Viagra

(Sildenafil)

ApprovedSmall molecule

Sildenafil is used to treat erectile dysfunction (impotence) in men and to treat high blood pressure in the lungs. It works by relaxing blood vessels to increase blood flow.[2] Viagra is currently approved and in use across 97 indications[4].[1]

Viagra is one of 1605 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

252

Total Trials

Active Trials

1,604

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

Coronary Artery DiseaseApproved

Coronary VasospasmApproved

Pulmonary Arterial Hypertension Associated With Portal HypertensionApproved

Premature BirthApproved

Cirrhosis of LiverActive, not recruiting

EmphysemaActive, not recruiting

Nephrogenic Diabetes InsipidusActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Persistent Fetal Circulation SyndromeApproved

Insulin ResistancePhase 1/Phase 2

Active, not recruiting

Coronary Artery DiseaseApproved

Approved

Coronary VasospasmApproved

Approved

Pulmonary Arterial Hypertension Associated With Portal HypertensionApproved

Approved

Premature BirthApproved

Approved

Cirrhosis of LiverPhase 1

Active, not recruiting

EmphysemaApproved

Active, not recruiting

Nephrogenic Diabetes InsipidusPreclinical

Active, not recruiting

Endothelial DysfunctionPhase 2

Active, not recruiting

Persistent Fetal Circulation SyndromeApproved

Approved

Showing 10 of 94 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Viagra

VViatris Specialty LLC

Approved

1 2

Biaxin

AbbVie

Preclinical

2 3

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 4

Olokizumab

UCB

Preclinical

1 5

Interferon-Gamma

SSPP Pharmaclon Ltd.

Preclinical

1 6

Tpa

UUniversity of Florida

Preclinical

1 7

COVID-19 Vaccines

UUniversity of British Columbia

Preclinical

10 8

Other Tkis

Bayer

Preclinical

1 9

Immunosuppressive

Chiesi Farmaceutici S.p.A.

Preclinical

1 10

Saliva Collection

DDirection Centrale du Service de Santé des Armées

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Vascular Disease

NCT04797286

Phase 2Recruiting

Hernia

NCT05201144

Q4 2026

Phase 3Not yet recruiting

Erectile Dysfunction

NCT07177326

Q1 2027

Post-ApprovalRecruiting

Prostate Cancer

NCT06875258

Q3 2027

Phase 1Active, not recruiting

Urinary Incontinence

NCT02983461

Clinical

Trials by Indication[1]

Pulmonary Hypertension17 trials

IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Withdrawn·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT01360671

Sildenofil in Persistent Pulmonary Hypertension in Newborns

Unknown status·HHamad Medical Corporation·Phase 3·NCT01558466·100 enrolled

Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

Completed·MMuhammad Aamir Latif·N/A·NCT06562036·42 enrolled

Show 14 more trials

Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

Unknown status·—·Phase 2/3·NCT03763045·60 enrolled

Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension

Completed·CCarelon Research·Phase 2/3·NCT00872170·27 enrolled

Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

Completed·—·Phase 1/2·NCT02595541·30 enrolled

Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension

Withdrawn·UUniversidad del Norte·N/A·NCT04912726

Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension

Terminated·UUniversity of Colorado, Denver·Phase 2·NCT01409031·3 enrolled

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Recruiting·—·Phase 2/3·NCT07462260·100 enrolled

VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension

Completed·KKerckhoff Heart Center·Phase 4·NCT01889966·10 enrolled

Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

Unknown status·—·Phase 4·NCT01449253·60 enrolled

Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00492531·74 enrolled

L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03402191·60 enrolled

Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Terminated·MMaya Guglin·Phase 4·NCT02304705·33 enrolled

Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension

Completed·RRania Ali El-Farrash·Phase 1·NCT04391478·40 enrolled

PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Completed·—·Phase 4·NCT02378649·60 enrolled

Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn

Completed·—·Phase 1/2·NCT06860399·55 enrolled

Pulmonary Arterial Hypertension11 trials

To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT00946114·32 enrolled

Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients

Terminated·CCompetence Network for Congenital Heart Defects·Phase 3·NCT00586794·24 enrolled

Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension

Completed·LLaval University·N/A·NCT01391104·22 enrolled

Show 8 more trials

Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT01642407·6 enrolled

Combination Therapy in Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00433329·100 enrolled

