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3,4-diaminopyridine
3,4-diaminopyridine is a Potassium channel blocker Small molecule drug developed by Oregon Health and Science University. It is currently in Phase 3 development for Lambert-Eaton myasthenic syndrome (LEMS). Also known as: 3,4DAP, 3,4-DAP, 3,4 DAP, DAP.
3,4-diaminopyridine blocks potassium channels to prolong action potential duration and increase acetylcholine release at the neuromuscular junction.
3,4-diaminopyridine blocks potassium channels to prolong action potential duration and increase acetylcholine release at the neuromuscular junction. Used for Lambert-Eaton myasthenic syndrome (LEMS).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | 3,4-diaminopyridine |
|---|---|
| Also known as | 3,4DAP, 3,4-DAP, 3,4 DAP, DAP |
| Sponsor | Oregon Health and Science University |
| Drug class | Potassium channel blocker |
| Target | Voltage-gated potassium channels |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
3,4-diaminopyridine is a potassium channel blocker that enhances neuromuscular transmission by prolonging the presynaptic action potential, thereby increasing the influx of calcium and the release of acetylcholine. This mechanism is particularly beneficial in conditions characterized by impaired neuromuscular transmission, such as Lambert-Eaton myasthenic syndrome (LEMS), where there is a deficiency in acetylcholine release.
Approved indications
- Lambert-Eaton myasthenic syndrome (LEMS)
Common side effects
- Paresthesia
- Seizures
- Abdominal pain
- Tremor
Key clinical trials
- Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome
- Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) (PHASE3)
- Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
- Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients (PHASE2)
- Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes (PHASE3)
- Treatment of Lambert-Eaton Syndrome With 3,4 DAP
- Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS) (PHASE2)
- A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS) (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:
- 3,4-diaminopyridine CI brief — competitive landscape report
- 3,4-diaminopyridine updates RSS · CI watch RSS
- Oregon Health and Science University portfolio CI
Frequently asked questions about 3,4-diaminopyridine
What is 3,4-diaminopyridine?
How does 3,4-diaminopyridine work?
What is 3,4-diaminopyridine used for?
Who makes 3,4-diaminopyridine?
Is 3,4-diaminopyridine also known as anything else?
What drug class is 3,4-diaminopyridine in?
What development phase is 3,4-diaminopyridine in?
What are the side effects of 3,4-diaminopyridine?
What does 3,4-diaminopyridine target?
Related
- Drug class: All Potassium channel blocker drugs
- Target: All drugs targeting Voltage-gated potassium channels
- Manufacturer: Oregon Health and Science University — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Lambert-Eaton myasthenic syndrome (LEMS)
- Also known as: 3,4DAP, 3,4-DAP, 3,4 DAP, DAP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing