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dalfampridine

Trade name: ampyra

Small moleculeapprovedOrphan Drug FDA

Approved

Jan 22, 2010

Dalfampridine is a potassium channel blocker, used as a research tool in characterizing subtypes of the potassium channel. Dalfampridine has also been used as a drug, to manage some of the symptoms of multiple sclerosis, and is indicated for symptomatic improvement of walking in adults with several variations of the disease. The mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated. Dalfampridine is a broad spectrum potassium channel blocker. In animal studies, dalfampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels. — NCATS

Clinical trial activity

52 trials · 89 clinical orgs · 14 marketing orgs

Phase 1
7
Phase 2
29
Phase 3
18
Phase 4
10

Earliest trial started Jun 1, 2002 (NCT01683838)

Timeline

1980s

  1. Jun 2, 1987

    Orphan Drug Designation

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Acorda Therapeutics — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 22, 2010

    Acorda Therapeutics — Earliest FDA Approval

  3. Jan 22, 2010

    Merz — Marketing Organization

  4. Jan 22, 2010

    Acorda Therapeutics — NDA Organization

  5. Jun 21, 2016

    Sun Pharmaceuticals — Marketing Organization

  6. Jul 19, 2016

    Teva — Marketing Organization

  7. Sep 14, 2016

    Mylan — Marketing Organization

  8. Jan 23, 2017

    Actavis — Marketing Organization

  9. Jan 23, 2017

    Aurobindo Pharma — Marketing Organization

  10. Jan 23, 2017

    Allergan PLC (2015) — Marketing Organization

  11. Jul 11, 2018

    Accord Research — Marketing Organization

  12. Jul 30, 2018

    Alkem Labs Ltd — Marketing Organization

  13. Oct 24, 2018

    West-Ward Pharmaceutical — Marketing Organization

  14. Oct 24, 2018

    Hikma — Marketing Organization

  15. Mar 11, 2019

    Micro Labs Ltd India — Marketing Organization

2020s

  1. Jul 6, 2020

    Rising Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJan 22, 2010

Chemistry & pharmacology

Loading structure…

SMILES

NC1=CC=NC=C1
Mol. weight
94.1145 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 4-aminopyridine
  • 4-aminopyridine
  • 4-aminopyridine
  • 4-aminopyridine
  • 4-ap
  • 4-ap
  • 4-pyridinamine
  • 4-pyridinamine
  • 4-pyridylamine
  • 4-pyridylamine
  • ampere
  • ampyra
  • ampyra
  • ampyra
  • ampyra
  • ampyra extended release
  • avitrol
  • avitrol
  • dalfampridine
  • dalfampridine
  • dalfampridine
  • dalfampridine
  • dalfampridine
  • dalfampridine
  • dalfampridine
  • dalfampridine
  • el-970
  • el-970
  • fampridina
  • fampridina
  • fampridine
  • fampridine
  • fampridine
  • fampridine
  • fampridine
  • fampridine
  • fampridine
  • fampridine-sr
  • fampridine-sr
  • fampridinum
  • fampridinum
  • fampyra
  • fampyra
  • fampyra
  • fampyra
  • fampyra
  • fampyra
  • fampyra
  • gamma-aminopyridine
  • gamma-aminopyridine
  • n07xx07
  • n07xx07
  • neurelan
  • neurelan
  • p-aminopyridine
  • p-aminopyridine
  • pyridin-4-amine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06853015Phase 1/Phase 2 (Phase 2)Feb 28, 2025Shirley Ryan AbilityLab
NCT06596434Phase 2Jan 31, 2025University of Arizona
NCT06136728Phase 4Jan 31, 2024Harvard University
NCT05447676Early Phase 1 (Phase 1)Jun 30, 2022National Institute of Neurological Disorders and Stroke (NINDS), Shirley Ryan AbilityLab
NCT05730738N/AJun 1, 2021Ain Shams University
NCT05613114N/AAug 3, 2020European University of Lefke
NCT03658408Phase 2Dec 1, 2018University of Rochester
NCT02868567Phase 1Mar 1, 2016Cornell University, Rockefeller University
NCT02656160Phase 2Jan 1, 2016Harvard University
NCT02422940Phase 3Apr 1, 2015Acorda Therapeutics
NCT02391961Phase 2Apr 1, 2015Department of Veteran Affairs
NCT02271217Phase 3Dec 1, 2014Acorda Therapeutics
NCT02259361Phase 4Nov 1, 2014Tel Aviv University
NCT02280096Phase 2Oct 1, 2014Government of Mexico, Instituto Mexicano del Seguro Social
NCT02219932Phase 3Sep 1, 2014Biogen
NCT02143167Phase 4May 1, 2014Biogen, University of Southern Denmark
NCT02208050Phase 4Mar 1, 2014National University of Ireland
NCT02166346Phase 2Feb 1, 2014Acorda Therapeutics, Johns Hopkins University
NCT02849782Phase 4Feb 1, 2014University of Franche-Comté
NCT02146534Phase 4Dec 1, 2013Clinique NeuroGym, Clinique Neuro-Outaouais, CogState Ltd.
Showing 20 of 52 trials
Page 1 / 3

Organizations

Research & Development (89)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Acorda TherapeuticsFor profit251452002
BiogenFor profit8642010
University of RochesterAcademic/Hospital3122011
Department of Veteran AffairsGovernment2122011
Harvard UniversityAcademic/Hospital2222016
Oregon Health and Science UniversityAcademic/Hospital2122011
Shirley Ryan AbilityLabAcademic/Hospital2222022
University of MiamiAcademic/Hospital2122011
University of Southern DenmarkAcademic/Hospital2212012
Advanced Neurology SpecialistsAcademic/Hospital1012011
Advanced Neurosciences InstituteAcademic/Hospital1012011
Ain Shams UniversityAcademic/Hospital1112021
Alta Bates Summit Medical CenterAcademic/Hospital1012011
Altru Health System Research CenterAcademic/Hospital1012011
Arizona Neurological InstituteAcademic/Hospital1012011
Axiom Clinical Research of FloridaFor profit1012011
Baylor UniversityAcademic/Hospital1012011
Brown, Theodore R., M.D., MPHAcademic/Hospital1012010
Clinique NeuroGymAcademic/Hospital1012013
Clinique Neuro-OutaouaisAcademic/Hospital1112013
89 organizations
Page 1 / 5

Marketing (20)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGJul 11, 2018
Acorda TherapeuticsFor profitNDAJan 22, 2010
ActavisFor profitMKTGJan 23, 2017
Alkem Labs LtdFor profitMKTGJul 30, 2018
Allergan PLC (2015)For profitMKTGJan 23, 2017
Aurobindo PharmaFor profitSYNJan 23, 2017
Aurobindo PharmaFor profitMKTGJan 23, 2017
HikmaFor profitMKTGOct 24, 2018
HikmaFor profitSYNOct 24, 2018
MerzFor profitMKTGJan 22, 2010
MerzFor profitSYNJan 22, 2010
Micro Labs Ltd IndiaFor profitMKTGMar 11, 2019
MylanFor profitMKTGSep 14, 2016
MylanFor profitSYNJul 6, 2020
Rising PharmaceuticalsFor profitSYNJul 6, 2020
Rising PharmaceuticalsFor profitMKTGJul 6, 2020
Sun PharmaceuticalsFor profitMKTGJun 21, 2016
Sun PharmaceuticalsFor profitSYNMay 21, 2019
TevaFor profitMKTGJul 19, 2016
West-Ward PharmaceuticalFor profitMKTGOct 24, 2018