Drugs / Vardenafil
Vardenafil
also known as
BAY38-9456 · Levitra · Staxyn · RT234 · NSC-759103 · Nuviva · TR-399 · VARD · +10 more
Small molecule targets CFTR, PDE5A via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | STAXYN | — | 2013-08-02 – 2017-08-02 | fda.gov ↗ |
| Approved | US (FDA) | LEVITRA | — | 2003-08-19 | fda.gov ↗ |
| Approved | EU (EMA) | Vivanza | — | 2003-03-04 | europa.eu ↗ |
Trials 61
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02279992 | Mar 2012 → Oct 2013 | glioma, metastatic malignant neoplasm in the brain | Cedars-Sinai Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 15 trials | ||||||
| Phase 1 | NCT05567367 | Jul 2018 → Dec 2019 | — | Respira Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01348880 | May → Dec 2011 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01260285 | Dec 2010 → Oct 2011 | ischemic disease | McGuire Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01110590 | Jan → Apr 2010 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00767598 | Dec 2007 | — | Inje University | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06860399 | May 2023 → Sep 2024 | pulmonary hypertension, neonatal | Damascus University | Completed | No outcome recorded |
| Phase 1/2 | NCT03102398 | Mar 2017 → Jan 2018 | erectile dysfunction | Tritech Biopharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 27 trials · 2 missed | ||||||
| Phase 2 | NCT04266197 | Sep 2020 → Nov 2024 | pulmonary arterial hypertension | Respira Therapeutics, Inc. | Completed | Mixed |
| Phase 2 | NCT05343637 | Jul 2019 → Jan 2020 | pulmonary arterial hypertension | Respira Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02219646 | Mar 2010 → Feb 2013 | erectile dysfunction, type 2 diabetes mellitus | Azienda USL Modena | Completed | No outcome recorded |
| Phase 2 | NCT00478881 | Aug 2007 → Nov 2008 | overactive bladder | Bayer | Completed | Missed primary |
| Phase 2 | NCT00461123 | Mar 2007 → Jun 2008 | benign prostatic hyperplasia | Bayer | Completed | Missed primary |
| Phase 2 | NCT00786253 | Oct 2005 → Jan 2007 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00657839 | Oct 2005 → Jun 2006 | benign prostatic hyperplasia | Bayer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01291199 | Nov 2006 → Aug 2009 | Raynaud disease | University of Cologne | Completed | No outcome recorded |
| Phase 322 trials · 2 met primary | ||||||
| Phase 3 | NCT06491108 | Jun 2024 → Jul 2025 overdue | benign prostatic hyperplasia | Tanta University | Recruiting | Mixed |
| Phase 3 | NCT00718952 | Jul 2008 → Dec 2009 | pulmonary hypertension | Tongji University | Completed | No outcome recorded |
| Phase 3 | NCT00631969 | Apr 2008 → Jan 2009 | erectile dysfunction | Bayer | Completed | Met primary |
| Phase 3 | NCT00655629 | Apr 2008 → Feb 2009 | erectile dysfunction | Bayer | Completed | Met primary |
| Phase 3 | NCT00492635 | Dec 2004 → Sep 2007 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00652262 | Mar → Nov 2004 | erectile dysfunction, sexual disorder, spinal cord injury | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00678704 | Jan → Nov 2004 | diabetes mellitus, erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00682019 | Dec 2003 → Aug 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00668109 | Dec 2003 → Jun 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00657033 | Oct 2003 → Aug 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00657644 | Aug 2003 → Mar 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00658177 | Jun 2003 → Feb 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00661297 | Jun 2003 → Jan 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00665496 | Jun → Nov 2003 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00661596 | May 2003 → Jan 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00654914 | May 2003 → Feb 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00661115 | May 2003 → Feb 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00661700 | Apr 2003 → May 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00668005 | Feb → Sep 2003 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00668018 | Jan → Oct 2003 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00668057 | Dec 2002 → Sep 2003 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00654680 | Oct 2002 → Jan 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 421 trials · 1 met primary | ||||||
| Phase 4 | NCT01649739 | Sep 2012 → May 2013 | pulmonary arterial hypertension | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00738400 | Nov 2008 → Oct 2009 | erectile dysfunction, metabolic syndrome X | Bayer | Completed | Met primary |
| Phase 4 | NCT00725790 | Aug 2008 → Aug 2009 | erectile dysfunction | China Rehabilitation Research Center | Unknown | No outcome recorded |
