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 60 indications[4].[1]

Viagra is one of 864 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

254

Total Trials

Active Trials

863

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseApproved

Coronary VasospasmApproved

Pulmonary Arterial Hypertension Associated With Portal HypertensionApproved

Premature BirthApproved

EmphysemaActive, not recruiting

Nephrogenic Diabetes InsipidusActive, not recruiting

Persistent Fetal Circulation SyndromeApproved

Migraine Without AuraActive, not recruiting

Raynaud DiseaseApproved

Cerebral Small Vessel DiseaseApproved

Coronary Artery DiseaseApproved

Approved

Coronary VasospasmApproved

Approved

Pulmonary Arterial Hypertension Associated With Portal HypertensionApproved

Approved

Premature BirthApproved

Approved

EmphysemaApproved

Active, not recruiting

Nephrogenic Diabetes InsipidusPreclinical

Active, not recruiting

Persistent Fetal Circulation SyndromeApproved

Approved

Migraine Without AuraPreclinical

Active, not recruiting

Raynaud DiseaseApproved

Approved

Cerebral Small Vessel DiseaseApproved

Approved

Showing 10 of 57 indications

Competition

Competitive Landscape

312 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Viagra

VViatris Specialty LLC

Approved

1 2

LHRH Agonist

Roche

Phase 3

10 3

Piflufolastat F 18

Novartis

Phase 3

1 4

Androgen Deprivation Treatment

MMedical University of Vienna

Phase 3

1 5

Lupron Depot

RRepros Therapeutics Inc.

Phase 3

2 6

Trexall

Jazz Pharmaceuticals

Preclinical

—7

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 8

Duragesic

CCephalon

Preclinical

1 9

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Erectile Dysfunction

NCT07177326

Q4 2029

Phase 1Recruiting

ILD

NCT06510322

Q1 2030

Phase 3Not yet recruiting

Rehabilitation

NCT06123156

Q2 2030

Phase 2/3Not yet recruiting

Cognitive Impairment

NCT06800092

Clinical

Trials by Indication[1]

Pulmonary Hypertension18 trials

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

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

Sildenofil in Persistent Pulmonary Hypertension in Newborns

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

Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease

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

Show 15 more trials

Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

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

Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Unknown status· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT01913847·144 enrolled

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

Unknown status·—·Phase 4·NCT01449253·60 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

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

Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?

Completed·UUniversity of Oregon·Phase 1·NCT03945643·82 enrolled

PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Completed·—·Phase 4·NCT02378649·60 enrolled

Copd Exacerbation and Pulmonary Hypertension Trial

Completed·CChronic Obstructive Pulmonary Disease Trial Network, Denmark·Phase 4·NCT04538976·250 enrolled

The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients With Secondary Pulmonary Hypertension

Completed·FFayoum University·N/A·NCT06778330·100 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

Erectile Dysfunction12 trials

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

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

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

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

Show 9 more trials

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 Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01352507·383 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

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

A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00654017·100 enrolled

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

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

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00644631·300 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

ILD11 trials

PK Study of Sildenafil in Neonate

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

Healthy Volunteer Study of Sildenafil Effects Upon Vision

Completed·UUniversity of Cambridge·Phase 4·NCT00251784

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

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

Show 8 more trials

Taste Test of a New Formulation of Sildenafil (Revatio)

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

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

Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547287·2,760 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

Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

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

Pulmonary Arterial Hypertension9 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

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

Show 6 more trials

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

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

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

Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension

Withdrawn·UUniversity Health Network, Toronto·Phase 3·NCT00780728

Heart Failure9 trials

Chronic Sildenafil Treatment in Heart Failure

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

Exercise Oscillatory Breathing and Sildenafil in Heart Failure

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

Study of Sildenafil in Advanced Heart Failure.

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

Show 6 more trials

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

Sildenafil Versus Placebo in Chronic Heart Failure

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

Study of Sildenafil in Patient With Heart Failure.