A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00644605·275 enrolled

Revatio Portal-Pulmonary Arterial Hypertension Trial

Terminated·UUniversity Health Network, Toronto·Phase 2·NCT01517854·12 enrolled

The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00302211·67 enrolled

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)

Completed· Gilead logo

Gilead·Phase 4·NCT00617305·38 enrolled

A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00853112·48 enrolled

Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

Completed· Novartis logo

Novartis·Phase 3·NCT01392469·21 enrolled

ILD11 trials

Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones

Unknown status·MMansoura University·Phase 4·NCT02519153·100 enrolled

Taste Test of a New Formulation of Sildenafil (Revatio)

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT00768573·4 enrolled

Motor Response to Sildenafil in PD

Completed·—·Phase 4·NCT01941732·8 enrolled

Show 8 more trials

Sildenafil To Prevent Clot

Completed·MMontefiore Medical Center·Phase 1·NCT03199612·20 enrolled

Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT00666198·3,337 enrolled

Sildenafil and Uteroplacental Perfusion

Unknown status·TTehran University of Medical Sciences·Phase 2/3·NCT01107782·70 enrolled

PK Study of Sildenafil in Neonate

Completed·SSeoul National University Hospital·Phase 2·NCT02244528·20 enrolled

Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

Completed·NN4 Pharma UK Ltd.·Phase 1·NCT03510338·12 enrolled

Sildenafil IV Bolus Study

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00800592·12 enrolled

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Recruiting·MMontefiore Medical Center·Phase 1·NCT06510322·50 enrolled

Healthy Volunteer Study of Sildenafil Effects Upon Vision

Completed·UUniversity of Cambridge·Phase 4·NCT00251784

Erectile Dysfunction10 trials

A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT01108900·100 enrolled

SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction

Completed· Sanofi logo

Sanofi·Phase 2·NCT00914277·24 enrolled

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

Unknown status·EEduardo Vargas-Baquero·Phase 4·NCT03169582·78 enrolled

Show 7 more trials

A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00654082·88 enrolled

Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study

Not yet recruiting·—·Phase 3·NCT07177326·142 enrolled

Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

Unknown status·SSeoul National University Bundang Hospital·N/A·NCT01054001·124 enrolled

Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction

Completed· Pfizer logo

Pfizer·Phase 2·NCT00862888·39 enrolled

A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00645268·300 enrolled

A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00644956·56 enrolled

Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction

Completed·XXintian Pharmaceutical·Phase 4·NCT06064448·254 enrolled

Treatment6 trials

Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

Completed· Bayer logo

Bayer·Phase 4·NCT00655590·200 enrolled

Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00547352·160 enrolled

Topical Sildenafil as Pre-Treatment for Hand-Foot Skin Reaction

Completed·NNorthwestern University·Phase 1·NCT03229512·2 enrolled

Show 3 more trials

Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00547092·386 enrolled

Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium

Completed·—·N/A·NCT02710981·42 enrolled

Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

No longer available·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT01897740

113 more indications

Heart Failure6 trials

Chronic Sildenafil Treatment in Heart Failure

Completed·UUniversity of Milan·Phase 3·NCT00975494·50 enrolled

Study of Sildenafil in Advanced Heart Failure.

Completed·MMassachusetts General Hospital·Phase 3·NCT00309790·40 enrolled

Sildenafil Versus Placebo in Chronic Heart Failure

Unknown status·HHelse Stavanger HF·Phase 3·NCT01616381·75 enrolled

Show 3 more trials

Exercise Oscillatory Breathing and Sildenafil in Heart Failure

Completed·UUniversity of Milan·Phase 2·NCT01185925·32 enrolled

Sildenafil in US Heart Failure Patients (SilHF-US)

Unknown status·HHartford Hospital·Phase 3·NCT03460470·25 enrolled

Effects of Viagra on Heart Function in Patients With Heart Failure

Completed·MMetroHealth Medical Center·Phase 4·NCT00781508·10 enrolled

Oral6 trials

Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers

Completed·UUniversity Hospital, Grenoble·N/A·NCT00710099·40 enrolled

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01254396·12 enrolled

A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer

Completed·IiX Biopharma Ltd.·Phase 3·NCT02850718·48 enrolled

Show 3 more trials

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01254383·36 enrolled

"As Required" Oral Sildenafil in Raynaud's Phenomenon

Completed·UUniversity Hospital, Grenoble·Phase 2/3·NCT02050360·41 enrolled

Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Unknown status·SShandong University··NCT04379180·500 enrolled

