Levitra

(Vardenafil)

ApprovedSmall molecule

Vardenafil is used to treat erectile dysfunction (impotence) in men by helping to increase blood flow to the penis during sexual stimulation.[2] Levitra is currently approved and in use across 9 indications[4].[1]

Levitra is one of 229 small molecule programs targeting Erectile Dysfunction. It is currently in Approved.

Indications

Total Trials

Active Trials

228

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Erectile DysfunctionCompleted

Raynaud DiseaseApproved

Ischemia Reperfusion InjuryApproved

TinnitusApproved

Overactive BladderApproved

Coronary Artery DiseaseActive, not recruiting

Pulmonary HypertensionUnknown status

Benign Prostatic HyperplasiaRecruiting

Spinal Cord InjuryCompleted

Erectile DysfunctionApproved

Completed

Raynaud DiseaseApproved

Approved

Ischemia Reperfusion InjuryApproved

Approved

TinnitusApproved

Approved

Overactive BladderApproved

Approved

Coronary Artery DiseasePreclinical

Active, not recruiting

Pulmonary HypertensionApproved

Unknown status

Benign Prostatic HyperplasiaPhase 3

Recruiting

Spinal Cord InjuryApproved

Completed

Competition

Competitive Landscape

114 competitors in Coronary Artery Disease

#DrugCompanyPhaseTrials

Bayer Aspirin

Bayer

Approved

14 2

Mounjaro

Eli Lilly

Approved

1 3

Glucotrol

Pfizer

Approved

1 4

Glucophage

EMD Serono

Approved

5 5

Lopid

Adempas

Levitra

1 8

Ranexa

MMenarini International Operations Luxembourg SA

Approved

1 9

Cardizem

BBausch Health Americas, Inc.

Approved

1 10

Colcrys

Jazz Pharmaceuticals

Phase 3

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

Clinical

Trials by Indication[1]

Erectile Dysfunction10 trials

Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice

Completed· Bayer logo

Bayer··NCT01106118·2,289 enrolled

Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Completed· Bayer logo

Bayer·Phase 4·NCT00738400·150 enrolled

Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

Completed· Bayer logo

Bayer·Phase 3·NCT00654680·418 enrolled

Show 7 more trials

Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Completed· Bayer logo

Bayer·Phase 4·NCT00668135·348 enrolled

Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS

Completed·HHospital Authority, Hong Kong·N/A·NCT00517179·40 enrolled

A Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury

Unknown status·—·Phase 4·NCT00725790·350 enrolled

Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)

Completed·UUniversity of Florence·Phase 4·NCT02450188·30 enrolled

Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors

Completed· Bayer logo

Bayer·Phase 2·NCT01168817·140 enrolled

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

Unknown status·MMedical University of Vienna·Phase 4·NCT02344823·30 enrolled

Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Completed·HHospital Universitario Pedro Ernesto·Phase 4·NCT01084187·100 enrolled

Drug2 trials

LEVITRA® 20mg Special Drug Use Investigation (Long-term)

Completed· Bayer logo

Bayer··NCT00909233·1,221 enrolled

LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

Completed· Bayer logo

Bayer··NCT01207947·491 enrolled

Pulmonary Hypertension2 trials

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

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

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

Unknown status·RRabin Medical Center·Phase 4·NCT00705588·30 enrolled

Hypertrophy1 trial

Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy

Completed· Bayer logo

Bayer·Phase 2·NCT00461123·50 enrolled

Safety and Efficacy1 trial

Real Life Safety and Efficacy of Vardenafil

Terminated· Bayer logo

Bayer··NCT01215409·372 enrolled

13 more indications

Function1 trial

FDA Phase IV - Commitment - Retinal Function Study

Completed· Bayer logo

Bayer·Phase 4·NCT00461565·63 enrolled

Spinal Cord Injury1 trial

Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Completed· Bayer logo

Bayer·Phase 4·NCT00667966·45 enrolled

Benign Prostatic Hyperplasia1 trial

Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Recruiting·TTanta University·Phase 3·NCT06491108·150 enrolled

Tics1 trial

A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234

Completed·RRespira Therapeutics, Inc.·Phase 1·NCT05567367·31 enrolled

Cystic Fibrosis1 trial

Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?

Terminated·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·Phase 2·NCT01002534·5 enrolled

Hemodynamic1 trial

Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Completed· GSK logo

GSK·Phase 4·NCT00853840·18 enrolled

Pulmonary Arterial Hypertension1 trial

The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension

Completed·TTongji University·Phase 3·NCT00718952·60 enrolled

Cardiac Surgery1 trial

The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Completed·MMcGuire Research Institute·Phase 1·NCT01260285·10 enrolled

Coronary Artery Disease1 trial

Improvement of Myocardial Blood Flow by PhosphoDiesterase 5 Inhibition in Coronary Artery Disease

Temporarily not available·MMedical University of Vienna··NCT01406535

Glioma1 trial

Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases

Terminated·—·Phase 1·NCT02279992·7 enrolled

Raynaud's Syndrome1 trial

Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome

Completed·UUniversity of Cologne·Phase 2/3·NCT01291199·57 enrolled

Effectiveness1 trial

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

Diabetes1 trial

Diabetes & Vardenafil

Completed·AAzienda USL Modena·Phase 2·NCT02219646·54 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 19, 2003

LEVITRA

NDA NDA021400

Jun 17, 2010

STAXYN

NDA NDA200179

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Vardenafil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Levitra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Vardenafil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Vardenafil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA200179). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Levitra. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bayer 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: Bayer

Patent Landscape[6]

Patent Cliff

Jul 23, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8273876Jul 23, 2027

8613950Dec 23, 2028

Levitra

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Erectile Dysfunction10 trials

Drug2 trials

Pulmonary Hypertension2 trials

Hypertrophy1 trial

Safety and Efficacy1 trial

Function1 trial

Spinal Cord Injury1 trial

Benign Prostatic Hyperplasia1 trial

Tics1 trial

Cystic Fibrosis1 trial

Hemodynamic1 trial

Pulmonary Arterial Hypertension1 trial

Cardiac Surgery1 trial

Coronary Artery Disease1 trial

Glioma1 trial

Raynaud's Syndrome1 trial

Effectiveness1 trial

Diabetes1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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