Firdapse, Firdapse (previously zenas)(amifampridine)
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 |
|---|---|
| neoplasms | D009369 |
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|
| FIRDAPSE | Catalyst Pharmaceuticals | N-208078 RX | 2018-11-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 011503 dapsone 6% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| 011504 dapsone 8.5% / niacinamide 4% | unapproved drug other | 2020-07-02 |
| aczone | New Drug Application | 2024-03-25 |
| cubicin | Export only | 2024-10-14 |
| cubicin rf | Export only | 2025-03-17 |
| dapagliflozin | NDA authorized generic | 2024-10-24 |
| dapagliflozin and metformin hydrochloride | NDA authorized generic | 2024-12-20 |
| dapiprazole | ANDA | 2024-01-09 |
| dapsone | ANDA | 2025-09-25 |
| dapsone 100 mg dapsone 25 mg | ANDA | 2024-07-11 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lambert-eaton myasthenic syndrome | EFO_0020094 | D015624 | G70.80 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMIFAMPRIDINE PHOSPHATE, FIRDAPSE, CATALYST PHARMS | |||
| 2025-11-28 | ODE-223 | ||
| 2025-09-29 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
76 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lambert-eaton myasthenic syndrome | D015624 | EFO_0020094 | G70.80 | — | — | 3 | — | 2 | 5 |
| Syndrome | D013577 | — | — | — | — | 3 | — | 1 | 4 |
| Congenital myasthenic syndromes | D020294 | Orphanet_590 | G70.2 | — | — | 1 | — | 2 | 3 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 2 | — | — | 2 |
| Muscle weakness | D018908 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscular atrophy | D009133 | — | — | — | 2 | — | — | — | 2 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | — | 2 | — | — | — | 2 |
| Atrophy | D001284 | — | — | — | 2 | — | — | — | 2 |
| Spinal muscular atrophies of childhood | D014897 | Orphanet_83419 | G12.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amifampridine |
| INN | amifampridine |
| 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-ID | 54-96-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL354077 |
| ChEBI ID | — |
| PubChem CID | 5918 |
| DrugBank | DB11640 |
| UNII ID | RU4S6E2G0J (ChemIDplus, GSRS) |
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Aczone – Warner Chilcott
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Firdapse – Catalyst Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Dapagliflozin and metformin hydrochloride, Jesduvroq, Xigduo
Adverse Events
Top Adverse Reactions
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252,762 adverse events reported
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