Product Description
Amifampridine is used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disease, wherein the immune system attacks the connection between the nerve and muscle (neuromuscular junction) and blocks the ability of the nerve cells to send signals to the muscle cells, leading to muscle weakness of the arms or legs. (Sourced from: https://www.mayoclinic.org/drugs-supplements/amifampridine-oral-route/description/drg-20463409)
Mechanisms of Action: Potassium Channel Blocker
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Lambert-Eaton Myasthenic Syndrome *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Netherlands | Norway | Poland | Portugal | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Catalyst
Company Location: SOUTH SAN FRANCISCO CA 94080
Company CEO: Nassim Usman
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Japan, Netherlands, Unknown Location
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Muscle Weakness|Myasthenia Gravis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031220702 | P3 |
Recruiting |
Unknown |
2024-12-31 |
|
| IMPACT-MG | P3 |
Recruiting |
Myasthenia Gravis|Muscle Weakness |
2024-09-22 |
|
| jRCT2031210552 | P3 |
Active, not recruiting |
Unknown |
2024-03-31 |