Completed·MMassachusetts General Hospital·Phase 3·NCT00309816·40 enrolled

Sildenafil Impact on Ventricular Function in Patients With Heart Failure

Completed·HHospital Ana Nery·Phase 2/3·NCT01936350·24 enrolled

Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH

Completed·UUniversity Medical Center Groningen·Phase 3·NCT01726049·52 enrolled

108 more indications

Oral6 trials

The Pharmacological Basis for the Increase in Visual Time Constants Induced by Single Oral Doses of Sildenafil

Unknown status·UUniversity of Cambridge·N/A·NCT00463957·12 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

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

Show 3 more trials

"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

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

Idiopathic Pulmonary Fibrosis5 trials

Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

Terminated·AAlicia Gerke·Phase 2/3·NCT00981747·12 enrolled

Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02802345·274 enrolled

Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis

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

Show 2 more 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

Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Withdrawn·UUniversity of California, Los Angeles·Phase 4·NCT00625079

Treatment4 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

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

Show 1 more trial

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

Hypertension3 trials

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Sildenafil and Exercise Capacity in Hypertension

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

Nebivolol in the Supine Hypertension of Autonomic Failure

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

Fatigue3 trials

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

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

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

Completed·—·Phase 4·NCT00598585·12 enrolled

Prostatectomy3 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

On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy

Unknown status·UUniversità Vita-Salute San Raffaele·Phase 3·NCT01315262·200 enrolled

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

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

Function3 trials

FDA Phase IV - Commitment - Retinal Function Study

Completed· Bayer logo

Bayer·Phase 4·NCT00461565·63 enrolled

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

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

Diastolic Heart Failure2 trials

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

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

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

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

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

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

Effectiveness2 trials

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

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

Ventricular Function2 trials

Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT01572363·10 enrolled

Improving Right Ventricular Function in Young Adults Born Preterm

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

ART2 trials

Sildenafil and Pulmonary Artery Pressure

Terminated·UUniversity of Chicago·Phase 2·NCT00145938·10 enrolled

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

Cystic Fibrosis2 trials

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

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

Blood Flow and Vascular Function in Cystic Fibrosis

Completed·—·Phase 2·NCT02057458·19 enrolled

Lymphatic Malformation2 trials

A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations

Completed·SStanford University·Phase 1/2·NCT01290484·7 enrolled

Sildenafil for the Treatment of Lymphatic Malformations

Completed·SStanford University·Phase 2·NCT02335242·22 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

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

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

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

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

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

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

Sexual Dysfunction1 trial

Lybrido for Female Sexual Dysfunction

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

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

Mortality1 trial

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

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

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

Vascular Disease1 trial

Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CF

Completed·NNational Jewish Health·Phase 1/2·NCT02626182·14 enrolled

Cognitive impairment1 trial

Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

Not yet recruiting·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT06800092·30 enrolled

Doxorubicin1 trial

Doxorubicin With or Without Sildenafil, With Analysis of Cardiac Markers

Completed·VVirginia Commonwealth University·Phase 1·NCT01375699·26 enrolled

Efficacy1 trial

An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT00746967·267 enrolled

Aortic Stenosis1 trial

Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Completed·WWashington University School of Medicine·Phase 4·NCT01060020·20 enrolled

Pediatric Patients1 trial

Revatio Special Investigation for Long-term Use in Pediatric Patients

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

Migraine Without Aura1 trial

Pharmacologically Triggered Migraine Without Aura and Neuroimaging

Unknown status·DDanish Headache Center·N/A·NCT03143465·36 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

Parkinson's Disease1 trial

Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

Terminated·LLoma Linda University·Phase 2·NCT02162979·2 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

Acute Myocardial Infarction1 trial

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

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

Endothelial Dysfunction1 trial

Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?

Terminated·KKimberly Liang·Phase 2·NCT02908490·25 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

Chronic Lung Disease1 trial

The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease

Completed·—·Phase 3·NCT00431418·20 enrolled

Tolerance1 trial

Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients

Unknown status·RRabin Medical Center·Phase 4·NCT01382368·60 enrolled

Chemotherapy1 trial

Nivolumab With Chemotherapy in Refractory MDS

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

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

Ischemia1 trial

Sildenafil for Treatment of Choroidal Ischemia

Completed·—·Phase 2·NCT04356716·22 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms

Completed·MMansoura University·Phase 4·NCT02345980·94 enrolled

After Cardiac Surgery1 trial

Does Oral Sildenafil (Viagra) Decrease Mean Pulmonary Artery Pressure After Cardiac Surgery?

