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Drug ReportsDalfampridine
Ampyra, Fampyra(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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2Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Ampyra, Dalfampridine (discontinued: Dalfampridine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dalfampridine
Tradename
Company
Number
Date
Products
AMPYRAMerzN-022250 RX2010-01-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ampyraNew Drug Application2025-05-05
dalfampridineANDA2025-07-28
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
— N07XX07: Fampridine
HCPCS
No data
Clinical
Clinical Trials
266 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 sclerosisD009103EFO_0003885G35—111591142
SclerosisD012598———11158838
PyelonephritisD011704EFO_1001141N10-N16—251—7
Whooping coughD014917EFO_0000650A372—2116
DiphtheriaD004165EFO_0005549A361—21—4
MalariaD008288EFO_0001068B541——2—3
IschemiaD007511EFO_0000556——2—1—3
TetanusD013742EFO_0005593A351—11—3
PoliomyelitisD011051EFO_0007450A80——21—3
Falciparum malariaD016778EFO_0007444B501——1—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——333—1119
Lambert-eaton myasthenic syndromeD015624EFO_0020094G70.80—13—913
Non-small-cell lung carcinomaD002289——452—212
Lung neoplasmsD008175—C34.90361—211
NeoplasmsD009369—C80541—19
Wounds and injuriesD014947—T14.8164——9
Urinary tract infectionsD014552EFO_0003103N39.0—26—18
InfectionsD007239EFO_0000544——23—26
Spinal cord injuriesD013119EFO_1001919—223——6
Congenital myasthenic syndromesD020294Orphanet_590G70.2——1—56
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951110———14
Healthy volunteers/patients———82——210
Myeloid leukemiaD007951—C9267———9
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—56———8
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.054——17
LymphomaD008223—C85.935———6
Non-hodgkin lymphomaD008228—C85.924———5
RecurrenceD012008——32———5
CarcinomaD002277—C80.022———4
AdenocarcinomaD000230——12——14
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E101———910
Diabetes mellitusD003920EFO_0000400E08-E131———67
PeriodontitisD010518EFO_0000649K05.31———23
Periapical periodontitisD010485EFO_1001391K04.51———23
GlioblastomaD005909EFO_0000515—2————2
Cerebral palsyD002547—G801———12
Huntington diseaseD006816Orphanet_399G102————2
Anxiety disordersD001008EFO_0006788F41.11———12
Hepatocellular carcinomaD006528—C22.01————1
Motor neuron diseaseD016472EFO_0003782G12.21————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1————33
OsteoarthritisD010003EFO_0002506M15-M19————33
Sleep initiation and maintenance disordersD007319—F51.01————22
AsthmaD001249EFO_0000270J45————22
Peripheral nervous system diseasesD010523—G64————22
HypoglycemiaD007003—E16.2————22
Bone fracturesD050723EFO_0003931T14.8————22
DermatitisD003872—L30.9————22
Patellofemoral pain syndromeD046788EFO_1001092—————22
Post-traumatic stress disordersD013313EFO_0001358F43.1————22
Show 113 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDalfampridine
INNfampridine
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—
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Structure (InChI/SMILES or Protein Sequence)
Nc1ccncc1
Identifiers
PDB—
CAS-ID504-24-5
RxCUI—
ChEMBL IDCHEMBL284348
ChEBI ID34385
PubChem CID1727
DrugBankDB06637
UNII IDBH3B64OKL9 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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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Fampyra – Biogen
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Tabular view
Estimated US medical usage
Dalfampridine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,132 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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66,308 adverse events reported
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