Last reviewed · How we verify
Fampyra
Fampyra is a Small molecule drug developed by Vestre Viken Hospital Trust. It is currently in Phase 2 development for Multiple sclerosis.
Fampyra, also known as extended release fampridine, is a small molecule that blocks voltage-gated potassium channels. It is indicated for the symptomatic improvement of walking in adults with multiple sclerosis.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Fampyra |
|---|---|
| Sponsor | Vestre Viken Hospital Trust |
| Target | Voltage-gated potassium channel, Potassium voltage-gated channel subfamily C member 1, Potassium voltage-gated channel subfamily C member 2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Approved indications
- Multiple sclerosis
Common side effects
Key clinical trials
- Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor (PHASE1)
- Fampridine-SR and Optic Neuritis Recovery (EARLY_PHASE1)
- A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS (PHASE4)
- Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine. (PHASE4)
- An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
- Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients (PHASE4)
- FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra (PHASE4)
- Resistance Training and Amino Pyridine in Multiple Sclerosis (PHASE4)
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:
- Fampyra CI brief — competitive landscape report
- Fampyra updates RSS · CI watch RSS
- Vestre Viken Hospital Trust portfolio CI
Frequently asked questions about Fampyra
What is Fampyra?
What is Fampyra used for?
Who makes Fampyra?
What development phase is Fampyra in?
What does Fampyra target?
Related
- Target: All drugs targeting Voltage-gated potassium channel, Potassium voltage-gated channel subfamily C member 1, Potassium voltage-gated channel subfamily C member 2
- Manufacturer: Vestre Viken Hospital Trust — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing