Drugs / VI-0521
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00821496 | Jan → Mar 2009 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT05215418 | Jan 2022 → Apr 2023 | hypertensive disorder | VIVUS LLC | Completed | Met primary |
| Phase 4 | NCT02714062 | Mar → Oct 2016 | obesity, hyperphagia, and developmental delay | VIVUS LLC | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00839891 Comparator | Feb → Apr 2009 | torsades de pointes | VIVUS LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-01-26 | VIVUS LLC | Results New Clinical Data Demonstrate that VIVUS’ QSYMIA in Combination with Digitally Enhanced Lifestyle Interventions (DELI) Leads to Significantly Greater Reductions in Weight and Cardiovascular Risk vivus.com ↗
Results show that QSYMIA in combination with DELI significantly improved weight loss, percentage of body weight lost, and atherosclerotic cardiovascular disease (ASCVD) risk compared with DELI plus placebo. |
| 2025-03-10 | VIVUS LLC | Regulatory VIVUS Launches QSYMIA in the United Arab Emirates vivus.com ↗
VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, announced the market approval of QSYMIA® (phentermine and topiramate extended-release capsules) CIV in the United Arab Emirates (UAE) for treatment of overweight and obesity in adults and pediatric patients, age 12 and older. |
| 2024-10-28 | VIVUS LLC | Regulatory VIVUS Shares Significant Regulatory Update on QSYMIA vivus.com ↗
VIVUS announced today that the U.S. Food and Drug Administration has removed the requirement for a cardiovascular outcome trial for its weight - management medication QSYMIA (phentermine and topiramate extended release capsules) CIV. |
| 2024-10-23 | VIVUS LLC | Regulatory VIVUS Announces Labeling Update vivus.com ↗
VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced the United States Food and Drug Administration (FDA) approved a labeling update for QSYMIA® (phentermine and topiramate extended-release capsules CIV). |
| 2023-11-28 | VIVUS LLC | Results New Clinical Data Demonstrate that QSYMIA, the Leading Once-Daily Oral Weight Management Medication, Reduces Blood Pressure vivus.com ↗
This data supports that beyond beneficial effects of reducing body weight, QSYMIA also favorably affects blood pressure – a common and important health metric. |
| 2023-05-17 | VIVUS LLC | Results VIVUS QSIVA in Combination with a Digital Lifestyle Intervention Leads to Significant Weight Loss and Decreased Cardiovascular Risk in Patients with Obesity vivus.com ↗
VIVUS BV, the European affiliate of VIVUS LLC (“VIVUS”), a biopharmaceutical company, today announced the results of a clinical study (NCT04408586) demonstrating that QSIVA (phentermine and topiramate modified-release) hard capsules in combination with a DLI resulted in significantly greater weight loss and cardiovascular risk reduction in patients with obesity compared with the DLI alone. |
| 2022-07-20 | VIVUS LLC | Regulatory FDA Approves QSYMIA for the Treatment of Obesity in Adolescents Ages 12 to 17 vivus.com ↗
FDA Approves QSYMIA® for the Treatment of Obesity in Adolescents Ages 12-17 |
| 2020-01-07 | VIVUS LLC | Results New Data Further Demonstrate Effectiveness of VIVUS Qsymia as a Weight Management Tool vivus.com ↗
Data published in Journal of General Internal Medicine show that patients using Qsymia and other weight loss tools, lost at least 5% of body weight loss compared with those not using Qsymia |
| 2019-12-18 | VIVUS LLC | Results VIVUS Announces New Data Supporting the Safety and Efficacy of Qsymia in Adolescents with Obesity vivus.com ↗
Data published in Diabetes, Obesity and Metabolism demonstrate that Qsymia provides statistically significant weight loss compared with placebo over an 8 week period, provide basis for ongoing 56 week phase 4 study in obese adolescents |
| 2019-11-20 | VIVUS LLC | Results New Clinical Data Demonstrate VIVUS Qsymia is Effective at Reducing Binge Eating in Patients with Binge Eating Disorder or Bulimia Nervosa vivus.com ↗
Additionally, Qsymia was well tolerated in these patient populations. |
| 2019-10-07 | VIVUS LLC | Regulatory VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe vivus.com ↗
VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe |
| 2019-08-21 | Alvogen Korea | Regulatory Alvogen receives approval of Qsymia® in the Republic of Korea alvogen.com ↗
Alvogen has obtained marketing approval for Qsymia (phentermine and topiramate extended-release) from the South Korea Ministry of Food and Drug Safety (MFDS) in partnership with VIVIS Inc. (Nasdaq:VVUS). |
| 2019-08-20 | VIVUS LLC | Results New Pilot Clinical Study Results Demonstrate that Addition of VIVUS Qsymia to Gastric Sleeve Surgery Significantly Improves Weight Loss Compared with Surgery Alone vivus.com ↗
Study results show that patients taking it lost significantly more weight before surgery and had improved outcomes with respect to weight loss and BMI than those not on AOM. |
| 2019-08-05 | VIVUS LLC | Regulatory VIVUS Announces Approval of Qsymia in the Republic of Korea vivus.com ↗ |
| 2019-01-14 | VIVUS LLC | Results Data Supporting the Cardiovascular Safety of VIVUS Qsymia Published in The Journal of Clinical Endocrinology & Metabolism vivus.com ↗
The new findings indicate that the combined risk of major adverse cardiovascular events (MACE) was not elevated in patients currently taking Qsymia, or concurrently taking both phentermine and topiramate, compared with former users of these medications. |
| 2018-08-27 | VIVUS LLC | Results VIVUS Reports Data Supporting the Cardiovascular Safety of Qsymia vivus.com ↗
Results show that the risk of major adverse cardiovascular events (MACE) trended lower in patients taking Qsymia compared with similar patients who were not taking Qsymia. |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VI-0521 | “VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule” NCT05215418 ↗ |
| Known as | PHEN/TPM | “This three-arm, parallel group, double-blind, active- and placebo-controlled study comparing VI-0521 at a potential therapeutic dose of PHEN/TPM 7.5/46 and PHEN/TPM 22.5/138 ,...” NCT00839891 ↗ |
| Route | Oral | “multiple oral doses of VI-0521” NCT00821496 ↗ |