Amifampridine

also known as 3,4 Diaminopyridine · 3, 4-DAP · Amifampridine Phosphate · DAP · 3,4-DAPP · 3,4-diammoniopyridinium · 4-DAP · Amifampridina · +9 more

Small molecule

Developed for: Lambert-Eaton myasthenic syndrome · congenital myasthenic syndrome · AChR+ myasthenia gravis · botulism · Brugada syndrome · chronic inflammatory demyelinating polyradiculoneuropathy · generalized myasthenia gravis · iatrogenic botulism
+7 more
· multiple sclerosis · muscle-specific tyrosine kinase-associated myasthenia gravis · myasthenia gravis · myopathy · pathologic nystagmus · spinal muscular atrophy · spinal muscular atrophy, type III
Investigated by: Catalyst Pharmaceuticals, Inc. · Jacobus Pharmaceutical · Assistance Publique - Hôpitaux de Paris · Augusta University · Centre Hospitalier Universitaire, Amiens · Compound Solutions Inc.
+19 more
· David Lacomis, MD · David P. Richman, MD · Duke University · FDA Office of Orphan Products Development · Jeffrey A. Cohen, MD · Lahey Clinic · Leiden University Medical Center · Louis H. Weimer, MD · Mayo Clinic · NMD Pharma A/S · National Center for Research Resources (NCRR) · Oregon Health and Science University · Ricardo Maselli · Rutgers, The State University of New Jersey · The Cleveland Clinic · University of Colorado, Denver · University of South Carolina · Vern C. Juel, M.D. · Wake Forest University Health Sciences

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed Lambert-Eaton myasthenic syndrome 1 milestone
Filed	US (FDA)	Firdapse	Lambert-Eaton myasthenic syndrome	2015-07-22	“initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for Firdapse®” globenewswire.com ↗
Approved Indication not stated 5 milestones
Label expansions (2)	US (FDA)	FIRDAPSE	—	2022-09-29 – 2024-05-30	fda.gov ↗
Approved	US (FDA)	FIRDAPSE	—	2018-11-28	fda.gov ↗
Rejected (CRL)	US (FDA)	Firdapse	Lambert-Eaton myasthenic syndrome, congenital myasthenic syndromes	2016-02-17	“received a "Refusal to File" letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Firdapse®” globenewswire.com ↗
Filed	US (FDA)	Firdapse	Lambert-Eaton myasthenic syndrome, congenital myasthenic syndromes	2015-12-17	“completion of its rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Firdapse®” globenewswire.com ↗
Approved	EU (EMA)	Firdapse (previously Zenas)	—	2009-12-23	europa.eu ↗

Trials 27

today

EU approved 2009

US approved 2018

NCT05769478 · Ph 1 NCT05919407 · Ph 3 NCT05123053 · Ph 2 NCT03937687 · Ph 0 NCT03819660 · Ph 2 NCT03781479 · Ph 2 NCT03579966 · Ph 3 NCT03304054 · Ph 3 NCT02970162 · Ph 3 NCT02562066 · Ph 3 NCT01441557 · Ph 2/3 NCT01377922 · Ph 3 NCT00701077 · Ph 3 NCT01378546 NCT00190268 · Ph 3 NCT02090725 · Ph 2 NCT01373333 NCT00004939 · Ph 3 NCT00004832 · not/applicable

