Drugs / Bexarotene
Bexarotene
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TARGRETIN | — | 2015-07-29 | fda.gov ↗ |
| Approved | EU (EMA) | Targretin | — | 2001-03-29 | europa.eu ↗ |
| Approved | US (FDA) | TARGRETIN | — | 1999-12-29 | fda.gov ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00718770 | Nov 2008 → Jan 2013 | thyroid cancer | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT05296304 | Mar 2022 → Mar 2027 expected | primary cutaneous T-cell lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04664829 | Oct 2020 → Aug 2025 | triple-negative breast carcinoma | National Cancer Centre, Singapore | Completed | No outcome recorded |
| Phase 1 | NCT03323658 | Jun 2018 → Aug 2021 | atypical lobular breast hyperplasia, ductal breast carcinoma in situ, flat ductal epithelial atypia, invasive breast carcinoma +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02061878 | Aug → Nov 2014 | Alzheimer disease | ReXceptor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01504490 | Dec 2011 → Dec 2016 | plasma cell myeloma | Georgetown University | Terminated | No outcome recorded |
| Phase 1 | NCT01001143 | May 2010 → May 2013 | acute myeloid leukemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01134341 | Mar 2010 → Aug 2015 | Sezary syndrome, mycosis fungoides, primary cutaneous anaplastic large cell lymphoma | Acrotech Biopharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00127101 | Sep 2005 → Oct 2008 | lymphoma | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00316030 | Jan 2004 → ? | acute myeloid leukemia | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01116622 | Apr 2003 → Apr 2014 | upper aerodigestive tract neoplasm | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00055991 | Sep 2001 → Sep 2006 | breast cancer | Baylor Breast Care Center | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT00845351 | Nov 2008 → Dec 2011 | Cushing disease due to pituitary adenoma | University of Virginia | Unknown | No outcome recorded |
| Phase 1/2 | NCT00238628 | Apr 2004 → Apr 2005 | lung cancer | Stanford University | Completed | No outcome recorded |
| Phase 1/2 | NCT00306969 | Dec 2001 → Apr 2004 | primary cutaneous T-cell lymphoma | Boston University | Completed | No outcome recorded |
| Phase 1/2 | NCT00153842 | Aug 2001 → Mar 2009 | non-small cell lung carcinoma | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT00615784 | May 2010 → Oct 2013 | acute myeloid leukemia | Abramson Cancer Center at Penn Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT00660231 | Mar 2008 → Sep 2011 | lymphoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT00514293 | Jan 2007 → Dec 2011 | lung cancer | Raghu Nandan, M.D., Inc | Unknown | No outcome recorded |
| Phase 2 | NCT00411632 | Nov 2006 → Feb 2018 | lung cancer | M.D. Anderson Cancer Center | Completed | Met primary |
| Phase 2 | NCT00425477 | Nov 2006 → Sep 2016 | leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative disease | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT00255801 | Nov 2005 → Oct 2017 | lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00125359 | Aug 2005 → Mar 2014 | non-small cell lung carcinoma | Konstantin Dragnev | Completed | No outcome recorded |
| Phase 2 | NCT00151008 | Nov 2003 → Aug 2005 | psoriasis | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase 2 | NCT00030849 | Oct 2001 → Sep 2004 | lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00322296 | Apr 2001 → Jul 2004 | parapsoriasis | Fox Chase Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00030589 | Feb 2001 → ? | lymphoma | Millennix | Unknown | No outcome recorded |
| Phase 2 | NCT00003752 | Oct 1998 → Mar 2003 | breast cancer | Ligand Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00002212 | — | HIV infectious disease, Kaposi's sarcoma | Ligand Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00063076 | May 2003 → Oct 2006 | alopecia areata | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT00141947 | Sep 2005 → Sep 2006 | schizophrenia | Beersheva Mental Health Center | Unknown | No outcome recorded |
