Drugs / Tazarotene
last change Sep 2026 re-read 9 days ago

Tazarotene

also known as Tazorac · IDP-123 · DFD-03 · Taz · AGN 190168 · Arazlo · Avage · Fabior · +5 more

Small molecule

Developed for
acne · psoriasis · hand-foot syndrome · acne keloid · actinic keratosis · exanthem · hyperpigmentation of the skin · idiopathic pulmonary fibrosis
+7 more · lentigo maligna melanoma · neoplastic syndrome · primary cutaneous T-cell lymphoma · skin carcinoma · skin disorder · skin disorder caused by infection · adult acne
Investigated by
GlaxoSmithKline · Stiefel, a GSK Company · Bausch Health Americas, Inc. · Dr. Reddy's Laboratories Limited · Allergan · Assiut University
+31 more · Bayer · Dow Pharmaceutical Sciences · Icahn School of Medicine at Mount Sinai · National Cancer Institute (NCI) · Ortho Dermatologics · UCSF Benioff Children's Hospital Oakland · University of Utah · All India Institute of Medical Sciences, Bhubaneswar · Almirall, S.A. · Austin Institute for Clinical Research · Columbia University · Dana-Farber Cancer Institute · Dermatology Consulting Services, PLLC · Dr. Emmy Graber · Fougera Pharmaceuticals Inc. · G & W Laboratories Inc. · GRI Bio Operations, Inc. · Jefferson Medical College of Thomas Jefferson University · Jinnah Postgraduate Medical Centre · KGL, Inc. · McGill University · Milton S. Hershey Medical Center · NYU Langone Health · Northwestern University · Post Graduate Institute of Medical Education and Research, Chandigarh · State University of New York - Downstate Medical Center · Stewart, Roger H., M.D., P.A. · Sun Pharmaceutical Industries, Inc. · Unilever R&D · University of Michigan · Zagazig University

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed acne 1 milestone
Filed US (FDA) — acne 2011-08-03

“it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for tazarotene foam” gsk.com ↗

Approved Indication not stated 2 milestones
Label expansions (2) US (FDA) TAZORAC — 2001-10-11 – 2002-09-30 fda.gov ↗
Approved US (FDA) TAZORAC — 1997-06-13 fda.gov ↗

