NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2012
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
3
Data completeness
4/8 — Partial
QSYMIA (phentermine and topiramate) by Teva is cytochrome p450 3a4 inducers [moa]. First approved in 2012.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QSYMIA is a fixed-dose combination of phentermine (sympathomimetic amine) and topiramate (anticonvulsant) approved in 2012 as an oral extended-release capsule for chronic weight management. The combination acts as a CYP3A4 inducer and works through dual mechanisms to suppress appetite and increase satiety. It is indicated for patients with obesity or overweight with weight-related comorbidities.
Peak3.0 years to LOE
Product is at peak market penetration with sustained commercial investment; brand teams remain focused on market defense against competitive alternatives.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Phase IV Study of Qsymia in Obese Patients
Started Sep 2021
232 enrolled
Obesity
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Started Dec 2014
25 enrolled
ObesityMetabolic SurgeryWeight Loss+1 more
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
Started Aug 2014
51 enrolled
Obesity
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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.