BEXAROTENE
Bexarotene is a topical gel used to manage skin lesions in patients with early-stage cutaneous T-cell lymphoma. It helps patients whose disease has remained persistent or returned after other therapies, as well as those who were unable to tolerate previous treatments. This medication provides an alternative option for controlling the skin-based symptoms of the condition when standard approaches are no longer effective.
How BEXAROTENE Works
This drug works by selectively activating retinoid X receptors, which then influence the expression of genes responsible for how cells grow and mature. By regulating these genetic pathways, the medication helps stop the growth of certain tumor cells and promotes the shrinking of existing lesions. Although the exact way it treats this specific lymphoma is unknown, it targets the cellular mechanisms that control tumor development.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-08-12
- Routes
- ORAL, TOPICAL
- Dosage Forms
- CAPSULE, GEL
BEXAROTENE Approval History
What BEXAROTENE Treats
1 indicationsBEXAROTENE is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous T-Cell Lymphoma
BEXAROTENE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
What's emerging in BEXAROTENE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BEXAROTENE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BEXAROTENE
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05296304 | 21-501 | Ph 1 | recruiting | A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides |
| NCT04664829 | BEXMET | Ph 1 | completed | The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC |
| NCT03323658 results posted | NCI-2017-01960 NCI-2017-01960, N01-CN-2012-00034 | Ph 1 | completed | Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer |
| NCT01578499 ALCANZA results posted | C25001 2010-024215-14 | Ph 3 | completed | A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) |
| NCT00615784 UPCC04407 results posted | UPCC 04407 UPCC 04407 | Ph 2 | terminated | Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia |
| NCT01007448 results posted | E7273-G000-401 | Ph 4 | completed | Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL) |
| NCT01782742 BEAT-AD results posted | CCF-IRB 12-783 | Ph 2 | completed | Bexarotene Amyloid Treatment for Alzheimer's Disease |
| NCT02061878 | REXCEPTOR-101 | Ph 1 | completed | A Study to Evaluate the Effect of Bexarotene on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects |
| NCT00660231 GemBex | UCL/06/009 CRUK-UCL-GEMBEX, EU-20841 | Ph 2 | completed | Gemcitabine and Bexarotene in Treating Patients With Progressive or Refractory Stage IB, Stage II, Stage III, or Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma |
| NCT01001143 AML | 09-1661 / 201012801 | Ph 1 | completed | Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML) |
| NCT00535574 | LRM250850 | Ph 3 | completed | Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia |
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.
BEXAROTENE FDA Label Details
Indications & Usage
BEXAROTENE is indicated for the treatment of Cutaneous T-Cell Lymphoma.
Looking for the branded version?
TARGRETIN
Full clinical data, patents, trials, and competitive landscape for bexarotene.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment