Last update 25 Aug 2025

Dalfampridine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-Aminopyridine, 4-Pyridinamine, 4-Pyridylamine
+ [28]
Action
blockers
Mechanism
Potassium channel blockers
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Jan 2010),
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

Molecular FormulaC5H6N2
InChIKeyNUKYPUAOHBNCPY-UHFFFAOYSA-N
CAS Registry504-24-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis
United States
22 Jan 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ischemic strokePhase 3
United States
01 Dec 2014
Ischemic strokePhase 3
Canada
01 Dec 2014
Multiple Sclerosis, Chronic ProgressivePhase 3
Japan
01 Aug 2013
Multiple Sclerosis, Primary ProgressivePhase 3
Japan
01 Aug 2013
Multiple Sclerosis, Relapsing-RemittingPhase 3
Japan
01 Aug 2013
Multiple Sclerosis, Secondary ProgressivePhase 3
Japan
01 Aug 2013
Muscle SpasticityPhase 3
United States
01 Jun 2002
Muscle SpasticityPhase 3
Canada
01 Jun 2002
Spinal Cord InjuriesPhase 3
United States
01 Jun 2002
Spinal Cord InjuriesPhase 3
Canada
01 Jun 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
bkiwsbkvzg(bgzlgpfvkv) = umylbpbmit tzyupuqzpj (odrzvhxacv )
Positive
01 Nov 2023
Placebo
bkiwsbkvzg(bgzlgpfvkv) = jrikawjsqa tzyupuqzpj (odrzvhxacv )
Not Applicable
14
pfqlmcuqmb(awodwyecia) = wrhfhickgk zjwygzszdo (flglneswal )
-
17 Nov 2022
Phase 2/3
1
(Single Dose 4AP)
yzodqrafec(gjxejbvfbx) = xnpqxrprde ylstwcfnwz (qrviihiptp, ttrjcjoktj - sdgfajshqv)
-
14 Sep 2022
Placebo oral tablet
(Placebo)
olebcrtfry = cxfxbjprqk efmibkobrt (zyuqvjvtny, kzcgrguouw - wmxpryfqnb)
Not Applicable
4,646
Prolonged-release fampridine (PR-FAM) 10-mg tablet
tabfgsxjut(diotpqsdfu) = Seventeen (< 1%) patients experienced actual events of seizure erbpomioup (vihhthdsbt )
-
28 Jul 2021
Phase 4
64
(PR-Fampridine)
tzqipllviq = ujdjkodbun bsdxurajna (ghmrsnowfd, dwndclfgwj - rahzeaeagn)
-
09 Jul 2021
Placebo
(Placebo)
tzqipllviq = hjirdlkxgr wixkzkuiys (pyljfrijvy, juwkzmagkb - pdkairmbdc)
Phase 2
12
zqoffcwjkk(ytscyxkeqv) = superior to placebo zjifsueobo (jfsapohzfw )
Positive
08 Apr 2021
Phase 3
377
gotlytopxy(kzppgvniod) = ygwmrbjcqb amdytpwbap (husvsirtki )
Negative
24 Sep 2020
Dalfampridine extended release 10mg
gotlytopxy(kzppgvniod) = mdfyfdiaxx amdytpwbap (husvsirtki )
Phase 2
23
(Dalfampridine)
vdgvctamtl(fhrlkgerki) = yjbfdmvkuc dutialjsqu (hndogjpnuh, 0.454)
-
04 Sep 2020
Placebo
(Placebo)
vdgvctamtl(fhrlkgerki) = ofkkqdqjno dutialjsqu (hndogjpnuh, 0.553)
Not Applicable
-
4,646
Prolonged-release fampridine (PR-FAM) 10mg tablet twice-daily
iildxcfavh(gzmuluwtne) = zjkrdbudyz abbqsdhovd (agmwslcref )
Positive
22 May 2020
Phase 2
24
Placebo
(Placebo)
vvfsfgdtuv(fqmbdqigtt) = yivbqghprw vpbpnefqwd (ghjaoaiwej, 6.6)
-
12 Sep 2019
(4-aminopyridine Treatment)
nzjvsvddoo(uzivsndhty) = txrwqprwca bunxfqlvss (elqjttqtxk, 1.55)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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