Trials 44

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT02411955 Jun 2014 → Jan 2015 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1 NCT01119651 Jun 2010 acne Stiefel, a GSK Company Completed No outcome recorded
Phase 1 NCT01115322 Apr 2010 acne Stiefel, a GSK Company Completed No outcome recorded
Phase 1 NCT01114841 Mar → Jun 2010 acne Stiefel, a GSK Company Completed No outcome recorded
Phase 1 NCT01112787 Mar → Apr 2010 acne Stiefel, a GSK Company Completed No outcome recorded
Phase 1 NCT01019603 Oct → Dec 2009 acne Stiefel, a GSK Company Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00779896 Oct 2008 → Dec 2011 primary cutaneous T-cell lymphoma McGill University Unknown No outcome recorded
Phase 212 trials
Phase 2 NCT06331624 Apr 2024 → Sep 2025 idiopathic pulmonary fibrosis GRI Bio Operations, Inc. Completed No outcome recorded
Phase 2 NCT05314127 Apr → Oct 2022 skin disorder caused by infection Zagazig University Unknown No outcome recorded
Phase 2 NCT04071756 Dec 2019 → Jun 2021 cancer, hand-foot syndrome Dana-Farber Cancer Institute Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03599193 Oct 2017 → Apr 2018 acne Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 2 NCT03341910 Aug 2017 → May 2018 acne Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 2 NCT02938494 Nov 2015 → Jul 2016 acne Bausch Health Americas, Inc. Completed No outcome recorded
Phase 2 NCT02235480 Feb → May 2014 psoriasis Almirall, S.A. Completed No outcome recorded
Phase 2 NCT02045277 Feb → Nov 2014 psoriasis Bausch Health Americas, Inc. Completed No outcome recorded
Phase 2 NCT00713609 Jun 2008 → Mar 2009 acne Stiefel, a GSK Company Completed Mixed
Phase 2 NCT00667589 Jun 2008 → Dec 2010 exanthem, hand-foot syndrome Northwestern University Terminated No outcome recorded Stop: Enrollment
Phase 311 trials · 2 met primary · 1 missed
Phase 3 NCT05608499 Oct 2022 → Apr 2024 acne keloid Icahn School of Medicine at Mount Sinai Terminated No outcome recorded
Phase 3 NCT05203315 Jan 2022 → Oct 2023 psoriasis Austin Institute for Clinical Research Completed No outcome recorded
Phase 3 NCT03290027 Jul 2017 → Apr 2018 acne Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 3 NCT03168334 Jul 2017 → Jul 2018 acne Bausch Health Americas, Inc. Completed No outcome recorded
Phase 3 NCT03292640 Jul 2017 → May 2018 acne Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 3 NCT03168321 Jun 2017 → Jun 2018 acne Bausch Health Americas, Inc. Completed No outcome recorded
Phase 3 NCT02886702 Sep 2016 → Aug 2017 psoriasis Fougera Pharmaceuticals Inc. Completed Missed primary
Phase 3 NCT02462083 Aug 2015 → Jan 2017 psoriasis Bausch Health Americas, Inc. Completed No outcome recorded
Phase 3 NCT02160665 May 2014 → May 2016 psoriasis G & W Laboratories Inc. Completed No outcome recorded
Phase 3 NCT01017120 Oct 2009 → Nov 2010 acne Stiefel, a GSK Company Completed Met primary
Phase 48 trials · 1 met primary
Phase 4 NCT05872256 Jun → Nov 2023 psoriasis Dermatology Consulting Services, PLLC Completed No outcome recorded
Phase 4 NCT05555797 Oct 2022 → Sep 2023 psoriasis Assiut University Unknown No outcome recorded
Phase 4 NCT05704114 Feb 2021 → Feb 2022 acne, hyperpigmentation of the skin Dr. Emmy Graber Completed No outcome recorded
Phase 4 NCT04720105 Nov 2020 → Mar 2022 psoriasis Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 4 NCT03263624 Oct 2017 → Oct 2018 psoriasis Assiut University Unknown No outcome recorded
Phase 4 NCT02721173 Apr → Dec 2016 acne All India Institute of Medical Sciences, Bhubaneswar Completed Met primary
Phase 4 NCT00648986 Aug 2005 → Dec 2006 — Columbia University Completed No outcome recorded
Phase 4 NCT00145106 Mar → Aug 2002 acne KGL, Inc. Completed No outcome recorded
Phase not applicable6 trials · 1 missed
— NCT06015152 Aug → Dec 2022 psoriasis Jinnah Postgraduate Medical Centre Completed No outcome recorded
— NCT03170596 Jun 2017 → Feb 2018 — Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
— NCT01053000 Jan → Nov 2010 actinic keratosis Stewart, Roger H., M.D., P.A. Completed No outcome recorded
— NCT01094717 Jan 2010 → Sep 2011 psoriasis University of Utah Terminated No outcome recorded Stop: Business
— NCT00440024 Feb 2007 → Nov 2009 skin disorder University of Michigan Completed No outcome recorded
— NCT00707174 Mar 2005 → Mar 2013 lentigo maligna melanoma University of Utah Completed Missed primary
Comparator or background therapy15 trials
Phase 1 NCT02849873 Comparator Jun → Dec 2016 acne Bausch Health Americas, Inc. Completed No outcome recorded
Phase 1 NCT03058744 Comparator Apr 2015 → Dec 2016 psoriasis Bausch Health Americas, Inc. Completed No outcome recorded
Phase 1 NCT02218034 Comparator Aug 2014 → Mar 2015 acne Allergan Completed No outcome recorded
Phase 2 NCT02785159 Comparator Feb → Nov 2016 psoriasis Bausch Health Americas, Inc. Completed No outcome recorded
Phase 2 NCT02525822 Comparator Sep 2015 → Jun 2016 acne Valeant Pharmaceuticals Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2026-09-08 GRI Bio Operations, Inc. Results GRI Bio Presents New Phase 2a Data at ERS 2026 Defining GRI-0621’s Mechanism of Action in IPF Across Nine Mechanistic Pillars gribio.com ↗
GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company developing innovative therapies for inflammatory, fibrotic and autoimmune diseases, today announced new translational biomarker data from the Phase 2a GRI-0621-IPF-02 study evaluating GRI-0621 (oral tazarotene) in patients with idiopathic pulmonary fibrosis (“IPF”).
2026-06-18 GRI Bio Operations, Inc. Regulatory GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis gribio.com ↗
2022-09-20 Cosette Pharmaceuticals, Inc. Regulatory Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Versions of TAZORAC® (tazarotene) gel, 0.05% and 0.1%, with 180 days Competitive Generic Therapy (CGT) exclusivity cosettepharma.com ↗
2012-05-11 GlaxoSmithKline Regulatory Stiefel receives US FDA approval of Fabior™ Foam, 0.1% gsk.com ↗
Stiefel, a GSK (NYSE:GSK) company, today announced that the US Food and Drug Administration has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%.
2011-08-03 GlaxoSmithKline Regulatory Regulatory update – Stiefel, a GSK company, files NDA for tazarotene foam gsk.com ↗
it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for tazarotene foam