Fatigue4 trials

Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability

Completed·TThe University of Texas Medical Branch, Galveston·N/A·NCT01059994·12 enrolled

The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue

Completed·TThe University of Texas Medical Branch, Galveston·N/A·NCT01661595·30 enrolled

Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS

Completed·—·Phase 4·NCT00598585·12 enrolled

Show 1 more trial

Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT02114775·34 enrolled

Function3 trials

The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Completed·MMilton S. Hershey Medical Center·Phase 4·NCT00964782·17 enrolled

Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males

Unknown status·RRambam Health Care Campus·Phase 4·NCT00313898·100 enrolled

FDA Phase IV - Commitment - Retinal Function Study

Completed· Bayer logo

Bayer·Phase 4·NCT00461565·63 enrolled

Experimental2 trials

Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00795938·18 enrolled

A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00866463·18 enrolled

Sexual Dysfunction2 trials

Study of Sildenafil for Treatment of SSRI-Antidepressant Sexual Dysfunction in Women

Completed·UUniversity of New Mexico·Phase 4·NCT00375297·100 enrolled

Lybrido for Female Sexual Dysfunction

Completed·EEmotional Brain NY Inc.·Phase 2·NCT01432665·196 enrolled

Diastolic Heart Failure2 trials

Phosphodiesterase-5 (PDE5) Inhibition and Pulmonary Hypertension in Diastolic Heart Failure

Completed·UUniversity of Milan·Phase 2/3·NCT01156636·44 enrolled

Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)

Completed·—·Phase 3·NCT00763867·216 enrolled

Encephalopathy2 trials

Sildenafil Administration to Treat Neonatal Encephalopathy

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 1·NCT02812433·28 enrolled

Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia

Recruiting·PPia Wintermark·Phase 2·NCT06098833·60 enrolled

Prostatectomy2 trials

Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy

Completed·JJohns Hopkins University·N/A·NCT00511498·100 enrolled

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

Unknown status·—·Phase 3·NCT03406169·180 enrolled

Duchenne Muscular Dystrophy2 trials

Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy

Terminated·HHugo W. Moser Research Institute at Kennedy Krieger, Inc.·Phase 2·NCT01168908·20 enrolled

Tadalafil and Sildenafil for Duchenne Muscular Dystrophy

Completed·—·Phase 1·NCT01359670·30 enrolled

Chronic Obstructive Pulmonary Disease2 trials

Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00491803·20 enrolled

Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension

Completed·HHospital Clinic of Barcelona·Phase 4·NCT01055405·65 enrolled

Preeclampsia2 trials

Efficacy of Sildenafil in Preterm Preeclampsia

Withdrawn·TThe University of Texas Health Science Center, Houston·Phase 2/3·NCT02782559

Use of Sildenafil Citrate in Management of Mild Pre-eclampsia

Unknown status·—·Phase 2/3·NCT03262961·80 enrolled

Endothelial Function2 trials

Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Completed·RRuhr University of Bochum·Phase 3·NCT00527995·40 enrolled

Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics

Completed·IIRCCS San Raffaele·Phase 3·NCT00420901·30 enrolled

Hypertension2 trials

Nebivolol in the Supine Hypertension of Autonomic Failure

Completed·VVanderbilt University·N/A·NCT01044693·20 enrolled

Sildenafil and Exercise Capacity in Hypertension

Completed·UUniversity of Edinburgh·N/A·NCT00599235·30 enrolled

Effectiveness2 trials

Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment

Unknown status·RRambam Health Care Campus·Phase 4·NCT01364701·30 enrolled

Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i

Unknown status·RRambam Health Care Campus·Phase 4·NCT00498680·46 enrolled

Adult2 trials

Single-Dose Relative Bioavailability Study of SST-6006, a Topical Sildenafil Cream Versus Oral Sildenafil in Healthy Male Adults

Completed·SStrategic Science & Technologies, LLC·Phase 1·NCT01986673·62 enrolled

A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05684289·61 enrolled

Hernia2 trials

A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)

Recruiting·UUniversity of Utah·Phase 2·NCT05201144·40 enrolled

Chronic Sildenafil for Severe Diaphragmatic Hernia

Terminated·UUniversity of California, San Francisco·Phase 4·NCT00133679·9 enrolled

Cystic Fibrosis2 trials

Blood Flow and Vascular Function in Cystic Fibrosis

Completed·—·Phase 2·NCT02057458·19 enrolled

Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease

Completed·NNational Jewish Health·Phase 1/2·NCT00659529·36 enrolled

Idiopathic Pulmonary Fibrosis2 trials

Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00352482·20 enrolled

Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis

Completed·VVA Office of Research and Development·Phase 2·NCT00359736·29 enrolled

AIN2 trials

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

Completed· Bayer logo

Bayer·Phase 4·NCT02891850·225 enrolled

Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.

