Skip to main content

amifampridine

Generic: AMIFAMPRIDINE PHOSPHATE·Brand: FIRDAPSE, Firdapse

amifampridine: sourced relationships with 1 company · 1 clinical trial tracked · 1 FDA decision.

amifampridine evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect amifampridine to CPRX; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could amifampridine → CPRX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Lambert-Eaton Myasthenic Syndrome (LEMS)

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
CATALYST PHARMACEUTICALS, INC. (CPRX)
licensee · Reported 2024-02-28 · Current development: unknownSource
Lambert-Eaton Myasthenic Syndrome (LEMS)
Approved
Clinical Trial Registry Records (1)

Amifampridine for the Treatment of Transient Vocal Weakness After OnabotulinumtoxinA Injection for Spasmodic Dysphonia

NCT05123053Registry updated 2025-10-03·Phase 2
Completed

Primary endpoint: Voice Handicap Index-10

Interventionalopen18 enrolledStarted 2021-10Completion 2025-091 site · United StatesAugusta University
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE FIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. ( 1 )(CPRX)FDA ↗
NDA208078Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Which companies have sourced relationships with amifampridine?

amifampridine has dated SEC/FDA relationship records for CATALYST PHARMACEUTICALS, INC..

How many clinical trials involve amifampridine?

BioSniper tracks 1 clinical trial involving amifampridine.

What is amifampridine's latest FDA decision?

The most recent tracked FDA decision for amifampridine is Approval for 1 INDICATIONS AND USAGE FIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. ( 1 ), dated November 28, 2018.