CLINICAL TRIALS PROFILE FOR BEXAROTENE

505(b)(2) Clinical Trials for Bexarotene

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01504490 ↗	Phase I Study of CS-7017 and Bexarotene	Terminated	Daiichi Sankyo Inc.	Phase 1	2011-12-01	This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells, including stopping cancer cells from growing and dividing, and causing the cancer cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together may have an even greater effect against cancer cells, hopefully, increasing the killing of cancer cells. CS-7017 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved by the FDA for patients with a specific type of cancer, cutaneous T-cell lymphoma. This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene, has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.
New Combination	NCT01504490 ↗	Phase I Study of CS-7017 and Bexarotene	Terminated	Daiichi Sankyo, Inc.	Phase 1	2011-12-01	This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells, including stopping cancer cells from growing and dividing, and causing the cancer cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together may have an even greater effect against cancer cells, hopefully, increasing the killing of cancer cells. CS-7017 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved by the FDA for patients with a specific type of cancer, cutaneous T-cell lymphoma. This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene, has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.
New Combination	NCT01504490 ↗	Phase I Study of CS-7017 and Bexarotene	Terminated	Georgetown University	Phase 1	2011-12-01	This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells, including stopping cancer cells from growing and dividing, and causing the cancer cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together may have an even greater effect against cancer cells, hopefully, increasing the killing of cancer cells. CS-7017 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved by the FDA for patients with a specific type of cancer, cutaneous T-cell lymphoma. This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene, has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.

All Clinical Trials for Bexarotene

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002212 ↗	A Study of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma	Completed	Ligand Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give Targretin capsules to patients with AIDS-related Kaposi's sarcoma (KS).
NCT00003752 ↗	Bexarotene in Treating Patients With Metastatic Breast Cancer	Completed	Ligand Pharmaceuticals	Phase 2	1998-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to study the effectiveness of bexarotene in treating patients who have metastatic breast cancer.
NCT00030589 ↗	Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma	Unknown status	Millennix	Phase 2	2001-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma. PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.
NCT00030849 ↗	Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
NCT00030849 ↗	Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2001-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
NCT00050960 ↗	Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer	Completed	Eisai Inc.	Phase 3	2002-05-01	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 patients who have not yet received chemotherapy for their lung cancer.

Clinical Trial Conditions for Bexarotene

Condition Name

Condition Name for Bexarotene
Intervention	Trials
Cutaneous T-cell Lymphoma	7
Lymphoma	7
Mycosis Fungoides	6
Sezary Syndrome	4

Condition MeSH

Condition MeSH for Bexarotene
Intervention	Trials
Lymphoma, T-Cell, Cutaneous	16
Lymphoma	15
Lymphoma, T-Cell	14
Carcinoma, Non-Small-Cell Lung	9

Clinical Trial Locations for Bexarotene

Trials by Country

Trials by Country for Bexarotene
Location	Trials
United States	171
Australia	10
United Kingdom	9
Israel	6
Canada	6

Trials by US State

Trials by US State for Bexarotene
Location	Trials
Texas	14
Pennsylvania	12
New York	12
California	10
Illinois	8

Clinical Trial Progress for Bexarotene

Clinical Trial Phase

Clinical Trial Phase for Bexarotene
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Bexarotene
Clinical Trial Phase	Trials
Completed	30
Terminated	8
Unknown status	4

Clinical Trial Sponsors for Bexarotene

Sponsor Name

Sponsor Name for Bexarotene
Sponsor	Trials
Ligand Pharmaceuticals	11
National Cancer Institute (NCI)	6
M.D. Anderson Cancer Center	5

Sponsor Type

Sponsor Type for Bexarotene
Sponsor	Trials
Other	54
Industry	39
NIH	6

Bexarotene: Clinical Trials, Market Analysis, and Projections

Introduction to Bexarotene

Bexarotene, a retinoid derivative, is primarily known for its use in treating cutaneous T-cell lymphoma (CTCL), a form of skin cancer. It belongs to a novel class of pharmacologic agents known as RXR-selective retinoids or rexinoids. Here, we will delve into the clinical trials, market analysis, and future projections of bexarotene.

