NDAORALCAPSULEPriority Review
Approved
Dec 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
3/8 — Basic
Priority Review
TARGRETIN (bexarotene) by Bausch + Lomb. Approved for retinoid [epc]. First approved in 1999.
Drug data last refreshed 16h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TARGRETIN (bexarotene) is an oral retinoid approved in 1999 for the treatment of cutaneous T-cell lymphoma and other retinoid-responsive conditions. It works by binding to retinoid X receptors (RXRs) to modulate gene expression and promote cell differentiation and apoptosis. Bexarotene represents a selective retinoid mechanism distinct from retinoic acid receptor (RAR)-selective agents.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30%), this brand faces consolidation risk and requires defensive strategies to maintain market position.
Mechanism of Action
Pharmacologic Class:
Retinoid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
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)
Started Jun 2012
131 enrolled
Primary Cutaneous Anaplastic Large Cell LymphomaMycosis FungoidesCutaneous T-Cell Lymphoma
Phase I Study of CS-7017 and Bexarotene
Started Dec 2011
9 enrolled
Solid TumorsLymphomaMultiple Myeloma
Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
Started Mar 2010
34 enrolled
Cutaneous T-cell LymphomaMycosis FungoidesSezary Syndrome+1 more
Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)
Started Jan 2010
59 enrolled
Refractory Cutaneous T-cell Lymphoma
BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Started Nov 2006
37 enrolled
Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.