Completed·UUniversity of Arizona·Phase 4·NCT01800292·9 enrolled

Smokers1 trial

A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

Completed·—·Phase 1/2·NCT04100759·36 enrolled

Non-Small Cell Lung Cancer1 trial

Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Completed·HHamamatsu University·Phase 2/3·NCT00752115·120 enrolled

Headache1 trial

Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache

Unknown status·DDanish Headache Center·N/A·NCT05669885·21 enrolled

Prostate Cancer1 trial

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)

Recruiting·TThe Netherlands Cancer Institute·Phase 4·NCT06875258·198 enrolled

Insulin resistance1 trial

Study of Sildenafil Citrate on Insulin Resistance in African American

Completed·VVanderbilt University Medical Center·Phase 1/2·NCT01334554·46 enrolled

Preterm Labor1 trial

Management of Acute Preterm Labor: Nifedipen Alone or Combined With Cildenafil Citrate

Unknown status·—·Phase 1·NCT02337881·227 enrolled

Growth1 trial

Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

Terminated·UUniversity of British Columbia·Phase 2/3·NCT02442492·21 enrolled

Scleroderma1 trial

Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY

Completed·UUniversity Hospital, Lille·Phase 3·NCT01295736·84 enrolled

Fetal Growth Restriction1 trial

The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

Terminated·—·Phase 2/3·NCT02277132·216 enrolled

High-Risk Pregnancy1 trial

Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin in High-risk Pregnancy

Withdrawn·FFayoum University Hospital··NCT04110444

Liver Disease1 trial

Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study

Completed·MMayo Clinic·Phase 3·NCT03154476·20 enrolled

Brain Injury1 trial

Sildenafil for Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury.

Completed·UUniformed Services University of the Health Sciences·Phase 2·NCT01762475·59 enrolled

Schizophrenia1 trial

A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia

Completed·MMassachusetts General Hospital·Phase 4·NCT00455715·18 enrolled

Peripheral Arterial Disease1 trial

VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

Active, not recruiting·RRennes University Hospital·Phase 3·NCT03686306·106 enrolled

Transplant Recipient1 trial

Phosphodiesterase-5 (PDE-5) Inhibition in Heart Transplant Recipients

Withdrawn·UUniversity of Minnesota·N/A·NCT01812434

Children1 trial

Sildenafil Trial in Children and Young Adults With CF

Withdrawn·—·Phase 1/2·NCT01194232

ESS1 trial

The Assessment of Right Ventricular Contractility in Response to Sildenafil

Terminated·TThe Hospital for Sick Children·Phase 3·NCT00742014·10 enrolled

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 1·NCT04481789·84 enrolled

Systemic Sclerosis1 trial

Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis

Recruiting·TTopadur Pharma AG·Phase 2·NCT06954597·15 enrolled

Type 2 Diabetes1 trial

Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes

Completed·UUniversity of Roma La Sapienza·Phase 4·NCT00692237·59 enrolled

Embryo Transfer1 trial

Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles

Completed·Ffarzaneh hojjat·Phase 4·NCT01668446·2 enrolled

Blood Pressure1 trial

Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.

Completed· Bayer logo

Bayer·Phase 2·NCT01179334·18 enrolled

Interaction1 trial

A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

Terminated· Pfizer logo

Pfizer·Phase 1·NCT01244620·16 enrolled

Mortality1 trial

Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

Unknown status·UUniversity Hospital, Angers·Phase 2/3·NCT02387450·400 enrolled

Congestive Heart Failure1 trial

Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure

Withdrawn·UUniversity of New Mexico·Phase 4·NCT00793338

Infertility1 trial

Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility

Completed·—·Phase 4·NCT05753098·148 enrolled

ART1 trial

A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04211272·47 enrolled

Acute Myocardial Infarction1 trial

SIDAMI - Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction (AMI)

