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BW430C (lamotrigine)
BW430C (lamotrigine) is a Anticonvulsant / Antiepileptic drug Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Epilepsy (adjunctive therapy for partial seizures), Bipolar disorder (maintenance treatment of bipolar I disorder).
Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability.
Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability. Used for Epilepsy (adjunctive therapy for partial seizures), Bipolar disorder (maintenance treatment of bipolar I disorder).
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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). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | BW430C (lamotrigine) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Anticonvulsant / Antiepileptic drug |
| Target | Voltage-gated sodium channels; glutamate release inhibition |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Lamotrigine stabilizes neuronal membranes by blocking sodium channels in a use-dependent manner, which prevents repetitive neuronal firing. It also inhibits the release of glutamate, an excitatory neurotransmitter, through effects on calcium channels. These combined actions reduce abnormal electrical activity in the brain.
Approved indications
- Epilepsy (adjunctive therapy for partial seizures)
- Bipolar disorder (maintenance treatment of bipolar I disorder)
Common side effects
- Rash (including Stevens-Johnson syndrome risk)
- Dizziness
- Ataxia
- Somnolence
- Headache
- Diplopia
Key clinical trials
- Lithium Versus Lamotrigine in Bipolar Disorder, Type II (PHASE4)
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) (PHASE3)
- A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants (PHASE1)
- A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine (PHASE3)
- Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (PHASE3)
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- Quality Improvement and Practice Based Research in Neurology Using the EMR (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:
- BW430C (lamotrigine) CI brief — competitive landscape report
- BW430C (lamotrigine) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about BW430C (lamotrigine)
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Related
- Drug class: All Anticonvulsant / Antiepileptic drug drugs
- Target: All drugs targeting Voltage-gated sodium channels; glutamate release inhibition
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Epilepsy (adjunctive therapy for partial seizures)
- Indication: Drugs for Bipolar disorder (maintenance treatment of bipolar I disorder)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing