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Drug

Sildenafil citrate

Approved · FDA / EMA
Late-stage development
Also known as Liqrev, Revatio, Viagra, Sildenafil+1 more

Liqrev, Revatio, Viagra, Sildenafil, sildenafil (as citrate).

RxNorm221161
6
Active clinical trials
15
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-08Results expected Q2 2027 · ClinicalTrials.gov

This Viagra ingredient just did something remarkable for a deadly childhood disease

Industry2026-03-31Science Daily

Effect of Sildenafil in Association to Hypothermia on Survival Without Brain Lesions In Term Neonates With Hypoxic-ischemic Encephalopathy (SHINE): Pharmacokinetic Study - Step 1

Clinical trial2026-03-31Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2025-12-16Results expected Q4 2026 · ClinicalTrials.gov

Phase 2 Randomized Controlled Trial of Sildenafil Citrate for Treatment of Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury

Clinical trial2025-12-10Results expected Q4 2027 · ClinicalTrials.gov

Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn

Clinical trial2025-04-30Primary completion · ClinicalTrials.gov

Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study

Clinical trial2024-12-31Completed · ClinicalTrials.gov

The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients: Randomized, Double-Blind, Placebo-Controlled Trial

Clinical trial2024-12-31Withdrawn · ClinicalTrials.gov

Supplemental approval: SILDENAFIL CITRATE (NDA203109)

Regulatory2024-10-25FDA

Indication expansion: SILDENAFIL CITRATE (NDA203109)

Regulatory2023-03-03FDA

Label change: SILDENAFIL CITRATE (NDA203109)

Regulatory2020-02-21FDA

Label change: SILDENAFIL CITRATE (NDA203109)

Regulatory2019-01-17FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sildenafil citrate
Aliases & brands
LiqrevRevatioViagraSildenafilsildenafil (as citrate)
RxNorm CUI
221161
Regulatory jurisdictions
fdaema

Regulatory timeline

15 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2015-01-12 → 2016-11-22)
Earliest approval
2012-08-30
Latest approval
2024-10-25
Authorities
FDA · EMA
Total events
15
fdaU.S. Food and Drug Administration· 14 events
2024-10-25Supplemental approval
Supplemental approval: SILDENAFIL CITRATE (NDA203109)
Evidence ↗
2023-03-03Indication expansion
Indication expansion: SILDENAFIL CITRATE (NDA203109)
Evidence ↗
2020-02-21Label change
Label change: SILDENAFIL CITRATE (NDA203109)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2016-11-14ApprovalMulti-authority
Approval: Granpidam (EMA)
Indication: Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in… Show full indication

Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

82 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
82
registered trials across all phases
LATEST COMPLETION 2024
6
Active studies
5
Recruiting
51
Late-stage (III+)
46
Completed
30
Discontinued
PHASE DISTRIBUTIONn = 82
Phase 112Phase 1 / 22Phase 217Phase 2 / 33Phase 313Phase 424Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study

CompletedPH IVBatterjee Medical Collegen=9002024

Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at LAUTECH Teaching Hospital, Ogbomoso, a Randomised Controlled Trial

Unknown statusPH IVLadoke Akintola University of Technology Teaching Hospital, Ogbomoson=1762022

A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)

TerminatedPH IVPfizer's Upjohn has merged with Mylan to form Viatris Inc.n=3852021

An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)

CompletedPH IVPfizer's Upjohn has merged with Mylan to form Viatris Inc.n=1002021

Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation

Unknown statusPH IVCairo Universityn=1002019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study

CompletedPH IVBatterjee Medical Collegen=9002024

Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma

CompletedPH IIVirginia Commonwealth Universityn=472023

Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women

CompletedPH II/IIIBeni-Suef Universityn=1302022

Sildenafil for Prevention of Swimming-Induced Pulmonary Edema (SIPE)

CompletedPH IIDuke Universityn=182021

A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

CompletedN/AInternational Islamic University, Islamabadn=1162019

Phase I Study of Regorafenib and Sildenafil for Advanced Solid Tumors

CompletedPH IVirginia Commonwealth Universityn=322019
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.