| Phase 4 | NCT00705588 | Aug 2008 → Jan 2010 | pulmonary arterial hypertension | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00853840 | Apr → May 2008 | AIDS | ViiV Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT00377793 | Jul 2006 → Aug 2007 | erectile dysfunction, sexual disorder | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00663845 | May 2006 → Apr 2007 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00667966 | Jul 2005 → Feb 2007 | erectile dysfunction, spinal cord injury | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00461565 | Feb 2005 → Oct 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00655590 | Jan 2005 → Jun 2006 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00667979 | Sep → Dec 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00663728 | Sep 2004 → Apr 2005 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00665054 | Aug 2004 → Aug 2005 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00665340 | Jul 2004 → Jan 2005 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00668096 | May 2004 → Jan 2005 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00663130 | Apr → Jul 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00663598 | Oct 2003 → Sep 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00662441 | Sep 2003 → Jun 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00681772 | Mar → Nov 2003 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00668135 | Mar 2003 → Apr 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00660998 | Feb 2003 → Jan 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00517179 | Apr 2006 → May 2007 | benign prostatic hyperplasia, erectile dysfunction | Hospital Authority, Hong Kong | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01406535 | — | coronary artery disorder | Medical University of Vienna | Temporarily not available | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 2 | NCT01002534 Comparator | Oct 2011 → Jun 2012 | cystic fibrosis | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Terminated | No outcome recorded |
| Phase 2 | NCT01168817 Comparator | Aug 2010 → May 2011 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00666809 Comparator | Oct 2006 → May 2007 | tinnitus | Bayer | Completed | No outcome recorded |
| Phase 2/3 | NCT00656188 Comparator | Oct 2002 → May 2003 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01063855 Background | Apr 2010 → Aug 2011 | erectile dysfunction, sexual disorder | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00661219 Comparator | Dec 2002 → Nov 2003 | depressive disorder, erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT01084369 Background | Oct 2013 → Sep 2014 | hypogonadism, male, type 2 diabetes mellitus | Tameside Hospital NHS Foundation Trust | Terminated | No outcome recorded |
| Phase 4 | NCT02344823 Comparator | Jun 2012 → Jun 2016 | cirrhosis of liver, erectile dysfunction | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 4 | NCT02450188 Comparator | Mar 2012 → Jan 2014 | erectile dysfunction | University of Florence | Completed | No outcome recorded |
| Phase 4 | NCT01084187 Comparator | Jan → Dec 2010 | erectile dysfunction, hypertensive disorder | Hospital Universitario Pedro Ernesto | Completed | No outcome recorded |
| Phase 4 | NCT00555087 Background | May 2007 → Jan 2008 | erectile dysfunction, hypogonadotropic hypogonadism | Hospital Santa Fe | Unknown | No outcome recorded |
| Phase 4 | NCT00498680 Comparator | Mar 2007 → Jan 2011 | erectile dysfunction | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 4 | NCT00379756 Comparator | May 2006 → May 2007 | erectile dysfunction | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | Respira Therapeutics, Inc. | Results A single dose of RT234, vardenafil inhaled via the AOS DPI acutely improves exercise capacity and reduces dyspnea in PAH patients respiratherapeutics.com ↗
A single dose of RT234, vardenafil inhaled via the Axial Oscillating Sphere Dry Powder Inhaler (AOS DPI), acutely improves exercise capacity and reduces dyspnea in PAH patients (WHO Group 1 PH) |
| 2022-06-23 | Respira Therapeutics, Inc. | Results Acute Hemodynamic Improvement in Chronic Pulmonary Arterial Hypertension on Dual Therapy Following RT234-PAH Inhalation respiratherapeutics.com ↗
Study CL201 validated that RT234 has the critical design features of a PRN vasodilator |
| 2022-03-29 | Respira Therapeutics, Inc. | Results Safety and Pharmacokinetics of Vardenafil Inhalation Powder (RT234-PAH) Following Oral Inhalation in Healthy Adult Volunteers. respiratherapeutics.com ↗
Vardenafil exposure (Cmax, AUC0-inf) was dose proportional from 0.2 mg to 2.4 mg |
| 2022-03-29 | Respira Therapeutics, Inc. | Results Acute Hemodynamic Improvement in Chronic Pulmonary Arterial Hypertension on Dual Therapy Following RT234-PAH Inhalation. respiratherapeutics.com ↗ |
| 2020-08-01 | Alembic Pharmaceuticals Ltd. | Regulatory 5th August, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base). |
| 2020-06-05 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approval for Vardenafil Tablets upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approval by the Ministry of Health, Labour and Welfare (MHLW) for Vardenafil tablets (the branded product: LEVITRA®). |
