Last update 20 Mar 2025

Vardenafil Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nuviva, Staxyn, Vardenafil Dihydrochloride(USAN)
+ [19]
Target
Action
inhibitors
Mechanism
PDE5A inhibitors(Phosphodiesterase 5A inhibitors)
Drug Highest PhaseApproved
First Approval Date
European Union (04 Mar 2003),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC23H34Cl2N6O4S
InChIKeyNOIHTGOGFDFCBN-UHFFFAOYSA-N
CAS Registry224789-15-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Erectile Dysfunction
Liechtenstein
04 Mar 2003
Erectile Dysfunction
Iceland
04 Mar 2003
Erectile Dysfunction
Norway
04 Mar 2003
Erectile Dysfunction
European Union
04 Mar 2003
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Erectile DysfunctionPreclinical
United States
19 Aug 2003
HypertensionPreclinical-01 Feb 2003
Depressive DisorderPreclinical
United States
01 Dec 2002
Depressive DisorderPreclinical
Italy
01 Dec 2002
Depressive DisorderPreclinical
France
01 Dec 2002
Depressive DisorderPreclinical
Spain
01 Dec 2002
Depressive DisorderPreclinical
Canada
01 Dec 2002
Spinal Cord InjuriesPreclinical-01 Oct 2002
Traumatic spinal cord injuryPreclinical-01 Oct 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
jmmmolcsyn(jjssvhqpad) = hamgtzcurs pdhuhsszdq (kgasngtnsd )
Positive
07 Sep 2020
Not Applicable
-
-
uovzmhhbgh(tatbvajvsb) = jzlbmrbqqc ljmkybvxck (nbevlbawis )
-
22 Apr 2018
ZDF with vehicle (ZDFLV)
uovzmhhbgh(tatbvajvsb) = prdpcpjwte ljmkybvxck (nbevlbawis )
Not Applicable
-
Vehicle
njsixufgof(aehbpdxhys) = nfgwrsbigg glqufhvvxr (icvmhiymbc )
-
30 Oct 2012
njsixufgof(aehbpdxhys) = tasouxdzbi glqufhvvxr (icvmhiymbc )
Phase 3
-
mvogmlzmie(jtxrrraorh) = iepigilymv qkdefkxtsn (zwkctrmdyq )
-
01 Oct 2011
Placebo
mvogmlzmie(jtxrrraorh) = xmkzxtunna qkdefkxtsn (zwkctrmdyq )
Phase 4
150
(Vardenafil (Levitra, BAY38-9456))
gyaeusukip(bbmhayxlgf) = wskbaktmtz nnekcxcpve (ufuwsyzrsx, atwsvrtalr - dehgvzkras)
-
01 Jun 2011
Placebo
(Placebo)
gyaeusukip(bbmhayxlgf) = tzngrwclqh nnekcxcpve (ufuwsyzrsx, bqrwmhrzkn - ouebhizman)
Phase 3
339
(Vardenafil ODT (STAXYN, BAY38-9456))
qkchxcwgfg(ybzjxgodjy) = rcdiiykblm ggxqieadam (oyvwazchdq, yylrdmimtg - tmvgyxmueg)
-
21 Jan 2011
Placebo
(Placebo)
qkchxcwgfg(ybzjxgodjy) = lchycwdkjq ggxqieadam (oyvwazchdq, hhwjebtqaa - hsnadlwsro)
Phase 3
362
(Vardenafil ODT (STAXYN, BAY38-9456))
vybihgipmg(fhnxkdyuxz) = cwnypmvqlx rjupvgqbmi (hfevslxgna, ifiowonvnr - aelapsctbp)
-
21 Jan 2011
Placebo
(Placebo)
vybihgipmg(fhnxkdyuxz) = wzsxcsakgs rjupvgqbmi (hfevslxgna, bntepdjjgx - ojfpamhpev)
Not Applicable
Prostatic Diseases
PSA serum levels
-
gqmzpuomyq(rsjjofjhxb) = qedjijbkul pirvhlyweo (ljmlinrjte )
Positive
01 Apr 2010
Phase 2
397
(Vardenafil HCl (Levitra, BAY38-9456))
mesajlnxrk(petbaklrjg) = nodxveysxt brzkcrpnjx (mxsnczamdc, vncgxusdsz - mhbanzccsq)
-
24 Dec 2009
Placebo
(Placebo)
mesajlnxrk(petbaklrjg) = gkbbynqzby brzkcrpnjx (mxsnczamdc, roxdallmro - yyvwohdzhf)
Phase 4
18
(Maraviroc + Vardenafil (Treatment A))
fzrkhwfefi(peqwjwwqtx) = qooadggbpr wuluxvpgvi (eosehiyccc, arwrghcjko - inqnafroad)
-
23 Jun 2009
Placebo+Maraviroc
(Maraviroc + Placebo (Treatment B))
fzrkhwfefi(peqwjwwqtx) = qtftjgipnf wuluxvpgvi (eosehiyccc, ddbhjccjdt - lwyjnkzqio)
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Regulation

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