Delving into the Latest Updates on Fadanafil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

XZP 5849, XZP-5849

Target

PDE5A

Mechanism

PDE5A inhibitors(Phosphodiesterase 5A inhibitors)

Therapeutic Areas

Urogenital DiseasesRespiratory DiseasesOther Diseases

Active Indication

Erectile DysfunctionPulmonary Arterial HypertensionProstatic Hyperplasia

Inactive Indication-

Originator Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Xuanzhu Biopharmaceutical Co., Ltd.Startup

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationSpecial Review Project (CN)

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The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics of single oral fadanafil tablet 100mg in healthy subjects.
Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a single center, randomized, open-label, two-period crossover study in approximately 14 Chinese healthy adult male subjects.

Start Date28 Apr 2019

Sponsor / Collaborator

Sihuan Pharmaceutical Holdings Group Ltd.

CTR20191367 / Active, not recruitingPhase 1

一项单中心、随机、开放、双周期交叉评价高脂餐对健康受试者单次口服复达那非片PK影响的Ⅰb期临床试验

[Translation] A single-center, randomized, open-label, two-period crossover phase Ib clinical trial evaluating the effect of a high-fat meal on the PK of a single oral dose of fadafil tablets in healthy subjects

主要目的：评价高脂餐对健康受试者单次口服复达那非片药代动力学的影响。次要目的：评价健康受试者单次口服复达那非片的安全性。

[Translation]

Primary objective: To evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of fadafil tablets in healthy subjects. Secondary objective: To evaluate the safety of a single oral dose of fadafil tablets in healthy subjects.

Start Date28 Apr 2019

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

NCT04312568 / CompletedPhase 1

Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects

The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study

Start Date10 Aug 2018

Sponsor / Collaborator

Sihuan Pharmaceutical Holdings Group Ltd.

100 Clinical Results associated with Fadanafil

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100 Translational Medicine associated with Fadanafil

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100 Patents (Medical) associated with Fadanafil

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100 Deals associated with Fadanafil

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 2	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	10 Aug 2021
Pulmonary Arterial Hypertension	Phase 1	CN	Xuanzhu Biopharmaceutical Co., Ltd.Startup	07 Sep 2021
Prostatic Hyperplasia	Phase 1	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	10 Aug 2018