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tazarotene 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| arotinoid derivatives | 2571 | 118292-40-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a topical acetylenic retinoid; a topical kerytolytic
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 3.55 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 37.20 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 6.22 hours | Lombardo F, Berellini G, Obach RS |
| BA (Bioavailability) | 3 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,TEK,TGFBR1,TTK,ZAP70 | 40 | |||
| kinase-selectivity-class | AXL,BRAF,PDK4 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 13, 1997 | FDA | ALLERGAN |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D05AX05 | DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use |
| ATC | D05AX55 | DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use |
| FDA CS | M0018962 | Retinoids |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D007641 | Keratolytic Agents |
| MeSH PA | D009676 | Noxae |
| MeSH PA | D013723 | Teratogens |
| FDA EPC | N0000175607 | Retinoid |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50176 | keratolytic drug |
| CHEBI has role | CHEBI:50266 | prodrug |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| CHEBI has role | CHEBI:50905 | teratogenic agent |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
Related Drugs by ATC class:
D05AX Other antipsoriatics for topical use 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Psoriasis | indication | 9014002 | DOID:8893 |
| Acne vulgaris | indication | 88616000 | |
| Facial Hyperpigmentation | indication | ||
| Benign Facial Lentigine | indication | ||
| Facial Fine Wrinkling | indication | ||
| Facial Hypopigmentation | indication | ||
| Sunburn | contraindication | 23346002 | |
| Photosensitivity | contraindication | 90128006 | |
| Pregnancy, function | contraindication | 289908002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.17 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.1% | FABIOR | MAYNE PHARMA | N202428 | May 11, 2012 | RX | AEROSOL, FOAM | TOPICAL | 10568859 | Feb. 24, 2030 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER |
| 0.1% | FABIOR | MAYNE PHARMA | N202428 | May 11, 2012 | RX | AEROSOL, FOAM | TOPICAL | 10688071 | Feb. 24, 2030 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 10478502 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11839656 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11986527 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 10426787 | June 6, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11648256 | June 6, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11679115 | June 6, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.045% | ARAZLO | BAUSCH | N211882 | Dec. 18, 2019 | RX | LOTION | TOPICAL | 11311482 | May 11, 2038 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER |
| 0.045% | ARAZLO | BAUSCH | N211882 | Dec. 18, 2019 | RX | LOTION | TOPICAL | 12128137 | May 11, 2038 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Retinoic acid receptor alpha | Nuclear hormone receptor | AGONIST | EC50 | 7.20 | CHEMBL | CHEMBL | |||
| Retinoic acid receptor beta | Nuclear hormone receptor | AGONIST | EC50 | 9.10 | CHEMBL | CHEMBL | |||
| Retinoic acid receptor gamma | Nuclear hormone receptor | AGONIST | EC50 | 7.40 | CHEMBL | CHEMBL | |||
| Cytochrome P450 3A4 | Enzyme | IC50 | 5.50 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021045 | VUID |
| N0000148509 | NUI |
| D01132 | KEGG_DRUG |
| 4021045 | VANDF |
| C0288792 | UMLSCUI |
| CHEBI:32184 | CHEBI |
| CHEMBL1657 | ChEMBL_ID |
| DB00799 | DRUGBANK_ID |
| C086827 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5381 | PUBCHEM_CID |
| 6952 | IUPHAR_LIGAND_ID |
| 7328 | INN_ID |
| 81BDR9Y8PS | UNII |
| 1293452 | RXNORM |
| 10196 | MMSL |
| 190198 | MMSL |
| 255259 | MMSL |
| 5542 | MMSL |
| 006668 | NDDF |
| 108906007 | SNOMEDCT_US |
| 386935009 | SNOMEDCT_US |
| 81BDR9Y8PS | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-0042 | GEL | 1 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-8335 | GEL | 0.50 mg | CUTANEOUS | NDA | 29 sections |
| Duobrii | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-0653 | LOTION | 0.45 mg | TOPICAL | NDA | 25 sections |
| Arazlo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-2098 | LOTION | 0.45 mg | TOPICAL | NDA | 24 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0670 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0765 | CREAM | 0.50 mg | TOPICAL | ANDA | 27 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0804 | GEL | 1 mg | TOPICAL | ANDA | 18 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0805 | GEL | 0.50 mg | TOPICAL | ANDA | 18 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-042 | GEL | 1 mg | CUTANEOUS | NDA | 29 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-042 | GEL | 1 mg | CUTANEOUS | NDA | 29 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-833 | GEL | 0.50 mg | CUTANEOUS | NDA | 29 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-833 | GEL | 0.50 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-915 | CREAM | 0.05 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-915 | CREAM | 0.05 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-916 | CREAM | 0.10 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-916 | CREAM | 0.10 mg | CUTANEOUS | NDA | 29 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45802-436 | GEL | 0.50 mg | TOPICAL | ANDA | 27 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45802-442 | GEL | 1 mg | TOPICAL | ANDA | 27 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45802-706 | CREAM | 0.50 mg | TOPICAL | ANDA | 26 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-1373 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-1374 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| FABIOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51862-295 | AEROSOL, FOAM | 1 mg | TOPICAL | NDA | 27 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4456 | GEL | 1 mg | ORAL | NDA | 14 sections |
| tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68308-685 | AEROSOL, FOAM | 1 mg | TOPICAL | NDA authorized generic | 28 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68308-745 | CREAM | 1 mg | TOPICAL | ANDA | 29 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2202 | GEL | 1 mg | TOPICAL | ANDA | 27 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2420 | CREAM | 0.50 mg | TOPICAL | ANDA | 26 sections |
| CLINDAMYCIN 1% / NIACINAMIDE 2% / TAZAROTENE 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 3 | 72934-1050 | GEL | 0.05 g | TOPICAL | unapproved drug other | 4 sections |
| NIACINAMIDE 4% / TAZAROTENE 0.1% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-1161 | GEL | 0.10 g | TOPICAL | unapproved drug other | 4 sections |
| HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-2093 | CREAM | 0.05 g | TOPICAL | unapproved drug other | 4 sections |