Last reviewed · How we verify
Lamotrigine novel formulation
Lamotrigine novel formulation is a Anticonvulsant / Antiepileptic agent Small molecule drug developed by University Hospitals Cleveland Medical Center. It is currently in Phase 3 development for Epilepsy (maintenance therapy), Bipolar disorder (maintenance therapy for bipolar depression). Also known as: Lamictal.
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 (maintenance therapy), Bipolar disorder (maintenance therapy for bipolar depression).
-
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 | Lamotrigine novel formulation |
|---|---|
| Also known as | Lamictal |
| Sponsor | University Hospitals Cleveland Medical Center |
| Drug class | Anticonvulsant / Antiepileptic agent |
| Target | Voltage-gated sodium channels; glutamate release inhibition |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Lamotrigine is an anticonvulsant that stabilizes neuronal membranes by blocking sodium channels and reducing the release of the excitatory neurotransmitter glutamate. This novel formulation likely aims to improve bioavailability, reduce dosing frequency, or enhance tolerability compared to standard lamotrigine formulations. The mechanism remains consistent with the established anticonvulsant action of lamotrigine.
Approved indications
- Epilepsy (maintenance therapy)
- Bipolar disorder (maintenance therapy for bipolar depression)
Common side effects
- Rash (including Stevens-Johnson syndrome risk)
- Dizziness
- Ataxia
- Diplopia
- Headache
- Nausea
Key clinical trials
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 novel formulation CI brief — competitive landscape report
- Lamotrigine novel formulation updates RSS · CI watch RSS
- University Hospitals Cleveland Medical Center portfolio CI
Frequently asked questions about Lamotrigine novel formulation
What is Lamotrigine novel formulation?
How does Lamotrigine novel formulation work?
What is Lamotrigine novel formulation used for?
Who makes Lamotrigine novel formulation?
Is Lamotrigine novel formulation also known as anything else?
What drug class is Lamotrigine novel formulation in?
What development phase is Lamotrigine novel formulation in?
What are the side effects of Lamotrigine novel formulation?
What does Lamotrigine novel formulation target?
Related
- Drug class: All Anticonvulsant / Antiepileptic agent drugs
- Target: All drugs targeting Voltage-gated sodium channels; glutamate release inhibition
- Manufacturer: University Hospitals Cleveland Medical Center — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Epilepsy (maintenance therapy)
- Indication: Drugs for Bipolar disorder (maintenance therapy for bipolar depression)
- Also known as: Lamictal
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing