NDAORALSUSPENSION
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
SUBVENITE (lamotrigine) by OWP Pharmaceuticals is organic cation transporter 2 inhibitors [moa]. Approved for bipolar disorder, epilepsy. First approved in 2025.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBVENITE (lamotrigine) is an oral suspension formulation of the established anticonvulsant lamotrigine, approved September 2025 by OWP Pharmaceuticals. It works as an organic cation transporter 2 inhibitor and is indicated for bipolar disorder, epilepsy, depression, binge eating disorder, schizophrenia, and mood disorders. The suspension formulation represents a new delivery mechanism for an existing active pharmaceutical ingredient.
$0.022BPart D
Launch14.1 years to LOEEarly-stage launch with minimal current market penetration suggests opportunities for field-building roles, though long-term commercial success depends on differentiation versus generic lamotrigine in the market.
Mechanism of Action
Organic Cation Transporter 2 Inhibitors
Pharmacologic Class:
Anti-epileptic Agent
Indications (2)
Clinical Trials (20)
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
Started Oct 2025
424 enrolled
ManiaBipolar Disorder
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
Started Dec 2024
133 enrolled
Healthy Volunteers
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Started Dec 2020
40 enrolled
Healthy
Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine
Started Mar 2020
75 enrolled
Emotions
A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults
Started Jul 2019
22 enrolled
Healthy Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.