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ESL - Part II
ESL - Part II is a Voltage-gated sodium channel inhibitor Small molecule drug developed by Bial - Portela C S.A.. It is currently in Phase 3 development for Partial-onset seizures (adjunctive therapy), Generalized tonic-clonic seizures (adjunctive therapy). Also known as: Eslicarbazepine acetate (ESL), BIA 2-093.
ESL (eslicarbazepine acetate) is a voltage-gated sodium channel blocker that reduces neuronal excitability to prevent seizures.
ESL (eslicarbazepine acetate) is a voltage-gated sodium channel blocker that reduces neuronal excitability to prevent seizures. Used for Partial-onset seizures (adjunctive therapy), Generalized tonic-clonic seizures (adjunctive therapy).
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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 | ESL - Part II |
|---|---|
| Also known as | Eslicarbazepine acetate (ESL), BIA 2-093 |
| Sponsor | Bial - Portela C S.A. |
| Drug class | Voltage-gated sodium channel inhibitor |
| Target | Voltage-gated sodium channels (Nav) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
ESL is a prodrug that is rapidly converted to eslicarbazepine, its active metabolite, which selectively inhibits voltage-gated sodium channels in their inactive state. This stabilization of the inactive channel conformation reduces repetitive neuronal firing and propagation of seizure activity. The drug also has weak inhibitory effects on calcium channels, contributing to its anticonvulsant properties.
Approved indications
- Partial-onset seizures (adjunctive therapy)
- Generalized tonic-clonic seizures (adjunctive therapy)
Common side effects
- Dizziness
- Somnolence
- Headache
- Diplopia
- Ataxia
- Hyponatremia
- Nausea
Key clinical trials
- Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy (PHASE3)
- Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures (PHASE3)
- Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children (PHASE3)
- Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy (PHASE3)
- Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder (PHASE2)
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:
- ESL - Part II CI brief — competitive landscape report
- ESL - Part II updates RSS · CI watch RSS
- Bial - Portela C S.A. portfolio CI
Frequently asked questions about ESL - Part II
What is ESL - Part II?
How does ESL - Part II work?
What is ESL - Part II used for?
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Is ESL - Part II also known as anything else?
What drug class is ESL - Part II in?
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What does ESL - Part II target?
Related
- Drug class: All Voltage-gated sodium channel inhibitor drugs
- Target: All drugs targeting Voltage-gated sodium channels (Nav)
- Manufacturer: Bial - Portela C S.A. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Partial-onset seizures (adjunctive therapy)
- Indication: Drugs for Generalized tonic-clonic seizures (adjunctive therapy)
- Also known as: Eslicarbazepine acetate (ESL), BIA 2-093
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing