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BIIB041 (Fampridine-SR)
Fampridine-SR is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in patients with multiple sclerosis.
Fampridine-SR is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in patients with multiple sclerosis. Used for Multiple sclerosis (MS) — to improve walking speed and motor function.
At a glance
| Generic name | BIIB041 (Fampridine-SR) |
|---|---|
| Also known as | Dalfampridine, Fampridine-ER, Ampyra, Fampyra, Fampridine-PR |
| Sponsor | Biogen |
| Drug class | Potassium channel blocker |
| Target | Voltage-gated potassium channels (Kv1.4, Kv3.1) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Fampridine (4-aminopyridine) blocks voltage-gated potassium channels on demyelinated axons, prolonging action potentials and increasing the probability of action potential propagation across demyelinated segments. The sustained-release (SR) formulation allows for twice-daily dosing with improved tolerability compared to immediate-release formulations. This mechanism restores conduction in partially demyelinated nerve fibers, leading to improved walking speed and motor function in MS patients.
Approved indications
- Multiple sclerosis (MS) — to improve walking speed and motor function
Common side effects
- Seizures
- Urinary tract infection
- Insomnia
- Dizziness
- Headache
- Asthenia/fatigue
Key clinical trials
- An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
- Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis (PHASE3)
- A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis (PHASE3)
- Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis (PHASE4)
- Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis. (PHASE2)
- Fampridine Pregnancy Exposure Registry
- A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers (PHASE1)
- Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BIIB041 (Fampridine-SR) CI brief — competitive landscape report
- BIIB041 (Fampridine-SR) updates RSS · CI watch RSS
- Biogen portfolio CI