Drugs / VI-0521
VI-0521
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | QSYMIA | — | 2012-07-17 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00821496 | Jan → Mar 2009 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06905626 | Nov 2026 → Oct 2030 expected | — | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03374956 | Dec 2017 → May 2022 | obesity disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05215418 | Jan 2022 → Apr 2023 | hypertensive disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT05378503 | Sep 2021 → Oct 2023 | obesity disorder | Alvogen Korea | Completed | No outcome recorded |
| Phase 4 | NCT02714062 | Mar → Oct 2016 | obesity, hyperphagia, and developmental delay | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT01922934 | Jan 2014 → Aug 2016 | obesity disorder | Denver Health and Hospital Authority | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00839891 Comparator | Feb → Apr 2009 | torsades de pointes | VIVUS LLC | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05812183 Background | Jul 2023 → Feb 2025 | — | University of California, Los Angeles | Withdrawn | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 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 ↗ |
| Known as | Phentermine-Topiramate | “Phentermine or phentermine-topiramate (Qsymia)” NCT01922934 ↗ |
| Known as | Qsymia | “Phentermine or phentermine-topiramate (Qsymia)” NCT01922934 ↗ |
| Route | Oral | “multiple oral doses of VI-0521” NCT00821496 ↗ |