Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 have evaluated bexarotene across diverse indications, prominently focusing on oncologic conditions such as cutaneous T-cell lymphoma, acute myeloid leukemia, non-small-cell lung carcinoma, and breast cancer, alongside neurodegenerative disorders like Alzheimer's disease. Encompassing active, completed, terminated, and withdrawn recruitment statuses, these investigations have been spearheaded by both academic institutions and industry sponsors, including the National Cancer Institute and Genentech.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05296304 RECRUITING
Cutaneous T-cell Lymphoma
Memorial Sloan Kettering Cancer Center
 2022-03-16 PHASE1
NCT04664829 COMPLETED
Metastatic Triple-Negative Breast Carcinoma
National Cancer Centre, Singapore
 2020-10-01 PHASE1
NCT05106192 WITHDRAWN
Mycosis Fungoides of Skin (Diagnosis); Cutaneous T-cell Lymphoma; Non Hodgkin Lymphoma; Lymphomatoid Papulosis; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Follicular
Case Comprehensive Cancer Center
 2022-04-01
NCT03323658 COMPLETED
Breast Atypical Ductal Hyperplasia; Breast Atypical Lobular Hyperplasia; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ; Invasive Breast Carcinoma
National Cancer Institute (NCI)
 2018-06-15 PHASE1
NCT03323658 Completed
Breast Atypical Ductal Hyperplasia|Breast Atypical Lobular Hyperplasia|Breast Ductal Carcinoma In Situ|Breast Lobular Carcinoma In Situ|Invasive Breast Carcinoma
National Cancer Institute (NCI)
 2018-06-15 Phase 1
NCT00411632 COMPLETED
Lung Cancer
M.D. Anderson Cancer Center
 2006-11-29 PHASE2
NCT00255801 COMPLETED
Lymphoma
Memorial Sloan Kettering Cancer Center
 2005-11 PHASE2
NCT01504490 TERMINATED
Solid Tumors; Lymphoma; Multiple Myeloma
Georgetown University
 2011-12 PHASE1
NCT01569724 COMPLETED
Hypertriglyceridemia; Cutaneous T Cell Lymphoma
Rennes University Hospital
 2012-01 PHASE4
NCT00425477 COMPLETED
Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2006-11 PHASE2
NCT01578499 COMPLETED
Primary Cutaneous Anaplastic Large Cell Lymphoma; Mycosis Fungoides; Cutaneous T-Cell Lymphoma
Millennium Pharmaceuticals, Inc.
 2012-06-11 PHASE3
NCT01134341 COMPLETED
Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome; Primary Cutaneous Anaplastic Large Cell Lymphoma
Acrotech Biopharma Inc.
 2010-03 PHASE1
NCT02061878 COMPLETED
Alzheimer's Disease
ReXceptor, Inc.
 2014-08 PHASE1
NCT01782742 COMPLETED
Alzheimer's Disease
The Cleveland Clinic
 2013-02 PHASE2
NCT01116622 COMPLETED
Advanced, Malignant Aerodigestive Tract Tumor (Lung, Head and Neck and Esophagus)
Dartmouth-Hitchcock Medical Center
 2003-04 PHASE1
NCT00125359 COMPLETED
Carcinoma, Non-small-cell Lung
Konstantin Dragnev
 2005-08 PHASE2
NCT01007448 COMPLETED
Refractory Cutaneous T-cell Lymphoma
Bausch Health Americas, Inc.
