Drugs / Udenafil
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT01928563 | Sep → Dec 2013 | — | Dong-A Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01929213 | Aug → Nov 2013 | — | Dong-A Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01967264 | Jul → Aug 2013 | erectile dysfunction | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01231997 | Nov 2009 → Nov 2010 | impaired renal function disease | Asan Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00767598 | Dec 2007 | — | Inje University | Completed | No outcome recorded |
| Phase 1 | NCT00956306 | Nov 2007 → Sep 2012 | — | Dong-A Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01241032 | Jun 2006 → Feb 2007 | erectile dysfunction | Asan Medical Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02201342 | Jul 2014 → Apr 2015 | univentricular cardiopathy | Mezzion Pharma Co. Ltd | Completed | No outcome recorded |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT01967251 | Sep 2015 → Sep 2016 | benign prostatic hyperplasia, erectile dysfunction | Takeda | Withdrawn | No outcome recorded |
| Phase 2 | NCT01553721 | Aug 2011 → Mar 2015 | pulmonary arterial hypertension | Dong-A ST Co., Ltd. | Completed | Missed primary |
| Phase 2 | NCT00607282 | Mar 2009 → Jan 2012 | erectile dysfunction, rectal cancer, sigmoid colon cancer | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00282607 | May 2005 → Jun 2006 | erectile dysfunction | Dong-A PharmTech Co., Ltd. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02304198 | Apr 2014 → Feb 2016 | pulmonary arterial hypertension | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT01280266 | Jan → May 2011 | Raynaud disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 310 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT05918211 | Oct 2023 → Oct 2025 overdue | univentricular cardiopathy | Mezzion Pharma Co. Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT03430583 | Feb 2018 → Sep 2020 | univentricular cardiopathy | Mezzion Pharma Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT03013751 | Feb 2017 → Dec 2019 | univentricular cardiopathy | Mezzion Pharma Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT02741115 | Jul 2016 → Dec 2018 | univentricular cardiopathy | Mezzion Pharma Co. Ltd | Completed | Missed primary |
| Phase 3 | NCT01901640 | Nov 2011 → Nov 2012 | erectile dysfunction | Dong-A Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01774864 | Apr 2011 → May 2012 | erectile dysfunction | Dong-A Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01364181 | Mar 2010 → Mar 2011 | chronic obstructive pulmonary disease, pulmonary hypertension | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01065012 | Jan 2010 → Feb 2011 | erectile dysfunction | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT01037244 | Sep 2009 → Mar 2010 | erectile dysfunction | Warner Chilcott | Completed | Met primary |
| Phase 3 | NCT01037218 | Sep 2009 → Apr 2010 | erectile dysfunction | Warner Chilcott | Completed | Met primary |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT03142542 | May 2017 → May 2019 | — | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01769482 | Dec 2011 → Dec 2014 | coronary microvascular disorder | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01421940 | Oct 2009 → Dec 2011 | rectal cancer | Kyungpook National University Hospital | Completed | Met primary |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT01230541 Comparator | Sep 2010 → Nov 2011 | erectile dysfunction, spermatogenic failure | Warner Chilcott | Completed | No outcome recorded |
| Phase 2 | NCT01466543 Comparator | Nov 2011 → Mar 2012 | vascular dementia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01940952 Comparator | Sep 2013 → Aug 2015 | Alzheimer disease | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01599117 Comparator | Oct 2012 → Apr 2013 | diastolic heart failure | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01696240 Comparator | Sep 2012 → Dec 2013 | pulmonary hypertension | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01646515 Comparator | Dec 2011 → Jan 2014 | systolic heart failure | Seoul National University Hospital | Terminated | No outcome recorded |
| Phase 3 | NCT01305083 Comparator | Oct 2010 → Aug 2011 | erectile dysfunction | Abdi Ibrahim Ilac San. ve Tic A.S. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2019-03-11 | Dong-A ST Co., Ltd. | Results 동아ST, 발기부전 치료제 자이데나 ‘배뇨후 요점적’ 개선 효과 확인 donga-st.com ↗
이번 임상연구에서 배뇨후 요점적 환자들에게 있어 자이데나 75mg 복용은 위약 대비 배뇨후 요점적 횟수 및 증상 평가 점수 감소 등 유의미한 배뇨후 요점적 증상의 개선 효과를 보였다. |
| 2019-03-11 | Dong-A ST Co., Ltd. | Results Dong-A ST’s erectile dysfunction treatment, Zydena, proven to improve ‘post-micturition dribble’ donga-st.com ↗
In the clinical trial, the use of Zydena 75mg in patients with PMD showed a significant improvement of PMD symptoms, including a reduction in PMD frequency and the symptom score compared to placebo. |
| 2019-03-07 | Dong-A ST Co., Ltd. | Results 동아ST, 발기부전 치료제 자이데나 ‘배뇨후 요점적’ 개선 효과 확인 donga-st.com ↗
이번 임상연구에서 배뇨후 요점적 환자들에게 있어 자이데나 75mg 복용은 위약 대비 배뇨후 요점적 횟수 및 증상 평가 점수 감소 등 유의미한 배뇨후 요점적 증상의 개선 효과를 보였다. |
| 2013-08-20 | Abdi Ibrahim Ilac San. ve Tic A.S. | Results Zydena türk erkeklerinden tam not aldı… com.tr ↗
Zydena’ nın etken maddesi Udenafil’in iyi tolere edildiği ve bu nedenle sertleşme tedavisinde iyi bir seçenek olduğu gösterdi. |
| 2008-07-04 | Dong-A ST Co., Ltd. | Results Zydena® Cleared as Safe for Patients with Diabetes, Hypertension donga-st.com ↗
Efficacy of Zydena®, the results showed, reported no continuous or severe post-dose symptoms, rendering the drug’s safety also excellent. |
| 2005-12-02 | Dong-A ST Co., Ltd. | Regulatory Erectile Dysfunction Drug, Zydena®, Released donga-st.com ↗
was approved as a new drug by the KFDA on November 29 after phase II and III clinical trials. |
All press releases naming this drug 22 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Udenafil | “single oral administration of 200mg udenafil” NCT00767598 ↗ |
| Known as | DA-8159 | “This study is designed to investigate the pharmacokinetic drug interaction and safety after oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers.” NCT01929213 ↗ |
| Known as | Udenafilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103849 ↗ |
| Known as | Zydena | “Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and...” NCT01696240 ↗4“The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake...” NCT01421940 ↗ “Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group” NCT01599117 ↗ “Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company” NCT01646515 ↗ “Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg” NCT01940952 ↗ |
| Known as | ZYDENA TAB.75mg | “ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks” NCT03142542 ↗ |
| Action | Inhibit | “potent and selective inhibitor of PDE5” NCT00282607 ↗1“Phosphodiesterase 5A inhibitor” CHEMBL2103849 ↗ |
| Modality | Small molecule | — CHEMBL2103849 ↗ |
| Route | Oral | “orally administered” NCT00282607 ↗ |
| Target | PDE5A | “Phosphodiesterase 5A inhibitor” CHEMBL2103849 ↗ |