Tazarotene
Arazlo, Avage, Duobrii, Fabior, Tazarotene, Tazorac (tazarotene) is a small molecule pharmaceutical. Tazarotene was first approved as Tazorac on 1997-06-13. It is used to treat acne vulgaris and psoriasis in the USA. The pharmaceutical is active against retinoic acid receptor beta, retinoic acid receptor gamma, and retinoic acid receptor alpha. In addition, it is known to target chemerin-like receptor 1 and chemerin-like receptor 2.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Arazlo, Avage, Fabior, Tazarotene, Tazorac (discontinued: Tazarotene)
CombinationsDuobrii
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tazarotene
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TAZORAC | Allergan | N-021184 RX | 2000-09-29 | 2 products, RLD, RS |
| AVAGE | Allergan | N-021184 RX | 2002-09-30 | 1 products, RLD, RS |
| TAZORAC | Allergan | N-020600 RX | 1997-06-13 | 2 products, RLD, RS |
| ARAZLO | Bausch Health Companies | N-211882 RX | 2019-12-18 | 1 products, RLD, RS |
| FABIOR | Mayne Group | N-202428 RX | 2012-05-11 | 1 products, RLD, RS |
Halobetasol propionate
+
Tazarotene
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUOBRII | Bausch Health Companies | N-209354 RX | 2019-04-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 011312 niacinamide 4% / tazarotene 0.05% | unapproved drug other | 2020-07-02 |
| arazlo | New Drug Application | 2023-09-26 |
| clindamycin 1% / niacinamide 2% / tazarotene 0.05% | unapproved drug other | 2019-05-09 |
| duobrii | New Drug Application | 2020-01-01 |
| fabior | New Drug Application | 2024-05-09 |
| hyaluronic acid sodium salt 0.5% / tazarotene 0.05% | unapproved drug other | 2019-05-09 |
| hyaluronic acid sodium salt 0.5% / tazarotene 0.1% | unapproved drug other | 2019-05-06 |
| niacinamide 4% / tazarotene 0.05% | unapproved drug other | 2019-04-23 |
| niacinamide 4% / tazarotene 0.1% | unapproved drug other | 2019-05-09 |
| tazarodex | C200263 | 2023-12-21 |
Show 2 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriasis | EFO_0000676 | D011565 | L40 |
| acne vulgaris | EFO_0003894 | D000152 | L70 |
| pruritus | — | D011537 | L29 |
| inflammation | MP_0001845 | D007249 | — |
| facial dermatoses | — | D005148 | — |
| foot dermatoses | — | D005533 | — |
| hand dermatoses | — | D006229 | — |
| scalp dermatoses | — | D012536 | — |
| leg dermatoses | — | D007868 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tazarotene, Arazlo, Bausch | |||
| 11311482 | 2038-05-11 | U-2368 | |
| 11679116 | 2036-06-06 | DP | |
| Halobetasol Propionate / Tazarotene, Duobrii, Bausch | |||
| 10251895 | 2036-06-06 | DP | |
| 10426787 | 2036-06-06 | U-2625 | |
| 11648256 | 2036-06-06 | DP | U-2625 |
| 11679115 | 2036-06-06 | DP | U-2625 |
| 8809307 | 2031-11-02 | DP | |
| 10478502 | 2031-11-02 | DP | U-2625 |
| 11839656 | 2031-11-02 | U-2625 | |
| Tazarotene, Fabior, Mayne Pharma | |||
| 8808716 | 2030-02-24 | DP | |
| 10568859 | 2030-02-24 | DP | U-2760 |
| 10688071 | 2030-02-24 | DP | U-2760 |
HCPCS
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Clinical
Clinical Trials
62 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 8 | 7 | 10 | 7 | — | 31 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 3 | 4 | 6 | 3 | 18 |
| Cicatrix | D002921 | — | L90.5 | — | — | — | 1 | 1 | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | — | 1 |
| Nail diseases | D009260 | — | L60 | — | — | — | 1 | — | 1 |
| Hyperpigmentation | D017495 | — | — | — | — | — | 1 | — | 1 |
| Erythema | D004890 | — | L53.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrophy | D001284 | — | — | — | 1 | 1 | — | 1 | 2 |
| Acne keloid | D000153 | — | L73.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 2 | — | — | 1 | 3 |
| Basal cell nevus syndrome | D001478 | EFO_0004136 | — | — | 2 | — | — | — | 2 |
| Paraneoplastic syndromes | D010257 | — | — | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | 1 | 1 | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | 1 | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hutchinson's melanotic freckle | D018327 | — | — | — | — | — | — | 1 | 1 |
| Lentigo | D007911 | — | L81.4 | — | — | — | — | 1 | 1 |
| Actinic keratosis | D055623 | — | L57.0 | — | — | — | — | 1 | 1 |
| Keratosis | D007642 | — | — | — | — | — | — | 1 | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tazarotene |
| INN | tazarotene |
| Description | Tazarotene is the ethyl ester of tazarotenic acid. A prodrug for tazarotenic acid, it is used for the treatment of psoriasis, acne, and sun-damaged skin. It has a role as a keratolytic drug, a prodrug and a teratogenic agent. It is a retinoid, a thiochromane, a member of pyridines, an acetylenic compound and an ethyl ester. It is functionally related to a tazarotenic acid. |
| Classification | Small molecule |
| Drug class | arotinoid derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)c1ccc(C#Cc2ccc3c(c2)C(C)(C)CCS3)nc1 |
Identifiers
| PDB | — |
| CAS-ID | 118292-40-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1657 |
| ChEBI ID | 32184 |
| PubChem CID | 5381 |
| DrugBank | DB00799 |
| UNII ID | 81BDR9Y8PS (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CMKLR2
CMKLR2
Organism
Homo sapiens
Gene name
CMKLR2
Gene synonyms
GPR1
NCBI Gene ID
Protein name
chemerin-like receptor 2
Protein synonyms
Chemerin chemokine-like receptor 2, Chemokine-like receptor 2, G protein-coupled receptor 1, G-protein coupled receptor 1, probable G-protein coupled receptor 1
Uniprot ID
Mouse ortholog
Cmklr2 (241070)
chemerin-like receptor 2 (Q8K087)
Variants
No data
Financial
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Estimated US medical usage
Tazarotene
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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757 adverse events reported
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