Udenafil

Generic Name: Udenafil

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₃₆N_₆O_₄S

CAS Number: 268203-93-6

Unique Ingredient Identifier: L5IB4XLY36

Background: 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

Associated Therapies: -

Clinical Trials

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Phase 3

Recruiting

Conditions: Single Ventricle Heart Disease

Interventions: Drug: Udenafil
Drug: Placebo

First Posted Date: 2023-06-26

Last Posted Date: 2024-10-21

Lead Sponsor: Mezzion Pharma Co. Ltd

Target Recruit Count: 436

Registration Number: NCT05918211

Locations: 🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States

and more 28 locations

A Extension Study of Udenafil in Adolescents

Phase 3

Conditions: Functional Single Ventricle Heart Disease

Interventions: Drug: Udenafil

First Posted Date: 2017-01-06

Last Posted Date: 2020-11-24

Lead Sponsor: Mezzion Pharma Co. Ltd

Target Recruit Count: 300

Registration Number: NCT03013751

Locations: 🇺🇸
Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇨🇦
The Hospital for Sick Children, Toronto, Ontario, Canada

and more 21 locations

Fontan Udenafil Exercise Longitudinal Assessment Trial

Phase 3

Completed

Conditions: Single Ventricle Heart Disease

Interventions: Drug: Placebo
Drug: Udenafil

First Posted Date: 2016-04-18

Last Posted Date: 2020-01-14

Lead Sponsor: Mezzion Pharma Co. Ltd

Target Recruit Count: 400

Registration Number: NCT02741115

Locations: 🇺🇸
Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Johns Hopkins All Children's Heart Institute, Saint Petersburg, Florida, United States
🇺🇸
Nemours Cardiac Center/Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States

and more 27 locations

Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH

Phase 2

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Udenafil

First Posted Date: 2014-12-01

Last Posted Date: 2016-04-18

Lead Sponsor: Dong-A ST Co., Ltd.

Target Recruit Count: 59

Registration Number: NCT02304198

Locations: 🇰🇷
Samsung Medical Center, Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

Phase 1

Completed

Conditions: Single Ventricle Heart Disease After Fontan Surgery

Interventions: Drug: Udenafil

First Posted Date: 2014-07-28

Last Posted Date: 2015-04-27

Lead Sponsor: Mezzion Pharma Co. Ltd

Target Recruit Count: 36

Registration Number: NCT02201342

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇨🇦
The Hospital for Sick Children, Toronto, Ontario, Canada
🇺🇸
Riley Hospital for Children, Indianapolis, Indiana, United States

and more 3 locations

Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Phase 1

Completed

Conditions: Erectile Dysfunction
Phosphodiesterase 5 Inhibitor

Interventions: Drug: Udenafil
Drug: Placebo

First Posted Date: 2013-10-22

Last Posted Date: 2013-10-22

Lead Sponsor: Takeda

Target Recruit Count: 83

Registration Number: NCT01967264

Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction

Phase 2

Withdrawn

Conditions: Erectile Dysfunction
Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Udenafil

First Posted Date: 2013-10-22

Last Posted Date: 2016-03-04

Lead Sponsor: Takeda

Registration Number: NCT01967251

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration

Phase 1

Conditions: Healthy Volunteers

Interventions: Drug: Udenafil/Bosentan
Drug: Udenafil
Drug: Bosentan

First Posted Date: 2013-08-27

Last Posted Date: 2014-01-09

Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Target Recruit Count: 30

Registration Number: NCT01929213

Locations: 🇰🇷
Severance Hospital Clinical Trial Center, Seoul, Korea, Republic of

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine

Phase 1

Conditions: Healthy Male Subjects

Interventions: Drug: Udenafil+Dapoxetine
Drug: Dapoxetine
Drug: Udenafil

First Posted Date: 2013-08-26

Last Posted Date: 2013-08-26

Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Target Recruit Count: 24

Registration Number: NCT01928563

Locations: 🇰🇷
Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of

Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image

Phase 4

Conditions: Microvascular Angina

Interventions: Drug: Udenafil
Drug: placebo

First Posted Date: 2013-01-16

Last Posted Date: 2014-03-26

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 70

Registration Number: NCT01769482

Locations: 🇰🇷
Korea University Guro Hospital, Seoul, Korea, Republic of
🇰🇷
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

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