COMPANY

VIVUS

FDA-cleared device company Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Obesity Erectile Dysfunction Diabetes Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension PAH Lymphoma Non-Hodgkin Lymphoma Hodgkin Lymphoma Blood Pressure Adolescent Obesity Obesity in Adolescence Adolescent Overweight Pediatric Obesity Childhood Obesity Vision Alzheimer's Disease Overweight Sleep Apnea Type 2 Diabetes Type 2 Diabetes Mellitus Hypoactive Sexual Desire Disorder Avanfil ADME Semen Exposure Sperm Function Renal Torsades de Pointes Renal Impairment Hepatic Impairment Physiological Sexual Dysfunction VI-0521 avanafil VI-0106 VI-0609

43Trials (company is sponsor)

Timeline

May 29, 2026 Trial start 3: A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations source ↗
Mar 12, 2025 Trial start Phase 2: A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma source ↗
Jan 25, 2022 Trial start Phase 4: A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects source ↗
May 2, 2019 Trial start IV: A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity source ↗
2016-03 Trial start Phase 4: A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents source ↗
2014-08 Trial start Phase 4: Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects source ↗
2014-01 Trial start Phase 4: Safety Study Looking at the Effects of Stendra on Vision source ↗
2012-12 Trial start Phase 4: Study Evaluating the Effects of Avanafil on Semen Parameters source ↗
2012-09 Trial start Phase 4: Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction source ↗
2011-08 Trial start Phase 2: VI-1121 for the Treatment Alzheimer's Disease source ↗
2010-04 Trial start Phase 1: Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects source ↗
2010-04 Trial start Phase 1: Drug Interaction Study of Avanafil and Enalapril or Amlodipine source ↗
2010-04 Trial start Phase 1: Study the Effect of Avanafil on the Pharmacodynamics and Pharmacokinetics of Warfarin in Healthy Male Subjects source ↗
2010-04 Trial start Phase 1: Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects source ↗
2010-02 Trial start Phase 1: A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa® source ↗
2010-02 Trial start Phase 1: Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin source ↗
2010-01 Trial start I: A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects. source ↗
2010-01 Trial start Phase 1: To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects. source ↗
2010-01 Trial start Phase 1: To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function. source ↗
2009-05 Trial start Phase 1: A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects source ↗
2009-04 Trial start Phase 3: Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy source ↗
2009-03 Trial start Phase 3: Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction source ↗
2009-02 Trial start Phase 1: A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers source ↗
2009-02 Trial start Phase 1: A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy Subjects. source ↗
2009-01 Trial start Phase 1: Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects source ↗

Showing 25 of 43 dated events.

Upcoming milestones

Mar 31, 2027 (ESTIMATED) · Phase 2 · A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma · NCT06915246
May 31, 2028 (ESTIMATED) · 3 · A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations · NCT07612657

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 43

Record	Title	Phase	Status	Start	Primary completion
NCT07612657	A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations	3	Not yet recruiting	May 29, 2026	May 31, 2028 (estimated)
NCT06915246	A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma	Phase 2	Recruiting	Mar 12, 2025	Mar 31, 2027 (estimated)
NCT05215418	A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects	Phase 4	Completed	Jan 25, 2022	Apr 11, 2023 (actual)
NCT03922945	A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity	IV	Completed	May 2, 2019	Apr 16, 2021 (actual)
NCT02714062	A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents	Phase 4	Completed	2016-03	2016-10 (actual)
NCT02229214	Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects	Phase 4	Completed	2014-08	2014-11 (actual)
NCT01768676	Study Evaluating the Effects of Avanafil on Semen Parameters	Phase 4	Completed	2012-12	2014-08 (actual)
NCT00563368	A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults	Phase 3	Completed	2007-12	2008-09 (actual)
NCT02033200	Safety Study Looking at the Effects of Stendra on Vision	Phase 4	Completed	2014-01	2014-01 (actual)
NCT01698684	Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction	Phase 4	Completed	2012-09	2013-04 (actual)
NCT01428362	VI-1121 for the Treatment Alzheimer's Disease	Phase 2	Completed	2011-08	2013-08 (actual)
NCT00806260	A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.	Phase 2	Completed	2008-12	2009-05 (actual)
NCT00745251	A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults	Phase 1/Phase 2	Completed	2008-08	2009-09 (actual)
NCT00895011	Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy	Phase 3	Completed	2009-04	2011-04 (actual)
NCT00554216	Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults	Phase 3	Completed	2007-11	2009-05 (actual)
NCT00796367	A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)	Phase 3	Completed	2008-12	2010-06 (actual)
NCT00553787	Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions	Phase 3	Completed	2007-11	2009-06 (actual)
NCT00737633	Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults	Phase 2	Terminated	2008-08	2009-03 (actual)
NCT00600067	A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults	Phase 2	Completed	2008-01	2008-11 (actual)
NCT00486291	Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics	Phase 2	Completed	2007-06	2008-04 (actual)
NCT00853606	Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction	Phase 3	Completed	2009-03	2010-04 (actual)
NCT00809471	Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)	Phase 3	Completed	2008-12	2010-02 (actual)
NCT00790751	Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED	Phase 3	Completed	2008-11	2009-08 (actual)
NCT01616485	Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo	Phase 1	Completed	2004-03	2004-05 (actual)
NCT01415128	Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects	Phase 1	Completed	2010-04	2010-05 (actual)
NCT01117038	Drug Interaction Study of Avanafil and Enalapril or Amlodipine	Phase 1	Completed	2010-04	2010-05 (actual)
NCT01096329	A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®	Phase 1	Terminated	2010-02	2010-04 (actual)
NCT00518466	Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults	Phase 1	Completed	2007-07	2007-09 (actual)
NCT00769041	A Thorough EKG Safety Study of TA-1790 (Avanafil)	Phase 1	Completed	2008-10	2009-01 (actual)
NCT01054859	A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.	I	Completed	2010-01	2010-01 (actual)
NCT01095588	Study the Effect of Avanafil on the Pharmacodynamics and Pharmacokinetics of Warfarin in Healthy Male Subjects	Phase 1	Completed	2010-04	2010-05 (actual)
NCT01054430	To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.	Phase 1	Completed	2010-01	2010-02 (actual)
NCT01095601	Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects	Phase 1	Completed	2010-04	2010-05 (actual)
NCT00914511	A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects	Phase 1	Completed	2009-05	2009-06 (actual)
NCT01054261	To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.	Phase 1	Completed	2010-01	2010-02 (actual)
NCT01100021	Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin	Phase 1	Completed	2010-02	2010-03 (actual)
NCT00839891	A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers	Phase 1	Completed	2009-02	2009-04 (actual)
NCT00842400	A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy Subjects.	Phase 1	Completed	2009-02	2009-03 (actual)
NCT00821496	Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects	Phase 1	Completed	2009-01	2009-03 (actual)
NCT00770042	To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil	Phase 1	Completed	2008-10	2008-11 (actual)
NCT00768404	A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment	Phase 1	Completed	2008-10	2009-03 (actual)
NCT00768209	A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment	Phase 1	Completed	2008-10	2009-03 (actual)
NCT00324948	Topical Alprostadil for Female Sexual Arousal Disorder	Phase 2	Completed	2004-09	2006-08 (actual)