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Placebo matched phentermine/topiramate
Phentermine/topiramate is a combination that suppresses appetite through sympathomimetic stimulation and enhances satiety through carbonic anhydrase inhibition and GABAergic effects.
Phentermine/topiramate is a combination that suppresses appetite through sympathomimetic stimulation and enhances satiety through carbonic anhydrase inhibition and GABAergic effects. Used for Chronic weight management in obese or overweight patients with weight-related comorbidities.
At a glance
| Generic name | Placebo matched phentermine/topiramate |
|---|---|
| Sponsor | VIVUS LLC |
| Drug class | Sympathomimetic amine + anticonvulsant combination |
| Target | Norepinephrine release (phentermine); carbonic anhydrase, GABA receptors, glutamate receptors (topiramate) |
| Modality | Small molecule |
| Therapeutic area | Obesity/Weight Management |
| Phase | Phase 3 |
Mechanism of action
Phentermine acts as a sympathomimetic amine that stimulates the release of norepinephrine in the hypothalamus, reducing appetite and increasing energy expenditure. Topiramate enhances weight loss through multiple mechanisms including carbonic anhydrase inhibition, potentiation of GABA signaling, and antagonism of kainate/AMPA glutamate receptors, which collectively promote satiety and reduce food intake. The combination produces synergistic weight loss effects beyond either agent alone.
Approved indications
- Chronic weight management in obese or overweight patients with weight-related comorbidities
Common side effects
- Paresthesia
- Cognitive dysfunction/memory impairment
- Insomnia
- Tachycardia
- Dry mouth
- Constipation
- Dizziness
Key clinical trials
- Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity (PHASE2)
- Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients (PHASE2)
- Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients (PHASE4)
- Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy (PHASE4)
- Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults (PHASE3)
- Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics (PHASE2)
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:
- Placebo matched phentermine/topiramate CI brief — competitive landscape report
- Placebo matched phentermine/topiramate updates RSS · CI watch RSS
- VIVUS LLC portfolio CI