Drugs / Phentermine
Phentermine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Qsiva | — | 2013-05-14 | europa.eu ↗ |
| Approved | US (FDA) | FASTIN | — | 1973-08-14 | fda.gov ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04881799 | Jul 2022 → Oct 2025 overdue | — | University of Minnesota | Active not recruiting | No outcome recorded |
| Phase 17 trials · 1 met primary | ||||||
| Phase 1 | NCT02553824 | Oct 2015 → Feb 2017 | binge eating disorder, bulimia nervosa | Stanford University | Completed | Met primary |
| Phase 1 | NCT02239913 | Sep 2014 → Sep 2019 | substance-related disorder | University of Kentucky | Completed | No outcome recorded |
| Phase 1 | NCT01500018 | Jan → Apr 2012 | substance abuse | AstraZeneca | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT00842400 | Feb → Mar 2009 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00768404 | Oct 2008 → Mar 2009 | impaired renal function disease | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00768209 | Oct 2008 → Mar 2009 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00518466 | Jul → Sep 2007 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT00745251 | Aug 2008 → Sep 2009 | sleep apnea syndrome | VIVUS LLC | Completed | Met primary |
| Phase 218 trials · 3 met primary | ||||||
| Phase 2 | NCT07790913 | Oct 2026 → Aug 2030 expected | Hodgkins lymphoma, acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07282340 | Jun 2026 → Jan 2028 expected | — | Russell McCulloh, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06299891 | Mar 2025 → Feb 2026 overdue | acquired hypothalamic obesity, craniopharyngioma, hypothalamic neoplasm | Seattle Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05834062 | Oct 2023 → Aug 2026 | — | University of Minnesota | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04572217 | Jun 2022 | — | Janey Pratt | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04621929 | Mar 2021 → Nov 2024 | obesity disorder, prediabetes syndrome, type 2 diabetes mellitus, urolithiasis | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT04721873 | Dec 2020 → Jun 2024 overdue | obesity disorder, ulcerative colitis | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT04095104 | Jan 2020 → Jan 2022 | morbid obesity | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT04007393 | Nov 2019 → Mar 2025 | — | University of Minnesota | Completed | No outcome recorded |
| Phase 2 | NCT02301416 | Dec 2014 → Jun 2018 | obesity disorder | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02243202 | Sep 2014 → Jun 2015 | obesity disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01950520 | Feb 2014 → Dec 2022 | — | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00806260 | Dec 2008 → May 2009 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 2 | NCT00737633 | Aug 2008 → Mar 2009 | type 2 diabetes mellitus | VIVUS LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00600067 | Jan → Nov 2008 | type 2 diabetes mellitus | VIVUS LLC | Completed | Met primary |
| Phase 2 | NCT00486291 | Jun 2007 → Apr 2008 | type 2 diabetes mellitus | VIVUS LLC | Completed | Met primary |
| Phase 2 | NCT00402077 | Nov 2006 → Aug 2007 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00000506 | May 1983 → Apr 1988 | heart disorder, obesity disorder, vascular disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT00796367 | Dec 2008 → Jun 2010 | obesity disorder | VIVUS LLC | Completed | Met primary |
| Phase 3 | NCT00553787 | Nov 2007 → Jun 2009 | obesity disorder, type 2 diabetes mellitus | VIVUS LLC | Completed | Met primary |
| Phase 412 trials · 4 met primary · 1 missed | ||||||
| Phase 4 | NCT07832084 | Nov 2026 → Apr 2027 expected | obesity disorder | Jing Luo | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07213466 | Jan 2026 → Feb 2028 expected | bipolar I disorder, bipolar II disorder, obesity disorder, schizoaffective disorder | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT05975580 | Aug 2023 → Jul 2027 expected | obesity disorder | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 4 | NCT05176626 | Jun 2022 → Dec 2026 expected | obesity disorder | Wake Forest University Health Sciences | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04614545 | Jan → Aug 2021 | obesity disorder | The Cleveland Clinic | Completed | Met primary |
| Phase 4 | NCT03922945 | May 2019 → Apr 2021 | — | VIVUS LLC | Completed | Met primary |
| Phase 4 | NCT03799198 | Jan 2019 → May 2020 | obesity disorder | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT02229214 | Aug → Nov 2014 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT01922934 | Jan 2014 → Aug 2016 | obesity disorder | Denver Health and Hospital Authority | Completed | Met primary |
| Phase 4 | NCT01987427 | Oct 2013 → Aug 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01834404 | Apr 2013 → Mar 2014 | obesity disorder | Mayo Clinic | Completed | Mixed |
| Phase 4 | NCT01886937 | Jul 2012 → Jun 2014 | obesity disorder | New York State Psychiatric Institute | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT00771654 | Feb 2009 → Sep 2010 | obesity disorder | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy17 trials | ||||||
| Phase 0 | NCT01719185 Background | Sep 2012 → Jan 2013 | hypertensive disorder, obesity disorder | Dr. Michael Lang | Completed | No outcome recorded |
| Phase 1 | NCT03152123 Comparator | Mar → Oct 2017 | substance abuse | Bioprojet | Completed | No outcome recorded |
| Phase 1 | NCT02609477 Comparator | Jan → Jul 2016 | substance abuse | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04298203 Comparator | Aug 2021 → May 2026 | obesity disorder | University of Minnesota | Completed | No outcome recorded |
| Phase 3 | NCT03374956 Comparator | Dec 2017 → May 2022 | obesity disorder | Mayo Clinic | Completed | Met primary |