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03937687	May 2019 → Nov 2020	—	University of South Carolina	Completed	No outcome recorded
Phase 11 trial
Phase 1	NCT05769478	Sep 2023 → Oct 2024	iatrogenic botulism	Wake Forest University Health Sciences	Completed	No outcome recorded
Phase 24 trials · 1 met primary
Phase 2	NCT05123053	Oct 2021 → May 2025	—	Augusta University	Completed	No outcome recorded
Phase 2	NCT03819660	Mar 2019 → Sep 2021	spinal muscular atrophy, type III	Catalyst Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 2	NCT03781479	Jan 2019 → Jul 2020	spinal muscular atrophy	Catalyst Pharmaceuticals, Inc.	Completed	Met primary
Phase 2	NCT02090725	Feb 2004 → Jul 2018	myopathy	Jeffrey A. Cohen, MD	Terminated	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT01441557	Sep 2011 → Feb 2012	botulism	Centre Hospitalier Universitaire, Amiens	Completed	No outcome recorded
Phase 39 trials · 2 met primary · 2 missed
Phase 3	NCT05919407	Mar 2023 → Sep 2024	myasthenia gravis	Leiden University Medical Center	Unknown	No outcome recorded
Phase 3	NCT03579966	Jun 2018 → Aug 2022	AChR+ myasthenia gravis, muscle-specific tyrosine kinase-associated myasthenia gravis	Catalyst Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 3	NCT03304054	Apr 2018 → Jan 2020	generalized myasthenia gravis	Catalyst Pharmaceuticals, Inc.	Completed	Missed primary
Phase 3	NCT02970162	Nov 2016 → Oct 2017	Lambert-Eaton myasthenic syndrome	Catalyst Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT02562066	Jan 2016 → Aug 2019	congenital myasthenic syndrome	Catalyst Pharmaceuticals, Inc.	Completed	Missed primary
Phase 3	NCT01377922	Jun 2011 → Jul 2016	Lambert-Eaton myasthenic syndrome	Catalyst Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT00701077	Sep 2008 → Mar 2010	Brugada syndrome	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00190268	Feb 2005 → Jun 2008	multiple sclerosis	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 3	NCT00004939	Aug 1996	chronic inflammatory demyelinating polyradiculoneuropathy	National Center for Research Resources (NCRR)	Completed	No outcome recorded
Phase not applicable1 trial
—	NCT00004832	Aug 1994 → Jun 1998	Lambert-Eaton myasthenic syndrome	FDA Office of Orphan Products Development	Completed	No outcome recorded
Phase not stated10 trials · 1 met primary
—	NCT01378546	May 2005 → May 2015	Lambert-Eaton myasthenic syndrome	Louis H. Weimer, MD	No longer available	No outcome recorded
—	NCT01373333	Sep 1997 → Sep 2012	Lambert-Eaton myasthenic syndrome	The Cleveland Clinic	No longer available	No outcome recorded
—	NCT01765140	—	congenital myasthenic syndrome	Vern C. Juel, M.D.	No longer available	Met primary
—	NCT01825395	—	Lambert-Eaton myasthenic syndrome	University of Colorado, Denver	Approved for marketing	No outcome recorded
—	NCT02189720	—	Lambert-Eaton myasthenic syndrome, congenital myasthenic syndrome, pathologic nystagmus	Catalyst Pharmaceuticals, Inc.	Approved for marketing	No outcome recorded
—	NCT00704925	—	Lambert-Eaton myasthenic syndrome	David P. Richman, MD	No longer available	No outcome recorded
—	NCT02012933	—	Lambert-Eaton myasthenic syndrome, congenital myasthenic syndrome	Oregon Health and Science University	No longer available	No outcome recorded
—	NCT03062631	—	congenital myasthenic syndrome	Ricardo Maselli	No longer available	No outcome recorded
—	NCT00872950	—	Lambert-Eaton myasthenic syndrome, congenital myasthenic syndrome	Lahey Clinic	Approved for marketing	No outcome recorded
—	NCT00994916	—	Lambert-Eaton myasthenic syndrome	David Lacomis, MD	No longer available	No outcome recorded
Comparator or background therapy2 trials
Phase 2	NCT01511978 Comparator	Jan 2012 → Feb 2014	Lambert-Eaton myasthenic syndrome	Jacobus Pharmaceutical	Completed	No outcome recorded
Phase 2	NCT00342381 Comparator	Jun 2006 → Dec 2007	multiple sclerosis	University of Aarhus	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 39

