaceuticals, Inc.
- Target Recruit Count
- 250
- Registration Number
- NCT06564974
- Locations
- 🇵🇷
San Jorge Children's Hospital, San Juan, Puerto Rico
🇺🇸Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸Arkansas Childrens Hospital, Little Rock, Arkansas, United States
Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3
- Conditions
- Spinal Muscular Atrophy Type 3
- Interventions
- First Posted Date
- 2019-01-28
- Last Posted Date
- 2023-11-30
- Lead Sponsor
- Catalyst Pharmaceuticals, Inc.
- Target Recruit Count
- 13
- Registration Number
- NCT03819660
- Locations
- 🇮🇹
Neurological Institute Carlo Besta, Milano, Lombardy, Italy
Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients
- Conditions
- Muscular Atrophy, Spinal
- Interventions
- Drug: Placebo Oral Tablet
- First Posted Date
- 2018-12-20
- Last Posted Date
- 2021-06-01
- Lead Sponsor
- Catalyst Pharmaceuticals, Inc.
- Target Recruit Count
- 13
- Registration Number
- NCT03781479
- Locations
- 🇮🇹
Neurological Institute Carlo Besta, Milano, Lombardy, Italy
Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
- Conditions
- Myasthenia Gravis, MuSKAChR Myasthenia Gravis
- Interventions
- First Posted Date
- 2018-07-09
- Last Posted Date
- 2024-05-07
- Lead Sponsor
- Catalyst Pharmaceuticals, Inc.
- Target Recruit Count
- 63
- Registration Number
- NCT03579966
- Locations
- 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸Univerity of Pennsylvania, Philadelphia, Pennsylvania, United States
🇮🇹Department of Neuroimmunology and Neuromuscular Diseases Carlo Besta Neurological Institute Via Celoria, Milan, Italy
Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG
- Conditions
- Myasthenia Gravis, Generalized
- Interventions
- Drug: Placebo Oral Tablet
- First Posted Date
- 2017-10-06
- Last Posted Date
- 2024-03-12
- Lead Sponsor
- Catalyst Pharmaceuticals, Inc.
- Target Recruit Count
- 93
- Registration Number
- NCT03304054
- Locations
- 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸Univerity of Pennsylvania, Philadelphia, Pennsylvania, United States
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News
Catalyst Pharmaceuticals Secures Patent Protection for FIRDAPSE Until 2035 Through Lupin Settlement
Catalyst Pharmaceuticals and SERB S.A. reached a settlement agreement with Lupin that prevents generic competition for FIRDAPSE (amifampridine) until February 25, 2035.
Catalyst Pharmaceuticals Appoints Dr. William Andrews as Chief Medical Officer to Lead Rare Disease Strategy
Catalyst Pharmaceuticals appointed Dr. William T. Andrews as Chief Medical Officer, succeeding retiring Dr. Gary Ingenito after his successful 10-year tenure with the company.
Catalyst Pharmaceuticals Expands Global Reach with FIRDAPSE Launch in Japan and AGAMREE Review in Canada
DyDo Pharma has launched FIRDAPSE (amifampridine) in Japan for Lambert-Eaton myasthenic syndrome, marking Catalyst Pharmaceuticals' continued expansion of its rare disease portfolio globally.
Santhera's Agamree Receives NICE Recommendation and China NMPA Approval for Duchenne Muscular Dystrophy Treatment
The National Institute for Health and Care Excellence (NICE) has recommended Agamree (vamorolone) for treating Duchenne muscular dystrophy (DMD) in patients aged four and older in England, Wales, and Northern Ireland.
FDA Approves Santhera's Agamree (Vamorolone) for Duchenne Muscular Dystrophy
The FDA has approved Agamree (vamorolone) for treating Duchenne Muscular Dystrophy (DMD) in patients aged two years and older, offering a novel corticosteroid treatment option.