Adapalene

Overview

Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne. Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.

Indication

Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over. It is also indicated for acne vulgaris in combination with benzoyl peroxide and in a triple combination therapy with benzoyl peroxide and clindamycin.

Associated Conditions

Acne Vulgaris

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy, Safety Profile, and Post-Acne Sequelae of 0.025% Retinoic Acid Cream vs. 0.1% Adapalene Cream in Mild Acne Vulgaris in Fitzpatrick Skin Types III-V	2025/06/11	NCT07015931	Phase 1	Completed	Indonesia University
Comparison of Effectiveness of Topical Retinoids Versus Liquid Nitrogen in Treatment of Plantar Warts(Viral Infection)	2025/06/11	NCT07016360	Phase 4	Recruiting	Khyber Teaching Hospital
The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol	2025/01/15	NCT06775314	Phase 3	Not yet recruiting	Dr.dr.Irma Bernadette, SpKK (K)
Vitamin D Supplementation in Acne	2023/11/21	NCT06141330	Not Applicable	Recruiting	HITEC-Institute of Medical Sciences
Effect of New Topical Preparation for Treatment of Acne Vulgaris	2023/06/12	NCT05899699	Phase 2	Not yet recruiting	Mansoura University
Experience With Topical Acne Treatment	2022/10/17	NCT05582434	Early Phase 1	Recruiting	Wake Forest University Health Sciences
MC RCT - BPO vs Adapalene	2022/09/13	NCT05536882	Phase 3	Withdrawn	University of Oklahoma
Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA	2022/08/11	NCT05497323	Phase 1	Active, not recruiting	Dr.dr.Irma Bernadette, SpKK (K)
Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients	2021/10/27	NCT05096312	Phase 4	Completed	East Avenue Medical Center, Philippines
Plantar Wart Treatment Using Adapalene Gel	2021/04/01	NCT04823845	Early Phase 1	Withdrawn	University of Louisville

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Adapalene	PruGen, Inc.	42546-720	TOPICAL	45 g in 1 g	1/24/2018
Differin	Physicians Total Care, Inc.	54868-5271	TOPICAL	1 mg in 1 g	1/21/2011
Differin	Galderma Laboratories, L.P.	0299-5912	TOPICAL	0.1 g in 100 mL	4/20/2023
EPIDUO	Galderma Laboratories, L.P.	0299-5908	TOPICAL	1 mg in 1 g	2/19/2018
Adapalene and benzoyl peroxide	Zydus Lifesciences Limited	70771-1716	TOPICAL	3 mg in 1 g	6/6/2022
epiduo forte	Galderma Laboratories, L.P.	0299-5906	TOPICAL	3 mg in 1 g	4/27/2022
Adapalene	A-S Medication Solutions	50090-2004	TOPICAL	1 mg in 1 g	8/25/2021
Adapalene	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0424	TOPICAL	1 mg in 1 g	8/22/2018
ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%	Sincerus Florida, LLC	72934-1002	TOPICAL	0.1 g in 100 g	6/3/2020
Adapalene and Benzoyl Peroxide	Taro Pharmaceuticals U.S.A., Inc.	51672-1384	TOPICAL	3 mg in 1 g	12/27/2022

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
DIFFERIN GEL 0.1%	LABORATOIRES GALDERMA	SIN08957P	GEL	0.1% w/w	10/7/1996
DIFACLEAR GEL 0.1%w/w	SUN PHARMACEUTICAL INDUSTRIES LIMITED	SIN15136P	GEL	1.00mg/g	12/13/2016
DIFFERIN CREAM 0.1%	LABORATOIRES GALDERMA	SIN11116P	CREAM	0.1%	9/16/1999
EPIDUO FORTE GEL 0.3%/2.5%	G PRODUCTION INC, Laboratoires Galderma	SIN15460P	GEL	0.30 %W/W	4/3/2018
EPIDUO GEL 0.1%/2.5%	LABORATOIRES GALDERMA	SIN13789P	GEL	0.10%	4/21/2010

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
EPIDUO adapalene / benzoyl peroxide 0.1%/2.5% gel tube	143869	Galderma Australia Pty Ltd	Medicine	A	1/22/2009
DIFFERIN adapalene 1mg/g cream tube	66174	Galderma Australia Pty Ltd	Medicine	A	9/22/1998
EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel bottle	273168	Galderma Australia Pty Ltd	Medicine	A	3/10/2017
EPIDUO 0.1%/2.5% adapalene / benzoyl peroxide gel bottle	222977	Galderma Australia Pty Ltd	Medicine	A	8/7/2014
ADAPAX 0.1%/0.25% adapalene/benzoyl peroxide 0.1%/2.5% gel bottle	427930	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	3/31/2025
DIFFERIN adapalene 1mg/g gel tube	53918	Galderma Australia Pty Ltd	Medicine	A	11/29/1995
NOVADUO 0.1%/0.25% adapalene/benzoyl peroxide 0.1%/2.5% gel bottle	427929	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	3/31/2025
EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel tube	273181	Galderma Australia Pty Ltd	Medicine	A	3/10/2017
DIFFERIN ACNE TREATMENT adapalene 1 mg/g cream tube	404329	Galderma Australia Pty Ltd	Medicine	A	2/3/2023
DIFFERIN ACNE TREATMENT adapalene 1 mg/g gel tube	404112	Galderma Australia Pty Ltd	Medicine	A	1/31/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DIFFERIN XP	galderma canada inc	02274000	Gel - Topical	0.3 %	7/19/2007
SANDOZ ADAPALENE / BENZOYL PEROXIDE	Sandoz Canada, Inc.	02489007	Gel - Topical	0.1 % / W/W	9/27/2019
TACTUPUMP FORTE	galderma canada inc	02446235	Gel - Topical	0.3 % / W/W	1/4/2016
TACTUPUMP	galderma canada inc	02365871	Gel - Topical	0.1 % / W/W	5/13/2011
DIFFERIN	galderma canada inc	02376660	Lotion - Topical	0.1 %	N/A
DIFFERIN	galderma canada inc	02231592	Cream - Topical	0.1 %	1/8/1998
TARO-ADAPALENE/BENZOYL PEROXIDE FORTE	Taro Pharmaceuticals Inc	02505053	Gel - Topical	0.3 % / W/W	1/24/2022
DIFFERIN	galderma canada inc	02148757	Liquid - Topical	0.1 %	8/8/2001
DIFFERIN	galderma canada inc	02148749	Gel - Topical	0.1 %	12/31/1996
TARO-ADAPALENE/BENZOYL PEROXIDE	Taro Pharmaceuticals Inc	02456923	Gel - Topical	0.1 % / W/W	10/1/2019

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ACNIDUO 1 MG/G + 25 MG/G GEL	Galenicum Derma S.L.U.	88704	GEL	Medicamento Sujeto A Prescripción Médica	Commercialized
EPIDUO FORTE 3 MG/G + 25 MG/G GEL	Laboratorios Galderma S.A.	81359	GEL	Medicamento Sujeto A Prescripción Médica	Commercialized
DIFFERINE 1 mg/g GEL	Laboratorios Galderma S.A.	61066	GEL	Medicamento Sujeto A Prescripción Médica	Commercialized
DIFFERINE 1 mg/g CREMA	Laboratorios Galderma S.A.	66158	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPIDUO 1 mg/g + 25 mg/g GEL	Laboratorios Galderma S.A.	69445	GEL	Medicamento Sujeto A Prescripción Médica	Commercialized
TACTUOBEN 1 mg/g + 25 mg/g GEL	Laboratorios Galderma S.A.	69446	GEL	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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