 2010-01-06 PHASE4
NCT00127881 TERMINATED
Mycosis Fungoides; Sezary Syndrome
Emergent Product Development Seattle LLC
 2005-07 PHASE3
NCT00615784 TERMINATED
Acute Myeloid Leukemia
Abramson Cancer Center at Penn Medicine
 2010-05-25 PHASE2
NCT01001143 COMPLETED
Leukemia, Myeloid, Acute
Washington University School of Medicine
 2010-05 PHASE1
NCT00718770 COMPLETED
Thyroid Cancer
University of Colorado, Denver
 2008-11 EARLY_PHASE1
NCT01569724 Completed
Hypertriglyceridemia|Cutaneous T Cell Lymphoma
Rennes University Hospital
 2012-01 Phase 4
NCT00514293 UNKNOWN
Lung Cancer
Raghu Nandan, M.D., Inc
 2007-01 PHASE2
NCT00845351 UNKNOWN
Cushing's Disease
University of Virginia
 2008-11 PHASE1; PHASE2
NCT00660231 COMPLETED
Lymphoma
University College, London
 2008-03 PHASE2
NCT00535574 COMPLETED
Schizophrenia
Beersheva Mental Health Center
 2008-11 PHASE3
NCT00125372 COMPLETED
Carcinoma, Non-small-cell Lung
Dartmouth-Hitchcock Medical Center
 2005-12
NCT01001143 Completed
Leukemia Myeloid Acute
Washington University School of Medicine
 2010-05 Phase 1
NCT00615784 Terminated
Acute Myeloid Leukemia
Abramson Cancer Center at Penn Medicine
 2010-05-25 Phase 2
NCT00056056 TERMINATED
Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 2003-01 PHASE3
NCT00153842 TERMINATED
Carcinoma, Non-small-cell Lung
Dartmouth-Hitchcock Medical Center
 2001-08 PHASE1; PHASE2
NCT00127101 TERMINATED
Lymphoma
Merck Sharp & Dohme LLC
 2005-09 PHASE1
NCT00178841 COMPLETED
Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome
Vanderbilt University
 2005-06 PHASE2
NCT00055991 COMPLETED
Breast Cancer
Baylor Breast Care Center
 2001-09 PHASE1
NCT00125372 Completed
Carcinoma Non-small-cell Lung
Dartmouth-Hitchcock Medical Center|Ligand Pharmaceuticals|Genentech Inc.
 2005-12 Not Applicable
NCT00238628 COMPLETED
Lung Cancer
Stanford University
 2004-04 PHASE1; PHASE2
NCT00050973 COMPLETED
Non-small Cell Lung Cancer
Eisai Inc.
 PHASE3
NCT00030849 COMPLETED
Lymphoma
Memorial Sloan Kettering Cancer Center
 2001-10 PHASE2
NCT00322296 TERMINATED
Parapsoriasis
Fox Chase Cancer Center
 2001-04 PHASE2
NCT00050960 COMPLETED
Non-small Cell Lung Cancer
Eisai Inc.
 2002-05 PHASE3
NCT00316030 Completed
AML|Acute Myeloid Leukemia
Abramson Cancer Center at Penn Medicine
 2004-01 Phase 1
NCT00030589 UNKNOWN
Lymphoma
Millennix
 2001-02 PHASE2
NCT00002212 COMPLETED
Sarcoma, Kaposi; HIV Infections
Ligand Pharmaceuticals
 PHASE2
NCT00003752 COMPLETED
Breast Cancer
Ligand Pharmaceuticals
 1998-10 PHASE2
NCT00316030 COMPLETED
AML; Acute Myeloid Leukemia
Abramson Cancer Center at Penn Medicine
 2004-01 PHASE1
NCT00534898 WITHDRAWN
Schizophrenia; Schizoaffective Disorder; Cognition
Beersheva Mental Health Center
 PHASE3
NCT00141947 UNKNOWN
Schizophrenia
Beersheva Mental Health Center
 2005-09 PHASE3
NCT00151008 COMPLETED
Psoriasis
University of Medicine and Dentistry of New Jersey
 2003-11 PHASE2
NCT00306969 COMPLETED
Cutaneous T-Cell Lymphoma
Boston University
 2001-12 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-02-04)

Check the Bexarotene product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bexarotene selectively binds and activates retinoid X receptors (RXRs), promoting the formation of RXR homodimers and heterodimers that selectively regulate transcriptional programs governing cell cycle progression, differentiation, and apoptosis. By suppressing malignant cellular proliferation and driving programmed cell death, this receptor-targeted mechanism underpins its therapeutic activity in cutaneous T-cell lymphoma, as well as its clinical evaluation in acute myeloid leukemia, non-small-cell lung cancer, and breast neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.