Zesly

(Udenafil)

ApprovedSmall molecule

Udenafil is used to treat erectile dysfunction (impotence) in men by improving blood flow to the penis to help achieve and maintain an erection.[2] Zesly is currently approved and in use across 13 indications[4].[1]

Zesly is one of 323 small molecule programs targeting Raynaud disease. It is currently in Approved.

Indications

Total Trials

Active Trials

322

Competitors

Pipeline

Status by Indication[4][1]

Indication

Raynaud DiseaseActive, not recruiting

Erectile DysfunctionUnknown

Benign Prostatic HyperplasiaActive, not recruiting

Diastolic Heart FailureActive, not recruiting

Pulmonary HypertensionActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Vascular DementiaActive, not recruiting

Liver DiseaseActive, not recruiting

Heart FailureActive, not recruiting

Pulmonary Arterial HypertensionActive, not recruiting

Raynaud DiseasePhase 2

Active, not recruiting

Erectile DysfunctionPreclinical

Unknown

Benign Prostatic HyperplasiaPhase 2

Active, not recruiting

Diastolic Heart FailurePhase 3

Active, not recruiting

Pulmonary HypertensionPhase 3

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 3

Active, not recruiting

Vascular DementiaPhase 2

Active, not recruiting

Liver DiseasePhase 1

Active, not recruiting

Heart FailurePhase 3

Active, not recruiting

Pulmonary Arterial HypertensionPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Zesly

MMezzion Pharma Co. Ltd

Approved

1 2

Medrol

Pfizer

Preclinical

1 3

Amidate

Pfizer

Preclinical

1 4

Zemplar

Xifaxan

2 6

Zoloft

VViatris Specialty LLC

Preclinical

2 7

Coumadin

AAbbott

Preclinical

1 8

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 9

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 10

Kuvan

BioMarin Pharmaceutical

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Erectile Dysfunction4 trials

Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

Completed·AAbdi Ibrahim Ilac San. ve Tic A.S.·Phase 3·NCT01305083·118 enrolled

Treatment of Erectile Dysfunction II

Completed·WWarner Chilcott·Phase 3·NCT01037218·601 enrolled

Treatment of Erectile Dysfunction I

Completed·WWarner Chilcott·Phase 3·NCT01037244·618 enrolled

Show 1 more trial

Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Completed·WWarner Chilcott·Phase 3·NCT01065012·1,027 enrolled

Clinical Trial3 trials

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

Completed·DDong-A ST Co., Ltd.·Phase 2/3·NCT02304198·59 enrolled

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

Unknown status·DDong-A Pharmaceutical Co., Ltd.·Phase 1·NCT01928563·24 enrolled

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

Unknown status·DDong-A Pharmaceutical Co., Ltd.·Phase 1·NCT01929213·30 enrolled

Adolescent2 trials

A Extension Study of Udenafil in Adolescents

Completed·MMezzion Pharma Co. Ltd·Phase 3·NCT03013751·301 enrolled

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

Completed·MMezzion Pharma Co. Ltd·Phase 1/2·NCT02201342·36 enrolled

Exercise2 trials

Fontan Udenafil Exercise Longitudinal Assessment Trial

Completed·MMezzion Pharma Co. Ltd·Phase 3·NCT02741115·400 enrolled

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Recruiting·MMezzion Pharma Co. Ltd·Phase 3·NCT05918211·436 enrolled

Interaction1 trial

Phase I Study to Investigate the Alcohol Interaction of DA8159

Completed·—·Phase 1·NCT01241032·24 enrolled

14 more indications

Adult1 trial

Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Completed· Takeda logo

Takeda·Phase 1·NCT01967264·83 enrolled

Pulmonary Arterial Hypertension1 trial

Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

Completed·DDong-A ST Co., Ltd.·Phase 2·NCT01553721·63 enrolled

Colon and Rectal Cancer1 trial

Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer

Completed·SSeoul National University Hospital·Phase 2·NCT00607282·46 enrolled

Chronic Obstructive Pulmonary Disease1 trial

The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed·SSeoul National University Hospital·Phase 3·NCT01364181·23 enrolled

Hepatic Function1 trial

A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

Completed·DDong-A Pharmaceutical Co., Ltd.·Phase 1·NCT00956306·18 enrolled

Pulmonary Hypertension1 trial

A Randomized Trial of Udenafil Therapy in Patients With Mild Pulmonary Hypertension [ULTIMATE-Mild PHT]

Unknown status·SSeoul National University Hospital·Phase 3·NCT01696240·40 enrolled

Heart Failure1 trial

A Randomized Trial of Udenafil Therapy in Patients With Heart Failure With Preserved Ejection Fraction [ULTIMATE-HFpEF]

Unknown status·SSeoul National University Hospital·Phase 3·NCT01599117·52 enrolled

Systolic Heart Failure1 trial

Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure

Terminated·SSeoul National University Hospital·Phase 3·NCT01646515·41 enrolled

Rehabilitation1 trial

The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

Completed·KKyungpook National University Hospital·Phase 4·NCT01421940·80 enrolled

Tics1 trial

Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Completed·—·Phase 1·NCT01231997·27 enrolled

Liver Stiffness1 trial

Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness

Completed·MMezzion Pharma Co. Ltd·Phase 3·NCT03430583·88 enrolled

Vascular Disease1 trial

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

Unknown status·SSamsung Medical Center·Phase 4·NCT01769482·70 enrolled

Benign Prostatic Hyperplasia1 trial

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

Withdrawn· Takeda logo

Takeda·Phase 2·NCT01967251

Unspecified1 trial

Effect of Udenafil on Spermatogenesis

Completed·WWarner Chilcott·Phase 1·NCT01230541·239 enrolled

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Udenafil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zesly drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Udenafil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Udenafil. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Mezzion Pharma Co. Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 5a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMezzion Pharma Co. Ltd

Zesly

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Erectile Dysfunction4 trials

Clinical Trial3 trials

Adolescent2 trials

Exercise2 trials

Interaction1 trial

Adult1 trial

Pulmonary Arterial Hypertension1 trial

Colon and Rectal Cancer1 trial

Chronic Obstructive Pulmonary Disease1 trial

Hepatic Function1 trial

Pulmonary Hypertension1 trial

Heart Failure1 trial

Systolic Heart Failure1 trial

Rehabilitation1 trial

Tics1 trial

Liver Stiffness1 trial

Vascular Disease1 trial

Benign Prostatic Hyperplasia1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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