Completed·JJacob E Mueller·Phase 4·NCT01046838·70 enrolled

Sex1 trial

Evaluation of the Index of Sexual Life Questionnaire

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00245596·120 enrolled

Ventricular Function1 trial

Improving Right Ventricular Function in Young Adults Born Preterm

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT03696758·10 enrolled

Altitude1 trial

Endurance Performance at Altitude

Completed·UUniversity of British Columbia·N/A·NCT03710369·10 enrolled

Thalassemia1 trial

Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)

Completed·CCarelon Research··NCT00000623·1,000 enrolled

Premature Infants1 trial

Safety of Sildenafil in Premature Infants

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT03142568·109 enrolled

Surgery1 trial

Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)

Terminated·—·Phase 2/3·NCT02435303·2 enrolled

Chemotherapy1 trial

Nivolumab With Chemotherapy in Refractory MDS

Terminated·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT03259516·2 enrolled

Lymphatic Malformation1 trial

Sildenafil for the Treatment of Lymphatic Malformations

Completed·SStanford University·Phase 2·NCT02335242·22 enrolled

Diabetes Mellitus1 trial

An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)

Completed·WWeill Medical College of Cornell University·Phase 4·NCT00194909·8 enrolled

Drug Interactions1 trial

Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers

Unknown status·—·N/A·NCT04170790·18 enrolled

Premature Ejaculation1 trial

Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation

Unknown status·—·Phase 4·NCT05183334·160 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Two Formulations of Sildenafil Tablet 100 mg in Healthy Male Volunteers Under Fasting Conditions

Unknown status·PPharmtechnology LLC·Phase 1·NCT04882826·44 enrolled

Magnetic Resonance Imaging (MRI)1 trial

Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT00640458·20 enrolled

Myopathy1 trial

Comparative Study of Strategies for Management of Duchenne Myopathy (DM)

Unknown status·—·Phase 4·NCT03633565·45 enrolled

Ischemic stroke1 trial

Sildenafil (Viagra) Treatment of Subacute Ischemic Stroke

Terminated·HHenry Ford Health System·Phase 1·NCT00452582·20 enrolled

Lung Disease1 trial

Effect of Sildenafil on Diffusion Capacity in Patients With PH and Parenchymal Lung Disease

Completed·TThe Cleveland Clinic·N/A·NCT01948518·15 enrolled

Smoking Cessation1 trial

Smoking Cessation and Functional CT Assessment

Completed·EEric A. Hoffman·Phase 4·NCT03382106·162 enrolled

Vascular Dysfunction1 trial

Vascular Dysfunction in Black Individuals: Roles of Nitric Oxide and Endothelin-1

Terminated·UUniversity of Mississippi Medical Center·Phase 1·NCT04770155·8 enrolled

Fibrosis1 trial

Sildenafil for Liver Fibrosis in Adolescents and Adults After Fontan Operation

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT04908657·40 enrolled

Oligohydramnios1 trial

Comparison Between Treatments of Oligohydramnios

Recruiting·KKafrelsheikh University·Phase 2·NCT07135037·40 enrolled

Exercise1 trial

Sildenafil Exercise: Role of PDE5 Inhibition

Completed·NNational Jewish Health·Phase 2/3·NCT04039087·26 enrolled

Preoperative1 trial

Preoperative Sildenafil Administration for Hepatectomy

Recruiting·FFirst People's Hospital of Chenzhou·N/A·NCT06237751·16 enrolled

Pregnancy1 trial

Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss

Completed·—·Phase 2·NCT04718233·80 enrolled

Humans1 trial

The Impact of Sildenafil on the Pulmonary Circulation in Healthy Trained and Untrained Humans

Completed·UUniversity of Alberta·Phase 2·NCT04985929·26 enrolled

Meconium Aspiration Syndrome1 trial

Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns

Completed·SSir Takhtasinhji General Hospital·Phase 4·NCT01757782·96 enrolled

Glaucoma1 trial

Phosphodiesterase Inhibitors in Glaucoma Study (PhiGS)

Suspended·IImperial College London·Phase 3·NCT04052269·30 enrolled

Labor1 trial

Intrapartum Sildenafil in Laboring Mothers

Withdrawn·UUniversity of Alabama at Birmingham·Phase 3·NCT06377098

Hemodynamic Response1 trial

Hemodynamic Response After Six Months of Sildenafil

Unknown status·UUniversity of Chile·Phase 4·NCT00483626·27 enrolled

Phase 21 trial

Phase 2a Topical Sildenafil Proof-of-Concept Study in Men With Mild to Moderate ED

