Targretin

(Bexarotene)

ApprovedSmall molecule

Bexarotene is used to treat cutaneous T-cell lymphoma, a type of blood cancer that affects the skin. It works by helping to slow or stop the growth of these cancer cells.[2] Targretin is currently approved and in use across 10 indications[4].[1]

Targretin is one of 255 small molecule programs targeting Cognitive impairment. It is currently in Approved.

Indications

Total Trials

Active Trials

254

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cognitive ImpairmentApproved

LymphomaApproved

Cutaneous T-Cell LymphomaCompleted

Schizoaffective DisorderApproved

Alzheimer DiseaseApproved

Mycosis FungoidesTerminated

ParapsoriasisApproved

PsoriasisApproved

Alopecia AreataApproved

Pituitary-Dependent Cushing's DiseaseApproved

Cognitive ImpairmentApproved

Approved

LymphomaApproved

Approved

Cutaneous T-Cell LymphomaApproved

Completed

Schizoaffective DisorderApproved

Approved

Alzheimer DiseaseApproved

Approved

Mycosis FungoidesPhase 3

Terminated

ParapsoriasisApproved

Approved

PsoriasisApproved

Approved

Alopecia AreataApproved

Approved

Pituitary-Dependent Cushing's DiseaseApproved

Approved

Competition

Competitive Landscape

370 competitors in Lymphoma

#DrugCompanyPhaseTrials

Targretin

BBausch Health Americas, Inc.

Approved

31 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Mycosis Fungoides

NCT05296304

Clinical

Trials by Indication[1]

Cutaneous T-cell lymphoma6 trials

Study of Oral Bexarotene in Combination With Photopheresis for Treatment of Cutaneous T-Cell Lymphoma

Completed·—·Phase 1/2·NCT00306969·18 enrolled

Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma

Unknown status·MMillennix·Phase 2·NCT00030589

Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00030849

Show 3 more trials

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)

Completed· Takeda logo

Takeda·Phase 3·NCT01578499·131 enrolled

Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)

Completed·BBausch Health Americas, Inc.·Phase 4·NCT01007448·59 enrolled

Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT01134341·34 enrolled

Non-Small Cell Lung Cancer4 trials

A Phase I/II Study of Bexarotene in Combination With ZD1839 (IRESSA®) in the Treatment of Non-Small Cell Lung Cancer

Completed·SStanford University·Phase 1/2·NCT00238628·12 enrolled

Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT00514293·39 enrolled

Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Completed· Eisai logo

Eisai·Phase 3·NCT00050973·623 enrolled

Show 1 more trial

BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00411632·37 enrolled

Schizophrenia3 trials

Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

Withdrawn·—·Phase 3·NCT00534898

Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

Completed·—·Phase 3·NCT00535574·90 enrolled

Bexarotene Treatment in Schizophrenia

Unknown status·—·Phase 3·NCT00141947·15 enrolled

Breast Cancer3 trials

Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

Completed·BBaylor Breast Care Center·Phase 1·NCT00055991·87 enrolled

Bexarotene in Treating Patients With Metastatic Breast Cancer

Completed·LLigand Pharmaceuticals·Phase 2·NCT00003752·180 enrolled

Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03323658·24 enrolled

Acute Myeloid Leukemia2 trials

Study of Bexarotene in Patients With Acute Myeloid Leukemia

Completed·—·Phase 1·NCT00316030·54 enrolled

Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Terminated·—·Phase 2·NCT00615784·24 enrolled

12 more indications

Mycosis Fungoides2 trials

Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00056056·93 enrolled

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05296304·20 enrolled

Cushing's Disease1 trial

Preoperative Bexarotene Treatment for Cushing's Disease

Unknown status·UUniversity of Virginia·Phase 1/2·NCT00845351·6 enrolled

Thyroid Cancer1 trial

A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression

Completed·UUniversity of Colorado, Denver·Phase 1·NCT00718770·10 enrolled

T-cell non-Hodgkin lymphoma1 trial

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

Completed·UUniversity College, London·Phase 2·NCT00660231·36 enrolled

Alzheimer's Disease1 trial

Bexarotene Amyloid Treatment for Alzheimer's Disease

Completed·TThe Cleveland Clinic·Phase 2·NCT01782742·20 enrolled

Advanced Cancers1 trial

Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Advanced Cancers of the Aerodigestive Tract

Completed·—·Phase 1·NCT01116622·24 enrolled

Lung Cancer1 trial

A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer

Terminated·—·Phase 1/2·NCT00153842·33 enrolled

Kaposi's sarcoma1 trial

A Study of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma

Completed·LLigand Pharmaceuticals·Phase 2·NCT00002212·27 enrolled

Leukemia1 trial

Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)

Completed·WWashington University School of Medicine·Phase 1·NCT01001143·19 enrolled

Metabolism1 trial

A Study to Evaluate the Effect of Bexarotene on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects

Completed·RReXceptor, Inc.·Phase 1·NCT02061878·12 enrolled

Chemotherapy1 trial

The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC

Completed·NNational Cancer Centre, Singapore·Phase 1·NCT04664829·12 enrolled

Myelodysplastic Syndrome1 trial

Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00425477·26 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 29, 1999

TARGRETIN

NDA NDA021055

Jun 28, 2000

TARGRETIN

NDA NDA021056

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Bexarotene. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Targretin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bexarotene compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bexarotene. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021056). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Retinoid X Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Targretin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Cutaneous T-cell lymphoma6 trials

Non-Small Cell Lung Cancer4 trials

Schizophrenia3 trials

Breast Cancer3 trials

Acute Myeloid Leukemia2 trials

Mycosis Fungoides2 trials

Cushing's Disease1 trial

Thyroid Cancer1 trial

T-cell non-Hodgkin lymphoma1 trial

Alzheimer's Disease1 trial

Advanced Cancers1 trial

Lung Cancer1 trial

Kaposi's sarcoma1 trial

Leukemia1 trial

Metabolism1 trial

Chemotherapy1 trial

Myelodysplastic Syndrome1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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