Sildenafil ODT

Phase 3Small molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sildenafil ODT is one of 207 small molecule programs targeting Oligohydramnios. It is currently in Phase 3.

Indications

Total Trials

Active Trials

206

Competitors

Pipeline

Status by Indication[3][1]

Indication

OligohydramniosActive, not recruiting

Major Depressive DisorderActive, not recruiting

GrowthActive, not recruiting

ExerciseUnknown status

Chronic Obstructive Pulmonary DiseaseRecruiting

Pulmonary HypertensionCompleted

EncephalopathyNot yet recruiting

Spinal Cord InjuriesActive, not recruiting

OligohydramniosPreclinical

Active, not recruiting

Major Depressive DisorderPreclinical

Active, not recruiting

GrowthPreclinical

Active, not recruiting

ExercisePreclinical

Unknown status

Chronic Obstructive Pulmonary DiseasePhase 2

Recruiting

Pulmonary HypertensionPhase 3

Completed

EncephalopathyPhase 2

Not yet recruiting

Spinal Cord InjuriesPhase 2

Active, not recruiting

Competition

Competitive Landscape

120 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

EXDENSUR

GGlaxo Dba Glaxosmithkline

Phase 3

2 2

Lunsekimig

Sanofi

Phase 3

3 3

Sildenafil ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

2 4

Tozorakimab

AstraZeneca

Phase 3

2 5

CM310

KKeymed Biosciences Co.Ltd

Phase 3

1 6

Astegolimab

Roche

Phase 3

3 7

Titrated Oxygen

RRigshospitalet, Denmark

Phase 3

1 8

Calciferol

Duragesic

2 10

Verekitug

UUpstream Bio Inc.

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Spinal Cord Injuries

NCT04565925

Q2 2027

Phase 2Recruiting

Chronic Obstructive Pulmonary Disease

NCT05061368

Q2 2029

Phase 2Not yet recruiting

Encephalopathy

NCT06810284

Clinical

Trials by Indication[1]

Erectile Dysfunction9 trials

A Study in Patients With Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01122264·770 enrolled

Satisfaction, Confidence and Naturalness in Men With Psychogenic Erectile Dysfunction (ED)

Completed·FFederal University of São Paulo·Phase 4·NCT01153204·30 enrolled

A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies

Unknown status·LLaboratório Teuto Brasileiro S/A·Phase 3·NCT01321489·78 enrolled

Show 6 more trials

Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction

Completed·NNational Institute of Cardiology, Laranjeiras, Brazil·Phase 4·NCT02620995·50 enrolled

A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00468650·117 enrolled

Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·N/A·NCT00057759·115 enrolled

Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00080808·111 enrolled

Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction

Completed·VVietstar Biomedical Research·Phase 2/3·NCT02798159·168 enrolled

Effect of Testosterone in Men With Erectile Dysfunction

Completed·—·Phase 4·NCT00512707·140 enrolled

Pulmonary Arterial Hypertension8 trials

Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

No longer available·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT00878943

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00323297·105 enrolled

Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00454207·44 enrolled

Show 5 more trials

Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00159887·260 enrolled

To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00430716·130 enrolled

A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00159913·235 enrolled

Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT01365585·227 enrolled

A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00159874·234 enrolled

Pulmonary Hypertension4 trials

Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

Completed·HHospital General Universitario Gregorio Marañon·Phase 4·NCT00862043·200 enrolled

SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD

Unknown status·—·Phase 3·NCT01441934·32 enrolled

The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD

Unknown status·—·N/A·NCT03185364·46 enrolled

Show 1 more trial

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Recruiting·SSohag University·Phase 1/2·NCT04898114·40 enrolled

Oral3 trials

Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01737203·53 enrolled

A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form

Withdrawn·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT04391868

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

Treatment3 trials

Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil

Completed·—·Phase 1·NCT01219023·10 enrolled

Sildenafil Treatment for Mild TBI

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT03598140·22 enrolled

QEQ Treatment Responsiveness Evaluation Study

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00151463·100 enrolled

49 more indications

Hypertension2 trials

Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension

Completed·UUniversity of Edinburgh·Phase 2·NCT00317421·20 enrolled

To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00150358·253 enrolled

Endometrial2 trials

Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Completed·—·Phase 2/3·NCT05846906·130 enrolled

Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium

Unknown status·—·Phase 1·NCT04283435·100 enrolled

Growth2 trials

Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses

Completed·—·N/A·NCT02362399·54 enrolled

Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction

Unknown status·—·Phase 2·NCT02678221·100 enrolled

Satisfaction2 trials

Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00245258·312 enrolled

Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00147628·209 enrolled

Prostate Cancer2 trials

Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

Terminated·—·N/A·NCT01996852·34 enrolled

ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

Terminated·—·Phase 3·NCT00544076·110 enrolled

Chronic Obstructive Pulmonary Disease2 trials

Sildenafil for Chronic Obstructive Pulmonary Disease

Completed·—·Phase 2·NCT00104637·10 enrolled

The Effect of Oral Sildenafil on Exercise Capacity, Dyspnea and Cardiopulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)

Recruiting·UUniversity of Alberta·Phase 2·NCT05061368·160 enrolled

Preeclampsia2 trials

Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

Unknown status·—·N/A·NCT03724838·180 enrolled

Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT00141310·76 enrolled

Frozen Embryo Transfer2 trials

Sildenafil Citrate in Frozen Embryo Transfer

Completed·OOmar Ahmed El Sayed Saad·Phase 2·NCT02845388·90 enrolled

The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

Unknown status·—·Phase 2/3·NCT05951413·110 enrolled

Glioma1 trial

Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma

Completed·VVirginia Commonwealth University·Phase 2·NCT01817751·47 enrolled

Embryo Transfer1 trial

Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles

Unknown status·—·N/A·NCT03854175·80 enrolled

Fetal Growth Restriction1 trial

A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction

Completed·—·Phase 3·NCT02590536·90 enrolled

In Vitro Fertilization1 trial

Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development

Unknown status·—·Phase 4·NCT03044561·80 enrolled

Randomized1 trial

Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness

Completed·AAltitude Physiology Expeditions·Phase 4·NCT00627965·62 enrolled

Systemic Sclerosis1 trial

Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis

Completed·FFederal University of São Paulo·Phase 3·NCT01347008·41 enrolled

Prolonged1 trial

Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle.

Completed·VVanderbilt University Medical Center·Phase 4·NCT02129725·15 enrolled

Acute Lymphoblastic Leukemia1 trial

Cerebrovascular Reactivity in American Football Players

Terminated·UUniversity of Pennsylvania·Phase 1·NCT03417492·7 enrolled

Aneurysm1 trial

Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm

Withdrawn·UUniversity of Nebraska·Phase 2·NCT00871065

Stroke1 trial

Sildenafil and Stroke Recovery

Terminated·UUniversity of Utah·Phase 1·NCT02628847·11 enrolled

Children1 trial

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Completed·—·Phase 4·NCT03431649·40 enrolled

Hemodynamic Response1 trial

Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo

Completed·VVIVUS LLC·Phase 1·NCT01616485·106 enrolled

Kidney Cancer1 trial

Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer

Completed·WWake Forest University Health Sciences·Phase 1·NCT01950923·30 enrolled

Liver1 trial

Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at Term

Unknown status·—·Phase 4·NCT05558176·176 enrolled

Blood Pressure1 trial

Blood Pressure Interaction Between Sildenafil and Sublingual Glyceryl Trinitrate (GTN) in Men With Angina

Completed·UUniversity of Edinburgh·Phase 4·NCT00479908·20 enrolled

ILD1 trial

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00904748·47 enrolled

Dysmenorrhea1 trial

Viagra in the Treatment of Primary Dysmenorrhea

Completed·MMilton S. Hershey Medical Center·Phase 1/2·NCT00123162·25 enrolled

Mortality1 trial

Effects of Oral Sildenafil on Mortality in Adults With PAH

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT02060487·385 enrolled

ESS1 trial

Effects of Sildenafil on Choroidal Thickness in AMD

Terminated·—·Phase 2·NCT01830790·10 enrolled

Local1 trial

Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil

No longer available·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT00866983

Macroglobulinemia1 trial

Sildenafil Citrate in Waldenstrom's Macroglobulinemia

Completed·—·Phase 2·NCT00165295·30 enrolled

Oligohydramnios1 trial

Sildenafil Citrate Therapy for Oligohydramnios

Unknown status·—·N/A·NCT02372487·184 enrolled

Infertility1 trial

Cost-effective Treatment of Unexplained Infertility

Completed·—·Phase 4·NCT06178523·900 enrolled

Pulmonary Edema1 trial

Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention

Completed·—·Phase 2·NCT03686813·18 enrolled

Brain Injury1 trial

Non-invasive Measurement of Cerebrovascular Reactivity After Traumatic Brain Injury