Date	Issuer	Release
2025-03-17	Lupin Limited	Regulatory Lupin Receives Tentative Approval from U.S. FDA for Amifampridine Tablets lupin.com ↗ Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Amifampridine Tablets, 10 mg.
2024-09-24	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces Sub-Licensee DyDo Pharma Received Approval to Commercialize FIRDAPSE® in Japan globenewswire.com ↗ We are pleased that our partner, DyDo, has secured regulatory approval for FIRDAPSE in Japan.
2024-05-30	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE® globenewswire.com ↗ FIRDAPSE is currently the only U.S. approved treatment for LEMS and this approval broadens the approved dosing options for prescribers treating LEMS.
2023-12-18	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma globenewswire.com ↗
2023-10-13	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE® globenewswire.com ↗ The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024.
2023-01-23	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Comments on FDA's Announcement of its Position on Orphan Drug Exclusivity In Light of the 11th Circuit Decision in Catalyst Pharmaceuticals, Inc. v. Becerra globenewswire.com ↗ Separately, Catalyst announced this morning that an abbreviated new drug application has been filed by Teva Pharmaceuticals, Inc., seeking authorization from the FDA to manufacture, use, or sell a generic version of FIRDAPSE® in the United States.
2023-01-23	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Notified of Abbreviated New Drug Application Filing for FIRDAPSE® globenewswire.com ↗
2022-09-29	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for FIRDAPSE® Expanding Patient Population to Include Pediatric Patients globenewswire.com ↗ today announced that the U.S. Food and Drug Administration ("FDA") has approved the supplemental New Drug Application ("sNDA") to expand the indicated age range for FIRDAPSE ® (amifampridine) Tablets 10 mg to include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").
2022-03-11	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce a Second Favorable Canadian Federal Court Ruling Setting Aside Approval of Ruzurgi® globenewswire.com ↗
2022-02-03	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Reports that the FDA Marketing Approval Previously Granted for Ruzurgi® is No Longer Valid globenewswire.com ↗ As a result of the District Court's order, the FDA marketing approval previously granted for Ruzurgi® is no longer valid.
2022-01-28	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces Issuance of Mandate by the U.S. Court of Appeals for the 11th Circuit Directing the District Court Judge in Catalyst's Lawsuit Against the FDA to Grant Summary Judgement in Favor of Catalyst globenewswire.com ↗ the U.S. Court of Appeals for the 11 th Circuit has issued a mandate directing the District Court that heard Catalyst's claim against the FDA to enter summary judgment in favor of Catalyst
2021-06-28	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Comments on Recent Decision by Health Canada to Re-issue an NOC for Ruzurgi® globenewswire.com ↗
2021-06-03	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals, Inc.’s and KYE Pharmaceuticals’ Lawsuit in Canadian Federal Court Quashes the Notice of Compliance (NOC) for Ruzurgi® globenewswire.com ↗
2020-08-10	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Business Update globenewswire.com ↗ Health Canada Approves Marketing Authorization for Firdapse ® for Treating LEMS Patients
2020-08-06	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals’ Firdapse® (amifampridine phosphate) Receives Marketing Approval in Canada for Patients with LEMS globenewswire.com ↗ Firdapse® was approved under Priority Review by Health Canada.
2019-10-30	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Top-Line Results of CMS-001, a Phase 3 Trial of Firdapse® (Amifampridine Phosphate) in Patients with Congenital Myasthenic Syndromes (CMS) globenewswire.com ↗ Results in full population across all tested subtypes of CMS did not achieve statistical significance for the primary or secondary endpoints
2019-02-26	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Publication of Phase 3 Clinical Trial Data for Firdapse® for the Treatment of Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗ The positive topline results from this trial were previously announced, but the full results of safety, efficacy, and other clinical data are now available online.
2019-01-04	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Publication of Clinical Data from the Investigator-Sponsored Phase IIb Study Evaluating Firdapse® for the Treatment of MuSK Antibody Positive Myasthenia Gravis globenewswire.com ↗ today announced the online publication in SAGE Open Medicine of the results of an investigator-sponsored Phase IIb clinical trial (MSK-001) evaluating Firdapse® (amifampridine phosphate) for the treatment of MuSK antibody positive Myasthenia Gravis (MuSK-MG).
2018-11-29	Catalyst Pharmaceuticals, Inc.	Regulatory FDA Approves Firdapse® (amifampridine) for the Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗ today announced that the U.S. Food and Drug Administration (FDA) has approved Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with Lambert-Eaton Myasthenic Syndrome (LEMS).
2018-05-29	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces FDA Acceptance of NDA and Priority Review Status for Firdapse® (Amifampridine Phosphate) for Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗ announced today that its New Drug Application (NDA) for Firdapse® for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) has been accepted for a Priority Review by the U.S. Food and Drug Administration (FDA).
