Back to discover
Drug

Bexarotene

Approved · EMA
Late-stage development
Also known as Bexarotene Topical, Targretin, Bexaroten, Bexaroteno+2 more

Bexarotene Topical, Targretin, Bexaroten, Bexaroteno, Bexarotenum, p-(1-(5,6,7,8-Tetrahydro-3,5,5,8,8-pentamethyl-2-naphthyl)vinyl)benzoic acid.

RxNorm233272ChEMBLCHEMBL1023UNIIA61RXM4375
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase Ib Trial Combining Bexarotene With Ultra-Low Dose Total Skin Electron Beam (Tseb) Radiotherapy For The Treatment Of Diffuse Cutaneous T-Cell Lymphomas

Clinical trial2026-02-04Results expected Q1 2027 · ClinicalTrials.gov

Metastatic Triple-Negative Taxane-Resistant Breast Cancer: Investigating the Role of Bexarotene in Inducing Susceptibility to Chemotherapy by Differentiating Cancer Cells From a Mesenchymal-Like to an Epithelial-Like Phenotype

Clinical trial2025-08-04Completed · ClinicalTrials.gov

A Phase I Dose Escalation Study of Topical Bexarotene in Women at High Risk for Breast Cancer

Clinical trial2023-01-10Results posted · ClinicalTrials.gov

A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Clinical trial2021-01-05Results posted · ClinicalTrials.gov

A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Clinical trial2020-01-29Results posted · ClinicalTrials.gov

Phase IV Randomized Study of Two Dose Levels of Targretin® Capsules in Subjects With Refractory Cutaneous T-Cell Lymphoma

Clinical trial2019-11-12Results posted · ClinicalTrials.gov

A Phase II Study of Bexarotene + Sargromastastin as Agents of Differentiation in MDS and AML

Clinical trial2018-10-05Results posted · ClinicalTrials.gov

A Phase I Study of Bexarotene in Patients With Acute Myeloid Leukemia

Clinical trial2016-06-08Completed · ClinicalTrials.gov

A Double Blind Placebo Controlled Randomized Study to Evaluate the Efficacy and Safety of Bexarotene in Patients With Mild to Moderate Alzheimer's Disease

Clinical trial2016-02-12Results posted · ClinicalTrials.gov

A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma

Clinical trial2015-08-01Completed · ClinicalTrials.gov

A Randomized Controlled Study to Evaluate the Effect of Bexarotene - an RXR Agonist - on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects

Clinical trial2014-11-01Completed · ClinicalTrials.gov

Approval: Targretin (EMA)

Regulatory2001-03-29EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Bexarotene
Aliases & brands
Bexarotene TopicalTargretinBexarotenBexarotenoBexarotenump-(1-(5,6,7,8-Tetrahydro-3,5,5,8,8-pentamethyl-2-naphthyl)vinyl)benzoic acid
RxNorm CUI
233272
ChEMBL ID
CHEMBL1023
UNII
A61RXM4375
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2001-03-29
Latest approval
2001-03-29
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2001-03-29Approval
Approval: Targretin (EMA)

Indication: Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

31 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
31
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
1
Recruiting
7
Late-stage (III+)
22
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 31
Early Phase 11Phase 19Phase 1 / 24Phase 210Phase 36Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Phase IV Randomized Study of Two Dose Levels of Targretin® Capsules in Subjects With Refractory Cutaneous T-Cell Lymphoma

CompletedPH IVBausch Health Americas, Inc.n=592014

A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

CompletedPH IIIMillennium Pharmaceuticals, Inc.n=1312018

A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides

TerminatedPH IIIEuropean Organisation for Research and Treatment of Cancer - EORTCn=932011

Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia: a 6-week, Randomized, Double-blind Placebo-controlled Trial

CompletedPH IIIBeersheva Mental Health Centern=902011

Comparison Efficacy of Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients: Double-blind Placebo Controlled Study

WithdrawnPH IIIBeersheva Mental Health Center2010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Metastatic Triple-Negative Taxane-Resistant Breast Cancer: Investigating the Role of Bexarotene in Inducing Susceptibility to Chemotherapy by Differentiating Cancer Cells From a Mesenchymal-Like to an Epithelial-Like Phenotype

CompletedPH INational Cancer Centre, Singaporen=122025

A Phase I Dose Escalation Study of Topical Bexarotene in Women at High Risk for Breast Cancer

CompletedPH INational Cancer Institute (NCI)n=242022

A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

CompletedPH IIIMillennium Pharmaceuticals, Inc.n=1312018

A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

CompletedPH IIM.D. Anderson Cancer Centern=372018

A Phase II Study of Bexarotene + Sargromastastin as Agents of Differentiation in MDS and AML

CompletedPH IISidney Kimmel Comprehensive Cancer Center at Johns Hopkinsn=262016

A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma

CompletedPH IAcrotech Biopharma Inc.n=342015
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.