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Lamotrigine IR tablets
Lamotrigine IR tablets is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 1 development. Also known as: Lamotrigine.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
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 | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Lamotrigine IR tablets |
|---|---|
| Also known as | Lamotrigine |
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions. (PHASE1)
- Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions (PHASE1)
- Study to Compare Two Formulations of Lamotrigine in Healthy Subjects (PHASE1)
- Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers (PHASE1)
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:
- Lamotrigine IR tablets CI brief — competitive landscape report
- Lamotrigine IR tablets updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Lamotrigine IR tablets
What is Lamotrigine IR tablets?
Who makes Lamotrigine IR tablets?
Is Lamotrigine IR tablets also known as anything else?
What development phase is Lamotrigine IR tablets in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Also known as: Lamotrigine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing