ARAZLO (tazarotene)
ARAZLO is indicated for the treatment of Acne Vulgaris.
How ARAZLO Works
Tazarotene is a retinoid prodrug converted to its active form, tazarotenic acid, via deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family (RARα, RARβ, and RARγ), showing relative selectivity for RARβ and RARγ. This binding leads to modifications in gene expression; however, the exact clinical significance of these receptor interactions in the treatment of acne is unknown.
Details
- Status
- Prescription
- First Approved
- 2019-12-18
- Patent Cliff
- 2038
- Routes
- TOPICAL
- Dosage Forms
- LOTION
ARAZLO Approval History
What ARAZLO Treats
1 indicationsARAZLO is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
ARAZLO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ARAZLO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01019603 | 114565 | Ph 1 | completed | A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris |
| NCT00834210 results posted | MA-ACZ0802 | Ph 4 | completed | Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARAZLO FDA Label Details
Indications & Usage
FDA Label (PDF)ARAZLO is indicated for the treatment of Acne Vulgaris.
Pro Intelligence Preview
Deep insights for ARAZLO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.