Drugs / Tazarotene
Tazarotene
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| 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 | NCT02045277 | Feb → Nov 2014 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02235480 | Feb → May 2014 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 2 | NCT00713609 | Jun 2008 → Mar 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 2 | NCT00667589 | Jun 2008 → Dec 2010 | exanthem, hand-foot syndrome | Northwestern University | Terminated | No outcome recorded |
| Phase 2 | NCT00489086 | Jul 2004 → Jun 2012 | neoplastic syndrome | UCSF Benioff Children's Hospital Oakland | Completed | No outcome recorded |
| Phase 2 | NCT00783965 | Jul 2004 → Jun 2012 | skin carcinoma | UCSF Benioff Children's Hospital Oakland | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01017146 | Oct 2009 → Nov 2010 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| — | 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 |
| — | NCT01094717 | Jan 2010 → Sep 2011 | psoriasis | University of Utah | Terminated | No outcome recorded |
| — | NCT01053000 | Jan → Nov 2010 | actinic keratosis | Stewart, Roger H., M.D., P.A. | Completed | No outcome recorded |
| — | 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 | No outcome recorded |
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 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 23 trials | ||||||
| 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 |
| Phase 2 | NCT01616654 Comparator | Jun 2012 → Jul 2013 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05573425 Comparator | Aug 2020 → Feb 2021 | adult acne | Jinnah Postgraduate Medical Centre | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02886715 Comparator | Sep 2016 → May 2017 | acne | Fougera Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02267746 Comparator | Jun → Sep 2014 | acne | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02160678 Comparator | May 2014 → Jul 2015 | acne | G & W Laboratories Inc. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06042647 Comparator | Jul → Nov 2023 | psoriasis | Dermatology Consulting Services, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT01016977 Comparator | Oct 2009 → Apr 2010 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00834210 Comparator | Dec 2008 → Sep 2009 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00829049 Comparator | Oct 2007 → Oct 2008 | acne | Allergan | Terminated | No outcome recorded |
| Phase 4 | NCT00469755 Comparator | Feb → Sep 2006 | acne | Galderma R&D | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited 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 ↗ “Tazarotene 0.045% Lotion” NCT03168334 ↗ |
| 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 ↗ |
| 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 200911“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 ↗ |
| 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 ↗ |