2018-03-29	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse® for Treatment of Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗ today announced its submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Firdapse® (amifampridine) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).
2017-11-27	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Positive Top-Line Results from Second Phase 3 Clinical Trial of Firdapse® in Patients with Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗ The first of these, quantitative myasthenia gravis score (QMG), achieved a statistically significant p-value of 0.0004, and the second, subject global impression (SGI), achieved a statistically significant p-value of 0.0003.
2017-08-30	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Provides Update on the Status of its Firdapse Development Activities globenewswire.com ↗ FDA grants Special Protocol Assessment agreement for Phase 3 MuSK-MG trial
2017-05-10	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Poster Presentation of MuSK-MG clinical data at the 13th International Conference on Myasthenia Gravis and Related Disorders globenewswire.com ↗ The current pilot study with MuSK-MG patients showed measurable evidence of benefit in all the assessed outcome measures, despite the small sample size.
2017-03-15	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Positive Data from Investigator-Sponsored Trial of Firdapse® in treating MuSK Antibody Positive Myasthenia Gravis globenewswire.com ↗ Amifampridine phosphate was well tolerated in this population of patients.
2016-10-31	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Receives Special Protocol Assessment (SPA) from the FDA for Second Phase 3 Clinical Trial Evaluating Firdapse for the Treatment of LEMS globenewswire.com ↗ Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach to be taken in Catalyst's upcoming Phase 3 study evaluating Firdapse® (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).
2016-09-02	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces FDA Orphan Drug Designation of Firdapse for the Treatment of Myasthenia Gravis globenewswire.com ↗ Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for Firdapse® (amifampridine phosphate) for the treatment of myasthenia gravis.
2016-05-18	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceutical’s Firdapse Phase 3 Study Published in Muscle & Nerve globenewswire.com ↗ The primary endpoint of change in quantitative myasthenia gravis score, or QMG, at day 14 reached statistical significance (p=0.0452).
2016-04-26	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Provides Regulatory Update on Firdapse globenewswire.com ↗ The FDA has stated that in addition to the results of the submitted multi-center, randomized, placebo-controlled, Phase 3 LMS-002 trial, the Company will need to submit positive results from an additional adequate and well-controlled study in patients with LEMS.
2016-02-17	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Receives "Refusal to File" Letter From the FDA on Its NDA for Firdapse globenewswire.com ↗ The "Refusal to File" letter states that after a preliminary review, the FDA has found that the application, which was submitted in December 2015, was not sufficiently complete, and requests additional supporting information.
2015-12-17	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Completes NDA Submission to FDA for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes globenewswire.com ↗
2015-07-22	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Initiates Rolling NDA Submission for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗ today announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for Firdapse® for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS).
2015-03-05	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceuticals Announces FDA Orphan Drug Designation of Firdapse for Treatment of Congenital Myasthenic Syndromes globenewswire.com ↗
2014-09-29	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceuticals Announces Positive Top-Line Phase 3 Data From Pivotal Firdapse Clinical Trial in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗ Both co-primary endpoints, quantitative myasthenia gravis score (QMG) and subject global impression (SGI), demonstrated that Firdapse was significantly superior to placebo, as did a secondary endpoint for the physician's clinical global impression of improvement (CGI-I).
2014-01-08	Catalyst Pharmaceuticals, Inc.	Results Catalyst Pharmaceutical Partners Reports Positive Cardiac Safety Results of Its Phase 3 Product, Firdapse Tablets globenewswire.com ↗ The study met the pre-specified primary endpoint, demonstrating that at and above therapeutic levels, there was no effect of Firdapse (administered as phosphate salt) on heart rate or cardiac depolarization.
2013-10-29	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceutical Updates on Its Development Activities for Firdapse(TM) globenewswire.com ↗ Firdapse™ for the treatment of LEMS has recently been granted Breakthrough Therapy designation by the U.S. Food & Drug Administration (FDA).
2013-08-27	Catalyst Pharmaceuticals, Inc.	Regulatory Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS globenewswire.com ↗
2010-01-05	BioMarin Pharmaceutical	Regulatory Amifampridine Phosphate Receives Marketing Approval in the EU for LEMS biomarin.com ↗ BioMarin Pharmaceutical Inc. announced today that the European Commission has granted marketing approval for 3,4-diaminopyridine (amifampridine phosphate), for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS).
2009-11-30	BioMarin Pharmaceutical	Regulatory FDA Grants Orphan Drug Designation for 3,4-DAP for LEMS biomarin.com ↗ BioMarin Pharmaceutical Inc. announced today that the Food and Drug Administration (FDA) has granted orphan drug designation for 3,4-diaminopyridine (3,4-DAP), amifampridine phosphate, for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS).