Completed·UUnity Health Toronto·Phase 2·NCT00334490·40 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

Air Pollution1 trial

Does Sildenafil Increase Exercise Performance in Air Pollution?

Completed·—·N/A·NCT00808912·24 enrolled

COVID-191 trial

Sildenafil in COVID-19

Completed·—·Phase 1/2·NCT04489446·40 enrolled

ESS1 trial

Using Thermography to Assess the Affects of Sildenafil Cream, 3.6%

Completed·DDaré Bioscience, Inc.·Phase 1·NCT05765487·13 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

Adult1 trial

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

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

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

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

Labor1 trial

Intrapartum Sildenafil in Laboring Mothers

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

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

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

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

Glaucoma1 trial

Phosphodiesterase Inhibitors in Glaucoma Study (PhiGS)

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

Hemodynamic Response1 trial

Hemodynamic Response After Six Months of Sildenafil

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

Fetal distress1 trial

Sildenafil Citrate and Intrapartum Fetal Distress

Completed·—·Phase 4·NCT04325243·410 enrolled

Smokers1 trial

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

Completed·—·Phase 1/2·NCT04100759·36 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

Fibrosis1 trial

Sildenafil for Liver Fibrosis in Adolescents and Adults After Fontan Operation

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

Myopathy1 trial

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

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

Hernia1 trial

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

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

Oligohydramnios1 trial

Comparison Between Treatments of Oligohydramnios

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

Preoperative1 trial

Preoperative Sildenafil Administration for Hepatectomy

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

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

Renal Transplant Recipients1 trial

PDE5i Use in Renal Transplant Recipients

Withdrawn·UUniversity of British Columbia·N/A·NCT04122105

Unspecified2 trials

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

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

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 — 254 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

Q4 2026

Q4 2029

Q1 2030

Q2 2030

Trials by Indication[1]

Pulmonary Hypertension18 trials

Erectile Dysfunction12 trials

ILD11 trials

Pulmonary Arterial Hypertension9 trials

Heart Failure9 trials

Oral6 trials

Idiopathic Pulmonary Fibrosis5 trials

Treatment4 trials

Hypertension3 trials

Fatigue3 trials

Prostatectomy3 trials

Function3 trials

Duchenne Muscular Dystrophy2 trials

Diastolic Heart Failure2 trials

Endothelial Function2 trials

Experimental2 trials

AIN2 trials

Chronic Obstructive Pulmonary Disease2 trials

Preeclampsia2 trials

Effectiveness2 trials

Ventricular Function2 trials

ART2 trials

Cystic Fibrosis2 trials

Lymphatic Malformation2 trials

Peripheral Arterial Disease1 trial

Transplant Recipient1 trial

Blood Pressure1 trial

Interaction1 trial

Congestive Heart Failure1 trial

Infertility1 trial

Benign Prostatic Hyperplasia1 trial

Insulin resistance1 trial

Preterm Labor1 trial

Growth1 trial

Scleroderma1 trial

Infection1 trial

Genetic Polymorphism1 trial

Type 2 Diabetes Mellitus1 trial

Sexual Dysfunction1 trial

High-Risk Pregnancy1 trial

Pancreatic Cancer1 trial

Encephalopathy1 trial

Anemia1 trial

Type 2 Diabetes1 trial

Embryo Transfer1 trial

Mortality1 trial

Satisfaction1 trial

Fontan1 trial

Hemodynamic1 trial

Congenital Heart Disease1 trial

Beta-Thalassemia1 trial

Rehabilitation1 trial

Postmenopausal Women1 trial

Vascular Disease1 trial

Cognitive impairment1 trial

Doxorubicin1 trial

Efficacy1 trial

Aortic Stenosis1 trial

Pediatric Patients1 trial

Cirrhosis of Liver1 trial

Migraine Without Aura1 trial

Bronchopulmonary Dysplasia1 trial

Pulmonary Embolism1 trial

Fibrinolysis1 trial

Parkinson's Disease1 trial

Frozen Embryo Transfer1 trial

Migraine1 trial

Acute Myocardial Infarction1 trial

Endothelial Dysfunction1 trial

Altitude1 trial

Thalassemia1 trial