All press releases naming this drug 26 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 61 sources stand behind the page.

FieldValueCited text
Known as tazarotene “Duobrii® lotion (halobetasol propionate \[HP\] and tazarotene \[Taz\] 0.01%/0.045%) is currently on the market for the treatment of moderate to severe stable plaque psoriasis,...” NCT05203315 ↗
53

“IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.” NCT02462083 ↗

“Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris” NCT02938494 ↗

“Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.” NCT02525822 ↗

“halobetasol propionate 0.01%/tazarotene 0.045% lotion” NCT04720105 ↗

“halobetasol propionate \[HP\], tazarotene \[Taz\]” NCT02045277 ↗

“halobetasol propionate and tazarotene” NCT05608499 ↗

“Tazorac (Tazarotene) Cream, 0.05%” NCT02785159 ↗

“DFD-03 (Tazarotene) Lotion, 0.1%” NCT03341910 ↗

“DFD-03 (0.1% tazarotene) Lotion” NCT03290027 ↗

“Tazarotene 0.045% Lotion” NCT03168321 ↗

Show 43 more sources

Known as AGN 190168 ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Known as Arazlo ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Known as Avage “Tazarotene (Tazorac, Avage, Allergan, Inc., Irvine, CA, USA) is a synthetic retinoic acid receptor- betagamma topical retinoid approved for the treatment of plaque psoriasis...” PMID 20213916 ↗ Feb 2009
Known as DFD-03 “DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off” NCT03599193 ↗
1

“DFD-03 (Tazarotene) Lotion, 0.1%” NCT03341910 ↗

Known as Fabior ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Known as GRI-0621 “Tazarotene (GRI-0621)” NCT06331624 ↗
Known as IDP-123 “Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris” NCT02938494 ↗
2

NCT02849873 ↗

NCT02525822 ↗

Known as Taz “Duobrii® lotion (halobetasol propionate \[HP\] and tazarotene \[Taz\] 0.01%/0.045%) is currently on the market for the treatment of moderate to severe stable plaque psoriasis,...” NCT05203315 ↗
1

“Tazarotene (TAZ) is a topical retinoid with retinoic acid receptor β / γ receptor specificity.” NCT05555797 ↗

Known as Tazarotene component of duobrii ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Known as Tazarotene component of idp-118 ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Known as Tazaroteno ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Known as Tazorac “Tazarotene (Tazorac, Avage, Allergan, Inc., Irvine, CA, USA) is a synthetic retinoic acid receptor- betagamma topical retinoid approved for the treatment of plaque psoriasis...” PMID 20213916 ↗ Feb 2009
11

“Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours” NCT03599193 ↗

“TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.” NCT02886702 ↗

“Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)” NCT02160665 ↗

“Tazorac® (Tazarotene) Cream, 0.1%” NCT03341910 ↗

NCT02160665 ↗

NCT02849873 ↗

NCT00648986 ↗

NCT00440024 ↗

NCT01053000 ↗

NCT03058744 ↗

Show 1 more source

Known as Zorac ChEMBL registry synonym — accepted as the source's own label CHEMBL1657 ↗
Modality Small molecule “a receptor-selective synthetic retinoid” NCT00648986 ↗
Route Topical “topical tazarotene” NCT00145106 ↗