Azelaic acid

Overview

Azelaic acid is a saturated dicarboxylic acid found naturally in wheat, rye, and barley. It is also produced by Malassezia furfur, also known as Pityrosporum ovale, which is a species of fungus that is normally found on human skin. Azelaic acid is effective against a number of skin conditions, such as mild to moderate acne, when applied topically in a cream formulation of 20%. It works in part by stopping the growth of skin bacteria that cause acne, and by keeping skin pores clear. Azelaic acid's antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.

Indication

For the topical treatment of mild-to-moderate inflammatory acne vulgaris.

Associated Conditions

Acne Vulgaris
Inflammatory lesions caused by rosacea
Susceptible Bacterial Infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation	2025/05/11	NCT06966388	Phase 1	Recruiting	Virginia Commonwealth University
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)	2022/06/13	NCT05416333	Early Phase 1	Recruiting	Wake Forest University Health Sciences
Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea	2021/08/20	NCT05014906	Phase 4	Completed	Dermatology Specialists Research
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea	2018/09/28	NCT03689010	Phase 1	Completed	Taro Pharmaceuticals USA
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea	2017/09/19	NCT03287791	Phase 3	Completed	Actavis Inc.
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel	2017/03/29	NCT03094403	Phase 1	Completed	Taro Pharmaceuticals USA
Azelaic Acid on Demodex Counts in Rosacea	2017/01/30	NCT03035955	Phase 2	Completed	Wake Forest University
Preferences & Treatment Satisfaction Drivers in Rosacea Patients	2015/11/11	NCT02602470	N/A	Completed	LEO Pharma
A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea	2014/04/23	NCT02120924	Phase 3	Completed	Actavis Inc.
Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris	2014/02/10	NCT02058628	Phase 4	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Finacea	A-S Medication Solutions	50090-4473	TOPICAL	0.15 g in 1 g	11/5/2021
AZELEX	Physicians Total Care, Inc.	54868-4442	CUTANEOUS	0.2 g in 1 g	6/11/2012
azelaic acid	Glenmark Pharmaceuticals Inc., USA	68462-626	TOPICAL	0.15 g in 1 g	12/23/2021
Finacea	Intendis Inc.	10922-825	TOPICAL	0.15 g in 1 g	10/20/2010
Azelaic Acid Gel	Encube Ethicals Private Limited	21922-038	TOPICAL	0.15 g in 1 g	11/24/2023
AZELAIC ACID 15% / NIACINAMIDE 4%	Sincerus Florida, LLC	72934-2008	TOPICAL	15 g in 100 g	4/23/2019
Azelaic Acid	Taro Pharmaceuticals U.S.A., Inc.	51672-1389	TOPICAL	0.15 g in 1 g	12/31/2021
Azelaic Acid Gel	Sandoz Inc.	0781-7172	TOPICAL	0.15 g in 1 g	11/11/2021
FINACEA FOAM	LEO Pharma Inc.	50222-303	TOPICAL	.15 g in 1 g	12/8/2020
azelaic acid	Actavis Pharma, Inc.	0591-2131	TOPICAL	0.15 g in 1 g	5/16/2022

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
SKINOREN CREAM 20%	LEO Pharma Manufacturing Italy S.r.I.	SIN07138P	CREAM	20g/100g	7/14/1992

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
SKINOREN CREAM 20%	N/A	DKSH Hong Kong Limited	N/A	N/A	9/18/1998

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SIBZEOS azelaic acid 150 mg/g gel tube	433350	Glenmark Pharmaceuticals Australia Pty Ltd	Medicine	A	1/10/2024
NEUTRIDERM OIL REGULATOR LOTION	211566	UAS Pharmaceuticals Pty Ltd	Medicine	A	7/1/2013
AZCLEAR ACTION azelaic acid 200 mg/g medicated lotion tube	71006	Ego Pharmaceuticals Pty Ltd	Medicine	A	9/28/1999
FINACEA azelaic acid 150mg/g gel tube	97747	LEO Pharma Pty Ltd	Medicine	A	10/23/2003

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FINACEA	LEO Pharma Inc	02270811	Gel - Topical	15 % / W/W	6/15/2010

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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