Delving into the Latest Updates on Adapalene/Clindamycin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Adapalene-Clindamycin, Adapalene/clindamycin, Clindamycin/adapalene

+ [2]

Target

50S subunit x RARs

Mechanism

50S subunit inhibitors(50S ribosomal subunit inhibitors), RARs agonists(Retinoic acid receptors agonists)

Therapeutic Areas

Skin and Musculoskeletal Diseases

Active Indication

Acne Vulgaris

Inactive Indication-

Originator Organization

Lee's Pharmaceutical (HK) Ltd.

Active Organization

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (20 Feb 2024),

Acne Vulgaris

Regulation-

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Structure/Sequence

Molecular FormulaC28H28O3

InChIKeyLZCDAPDGXCYOEH-UHFFFAOYSA-N

CAS Registry106685-40-9

View All Structures (2)

This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.

Start Date14 Aug 2018

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

[+1]

CTR20181049

/ Active, not recruitingPhase 3

复方凝胶治疗中度寻常性痤疮的有效性和安全性的多中心、随机、单盲、阳性平行对照的Ⅲ期临床试验

[Translation] A multicenter, randomized, single-blind, positive parallel controlled phase III clinical trial on the efficacy and safety of the compound gel in the treatment of moderate acne vulgaris

本研究为Ⅲ期临床研究，旨在探索阿达帕林盐酸克林霉素复方凝胶对比阿达帕林凝胶、克林霉素磷酸酯凝胶单独用药治疗中度寻常性痤疮的疗效和安全性。

[Translation]

This is a phase III clinical study, which aims to explore the efficacy and safety of adapalene hydrochloride and clindamycin gel compared with adapalene gel or clindamycin phosphate gel alone in the treatment of moderate acne vulgaris.

Start Date14 Aug 2018

Sponsor / Collaborator

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

CTR20150045

/ CompletedPhase 1

阿达帕林盐酸克林霉素复方凝胶人体药代动力学研究

[Translation] Study on the pharmacokinetics of adapalene and clindamycin hydrochloride compound gel in healthy volunteers

研究健康中国志愿者单次给予阿达帕林盐酸克林霉素复方凝胶后药物在人体内的药代动力学行为，评价外用阿达帕林盐酸克林霉素复方凝胶后药物在健康人体内的药代动力学特征，为后续的患者药代动力学研究和药物暴露研究提供依据。

[Translation]

To study the pharmacokinetic behavior of adapalene-clindamycin hydrochloride combination gel in healthy Chinese volunteers after a single administration, and to evaluate the pharmacokinetic characteristics of adapalene-clindamycin hydrochloride combination gel in healthy humans after topical application, so as to provide a basis for subsequent patient pharmacokinetic studies and drug exposure studies.

Start Date20 Jul 2015

Sponsor / Collaborator

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

100 Clinical Results associated with Adapalene/Clindamycin Hydrochloride

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100 Translational Medicine associated with Adapalene/Clindamycin Hydrochloride

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100 Patents (Medical) associated with Adapalene/Clindamycin Hydrochloride

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100 Deals associated with Adapalene/Clindamycin Hydrochloride

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	CN	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	20 Feb 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acne Vulgaris	NDA/BLA	CN	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	03 Feb 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03615768 (CACTUS, Pubmed) Manual	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	(ypmvbvqjlr) = ikthwpxnvf fwmkzsbaiq (rfuwyhamqt ) View more	Positive	01 Nov 2024
				Adapalene gel	(ypmvbvqjlr) = fhwdjgrwyt fwmkzsbaiq (rfuwyhamqt ) View more
NCT03615768 (Corporate Publications) Manual	Phase 3	Acne Vulgaris	1,617	Adapalene/Clindamycin(5mg/50mg)	(rgrvupnozr) = lmjkofutnn dxunrzducg (wffwujpjae ) Met	Superior	13 Sep 2021
				Adapalene(0.1%)	(rgrvupnozr) = vxglyxuarq dxunrzducg (wffwujpjae ) Met