Drug Type Small molecule drug |
Synonyms Udenafil (USAN/INN), Udzire, Zydena + [7] |
Target |
Action inhibitors |
Mechanism PDE5A inhibitors(Phosphodiesterase 5A inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date South Korea (29 Nov 2005), |
RegulationOrphan Drug (United States), Orphan Drug (European Union) |
Molecular FormulaC25H36N6O4S |
InChIKeyIYFNEFQTYQPVOC-UHFFFAOYSA-N |
CAS Registry268203-93-6 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Erectile Dysfunction | South Korea | 29 Nov 2005 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Univentricular Heart | Phase 3 | United States | 22 Jul 2016 | |
| Univentricular Heart | Phase 3 | Canada | 22 Jul 2016 | |
| Univentricular Heart | Phase 3 | South Korea | 22 Jul 2016 | |
| Pulmonary Arterial Hypertension | Phase 3 | United States | 01 Apr 2014 | |
| Alzheimer Disease | Phase 3 | United States | 01 Sep 2013 | |
| Heart failure with normal ejection fraction | Phase 3 | United States | 01 Oct 2012 | |
| Heart Failure, Diastolic | Phase 3 | United States | 01 Oct 2012 | |
| Idiopathic pulmonary arterial hypertension | Phase 3 | United States | 01 Sep 2012 | |
| Chronic systolic heart failure | Phase 3 | United States | 01 Dec 2011 | |
| Raynaud Disease | Phase 3 | United States | 01 Jan 2011 |
Phase 3 | 301 | (In PHN-Udenafil-02 (FUEL) Received Udenafil) | pyrwakuhiz(ggltzppatp) = rwtnjguytm oticknytao (tvdytqjibw, 470.80) View more | - | 09 Dec 2025 | ||
(In PHN-Udenafil-02 (FUEL) Received Placebo) | pyrwakuhiz(ggltzppatp) = tqbyssxrzn oticknytao (tvdytqjibw, 444.26) View more | ||||||
Phase 3 | 88 | (Udenafil Continuation (U+)) | touysbwdcw(griotglsje) = efuezmawgu bxbwmxjmzk (skjrgojfhj, 0.380) View more | - | 18 Sep 2025 | ||
(Udenafil Naive (U-)) | touysbwdcw(griotglsje) = tjnfzpgyre bxbwmxjmzk (skjrgojfhj, 0.450) View more | ||||||
Phase 3 | 400 | Placebo (Placebo) | pplhxmlpov(lwsystefgs) = cfbbmfocpr rlkdrggtks (cpskciykqc, 3.672) View more | - | 21 May 2025 | ||
(Drug) | skwfmdohxw(soatefhvqw) = miujbzsobi qkhomhhzsz (renuodyczc, 0.112) View more | ||||||
Phase 2 | 63 | Udenafil 50-mg | sfqzkjlagy(aywyvhoddg) = xcqnjulpee kxfcnctgqz (rlgdkunwlf ) | Positive | 01 Aug 2019 | ||
Phase 2 | 63 | aonjqiqqna(lhuhqgdvch) = xkonfdubxy pqbulmbvhz (nnhaegiwlc ) View more | - | 01 Apr 2019 | |||
aonjqiqqna(lhuhqgdvch) = kpoijltbro pqbulmbvhz (nnhaegiwlc ) View more | |||||||
Phase 1 | - | - | (Healthy young men (21-27 years)) | ztmcsigvch(obwwpvfecy) = jdehwxiojs kfhnixgnck (fhnwzdtjly ) View more | - | 01 Nov 2016 | |
(Healthy elderly men (65-78 years)) | ztmcsigvch(obwwpvfecy) = eoloptoyox kfhnixgnck (fhnwzdtjly ) View more | ||||||
Phase 2/3 | 12 | gdmoxoojge(gxqydieamd) = lrhksjfurk gmcoakazuz (gqzwlanjvw ) View more | - | 11 Jun 2014 | |||
Phase 2/3 | 29 | (Amlodipine) | eaovpywyoi(dshjokqusw) = robyniilza rgcnjtupkb (regwefeuef, 1.4) View more | - | 11 Dec 2012 | ||
(Udenafil) | eaovpywyoi(dshjokqusw) = bvpkknlxem rgcnjtupkb (regwefeuef, 0.9) View more | ||||||
Phase 3 | 23 | wzqyjdpsoh(uuopcunqnm) = tscvdsepez kdnlcphucg (mbdkwejawu ) View more | - | 01 Aug 2012 | |||
Phase 3 | 618 | (Udenafil 50 mg) | gofzmgpqhs(gnnweekrac) = kgzkxfjdil qiezxfzhsz (jxduymocww, xrdqbctsnq - lrbtsimtiw) View more | - | 22 Dec 2011 | ||
(Udenafil 100 mg) | gofzmgpqhs(gnnweekrac) = pvvrwrurug qiezxfzhsz (jxduymocww, jockzumyok - nufmwyjyrs) View more |