| Phase 3 | NCT00056056 | Jan 2003 → May 2010 | lymphoma | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT00050960 | May 2002 → Jul 2004 | non-small cell lung carcinoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00050973 | ? → Nov 2004 | non-small cell lung carcinoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00534898 | — | schizoaffective disorder, schizophrenia | Beersheva Mental Health Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 41 trial | ||||||
| Phase 4 | NCT01007448 | Jan 2010 → Feb 2014 | primary cutaneous T-cell lymphoma | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT00125372 | Dec 2005 → Aug 2010 | non-small cell lung carcinoma | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT01782742 Comparator | Feb 2013 → Aug 2014 | Alzheimer disease | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00178841 Background | Jun 2005 → Mar 2007 | Sezary syndrome, mycosis fungoides | Vanderbilt University | Completed | No outcome recorded |
| Phase 3 | NCT01578499 Comparator | Jun 2012 → May 2016 | mycosis fungoides, primary cutaneous anaplastic large cell lymphoma | Millennium Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT00535574 Comparator | Nov 2008 → Dec 2010 | schizophrenia | Beersheva Mental Health Center | Completed | No outcome recorded |
| — | NCT05106192 Background | Apr 2022 → Jun 2025 | anaplastic large cell lymphoma, follicular lymphoma, lymphomatoid papulosis, mycosis fungoides | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2015-04-24 | Eisai Inc. | Regulatory EISAI COMMENCES BUSINESS IN MEXICO, AIMS TO EXPAND CONTRIBUTION TO PATIENTS IN LATIN AMERICA ANTICANCER AGENTS HALAVEN® AND GLIADEL® NEWLY LAUNCHED eisai.com ↗
In addition to these newly launched anticancer products, Eisai Mexico has submitted the antiepileptic agents Inovelon® and Fycompa®, the anticancer agent Targretin® as well as the antiobesity agent BELVIQ® for regulatory review. |
All press releases naming this drug 4 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bexarotene | “Targretin® (bexarotene) Gel 1% a synthetic vitamin A compound that is approved for the topical treatment and oral treatment of cutaneous T cell lymphoma (CTCL).” NCT00063076 ↗42“Azacitidine Bexarotene Bortezomib” NCT02551718 ↗ |
| Known as | Bexaroteno | ChEMBL registry synonym — accepted as the source's own label CHEMBL1023 ↗ |
| Known as | LG-100069 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1023 ↗ |
| Known as | LGD1069 | “In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-\[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl\] benzoic...” NCT00141947 ↗3“OBJECTIVES: I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose levels in patients with advanced breast cancer.” NCT00003752 ↗ “bexarotene (Targretin; LGD1069;” NCT00534898 ↗ “Bexarotene (Targretin LGD1069)” NCT00535574 ↗ |
| Known as | NSC-747528 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1023 ↗ |
| Known as | Targretin | “In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-\[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl\] benzoic...” NCT00141947 ↗11“This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in...” NCT00050973 ↗ “Investigator-Initiated, Double Blind, Vehicle-Controlled, Bilateral Comparison Trial of Bexarotene (Targretin) Gel 1% vs. Vehicle Gel in Combination With Narrow Band UVB...” NCT00151008 ↗ “The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.” NCT00125359 ↗ “bexarotene (Targretin capsules, Ligand Pharmaceuticals, San Diego, Calif) alone and then with the addition of interferon alfa-2b (Intron-A, Schering-Plough, Kenilworth, NJ).” PMID 17366595 ↗ May 2007 “Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of patients suffer from oncological or dermatological diseases.” NCT00535574 ↗ “combined bexarotene (Targretin(®) ) and PUVA vs. PUVA alone in patients with stage IB and IIA mycosis fungoides (MF).” PMID 22924950 ↗ Sep 2012 “A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer” NCT00003752 ↗ “Targretin capsules (bexarotene)” NCT00050960 ↗ “bexarotene (Targretin; LGD1069;” NCT00534898 ↗ “Targretin® (bexarotene)” NCT00255801 ↗ |
| Known as | Targretine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1023 ↗ |
| Action | Deplete | “can cause the death of T-cells” NCT00063076 ↗ |
| Modality | Small molecule | “This drug is a retinoid.” NCT00055991 ↗ |
| Route | Oral | “All patients receive oral bexarotene once daily.” NCT00003752 ↗ |