Drugs / Dalfampridine
Dalfampridine
also known as
fampridine · 4-aminopyridine · Fampridine-SR · 4-AP · BIIB041 · Ampyra · D-ER · Fampyra · +9 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Fampyra | — | 2011-07-20 | europa.eu ↗ |
| Approved | US (FDA) | AMPYRA | — | 2010-01-22 | fda.gov ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05447676 | Jun 2022 → Jun 2024 | spinal cord injury | Shirley Ryan AbilityLab | Completed | No outcome recorded |
| Phase 0 | NCT04148781 | Mar 2022 → Dec 2023 | optic neuritis | Courtney Casserly | Unknown | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT07171203 | May 2026 → Jul 2030 expected | gastrointestinal stromal tumor | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1 | NCT02868567 | Mar 2016 → Jul 2026 overdue | motor neuron disorder | Hospital for Special Surgery, New York | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01215084 | Oct → Nov 2010 | — | Biogen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06853015 | Feb 2025 → Mar 2026 overdue | spinal cord injury | Shirley Ryan AbilityLab | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01491022 | Jul 2012 → Jul 2014 | Parkinson disease | University of Miami | Completed | No outcome recorded |
| Phase 27 trials · 3 missed | ||||||
| Phase 2 | NCT04516603 | Jan 2040 → Dec 2041 | — | University of Basel | Withdrawn | No outcome recorded |
| Phase 2 | NCT04652557 | Nov 2021 → Jan 2023 | — | University of Basel | Completed | Missed primary |
| Phase 2 | NCT02391961 | Apr 2015 → Jan 2019 | internuclear ophthalmoplegia, multiple sclerosis | VA Office of Research and Development | Completed | Missed primary |
| Phase 2 | NCT02166346 | Feb 2014 → Jan 2017 | idiopathic acute transverse myelitis, neuromyelitis optica, transverse myelitis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT01621113 | Jun 2012 → Oct 2017 | spinal cord injury | Kessler Foundation | Completed | No outcome recorded |
| Phase 2 | NCT01444300 | Sep 2011 → Sep 2013 | multiple sclerosis | Oregon Health and Science University | Completed | Missed primary |
| Phase 2 | NCT00053417 | Feb → Dec 2003 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01667497 | Sep 2012 → Jul 2015 | — | London Health Sciences Centre | Completed | No outcome recorded |
| Phase 2/3 | NCT05859802 | Jul 2011 → Mar 2015 | multiple sclerosis | D'Youville College | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT07185347 | Oct 2025 → May 2027 expected | spinocerebellar ataxia 27B, late-onset | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT02219932 | Sep 2014 → Feb 2016 | multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT01917019 | Aug 2013 → Oct 2015 | primary progressive multiple sclerosis, progressive relapsing multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01235221 | Dec 2010 → Jun 2012 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00127530 | May 2005 → Jun 2006 | multiple sclerosis | Acorda Therapeutics | Completed | Met primary |
| Phase 46 trials | ||||||
| Phase 4 | NCT02208050 | Feb 2014 → Feb 2016 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | University College Dublin | Completed | No outcome recorded |
| Phase 4 | NCT02849782 | Feb 2014 → Mar 2019 | multiple sclerosis | Centre Hospitalier Universitaire de Besancon | Completed | No outcome recorded |
| Phase 4 | NCT02146534 | Dec 2013 → Jan 2016 | multiple sclerosis | Clinique Neuro-Outaouais | Completed | No outcome recorded |
| Phase 4 | NCT01975324 | Jul 2013 → Dec 2015 | non-arteritic anterior ischemic optic neuropathy | Neuro-Ophthalmologic Associates, PC | Completed | No outcome recorded |
| Phase 4 | NCT01656148 | Jun 2012 → May 2014 | multiple sclerosis | University of Southern Denmark | Completed | No outcome recorded |
| Phase 4 | NCT01480076 | Feb 2012 → Jul 2013 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary · 1 missed | ||||||
| — | NCT05274477 | Jun 2022 → Jun 2024 | post-COVID-19 disorder | University of Basel | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT05613114 | Aug 2020 → Mar 2021 | hereditary spastic paraplegia | European University of Lefke | Completed | Met primary |
| — | NCT03847545 | Dec 2018 → Oct 2021 | multiple sclerosis | University of Southern Denmark | Completed | No outcome recorded |
| — | NCT01811706 | Feb → Dec 2013 | Machado-Joseph disease, spinocerebellar ataxia type 1, spinocerebellar ataxia type 2, spinocerebellar ataxia type 6 | University of Florida | Completed | Missed primary |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT01468350 Comparator | Dec 2011 → Jan 2013 | cerebral palsy | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01316055 Comparator | Jan → Aug 2011 | impaired renal function disease | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT06751784 Comparator | May 2025 → Jul 2026 overdue | major depressive disorder | University of Basel | Recruiting | No outcome recorded |
| Phase 2 | NCT02656160 Comparator | Jan → May 2016 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01605825 Comparator | May 2012 → Feb 2013 | ischemic stroke | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01576354 Comparator | Mar 2012 → Apr 2017 | multiple sclerosis | University of Zurich | Unknown | No outcome recorded |
| Phase 2/3 | NCT02006160 Comparator | Dec 2011 → Feb 2016 | multiple sclerosis | State University of New York at Buffalo | Completed | No outcome recorded |
| Phase 2/3 | NCT01337986 Comparator | May 2011 → Dec 2013 | multiple sclerosis, optic neuritis | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 3 | NCT06136728 Comparator | Jun 2024 → Dec 2026 expected | multiple sclerosis | MGH Institute of Health Professions | Recruiting | No outcome recorded |
| Phase 3 | NCT02422940 Comparator | Apr 2015 → Jan 2017 | ischemic stroke | Acorda Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT02271217 Comparator | Dec 2014 → Sep 2016 | ischemic stroke | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01328379 Comparator | Mar 2011 → Apr 2012 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01683838 Comparator | Jun 2002 → Nov 2003 | spinal cord injury | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT02259361 Comparator | Nov 2014 | multiple sclerosis | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01356940 Comparator | Nov 2010 → Apr 2013 | multiple sclerosis | Brown, Theodore R., M.D., MPH | Completed | No outcome recorded |
| — | NCT05730738 Comparator | Jun 2021 → Dec 2023 | multiple sclerosis | Ain Shams University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2016-09-08 | Biogen | Results Biogen Demonstrates Commitment to Improving Patient Outcomes with Study on Burden of MS and New Clinical Data from Its Leading MS Portfolio biogen.com ↗
FAMPYRA Sustained Clinically Meaningful Improvements in Walking Ability with Prolonged-Release Fampridine: Results from the Placebo-Controlled ENHANCE Study |
| 2011-07-25 | Biogen | Regulatory Biogen Idec Receives Conditional Approval in the European Union for FAMPYRA® to Improve Walking in Adults with Multiple Sclerosis biogen.com ↗
Biogen Idec (NASDAQ: BIIB) announced today it has received conditional approval from the European Commission for FAMPYRA ® (prolonged-release fampridine tablets) to improve walking in adult patients with multiple sclerosis (MS) who have walking disability (Expanded Disability Status Scale 4-7). |
| 2011-05-20 | Biogen | Regulatory European Medicines Agency’s Committee for Medicinal Products for Human Use Issues Positive Opinion on Marketing Authorisation Application for FAMPYRA biogen.com ↗
Biogen Idec (NASDAQ: BIIB) announced today that FAMPYRA ® (prolonged-release fampridine tablets) has been granted a positive opinion for conditional approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). |
| 2011-05-16 | Biogen | Regulatory Biogen Idec Receives Approval for FAMPYRA in Australia to Improve Walking Ability in Adult Patients with MS biogen.com ↗
The Australian Therapeutic Goods Administration (TGA) has granted approval for FAMPYRA ™ , (fampridine) 10 mg Modified Release (MR) tablet, for the symptomatic improvement of walking ability in adult patients with multiple sclerosis (MS) who have shown improvement after eight weeks of treatment. |
| 2011-04-11 | Biogen | Results Biogen Idec’s Ongoing Dedication to People Living with MS Showcased in Data Presented at the 63rd Annual Meeting of the American Academy of Neurology biogen.com ↗
Dalfampridine Extended Release Tablets Improved Walking Speed in Patients with Severe Walking Impairment |
| 2011-01-21 | Biogen | Regulatory Biogen Idec Receives Negative Opinion from the CHMP on FAMPYRA biogen.com ↗
The Company intends to appeal the negative CHMP opinion |
| 2010-01-23 | Biogen | Regulatory Biogen Idec Issues Statement on U.S. Approval of AMPYRA™ (dalfampridine) biogen.com ↗
The U.S. FDA approval was granted on January 22, 2010. |
| 2010-01-12 | Biogen | Regulatory Biogen Idec Submits Application in Europe for the Approval of Fampridine-PR Tablets to Improve Walking Ability in People with Multiple Sclerosis biogen.com ↗
Biogen Idec (NASDAQ: BIIB) announced today the submission of a marketing authorization application (MAA) to the European Medicines Agency for Fampridine Prolonged Release (Fampridine-PR) tablets, a novel oral therapy for the improvement of walking ability in adult patients with multiple sclerosis (MS). |
All press releases naming this drug 10 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dalfampridine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02391961 ↗ |
