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Firdapse, Firdapse (previously zenas)(amifampridine)
Firdapse, Zenas (amifampridine) is a small molecule pharmaceutical. Amifampridine was first approved as Firdapse (previously zenas) on 2009-12-23. It is used to treat lambert-eaton myasthenic syndrome in the USA. It has been approved in Europe to treat autoimmune diseases, autoimmune diseases of the nervous system, immune system diseases, lambert-eaton myasthenic syndrome, and neoplasms amongst others.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Firdapse
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amifampridine phosphate
Tradename
Company
Number
Date
Products
FIRDAPSECATALYST PHARMSN-208078 RX2018-11-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
firdapseNew Drug Application2020-10-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lambert-eaton myasthenic syndromeEFO_0020094D015624G70.80
Agency Specific
FDA
EMA
Expiration
Code
AMIFAMPRIDINE PHOSPHATE, FIRDAPSE, CATALYST PHARMS
2025-11-28ODE-223
2025-09-29NPP
2023-11-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Amifampridine Phosphate, Firdapse, Catalyst Pharms
106260882037-02-25DP
107938932034-05-26U-2956
110601282032-06-29U-2956
112681282032-06-29U-2956
112743312032-06-29U-2956
112743322032-06-29U-2956
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX05: Amifampridine
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lambert-eaton myasthenic syndromeD015624EFO_0020094G70.80—12—25
Myasthenia gravisD009157EFO_0004991G70.0——2——2
Congenital myasthenic syndromesD020294Orphanet_590G70.2——1—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Muscular atrophyD009133HP_0003202—1———1
Spinal muscular atrophyD009134EFO_0008525G12.1—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMIFAMPRIDINE
INNamifampridine
Description
Amifampridine is an aminopyridine.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1ccncc1N
Identifiers
PDB—
CAS-ID54-96-6
RxCUI2106338
ChEMBL IDCHEMBL354077
ChEBI ID—
PubChem CID5918
DrugBankDB11640
UNII IDRU4S6E2G0J (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Firdapse - CATALYST PHARMACEUTICALS, INC.
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 311 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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98,007 adverse events reported
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