Last reviewed · How we verify
VI-0521 Top Dose
VI-0521 is a phentermine-based combination product that acts as a sympathomimetic amine to suppress appetite and increase energy expenditure for weight management.
VI-0521 is a phentermine-based combination product that acts as a sympathomimetic amine to suppress appetite and increase energy expenditure for weight management. Used for Obesity management in patients with BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities.
At a glance
| Generic name | VI-0521 Top Dose |
|---|---|
| Also known as | Phentermine/Topiramate |
| Sponsor | VIVUS LLC |
| Drug class | Sympathomimetic amine; appetite suppressant |
| Target | Norepinephrine release; adrenergic system |
| Modality | Small molecule |
| Therapeutic area | Obesity; Weight Management |
| Phase | FDA-approved |
Mechanism of action
VI-0521 Top Dose contains phentermine, which stimulates the release of norepinephrine in the central nervous system, leading to appetite suppression and increased metabolic rate. This mechanism helps reduce caloric intake and promote weight loss when combined with diet and exercise modifications.
Approved indications
- Obesity management in patients with BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities
Common side effects
- Insomnia
- Dry mouth
- Increased heart rate
- Elevated blood pressure
- Nervousness or anxiety
- Headache
Key clinical trials
- A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects (PHASE4)
- A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity (PHASE4)
- A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents (PHASE4)
- A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults (PHASE3)
- Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults (PHASE3)
- Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions (PHASE3)
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 |