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Drug

Vardenafil

Approved · EMA
Late-stage development
Also known as Levitra, Staxyn, Vardenafilo, Vardenafil Hydrochloride+1 more

Levitra, Staxyn, Vardenafilo, Vardenafil Hydrochloride, Vardenafilum.

RxNorm306674ChEMBLCHEMBL1520UNIIUCE6F4125H
1
Active clinical trials
1
Regulatory events
Latest activity
beta

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

Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.

Clinical trial2025-07-01Primary completion · ClinicalTrials.gov

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

Clinical trial2024-09-30Completed · ClinicalTrials.gov

A Phase 1, Two-Part, Single-Center, Open-Label, Randomized, Cross-Over, Single Ascending Doses (SAD), Followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects

Clinical trial2019-12-04Completed · ClinicalTrials.gov

Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study.

Clinical trial2018-03-01Terminated · ClinicalTrials.gov

Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis

Clinical trial2016-06-01Primary completion · ClinicalTrials.gov

CSMC IIT: Pilot Study of Phosphodiesterase-V Inhibition to Increase Intratumoral Concentration of Carboplatin in Patients With Recurrent High Grade Gliomas and Brain Metastases

Clinical trial2016-02-11Terminated · ClinicalTrials.gov

Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

Clinical trial2015-11-16Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Parallel Group Prospective Pilot Study to Assess the Effect of Vardenafil on Clinical Outcome and on Procedure Duration After Green Light Laser-ablation of the Prostate Gland for Therapy of Benign Prostate Hypertrophy (BPH)

Clinical trial2014-12-19Results posted · ClinicalTrials.gov

Monitoring of Endothelial Dysfunction During Chronic Administration of Vardenafil in Patients With Type 2 Diabetes Mellitus: A Longitudinal, Randomised, Placebo-controlled, Double Blind, Phase II b, Clinical Trial

Clinical trial2014-02-01Completed · ClinicalTrials.gov

An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)

Clinical trial2014-01-01Completed · ClinicalTrials.gov

A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Clinical trial2013-01-25Results posted · ClinicalTrials.gov

Approval: Levitra (EMA)

Regulatory2003-03-06EMA

Profile

Identifiers & mechanism

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

Canonical name
Vardenafil
Aliases & brands
LevitraStaxynVardenafiloVardenafil HydrochlorideVardenafilum
RxNorm CUI
306674
ChEMBL ID
CHEMBL1520
UNII
UCE6F4125H
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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.

Earliest approval
2003-03-06
Latest approval
2003-03-06
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2003-03-06Approval
Approval: Levitra (EMA)
Indication: Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In… Show full indication

Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Levitra to be effective, sexual stimulation is required. Levitra is not indicated for use by women.

Evidence ↗

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

Clinical trials

24 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
24
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
16
Late-stage (III+)
17
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 24
Early Phase 11Phase 12Phase 1 / 21Phase 24Phase 2 / 31Phase 33Phase 411Phase N / A1

Late-stage studies

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

Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis

Unknown statusPH IVMedical University of Viennan=302016

An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)

CompletedPH IVUniversity of Florencen=302014

A Prospective, Randomized, 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Treatment

Unknown statusPH IVRambam Health Care Campusn=462011

Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men

CompletedPH IVHospital Universitario Pedro Erneston=1002011

Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

Unknown statusPH IVRabin Medical Centern=302010

Recent completions

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

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

CompletedPH I/IIDamascus Universityn=552024

A Phase 1, Two-Part, Single-Center, Open-Label, Randomized, Cross-Over, Single Ascending Doses (SAD), Followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects

CompletedPH IRespira Therapeutics, Inc.n=312019

Monitoring of Endothelial Dysfunction During Chronic Administration of Vardenafil in Patients With Type 2 Diabetes Mellitus: A Longitudinal, Randomised, Placebo-controlled, Double Blind, Phase II b, Clinical Trial

CompletedPH IIAzienda USL Modenan=542014

An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)

CompletedPH IVUniversity of Florencen=302014

The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

CompletedPH IMcGuire Research Instituten=102011

A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

CompletedPH IIBayern=1402011
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.