| 2018-11-01 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Vardenafil Hydrochloride tablets and Ursodiol tablets zyduslife.com ↗
Zydus Cadila has launched Vardenafil Hydrochloride Tablets (US RLD - LEVITRA Tablets), 2.5 mg, 5 mg, 10 mg and 20 mg in the US market upon receiving the final approval from the USFDA. |
| 2018-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 2Q1h November, 2018, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug·Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg (base). |
All press releases naming this drug 11 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 78 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vardenafil | “Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED)...” NCT01063855 ↗72“In this study we plan to study how exercise performance changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain symptomatic from PAH when...” NCT01649739 ↗ “Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II” NCT00377793 ↗ “single oral administration of 20mg vardenafil” NCT00767598 ↗ “Vardenafil (a drug used to treat impotence)” NCT01084369 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00663598 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00665340 ↗ |
| Known as | BAY38-9456 | “BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.” NCT00657033 ↗44“Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II” NCT00377793 ↗ “Vardenafil (Levitra, BAY 38-9456), 10 mg” NCT00667966 ↗ “Drug: Vardenafil (Levitra, BAY38-9456)” NCT00461123 ↗ “Vardenafil HCl (Levitra, BAY38-9456)” NCT00478881 ↗ “Vardenafil ODT, (Staxyn, BAY38-9456)” NCT01348880 ↗ “Vardenafil ODT (STAXYN, BAY38-9456)” NCT00655629 ↗ “Vardenafil ODT (STAXYN, BAY38-9456)” NCT00631969 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00666809 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00656188 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00492635 ↗ |
| Known as | Levitra | “Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction.” NCT00461565 ↗44“Vardenafil (Levitra®) 20 mg oral administered 1 hour prior to start of craniotomy” NCT02279992 ↗ “Vardenafil (Levitra, BAY 38-9456), 10 mg” NCT00667966 ↗ “Drug: Vardenafil (Levitra, BAY38-9456)” NCT00461123 ↗ “Vardenafil HCl (Levitra, BAY38-9456)” NCT00478881 ↗ “Vardenafil (Levitra, BAY38-9456)” NCT00654680 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00654914 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00492635 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00655590 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00652262 ↗ “Levitra (Vardenafil, BAY38-9456)” NCT00656188 ↗ |
| Known as | NSC-759103 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | Nuviva | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | RT234 | “The drawbacks of current therapies and the lack of an approved as needed (PRN) treatment for PAH that improves exercise ability and quality of life, form the basis for...” NCT05343637 ↗1“This study was designed to evaluate safety and tolerability and to characterize the PK profiles of single and repeated doses of inhaled vardenafil as RT234.” NCT05567367 ↗ |
| Known as | Staxyn | “Vardenafil ODT, (Staxyn, BAY38-9456)” NCT01348880 ↗2“Vardenafil ODT (STAXYN, BAY38-9456)” NCT00655629 ↗ “Vardenafil ODT (STAXYN, BAY38-9456)” NCT00631969 ↗ |
| Known as | TR-399 | “TR-399 (5% Vardenafil HCl·3H2O, topical gel)” NCT03102398 ↗ |
| Known as | VARD | “we compared the efficacy of combined vardenafil orodispersible tablet (VARD) and cognitive-behavioral sex therapy (CBST) vs. VARD alone” PMID 26311340 ↗ Sep 2015 |
| Known as | Vardenafil (Levitra) | “Vardenafil (Levitra)” NCT01084369 ↗ |
| Known as | VARDENAFIL DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | Vardenafil HCl | “Vardenafil HCl (Levitra, BAY38-9456)” NCT00478881 ↗ |
| Known as | Vardenafil HCL Tablet | “BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.” NCT00668057 ↗ |
| Known as | vardenafil hydrochloride | “vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks” NCT00478881 ↗ |
| Known as | Vardenafil hydrochloride anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | Vardenafil hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | Vardenafil hydrochloride trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | Vardenafil monohydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Known as | Vivanza | ChEMBL registry synonym — accepted as the source's own label CHEMBL1520 ↗ |
| Action | Inhibit | “Vardenafil is a potent and highly selective oral phosphodiesterase type 5 (PDE-5) inhibitor” PMID 20925442 ↗ 20111“Phosphodiesterase 5A inhibitor” CHEMBL1520 ↗ |
| Modality | Small molecule | — CHEMBL1520 ↗ |
| Route | Oral | “One tablet vardenafil 10 mg with a glass of water” NCT00461123 ↗ |
| Target | CFTR | “both drugs stimulate chloride transport activity of F508del-CFTR protein” PMID 18006891 ↗ Nov 2007 |
| Target | PDE5A | “Phosphodiesterase 5A inhibitor” CHEMBL1520 ↗ |