Completed·SStrategic Science & Technologies, LLC·Phase 2·NCT02390960·33 enrolled

Fetal distress1 trial

Sildenafil Citrate and Intrapartum Fetal Distress

Completed·—·Phase 4·NCT04325243·410 enrolled

Randomized1 trial

A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses

Completed· Pfizer logo

Pfizer·Phase 2·NCT00273416·32 enrolled

Neonatal1 trial

Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings

Withdrawn·UUniversity of Alabama at Birmingham·Phase 3·NCT06522854

Type 2 Diabetes Mellitus1 trial

Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Completed· Sanofi logo

Sanofi·Phase 1·NCT03462017·54 enrolled

Nephrogenic Diabetes Insipidus1 trial

Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

Completed·UUniversity of Colorado, Denver·N/A·NCT00478335·4 enrolled

Priapism1 trial

Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Completed·JJohns Hopkins University·Phase 2·NCT00940901·13 enrolled

Efficacy and Safety1 trial

Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder

Unknown status·SStrategic Science & Technologies, LLC·Phase 2·NCT04948151·440 enrolled

Pediatric Patients1 trial

Revatio Special Investigation for Long-term Use in Pediatric Patients

Completed·VViatris Pharmaceuticals Japan Inc··NCT03364244·1,023 enrolled

Urinary incontinence1 trial

Use of Sildenafil for Treatment of Urinary Incontinence

Active, not recruiting·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT02983461·24 enrolled

Satisfaction1 trial

Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00249730·510 enrolled

Cirrhosis of Liver1 trial

Efficacy of Sildenafil in the Improvement of Cognition and Quality of Life in Patients With Cirrhosis of Liver. A Proof of Concept Study.

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 1/2·NCT02028429·50 enrolled

Endothelial Dysfunction1 trial

Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?

Terminated·KKimberly Liang·Phase 2·NCT02908490·25 enrolled

Vascular Disease1 trial

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Recruiting·JJohns Hopkins University·Phase 2·NCT04797286·30 enrolled

Bronchopulmonary Dysplasia1 trial

Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

Completed·CChristoph Hornik·Phase 2·NCT04447989·125 enrolled

Pulmonary Embolism1 trial

Sildenafil in Acute Pulmonary Embolism

Completed·UUniversity of Aarhus·Phase 1·NCT04283240·20 enrolled

Fibrinolysis1 trial

Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis

Terminated·VVanderbilt University·Phase 4·NCT01409993·78 enrolled

Cardiac Surgery1 trial

A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery

Completed·UUniversity of Leicester·Phase 1·NCT02136329·36 enrolled

Frozen Embryo Transfer1 trial

Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes

Unknown status·—·Phase 2/3·NCT05971667·200 enrolled

Migraine1 trial

Induction of Migraine Aura With Sildenafil

Completed·HHerlev Hospital·Phase 1·NCT02795351·16 enrolled

Benign Prostatic Hyperplasia1 trial

A Study to Investigate the Effects on Blood Pressure and Pulse Rate of a Single 100mg Dose of Sildenafil in Patients With Benign Prostatic Hyperplasia Who Are Being Treated With Doxazosin

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT00645034·20 enrolled

Chronic Kidney Disease1 trial

Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula

Completed·UUniversity of Alabama at Birmingham·N/A·NCT02414204·4 enrolled

Double-blind1 trial

A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

Completed· Pfizer logo

Pfizer·Phase 1·NCT00814736·22 enrolled

Ischemia1 trial

Sildenafil for Treatment of Choroidal Ischemia

Completed·—·Phase 2·NCT04356716·22 enrolled

Insulin Sensitivity1 trial

Sildenafil Activates Browning of White Adipose and Improves Insulin Sensitivity

Unknown status·XXiang Guang-da·Phase 4·NCT02524184·11 enrolled

Infection1 trial

Sildenafil for PNTM Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT01853540·10 enrolled

Genetic Polymorphism1 trial

Effects of Sildenafil in Resistant Hypertensives and Genetic Polymorphism

Completed·UUniversity of Campinas, Brazil·N/A·NCT01392638·120 enrolled

Becker muscular dystrophy1 trial

Effect of Modulating the nNOS System on Cardiac, Muscular and Cognitive Function in Becker Muscular Dystrophy Patients

