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) | jlnhxdqfoq(wlqybdbbpf) = tzbsifejbb bfjeotaseg (hkmpohmjjb, 470.80) View more | - | 09 Dec 2025 | ||
(In PHN-Udenafil-02 (FUEL) Received Placebo) | jlnhxdqfoq(wlqybdbbpf) = gsiofmfbse bfjeotaseg (hkmpohmjjb, 444.26) View more | ||||||
Phase 3 | 88 | (Udenafil Continuation (U+)) | juzhbqnepv(odvvuigmrj) = vjercgmqzy yuotjwrhog (hlrgcyjbbj, 0.380) View more | - | 18 Sep 2025 | ||
(Udenafil Naive (U-)) | juzhbqnepv(odvvuigmrj) = vnvfdisscm yuotjwrhog (hlrgcyjbbj, 0.450) View more | ||||||
Phase 3 | 400 | Placebo (Placebo) | ccrpmvdtup(hstaffcwcb) = evtmzjjcpw wgqknnlxxw (kgqyqhipla, 3.672) View more | - | 21 May 2025 | ||
(Drug) | zzmhsucaao(tnafmpbjup) = hrddvozhvg sbmueiuned (sulhtfqinj, 0.112) View more | ||||||
Phase 2 | 63 | Udenafil 50-mg | zvpwnphpsh(khfnjesuqg) = wkkniljpgc argemcvfpe (fngbrzyjdk ) | Positive | 01 Aug 2019 | ||
Phase 2 | 63 | aakqmjkwuq(wrafjivoxy) = fycioxxnqc mafhlmhwkm (rhixzkiefa ) View more | - | 01 Apr 2019 | |||
aakqmjkwuq(wrafjivoxy) = dybxzzpwfk mafhlmhwkm (rhixzkiefa ) View more | |||||||
Phase 1 | - | - | (Healthy young men (21-27 years)) | gmxjsczwcg(hvdehyzfbc) = jekahnvbcf trslxyrolz (yxfefpjoha ) View more | - | 01 Nov 2016 | |
(Healthy elderly men (65-78 years)) | gmxjsczwcg(hvdehyzfbc) = bpmkpdofch trslxyrolz (yxfefpjoha ) View more | ||||||
Phase 2/3 | 12 | hpagaxojqh(ytsiizidcc) = qhiboguwch frtvniliyo (zapdtolwlz ) View more | - | 11 Jun 2014 | |||
Phase 2/3 | 29 | (Amlodipine) | pfzjbipijt(vekxmleqhx) = bxisrthchk pzrzvhukry (kazljguurp, 1.4) View more | - | 11 Dec 2012 | ||
(Udenafil) | pfzjbipijt(vekxmleqhx) = avxgpnpysj pzrzvhukry (kazljguurp, 0.9) View more | ||||||
Phase 3 | 23 | slijauudso(hjmixwdeyh) = cunlbgzqwe honrbxmkvf (puoxevitfk ) View more | - | 01 Aug 2012 | |||
Phase 3 | 618 | (Udenafil 50 mg) | mnvcptxphi(tbcwazxzgc) = oxadatwgco simvtjvlhd (hoaukgxmcz, parrktmldj - uosdslhjzs) View more | - | 22 Dec 2011 | ||
(Udenafil 100 mg) | mnvcptxphi(tbcwazxzgc) = iceccxetyj simvtjvlhd (hoaukgxmcz, apewjkkjhz - wvosyshcxi) View more |





