udenafil
Small moleculeexperimental
The drug udenafil is marketed under the trade name Zydena. It is within the PDE5 inhibitor class (which also includes avanafil, sildenafil, tadalafil, and vardenafil). Like other PDE5 inhibitors, it is used to treat erectile dysfunction. Udenafil was developed by Dong-A Pharmaceutical. It has fairly rapid onset of action (peak plasma concentration after 1 to 1.5 hours), and has long duration of action (plasma half-life of 11 to 13 hours). Udenafil's pharmacokinetics allows once-daily dosage (in addition to on-demand use). Typical doses are 100 and 200 mg. Udenafil is available in Korea, Russia, and the Philippines. It has not yet been approved for use in the United States by the U.S. Food and Drug Administration. — Wikipedia
Clinical trial activity
33 trials · 22 clinical orgs · 0 marketing orgs
Phase 1
9
Phase 2
20
Phase 3
15
Phase 4
3
Earliest trial started May 1, 2005 (NCT00282607)
Timeline
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 3
- Dementia, Vascular · Phase 2
- Dyspnea · Phase 3
- Erectile Dysfunction · Phase 3
- General Surgery · Phase 1/Phase 2
- Genetic Diseases, Inborn · Phase 1
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 3
- Heart Failure, Diastolic · Phase 3
- Heart Failure, Systolic · Phase 3
- Hypertension, Pulmonary · Phase 3
- Kidney Diseases · Phase 1
- Liver Diseases · Phase 1
- Microvascular Angina · Phase 4
- Pharmacokinetics · Phase 1
- Phosphodiesterase 5 Inhibitors · Phase 1
- Prostatic Hyperplasia · Phase 2
- Pulmonary Arterial Hypertension · Phase 2/Phase 3
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Raynaud Disease · Phase 2/Phase 3
- Rectal Neoplasms · Phase 4
- Renal Insufficiency · Phase 1
- Sigmoid Neoplasms · Phase 2
- Spermatogenesis · Phase 1
- Urologic Diseases · Phase 1
Mechanism of action
- Phosphodiesterase 5AINHIBITOR
PDE5A inhibitor
Chemistry & pharmacology
Loading structure…
SMILES
CCCOc1ccc(S(=O)(=O)NCCC2CCCN2C)cc1-c1nc2c(CCC)nn(C)c2c(=O)[nH]1- Mol. weight
- 516.67 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaUdenafil ↗
- ChEMBLCHEMBL2103849 ↗
Also known as
- 5-(2-propyloxy-5-(1-methyl-2-pyrollidinylethylamidosulfonyl)phenyl)-1-methyl-3-propyl-1,6-dihydro-7h-pyrazolo (4,3-d) pyrimidine-7-one
- da 8159
- da-8159
- da-8159
- da-8159
- da-8159
- da-8159
- udenafil
- udenafil
- udenafil
- udenafil
- udenafil
- udenafil
- udenafil
- udenafil
- wc3055
- zidena
- zydena
- zydena
- zydena
- zydena
- zydena
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03142542 | Phase 4 | May 1, 2017 | Dong-A Pharmaceutical, Sungkyunkwan University |
| NCT03013751 | Phase 3 | Jan 1, 2017 | Mezzion Pharma Co. Ltd, National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania |
| NCT02741115 | Phase 3 | Jun 1, 2016 | Mezzion Pharma Co. Ltd, National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania |
| NCT01967251 | Phase 2 | Sep 1, 2015 | Takeda |
| NCT02201342 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2014 | Mezzion Pharma Co. Ltd, National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania |
| NCT02304198 | Phase 2/Phase 3 (Phase 3) | Apr 1, 2014 | Catholic University of Korea, Chonbuk National University, Chonnam National University, Chungnam National University, Dong-A Pharmaceutical, Pusan National University, Seoul National University, Sungkyunkwan University, University of Ulsan, Yonsei University |