Completed·RRigshospitalet, Denmark·Phase 2·NCT01350154·17 enrolled

Fontan1 trial

Sildenafil After the Fontan Operation

Completed·—·Phase 2·NCT00507819·28 enrolled

Hemodynamic1 trial

A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH

Terminated·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT02284737·100 enrolled

Congenital Heart Disease1 trial

Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease

Withdrawn·UUniversity Hospital, Montpellier·Phase 3·NCT03997097

Beta-Thalassemia1 trial

Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity

Unknown status·TTanta University·Phase 3·NCT05584956·44 enrolled

Rehabilitation1 trial

Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer

Not yet recruiting·UUniversity Hospital, Rouen·Phase 3·NCT06123156·188 enrolled

Postmenopausal Women1 trial

A Open-Label, Within-Subject Dose-Escalation Study to Evaluate the Clinical Safety and Pharmacokinetic Profile of a Topical Sildenafil Cream (5% w/w), in Healthy Postmenopausal Women

Completed·SStrategic Science & Technologies, LLC·Phase 1·NCT02364882·21 enrolled

Unspecified2 trials

Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

Completed·SSeoul National University Hospital·Phase 1·NCT02975037·32 enrolled

A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00648596·780 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 27, 1998

VIAGRA

NDA NDA020895

Jun 3, 2005

REVATIO

NDA NDA021845

Nov 18, 2009

REVATIO

NDA NDA022473

Aug 30, 2012

REVATIO

NDA NDA203109

Apr 28, 2023

LIQREV

NDA NDA214952

Dec 16, 2025

VYBRIQUE

NDA NDA210858

Sources

References

[1]
ClinicalTrials.gov — 252 trial records for Sildenafil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Viagra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sildenafil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sildenafil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210858). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Viagra. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 5a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Patent Landscape[6]

Patent Cliff

Dec 16, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11123287Dec 16, 2033

11337979Dec 24, 2038

11464778Dec 24, 2038

12186321Dec 24, 2038

11759468Dec 24, 2038

1 more patents

12005062Dec 24, 2038

Viagra

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Pulmonary Hypertension17 trials

Pulmonary Arterial Hypertension11 trials

ILD11 trials

Erectile Dysfunction10 trials

Treatment6 trials

Heart Failure6 trials

Oral6 trials

Fatigue4 trials

Function3 trials

Experimental2 trials

Sexual Dysfunction2 trials

Diastolic Heart Failure2 trials

Encephalopathy2 trials

Prostatectomy2 trials

Duchenne Muscular Dystrophy2 trials

Chronic Obstructive Pulmonary Disease2 trials

Preeclampsia2 trials

Endothelial Function2 trials

Hypertension2 trials

Effectiveness2 trials

Adult2 trials

Hernia2 trials

Cystic Fibrosis2 trials

Idiopathic Pulmonary Fibrosis2 trials

AIN2 trials

Smokers1 trial

Non-Small Cell Lung Cancer1 trial

Headache1 trial

Prostate Cancer1 trial

Insulin resistance1 trial

Preterm Labor1 trial

Growth1 trial

Scleroderma1 trial

Fetal Growth Restriction1 trial

High-Risk Pregnancy1 trial

Liver Disease1 trial

Brain Injury1 trial

Schizophrenia1 trial

Peripheral Arterial Disease1 trial

Transplant Recipient1 trial

Children1 trial

ESS1 trial

Pancreatic Cancer1 trial

Anemia1 trial

Clinical Pharmacology1 trial

Systemic Sclerosis1 trial

Type 2 Diabetes1 trial

Embryo Transfer1 trial

Blood Pressure1 trial

Interaction1 trial

Mortality1 trial

Congestive Heart Failure1 trial

Infertility1 trial

ART1 trial

Acute Myocardial Infarction1 trial

Sex1 trial

Ventricular Function1 trial

Altitude1 trial

Thalassemia1 trial

Premature Infants1 trial

Surgery1 trial

Chemotherapy1 trial

Lymphatic Malformation1 trial

Diabetes Mellitus1 trial

Drug Interactions1 trial

Premature Ejaculation1 trial

Fasting Conditions1 trial

Magnetic Resonance Imaging (MRI)1 trial

Myopathy1 trial

Ischemic stroke1 trial

Lung Disease1 trial