Terminated·UUniversity of Pennsylvania··NCT02990078·26 enrolled

Ovulation Induction1 trial

Sildenafil Effect After Ovulation Induction

Unknown status·—·Phase 4·NCT02890238·100 enrolled

Exercise1 trial

Reversibility by Sildenafil of Exercise-Induced Abnormal Right Ventricular Pressure Response in ASD and VSD-Operated Patients

Unknown status·OOslo University Hospital·N/A·NCT00772135·15 enrolled

Encephalopathy1 trial

Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06810284·24 enrolled

Heart Failure1 trial

Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation

Unknown status·UUniversity of Calgary·Phase 3·NCT03356353·24 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00159861·267 enrolled

Advanced Solid Tumors1 trial

Study of Regorafenib and Sildenafil for Advanced Solid Tumors

Completed·VVirginia Commonwealth University·Phase 1·NCT02466802·32 enrolled

Complication1 trial

Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

Unknown status·NNHS Greater Glasgow Yorkhill Division·Phase 4·NCT00350441·12 enrolled

Fasting Conditions1 trial

A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01247805·42 enrolled

Pregnancy1 trial

Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

Completed·—·Phase 1·NCT03766594·90 enrolled

Idiopathic Pulmonary Fibrosis1 trial

Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

Completed·—·Phase 3·NCT00517933·180 enrolled

Miscarriage1 trial

Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

Unknown status·—·Phase 4·NCT01419392·80 enrolled

Major Depressive Disorder1 trial

The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Withdrawn·SSadat City University·N/A·NCT04344678

COVID-191 trial

A Pilot Study of Sildenafil in COVID-19

Unknown status·TTongji Hospital·Phase 3·NCT04304313·10 enrolled

Birth Asphyxia1 trial

Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia: An Open-label Dose-finding Clinical Trial (Phase Ib Study)

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 1·NCT04169191·20 enrolled

Spinal Cord Injuries1 trial

Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries

Active, not recruiting·TThe University of Texas Medical Branch, Galveston·Phase 2·NCT04565925·24 enrolled

Unspecified2 trials

Quality of Erection Study

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00159900·300 enrolled

Food Effect Study For New Formulation

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01656798·12 enrolled

Sources

References

[1]
ClinicalTrials.gov — 85 trial records for Sildenafil ODT. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sildenafil ODT compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sildenafil ODT. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sildenafil ODT

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q2 2029

Trials by Indication[1]

Erectile Dysfunction9 trials

Pulmonary Arterial Hypertension8 trials

Pulmonary Hypertension4 trials

Oral3 trials

Treatment3 trials

Hypertension2 trials

Endometrial2 trials

Growth2 trials

Satisfaction2 trials

Prostate Cancer2 trials

Chronic Obstructive Pulmonary Disease2 trials

Preeclampsia2 trials

Frozen Embryo Transfer2 trials

Glioma1 trial

Embryo Transfer1 trial

Fetal Growth Restriction1 trial

In Vitro Fertilization1 trial

Randomized1 trial

Systemic Sclerosis1 trial

Prolonged1 trial

Acute Lymphoblastic Leukemia1 trial

Aneurysm1 trial

Stroke1 trial

Children1 trial

Hemodynamic Response1 trial

Kidney Cancer1 trial

Liver1 trial

Blood Pressure1 trial

ILD1 trial

Dysmenorrhea1 trial

Mortality1 trial

ESS1 trial

Local1 trial

Macroglobulinemia1 trial

Oligohydramnios1 trial

Infertility1 trial

Pulmonary Edema1 trial

Brain Injury1 trial

Ovulation Induction1 trial

Exercise1 trial

Encephalopathy1 trial

Heart Failure1 trial

Efficacy and Safety1 trial

Advanced Solid Tumors1 trial

Complication1 trial

Fasting Conditions1 trial

Pregnancy1 trial

Idiopathic Pulmonary Fibrosis1 trial

Miscarriage1 trial

Major Depressive Disorder1 trial

COVID-191 trial

Birth Asphyxia1 trial

Spinal Cord Injuries1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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