| Known as | 4-aminopyridine | “Hence, to confirm the beneficial effect of 4-aminopyridine treatment, this study will compare fampridine 10 mg bid (sustained-release form) to placebo during a 3-month...” NCT07185347 ↗10“In the present study, we aim at investigating the effects of 10 mg fampridine (4-Aminopyridine), a potassium channel-blocking agent, on working memory performance in...” NCT05274477 ↗ “Studies have shown that MS symptomatic treatment by fampridine (4-aminopyridine) is associated with improvements in walking and muscle strength and possibly with cognition,...” NCT02849782 ↗ “The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects” NCT02656160 ↗ “BACKGROUND: Clinical studies suggested that fampridine (4-aminopyridine) improves motor function in people with multiple sclerosis.” PMID 19249634 ↗ Feb 2009 “Extended release dalfampridine (also known as fampridine or 4-aminopyridine \[4-AP\]) is a broad spectrum potassium channel blocker” NCT01621113 ↗ “The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP).” NCT05730738 ↗ “Prolonged-release fampridine (4-aminopyridine) is a voltage-gated potassium channel blocking agent.” NCT02146534 ↗ “Treatment with fampridine (4-aminopyridine), a potassium channel blocker” NCT02208050 ↗ “Fampridine-SR (4-aminopyridine) is a slow release oral medication” NCT01667497 ↗ “10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)” NCT00053417 ↗ |
| Known as | 4-AP | “Extended release dalfampridine (also known as fampridine or 4-aminopyridine \[4-AP\]) is a broad spectrum potassium channel blocker” NCT01621113 ↗2“The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP).” NCT05730738 ↗ “10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)” NCT00053417 ↗ |
| Known as | Ampyra | “Fampridine, Dalfampridine, Ampyra” NCT01328379 ↗ |
| Known as | BIIB041 | “BIIB041 (Fampridine-PR)” NCT01215084 ↗ |
| Known as | D-ER | “The goal of this study was to evaluate the safety and tolerability of dalfampridine extended release (D-ER) in a pilot study of adults with cerebral palsy (CP) and limited...” PMID 28131322 ↗ Jan 20171“Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.” PMID 32651338 ↗ 2020 |
| Known as | Dalfampridine-ER | “Dalfampridine-ER 5mg” NCT01328379 ↗ |
| Known as | extended release fampridine | “extended release fampridine 10mg BID PO for 14 weeks” NCT02146534 ↗ |
| Known as | fampridine | “Extended release dalfampridine (also known as fampridine or 4-aminopyridine \[4-AP\]) is a broad spectrum potassium channel blocker” NCT01621113 ↗23“The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP).” NCT05730738 ↗ |
| Known as | fampridine prolonged-release (PR) | “A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants” NCT01215084 ↗ |
| Known as | Fampridine-PR | “BIIB041 (Fampridine-PR)” NCT01215084 ↗ |
| Known as | Fampridine-SR | “Active study medication consists of 15 tablets of fampridine SR 10 mg formulated for oral administration taken in the morning and evening 12 h apart without food.” NCT06751784 ↗5“Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses.” NCT01683838 ↗ “Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks.” NCT01656148 ↗ “10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)” NCT00053417 ↗ “BIIB041 (Fampridine-SR)” NCT01235221 ↗ “Drug: Fampridine-SR” NCT00127530 ↗ |
| Known as | Fampridine-Sustained Release (SR) | “Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury” NCT01683838 ↗ |
| Known as | Fampyra | “Fampridine, especially its slow-release formulation (Fampyra®) is generally a safe drug with well-studied pharmacokinetic properties.” NCT05274477 ↗1“Twice daily oral administration of 10 mg fampridine (Fampyra®) for 7.5 days with a wash-out period of at least 6.5 days” NCT06751784 ↗ |
| Known as | PRF | “BACKGROUND: Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients.” PMID 29552356 ↗ Mar 2018 |
| Known as | prolonged-release fampridine | “Prolonged-release fampridine (4-aminopyridine) is a voltage-gated potassium channel blocking agent.” NCT02146534 ↗ |
| Known as | slow-release Fampridine | “The objectives of this study were 1) to examine the effect of SR-Fampridine treatment on muscle strength in terms of maximal voluntary contraction (MVC) and rate of force...” PMID 27919481 ↗ Sep 2016 |
| Known as | SR Fampridine | “The objectives of this study were 1) to examine the effect of SR-Fampridine treatment on muscle strength in terms of maximal voluntary contraction (MVC) and rate of force...” PMID 27919481 ↗ Sep 2016 |
| Action | Inhibit | “potassium-channel antagonist” NCT01337986 ↗ |
| Route | Oral | “Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis” NCT00053417 ↗ |