NDAORALCAPSULE, EXTENDED RELEASE1 Generic Approved
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
6/8 — Strong
CARBATROL (carbamazepine) by Takeda is cytochrome p450 3a4 inducers [moa]. Approved for mood stabilizer [epc]. First approved in 1997.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARBATROL is an extended-release oral capsule formulation of carbamazepine, a cytochrome P450 3A4 inducer approved in 1997 for mood stabilization. It is indicated as a mood stabilizer and works by modulating sodium channels and enhancing GABAergic neurotransmission. The extended-release formulation allows for reduced dosing frequency compared to immediate-release alternatives.
$4.0MPart D
LOE ApproachingProduct is in late-stage lifecycle with modest Part D spending of $4M and declining relevance, suggesting smaller commercial team and focus on retention rather than growth initiatives.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Pharmacologic Class:
Mood Stabilizer
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole
Started Apr 2026
28 enrolled
Healthy Participants
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
Started Feb 2026
54 enrolled
Healthy Volunteer
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
Started Dec 2025
36 enrolled
HealthyVolunteer
A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144
Started Sep 2025
12 enrolled
Healthy Adults
Worked on CARBATROL at Takeda? Share your interview experience or compensation data (+7 days Pro)
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.