All press releases naming this drug 83 releases

Date	Issuer	Release
2026-05-07	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Hetero Labs Ltd. globenewswire.com ↗
2025-08-26	Catalyst Pharmaceuticals, Inc.	UPDATED- Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin Pharmaceuticals globenewswire.com ↗
2025-08-25	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin Pharmaceuticals globenewswire.com ↗
2025-03-17	Lupin Limited	Lupin Receives Tentative Approval from U.S. FDA for Amifampridine Tablets lupin.com ↗
2025-01-21	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Sub-Licensee DyDo Pharma Launched FIRDAPSE® in Japan globenewswire.com ↗
2025-01-08	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Teva Pharmaceuticals globenewswire.com ↗
2024-09-24	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Sub-Licensee DyDo Pharma Received Approval to Commercialize FIRDAPSE® in Japan globenewswire.com ↗
2024-05-30	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE® globenewswire.com ↗
2023-12-18	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma globenewswire.com ↗
2023-11-02	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Receives Two New U.S. Patent Allowances For FIRDAPSE® globenewswire.com ↗
2023-10-13	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE® globenewswire.com ↗
2023-05-09	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE® From 80 mg Per Day To 100 mg Per Day globenewswire.com ↗
2023-01-23	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Comments on FDA's Announcement of its Position on Orphan Drug Exclusivity In Light of the 11th Circuit Decision in Catalyst Pharmaceuticals, Inc. v. Becerra globenewswire.com ↗
2023-01-23	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Notified of Abbreviated New Drug Application Filing for FIRDAPSE® globenewswire.com ↗
2022-09-29	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for FIRDAPSE® Expanding Patient Population to Include Pediatric Patients globenewswire.com ↗
2022-08-09	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Delivers Strong Second Quarter 2022 Financial Results with Record FIRDAPSE® Revenues and Provides Corporate Update globenewswire.com ↗
2022-07-12	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Settlement of U.S. Patent Litigation and Resolution of Litigation Challenging Ruzurgi® Approval with Jacobus Pharmaceutical globenewswire.com ↗
2022-03-11	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce a Second Favorable Canadian Federal Court Ruling Setting Aside Approval of Ruzurgi® globenewswire.com ↗
2022-03-02	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Further Strengthens FIRDAPSE® U.S. Patent Portfolio globenewswire.com ↗
2022-02-03	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Reports that the FDA Marketing Approval Previously Granted for Ruzurgi® is No Longer Valid globenewswire.com ↗
2022-01-28	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Issuance of Mandate by the U.S. Court of Appeals for the 11th Circuit Directing the District Court Judge in Catalyst's Lawsuit Against the FDA to Grant Summary Judgement in Favor of Catalyst globenewswire.com ↗
2021-12-06	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces DyDo Pharma Initiation of a Phase 3 Study for FIRDAPSE® (amifampridine) in Japan globenewswire.com ↗
2021-09-30	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Receives Positive Decision from Appeals Court That Supports Orphan Drug Exclusivity for Firdapse® for LEMS globenewswire.com ↗
2021-07-19	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Issuance of U.S. Patent 11,060,128 a Method of Use Patent with Claims Covering Firdapse® globenewswire.com ↗
2021-06-28	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Comments on Recent Decision by Health Canada to Re-issue an NOC for Ruzurgi® globenewswire.com ↗
2021-06-28	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Exclusive License and Supply Agreement with DyDo Pharma for the Development and Commercialization of Firdapse® in Japan globenewswire.com ↗
2021-06-03	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals, Inc.’s and KYE Pharmaceuticals’ Lawsuit in Canadian Federal Court Quashes the Notice of Compliance (NOC) for Ruzurgi® globenewswire.com ↗
2020-10-06	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Issuance of U.S. Patent for Firdapse® globenewswire.com ↗
2020-08-26	Catalyst Pharmaceuticals, Inc.	KYE Pharmaceuticals and Catalyst Pharmaceuticals Challenge Health Canada’s Decision to Overlook Firdapse® Data Exclusivity globenewswire.com ↗
2020-08-18	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce Agreement to Make Firdapse® (amifampridine phosphate) Available to LEMS Patients in Canada globenewswire.com ↗
2020-08-11	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Notice of Allowance of a U.S. Patent Application for "Methods of Administering 3,4-Diaminopyridine" globenewswire.com ↗
2020-08-10	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Business Update globenewswire.com ↗
2020-08-06	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals’ Firdapse® (amifampridine phosphate) Receives Marketing Approval in Canada for Patients with LEMS globenewswire.com ↗
2020-01-06	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Pre-Announces Estimated Firdapse® Revenues and Provides Updates on Advancement of Clinical Development Programs globenewswire.com ↗
2019-10-30	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Top-Line Results of CMS-001, a Phase 3 Trial of Firdapse® (Amifampridine Phosphate) in Patients with Congenital Myasthenic Syndromes (CMS) globenewswire.com ↗
2019-05-30	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Expansion of Firdapse License to Include Japan globenewswire.com ↗
2019-02-26	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Publication of Phase 3 Clinical Trial Data for Firdapse® for the Treatment of Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2019-01-04	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Publication of Clinical Data from the Investigator-Sponsored Phase IIb Study Evaluating Firdapse® for the Treatment of MuSK Antibody Positive Myasthenia Gravis globenewswire.com ↗
2018-12-03	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Conference Call to Discuss Commercialization Plan for Firdapse® (amifampridine) for Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗
2018-11-29	Catalyst Pharmaceuticals, Inc.	FDA Approves Firdapse® (amifampridine) for the Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗
2018-11-27	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Firdapse® (amifampridine) New Drug Application Continues Under Review globenewswire.com ↗
2018-05-29	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces FDA Acceptance of NDA and Priority Review Status for Firdapse® (Amifampridine Phosphate) for Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2018-04-19	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Enrollment of First Patient in Phase 3 Trial of Firdapse® in MuSK Antibody Positive Myasthenia Gravis globenewswire.com ↗
2018-03-29	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse® for Treatment of Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2018-02-12	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Plans to Resubmit New Drug Application for Firdapse® globenewswire.com ↗
2017-11-27	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Positive Top-Line Results from Second Phase 3 Clinical Trial of Firdapse® in Patients with Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2017-11-21	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Phase 2 Study of Firdapse® in Ambulatory Patients with Spinal Muscular Atrophy (SMA) globenewswire.com ↗
2017-10-31	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Completes Enrollment in Second Phase 3 Trial of Firdapse® in Patients with Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2017-08-30	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Provides Update on the Status of its Firdapse Development Activities globenewswire.com ↗
2017-05-10	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Poster Presentation of MuSK-MG clinical data at the 13th International Conference on Myasthenia Gravis and Related Disorders globenewswire.com ↗
2017-03-15	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Positive Data from Investigator-Sponsored Trial of Firdapse® in treating MuSK Antibody Positive Myasthenia Gravis globenewswire.com ↗
2016-12-15	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces First Patient Enrolled in Second Phase 3 Trial of Firdapse in Lambert-Eaton myasthenic syndrome (LEMS) globenewswire.com ↗
2016-10-31	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Receives Special Protocol Assessment (SPA) from the FDA for Second Phase 3 Clinical Trial Evaluating Firdapse for the Treatment of LEMS globenewswire.com ↗
2016-09-02	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces FDA Orphan Drug Designation of Firdapse for the Treatment of Myasthenia Gravis globenewswire.com ↗
2016-06-13	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Agreement with FDA on Confirmatory Phase 3 Study Protocol for Firdapse in Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2016-05-18	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical’s Firdapse Phase 3 Study Published in Muscle & Nerve globenewswire.com ↗
2016-04-26	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Provides Regulatory Update on Firdapse globenewswire.com ↗
2016-02-17	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Receives "Refusal to File" Letter From the FDA on Its NDA for Firdapse globenewswire.com ↗
2016-02-08	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Initiation of Investigator-Sponsored Study of Firdapse in Patients With MuSK-Antibody Positive Myasthenia Gravis globenewswire.com ↗
2015-12-17	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Completes NDA Submission to FDA for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes globenewswire.com ↗
2015-07-22	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Initiates Rolling NDA Submission for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗
2015-04-14	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Oral Presentation of Firdapse Phase 3 Trial Data at American Academy of Neurology Annual Meeting (AAN) globenewswire.com ↗
2015-03-05	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces FDA Orphan Drug Designation of Firdapse for Treatment of Congenital Myasthenic Syndromes globenewswire.com ↗
2015-02-02	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Encouraging Pre-NDA Meeting With the FDA for Firdapse(TM) as a Treatment for Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗
2014-10-27	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals to Present Firdapse Phase 3 Trial Results at the 61st Annual Meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine globenewswire.com ↗
2014-10-08	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals to Present Top-Line Safety and Efficacy Results From Phase 3 Firdapse Trial at 139th Annual Meeting of the American Neurological Association globenewswire.com ↗
2014-09-29	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceuticals Announces Positive Top-Line Phase 3 Data From Pivotal Firdapse Clinical Trial in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗
2014-08-11	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Provides Updates on Progress of Phase 3 Firdapse Study in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS) globenewswire.com ↗
2014-04-01	Catalyst Pharmaceuticals, Inc.	Catalyst Announces Completion of Enrollment in Pivotal Phase 3 Trial of Firdapse(TM) in Patients With Lambert-Eaton Myasthenic Syndrome globenewswire.com ↗
2014-03-28	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Expands Executive Leadership Team to Support the Commercialization of Firdapse(TM) globenewswire.com ↗
2014-03-25	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Announces Recommendation of Data Monitoring Committee to Continue Pivotal Phase 3 Clinical Trial for Firdapse(TM) globenewswire.com ↗
2014-01-08	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Reports Positive Cardiac Safety Results of Its Phase 3 Product, Firdapse Tablets globenewswire.com ↗
2014-01-06	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Reports Successful Completion of Type B Breakthrough Therapy Meeting With FDA on Firdapse Tablets Development Program globenewswire.com ↗
2013-10-29	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Updates on Its Development Activities for Firdapse(TM) globenewswire.com ↗
2013-10-15	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Announces Recommendation of Data Monitoring Committee to Continue Pivotal Phase lll Clinical Trial for Firdapse(TM) globenewswire.com ↗
2013-08-27	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS globenewswire.com ↗
2013-06-27	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Provides Update on FIRDAPSE(TM) Progress globenewswire.com ↗
2013-03-27	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners Announces Recommendation of Data Monitoring Committee for Pivotal Phase lll Clinical Trial for Firdapse(TM) globenewswire.com ↗
2012-10-31	Catalyst Pharmaceuticals, Inc.	Catalyst Pharmaceutical Partners and BioMarin Pharmaceutical Enter Into Strategic Collaboration for Firdapse(TM) in North America globenewswire.com ↗
2011-06-07	BioMarin Pharmaceutical	BioMarin Initiates Phase 3 Trial for Amifampridine Phosphate for the Treatment of LEMS biomarin.com ↗
2010-04-19	BioMarin Pharmaceutical	BioMarin Launches Firdapse in the European Union biomarin.com ↗
2010-01-05	BioMarin Pharmaceutical	Amifampridine Phosphate Receives Marketing Approval in the EU for LEMS biomarin.com ↗
2009-11-30	BioMarin Pharmaceutical	FDA Grants Orphan Drug Designation for 3,4-DAP for LEMS biomarin.com ↗

