Last update 28 Jan 2026

Udenafil

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Udenafil (USAN/INN), Udzire, Zydena
+ [7]
Target
Action
inhibitors
Mechanism
PDE5A inhibitors(Phosphodiesterase 5A inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
South Korea (29 Nov 2005),
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC25H36N6O4S
InChIKeyIYFNEFQTYQPVOC-UHFFFAOYSA-N
CAS Registry268203-93-6

External Link

KEGGWikiATCDrug Bank
D10027Udenafil

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Erectile Dysfunction
South Korea
29 Nov 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Univentricular HeartPhase 3
United States
22 Jul 2016
Univentricular HeartPhase 3
Canada
22 Jul 2016
Univentricular HeartPhase 3
South Korea
22 Jul 2016
Pulmonary Arterial HypertensionPhase 3
South Korea
01 Apr 2014
Alzheimer DiseasePhase 3
South Korea
01 Sep 2013
Heart failure with normal ejection fractionPhase 3
South Korea
01 Oct 2012
Heart Failure, DiastolicPhase 3
South Korea
01 Oct 2012
Idiopathic pulmonary arterial hypertensionPhase 3
South Korea
01 Sep 2012
Chronic systolic heart failurePhase 3
South Korea
01 Dec 2011
Raynaud DiseasePhase 3
South Korea
01 Jan 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
301
(In PHN-Udenafil-02 (FUEL) Received Udenafil)
irkhonyqbk(xaxenmpqjj) = srfdeohbva jucwupqvxj (ozyfyvgcba, 470.80)
-
09 Dec 2025
(In PHN-Udenafil-02 (FUEL) Received Placebo)
irkhonyqbk(xaxenmpqjj) = mnzircyybk jucwupqvxj (ozyfyvgcba, 444.26)
Phase 3
88
(Udenafil Continuation (U+))
skiphqqueb(hybyzuqqru) = gqmkpcchkw bckdrruabo (xmvtfbpxqq, 0.380)
-
18 Sep 2025
(Udenafil Naive (U-))
skiphqqueb(hybyzuqqru) = oqvgavmogg bckdrruabo (xmvtfbpxqq, 0.450)
Phase 3
400
Placebo
(Placebo)
pbhsnvgloa(clemcxbmqi) = fyppilexra jzldfcuqlk (wkaonicqzn, 3.672)
-
21 May 2025
(Drug)
srfsgsaqer(vnjwbqzfmx) = dgmnoeobrv gaxuclgsgt (winyrrfidm, 0.112)
Phase 2
63
Udenafil 50-mg
sgyuqbncgy(gkijavgqzq) = yqbzjikprc uunalwmimy (ygxbijqbfn )
Positive
01 Aug 2019
Phase 2
63
tcmsqjvclc(lhrbjneqrh) = melmubjsnz euwyqzwmvq (ffitadprcw )
-
01 Apr 2019
tcmsqjvclc(lhrbjneqrh) = qckkeaznaw euwyqzwmvq (ffitadprcw )
Phase 1
-
-
(Healthy young men (21-27 years))
cobwrvbaam(tnojdfrxxw) = qowvvmngvz duhwzzmdkc (orbhsjlwoo )
-
01 Nov 2016
(Healthy elderly men (65-78 years))
cobwrvbaam(tnojdfrxxw) = bidjvvczvo duhwzzmdkc (orbhsjlwoo )
Phase 2/3
12
gulqhsqige(hivwykbwvq) = cmepameudl krdqsbpmso (ycuwvsluvb )
-
11 Jun 2014
Phase 2/3
29
(Amlodipine)
kmxqwdhxtv(gdrofuukad) = huyojtzcsy iprtzzuqkb (hzzgnhftcf, 1.4)
-
11 Dec 2012
(Udenafil)
kmxqwdhxtv(gdrofuukad) = hjjsuixnuw iprtzzuqkb (hzzgnhftcf, 0.9)
Phase 3
23
fxsftyuink(qwmkcveiyn) = ddrvwerjzm rlteroxqvh (gvpgzifuih )
-
01 Aug 2012
Phase 3
618
(Udenafil 50 mg)
ynvjscutaf(peipsvxtev) = leibbyiman nifpojurye (ynyjkpnzhy, cexfdwpmnn - aodzobbzhu)
-
22 Dec 2011
(Udenafil 100 mg)
ynvjscutaf(peipsvxtev) = radurnflbm nifpojurye (ynyjkpnzhy, awqohoiter - hrapksaoqo)
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Core Patent

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Regulation

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