| Phase 3 | NCT02635386 Comparator | Mar 2016 → Jul 2020 | obesity disorder, polycystic ovary syndrome | Woman's | Completed | No outcome recorded |
| Phase 3 | NCT00563368 Comparator | Dec 2007 → Sep 2008 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 3 | NCT00554216 Comparator | Nov 2007 → May 2009 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT07058155 Comparator | Dec 2025 → Feb 2029 expected | cirrhosis of liver, morbid obesity, portal hypertension | The Cleveland Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT05215418 Comparator | Jan 2022 → Apr 2023 | hypertensive disorder | VIVUS LLC | Completed | Met primary |
| Phase 4 | NCT04408586 Comparator | Jun 2020 → Jun 2022 | obesity disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03779048 Comparator | Jul 2019 → May 2022 | obesity disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT03849729 Comparator | Mar 2018 → Apr 2020 | NAFLD1, morbid obesity | Hospital Juarez de Mexico | Completed | No outcome recorded |
| Phase 4 | NCT02911818 Comparator | Sep 2016 → Nov 2018 | obesity disorder | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT03675191 Background | Oct 2018 → Jul 2019 | obesity disorder | Gangnam Severance Hospital | Completed | Met primary |
| — | NCT01616082 Comparator | Sep 2011 → Nov 2012 | metabolic disease, obesity disorder | AdventHealth Translational Research Institute | Completed | No outcome recorded |
| — | NCT01402674 Comparator | Aug 2011 → Nov 2012 | obesity disorder | Center for Weight Management, California | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-03-10 | VIVUS LLC | Regulatory VIVUS Launches QSYMIA in the United Arab Emirates vivus.com ↗
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 ↗
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 positive topline data from a post-marketing study to evaluate the effect of QSYMIA® (phentermine and topiramate extended-release capsules CIV) on 24-hour ambulatory blood pressure (ABPM) (#NCT05215418). |
| 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 |
| 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 ↗
New Clinical Data Demonstrate VIVUS’ Qsymia® is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder or Bulimia Nervosa |
| 2019-10-07 | VIVUS LLC | Regulatory VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe vivus.com ↗ |
| 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 ↗
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical company, announced today that its Korean marketing partner, Alvogen, has obtained marketing approval for Qsymia (phentermine and topiramate extended-release) from the South Korea Ministry of Food and Drug Safety (MFDS). |
| 2019-08-01 | Lotus Pharmaceutical | Regulatory Lotus's Korean subsidiary received approval of the anti-obesity drug Qsymia® lotuspharm.com ↗
Alvogen Korea Co., Ltd. (Alvogen Korea) received the final approval of the anti-obesity drug Qsymia® (phentermine and topiramate extended-release) from South Korea Ministry of Food and Drug Safety (MFDS). |
| 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. |
| 2016-09-20 | KVK-Tech, Inc. | Regulatory KVK Tech Announces FDA-Approval of Lomaira™ kvktech.com ↗
KVK Tech Announces FDA-Approval of Lomaira™ |
| 2014-10-29 | Eisai Inc. | Results EISAI ANNOUNCES TOP-LINE RESULTS OF INVESTIGATIONAL STUDY ON COADMINISTRATION OF LORCASERIN AND PHENTERMINE Trial Supports Safety and Tolerability After 12 Weeks of Treatment eisai.com ↗
The results of the study demonstrate that the short-term combination of lorcaserin plus phentermine does not appear to be associated with an exacerbation in the proportion of pre-specified adverse events compared to therapy with lorcaserin alone. |
All press releases naming this drug 33 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Phentermine | “Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily...” NCT00806260 ↗57“This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight” NCT05834062 ↗ “Agents may include incretin-based therapies (e.g., Semaglutide, Tirzepatide) or other FDA-approved AOMs such as Topiramate or Phentermine.” NCT07058155 ↗ “Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg, Phentermine 45 mg, Phentermine 90 mg, Placebo” NCT02609477 ↗ “Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks” NCT00737633 ↗ “VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days” NCT00842400 ↗ “Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)” NCT01950520 ↗ “VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule” NCT03922945 ↗ “Participants will then start phentermine at 15mg once a day.” NCT07832084 ↗ “7.5 mg phentermine/46 mg controlled-release topiramate” PMID 22158731 ↗ Dec 2011 “Phentermine or phentermine-topiramate (Qsymia)” NCT01922934 ↗ |
| Known as | 2-methyl-1-phenylpropan-2-amine | “Phentermine belongs to a class of drugs called anorectics, also known as appetite suppressants. IUPAC name 2-methyl-1-phenylpropan-2-amine” NCT05975580 ↗ |
| Known as | PHEN | “The safety and efficacy of treatment with phentermine
(PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were...” PMID 25249652 ↗ Sep 20141“initially randomized in a 3:3:2 ratio to daily treatment with topiramate (TPM) or phentermine (PHEN) or placebo” NCT05975580 ↗ |
| Known as | Phentermine Hydrochloride | “Phentermine Hydrochloride 8 MG” NCT05176626 ↗ |
| Known as | Phentermine/topiramate extended-release | “Phentermine/topiramate extended-release (Qsymia® pills, p.o.)” NCT03799198 ↗ |
| Known as | Qsymia | “Phentermine/topiramate extended-release (Qsymia® pills, p.o.)” NCT03799198 ↗ |
| Action | Inhibit | “reducing appetite through inhibition of norepinephrine reuptake (phentermine)” NCT04298203 ↗ |
| Modality | Small molecule | “Phentermine, an amphetamine congener, is the most widely used anti-obesity drug in the U.S.” NCT01402674 ↗ |
| Route | Oral | “oral tablet” NCT00402077 ↗ |