Tazarotene

Overview

Tazarotene, commonly marketed as Tazorac®, Avage®, and Zorac®, is member of the acetylenic class of retinoids. It is a prodrug that is found in topical formulations used in the treatment of various conditons, such as psoriasis, acne, and sun damaged skin (photodamage).

Indication

Used to treat psoriasis, acne and sun damaged skin (photodamage).

Associated Conditions

Psoriasis Vulgaris (Plaque Psoriasis)
Benign facial lentigines
Facial fine wrinkling
Facial hyperpigmentation
Facial hypopigmentation
Mild Acne vulgaris
Moderate Acne vulgaris

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF	2024/03/26	NCT06331624	Phase 2	Active, not recruiting	GRI Bio Operations, Inc.
Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis	2023/09/18	NCT06042647	Phase 4	Completed	Dermatology Consulting Services, PLLC
Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis	2023/08/29	NCT06015152	Not Applicable	Completed	Jinnah Postgraduate Medical Centre
Tazarotene 0.045% Lotion for Treating PIE and PIH in Subjects With Acne	2023/01/30	NCT05704114	Phase 4	Completed	Dr. Emmy Graber
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)	2022/11/08	NCT05608499	Phase 3	Active, not recruiting	Icahn School of Medicine at Mount Sinai
Comparing the Efficacy of Topical Tazarotene Gel 0.1% v/s Microneedling in Atrophic Post Acne Scars	2022/10/10	NCT05573425	Phase 2	Completed	Jinnah Postgraduate Medical Centre
Excimer Laser With Topical Agents in Psoriasis Vulgaris	2022/09/27	NCT05555797	Phase 4	Not yet recruiting	Assiut University
Efficacy of Tazarotene in Treatment of Verruca Plana	2022/04/06	NCT05314127	Phase 2	UNKNOWN	Zagazig University
A Study Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.	2022/03/16	NCT05282771	Early Phase 1	Completed	Taro Pharmaceuticals USA
Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults	2022/01/24	NCT05203315	Phase 3	Completed	Austin Institute for Clinical Research

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
FABIOR	Mayne Pharma	51862-295	TOPICAL	1 mg in 1 g	2/28/2023
tazarotene	Mayne Pharma Inc.	68308-685	TOPICAL	1 mg in 1 g	1/1/2021
TAZORAC	Allergan, Inc.	0023-0042	CUTANEOUS	1 mg in 1 g	11/20/2023
TAZAROTENE	Cosette Pharmaceuticals, Inc.	0713-0804	TOPICAL	1 mg in 1 g	11/29/2023
Duobrii	Bausch Health US, LLC	0187-0653	TOPICAL	0.45 mg in 1 g	1/1/2020
HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.05%	Sincerus Florida, LLC	72934-2093	TOPICAL	0.05 g in 100 g	5/9/2019
TAZORAC	Almirall, LLC	16110-915	CUTANEOUS	0.05 mg in 1 g	2/3/2020
NIACINAMIDE 4% / TAZAROTENE 0.1%	Sincerus Florida, LLC	72934-2161	TOPICAL	0.1 g in 100 g	4/23/2019
TAZAROTENE	Cosette Pharmaceuticals, Inc.	0713-0805	TOPICAL	0.5 mg in 1 g	11/29/2023
011312 NIACINAMIDE 4% / TAZAROTENE 0.05%	Sincerus Florida, LLC	72934-2208	TOPICAL	0.05 g in 100 g	7/2/2020

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
No HSA approvals found for this drug.

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
FABIOR tazarotene 0.1% w/w foam aerosol can	364526	Mayne Pharma International Pty Ltd	Medicine	A	11/2/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TAZORAC	Allergan, Inc.	02243894	Cream - Topical	0.05 %	8/31/2001
DUOBRII	bausch health, canada inc.	02499967	Lotion - Topical	0.045 % / W/W	8/4/2020
TAZORAC	Allergan, Inc.	02230785	Gel - Topical	0.1 %	4/10/1997
ARAZLO	bausch health, canada inc.	02517868	Lotion - Topical	0.045 % / W/W	9/16/2021
TAZORAC	Allergan, Inc.	02243895	Cream - Topical	0.1 %	8/31/2001
TAZORAC	Allergan, Inc.	02230784	Gel - Topical	0.05 %	4/10/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ZORAC 0,1%, GEL	Allergan Pharmaceuticals International Limited	61861	GEL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZORAC 0,05%, GEL	Allergan Pharmaceuticals International Limited	61862	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.

Related News

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7 months ago

Triple combination therapy containing clindamycin, adapalene, and benzoyl peroxide achieved clear or near-clear skin in over 50% of patients with a 70% reduction in lesion counts.

GRI Bio Advances Phase 2a Trial of GRI-0621 for Idiopathic Pulmonary Fibrosis with Promising Interim Safety Data

10 months ago

GRI Bio has completed enrollment for the interim analysis of its Phase 2a trial evaluating GRI-0621 in idiopathic pulmonary fibrosis patients, with 24 of 36 planned patients randomized.

Clascoterone, Trifarotene, and Tazarotene Show Comparable Efficacy in Acne Treatment: Meta-Analysis

a year ago

• A meta-analysis of randomized controlled trials reveals that clascoterone, trifarotene, and tazarotene demonstrate similar efficacy in treating moderate to severe acne vulgaris. • The study, involving over 5,400 patients, found no statistically significant differences in reducing inflammatory and non-inflammatory lesion counts among the three treatments. • Odds ratios for treatment success were comparable, suggesting clinicians can select treatments based on individual patient needs and potential side effects. • Further research is needed to compare the safety profiles of these agents to inform comprehensive treatment decisions.

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