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

Field	Value	Cited text
Known as	amifampridine	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02970162 ↗ 10 NCT01377922 ↗ NCT02562066 ↗ NCT05769478 ↗ NCT05123053 ↗ NCT02189720 ↗ NCT03781479 ↗ NCT03304054 ↗ NCT03579966 ↗ NCT05919407 ↗ NCT03819660 ↗
Known as	3, 4-DAP	“A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS).” NCT00704925 ↗ 6 “3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS” NCT01378546 ↗ “The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.” NCT00701077 ↗ “oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days” NCT00004939 ↗ NCT01373333 ↗ NCT00704925 ↗ NCT01511978 ↗
Known as	3,4 Diaminopyridine	“A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS).” NCT00704925 ↗ 15 “Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS).” NCT01373333 ↗ “oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days” NCT00004939 ↗ NCT01441557 ↗ NCT00004832 ↗ NCT03062631 ↗ NCT00342381 ↗ NCT01378546 ↗ NCT01825395 ↗ NCT00190268 ↗ NCT00994916 ↗ Show 5 more sources
Known as	3,4-DAPP	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	3,4-diammoniopyridinium	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	4-DAP	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	Amifampridina	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	Amifampridine Phosphate	“Amifampridine Phosphate 10 MG Oral Tablet” NCT03819660 ↗ 1 “Drug: Amifampridine Phosphate” NCT03579966 ↗
Known as	Amifampridine serb	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	DAP	“Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS).” NCT00004832 ↗ 1 “Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS).” NCT01373333 ↗
Known as	DAPP	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	Dynamine	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03937687 ↗
Known as	FIRDAPSE	“Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe botulinic poisoning in measuring the effect on electrophysiological and...” NCT01441557 ↗
Known as	Firdapse (previously zenas)	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	NSC-521760	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	Pyridine-3,4-diamine	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	Ruzurgi	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Known as	Zenas	ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗
Action	Inhibit	“3,4-DAP is a pharmacological Ito blocker” NCT00701077 ↗
Modality	Small molecule	— CHEMBL354077 ↗
Route	Oral	“patients are randomized to receive 3,4-diaminopyridine (DAP) or placebo orally 3 times daily for 5 days” NCT00004832 ↗