Overview
Udenafil is a new phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED). It has been approved in South Korea and will be marketed under the brand name Zydena. It is not yet approved for use in the U.S., E.U., or Canada.
Indication
Investigated for use/treatment in erectile dysfunction and hypertension.
Associated Conditions
- Erectile Dysfunction
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/26 | Phase 3 | Recruiting | |||
2018/02/13 | N/A | Completed | |||
2017/01/06 | Phase 3 | UNKNOWN | |||
2016/04/18 | Phase 3 | Completed | |||
2014/12/01 | Phase 2 | Completed | |||
2014/07/28 | Phase 1 | Completed | |||
2013/10/22 | Phase 1 | Completed | |||
2013/10/22 | Phase 2 | Withdrawn | |||
2013/09/11 | Phase 2 | Completed | |||
2013/08/27 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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