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BIIB041 (fampridine)
BIIB041 (fampridine) is a Potassium channel blocker Small molecule drug developed by Biogen. It is currently in Phase 3 development for Multiple sclerosis with gait impairment, Spinal cord injury (Phase 3 development). Also known as: Fampyra, prolonged-release fampridine, dalfampridine, Ampyra.
Fampridine is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in demyelinating diseases.
Fampridine is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in demyelinating diseases. Used for Multiple sclerosis with gait impairment, Spinal cord injury (Phase 3 development).
At a glance
| Generic name | BIIB041 (fampridine) |
|---|---|
| Also known as | Fampyra, prolonged-release fampridine, dalfampridine, Ampyra |
| Sponsor | Biogen |
| Drug class | Potassium channel blocker |
| Target | Voltage-gated potassium channels (Kv) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Fampridine blocks voltage-gated potassium channels on demyelinated axons, prolonging action potentials and increasing the likelihood of action potential propagation across damaged nerve segments. This mechanism restores conduction in partially demyelinated nerve fibers, leading to improved motor function and walking ability in patients with multiple sclerosis and other demyelinating conditions.
Approved indications
- Multiple sclerosis with gait impairment
- Spinal cord injury (Phase 3 development)
Common side effects
- Seizures
- Urinary tract infection
- Insomnia
- Dizziness
- Headache
- Asthenia
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) CI brief — competitive landscape report
- BIIB041 (fampridine) updates RSS · CI watch RSS
- Biogen portfolio CI
Frequently asked questions about BIIB041 (fampridine)
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Related
- Drug class: All Potassium channel blocker drugs
- Target: All drugs targeting Voltage-gated potassium channels (Kv)
- Manufacturer: Biogen — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Multiple sclerosis with gait impairment
- Indication: Drugs for Spinal cord injury (Phase 3 development)
- Also known as: Fampyra, prolonged-release fampridine, dalfampridine, Ampyra
- Compare: BIIB041 (fampridine) vs similar drugs
- Pricing: BIIB041 (fampridine) cost, discount & access