Dalfampridine
Ampyra, Dalfampridine (dalfampridine) is a small molecule pharmaceutical. Dalfampridine was first approved as Ampyra on 2010-01-22. It is used to treat multiple sclerosis and neurologic gait disorders in the USA.
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Commercial
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Ampyra (generic drugs available since 2017-01-23)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dalfampridine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMPYRA | Acorda Therapeutics | N-022250 RX | 2010-01-22 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ampyra | New Drug Application | 2023-01-23 |
| dalfampridine | ANDA | 2024-02-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
| neurologic gait disorders | HP_0003376 | D020233 | R26.1 |
Agency Specific
FDA
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Clinical
Clinical Trials
73 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 9 | 13 | 8 | 11 | 38 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 1 | 3 | — | — | 5 |
| Optic neuritis | D009902 | EFO_0007405 | H46 | 1 | 1 | 1 | — | — | 2 |
| Ocular motility disorders | D015835 | EFO_1001990 | H50.54 | — | 1 | 1 | — | — | 2 |
| Muscle spasticity | D009128 | HP_0001257 | — | — | — | 2 | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | 1 | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | 1 | — | — | 1 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Short-term memory | D008570 | EFO_0004335 | — | — | 2 | — | — | 1 | 3 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 2 | — | — | — | 2 |
| Prostatic diseases | D011469 | — | N42.9 | — | 1 | — | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | — | — | — | 1 |
| Vestibular diseases | D015837 | EFO_0009691 | H81 | — | 1 | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | — | — | — | 1 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 1 | — | — | — | 1 |
| Transverse myelitis | D009188 | — | G37.3 | — | 1 | — | — | — | 1 |
| Myelitis | D009187 | — | G04.91 | — | 1 | — | — | — | 1 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | — | — | — | — | 1 |
| Cerebral palsy | D002547 | — | G80 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Neurologic manifestations | D009461 | — | — | — | — | — | — | 1 | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | — | — | 1 | 1 |
| Nerve degeneration | D009410 | HP_0002180 | — | — | — | — | — | 1 | 1 |
| Spinocerebellar ataxias | D020754 | HP_0007263 | — | — | — | — | — | 1 | 1 |
| Machado-joseph disease | D017827 | EFO_0004135 | — | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Hereditary spastic paraplegia | D015419 | EFO_0000529 | G11.4 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dalfampridine |
| INN | fampridine |
| Description | 4-aminopyridine is an aromatic amine that is pyridine bearing a single amino substituent at position 4. An orphan drug in the US, it is used to improve walking in adults with multiple sclerosis. It has a role as an avicide, a potassium channel blocker and an orphan drug. It is an aromatic amine and an aminopyridine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1ccncc1 |
Identifiers
| PDB | — |
| CAS-ID | 504-24-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL284348 |
| ChEBI ID | 34385 |
| PubChem CID | 1727 |
| DrugBank | DB06637 |
| UNII ID | BH3B64OKL9 (ChemIDplus, GSRS) |
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Ampyra – Acorda Therapeutics
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Ampyra – Alkermes
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Ampyra – Elan Corporation
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Ampyra – Biogen
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Estimated US medical usage
Dalfampridine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 922 documents
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Safety
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59,937 adverse events reported
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