| NCT01928563 | Phase 1 | Sep 1, 2013 | Dong-A Pharmaceutical, University of Ulsan |
| NCT01940952 | Phase 3 | Sep 1, 2013 | Dong-A Pharmaceutical, Sungkyunkwan University |
| NCT01929213 | Phase 1 | Aug 1, 2013 | Dong-A Pharmaceutical, Yonsei University |
| NCT01939184 | Phase 2 | Aug 1, 2013 | Warner Chilcott |
| NCT01967264 | Phase 1 | Jul 1, 2013 | Takeda |
| NCT01599117 | Phase 3 | Oct 1, 2012 | Dong-A Pharmaceutical, Seoul National University |
| NCT01696240 | Phase 3 | Sep 1, 2012 | Dong-A Pharmaceutical, Seoul National University |
| NCT01646515 | Phase 3 | Dec 1, 2011 | Dong-A Pharmaceutical, Seoul National University |
| NCT01769482 | Phase 4 | Dec 1, 2011 | Sungkyunkwan University |
| NCT01901640 | Phase 3 | Nov 1, 2011 | Catholic University of Korea, Chonbuk National University, Dong-A Pharmaceutical, Ewha Womans University, Hallym University, Inje University, Korea University, Pusan National University, Seoul National University, Sungkyunkwan University, University of Ulsan, Yeungnam University |
| NCT01466543 | Phase 2 | Nov 1, 2011 | Dong-A Pharmaceutical, Sungkyunkwan University |
| NCT01553721 | Phase 2 | Aug 1, 2011 | Dong-A Pharmaceutical, Sungkyunkwan University |
| NCT01774864 | Phase 3 | Apr 1, 2011 | Catholic University of Korea, Chonbuk National University, Dong-A Pharmaceutical, Ewha Womans University, Hallym University, Inje University, Korea University, Pusan National University, Seoul National University, Sungkyunkwan University, University of Ulsan, Yeungnam University |
| NCT01280266 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2011 | Dong-A Pharmaceutical, Seoul National University |
Showing 20 of 33 trials
Page 1 / 2
Organizations
Research & Development (22)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Dong-A Pharmaceutical | For profit | 18 | 8 | 4 | 2005 |
| Seoul National University | Academic/Hospital | 10 | 6 | 3 | 2007 |
| Sungkyunkwan University | Academic/Hospital | 8 | 4 | 3 | 2011 |
| University of Ulsan | Academic/Hospital | 7 | 2 | 2 | 2006 |
| Warner Chilcott | For profit | 5 | 5 | 3 | 2009 |
| Catholic University of Korea | Academic/Hospital | 3 | 0 | 1 | 2011 |
| Chonbuk National University | Academic/Hospital | 3 | 0 | 1 | 2011 |
| Inje University | Academic/Hospital | 3 | 1 | 2 | 2007 |
| Mezzion Pharma Co. Ltd | For profit | 3 | 3 | 2 | 2014 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 3 | 0 | 2 | 2014 |
| Pusan National University | Academic/Hospital | 3 | 0 | 1 | 2011 |
| University of Pennsylvania | Academic/Hospital | 3 | 0 | 2 | 2014 |
| Ewha Womans University | Academic/Hospital | 2 | 0 | 1 | 2011 |
| Hallym University | Academic/Hospital | 2 | 0 | 1 | 2011 |
| Korea University | Academic/Hospital | 2 | 0 | 1 | 2011 |
| Takeda | For profit | 2 | 2 | 2 | 2013 |
| Yeungnam University | Academic/Hospital | 2 | 0 | 1 | 2011 |
| Yonsei University | Academic/Hospital | 2 | 0 | 2 | 2013 |
| Abdi Ibrahim Pharmaceuticals | For profit | 1 | 1 | 1 | 2010 |
| Chonnam National University | Academic/Hospital | 1 | 0 | 1 | 2014 |
22 organizations
Page 1 / 2