Clinical Trials and Efficacy

Treatment of Cutaneous T-cell Lymphoma (CTCL)

Bexarotene has been extensively studied and proven effective in treating advanced-stage CTCL. A multinational Phase II-III trial demonstrated that bexarotene is safe and effective as a single-agent oral therapy. The trial involved 94 patients with biopsy-confirmed CTCL in advanced stages, showing clinical complete and partial responses in 45% and 55% of patients at different dosing levels[3].

Myelin Repair in Multiple Sclerosis

In addition to its use in CTCL, bexarotene was investigated for its potential to repair myelin in multiple sclerosis (MS). Laboratory studies and an early-stage clinical trial indicated that bexarotene could stimulate myelin production by targeting the retinoid X receptor on oligodendrocytes. However, the required dose led to significant side effects, and no further clinical trials are planned for this application[1][4].

Side Effects and Safety Profile

Bexarotene is generally well-tolerated but comes with several notable side effects. Common adverse events include hypertriglyceridemia, hypercholesterolemia, hypothyroidism, headache, itchy rash, vomiting, and diarrhea. These side effects are often reversible but can be severe, particularly at higher doses[3][4].

Market Analysis

Market Size and Growth

The bexarotene market is expected to grow significantly over the forecast period. As of 2024, the market was valued at USD XX Million and is projected to increase at a compound annual growth rate (CAGR) of XX% until 2034[2].

Market Segmentation

The bexarotene market is segmented by application, with the CTCL segment accounting for the largest share, approximately 87% in 2024. Other applications, including potential uses in Alzheimer's disease due to its effects on lipid metabolism, are also being explored[2].

Distribution Channels

The market is further segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a significant segment, reflecting the drug's primary use in treating serious medical conditions like CTCL[2].

Regional Market

Geographically, the bexarotene market is dominated by North America, which holds an active share of around 47%. Other regions, including Europe, Asia Pacific, Middle East & Africa, and South America, also contribute to the market's growth[2].

Market Dynamics

Drivers

• Increasing Incidence of CTCL: The rising incidence of cutaneous T-cell lymphoma drives the demand for effective treatments like bexarotene.
• Research and Development: Ongoing research into new applications, such as Alzheimer's disease, could expand the market.
• Global Healthcare Spending: Increasing healthcare expenditure globally supports the growth of the pharmaceutical market, including bexarotene[2][5].

Restraints

• Side Effects: The significant side effects associated with bexarotene, particularly at higher doses, can limit its use.
• Regulatory Challenges: Strict regulatory environments can slow down the approval and market entry of new drugs or new uses for existing drugs.
• Competition: The presence of other treatments for CTCL and potential future competitors could impact market share[2][5].

Projections and Future Outlook

Market Forecast

The bexarotene market is anticipated to continue its growth trajectory, driven by the increasing demand for effective treatments for CTCL and potential new applications. By 2034, the market is projected to reach USD XX Million, reflecting a steady CAGR over the forecast period[2].

Emerging Trends

• API Market Growth: The bexarotene API market is expected to see substantial growth from 2023 to 2031, driven by the increasing demand for the active pharmaceutical ingredient in various formulations[5].
• New Formulations: Research into new formulations, such as gels and soft capsules, could enhance patient compliance and expand market opportunities[5].

Key Takeaways

• Clinical Efficacy: Bexarotene is effective in treating advanced-stage CTCL and has shown potential in myelin repair, although further trials for the latter are not planned.
• Market Growth: The bexarotene market is expected to grow significantly, driven by the increasing incidence of CTCL and potential new applications.
• Side Effects: The drug comes with notable side effects, which must be carefully managed.
• Market Segmentation: The market is dominated by the CTCL segment and North America region.
• Future Outlook: The market is projected to continue growing, with emerging trends in API market growth and new formulations.

FAQs

What is bexarotene primarily used for?

Bexarotene is primarily used to treat cutaneous T-cell lymphoma (CTCL), a form of skin cancer.

What are the common side effects of bexarotene?

Common side effects include hypertriglyceridemia, hypercholesterolemia, hypothyroidism, headache, itchy rash, vomiting, and diarrhea.

Has bexarotene shown potential in treating multiple sclerosis?

Yes, bexarotene has shown potential in myelin repair in laboratory studies and an early-stage clinical trial, but no further trials are planned due to significant side effects.

What is the projected growth rate of the bexarotene market?

The bexarotene market is projected to grow at a compound annual growth rate (CAGR) of XX% from 2024 to 2034.

Which region dominates the bexarotene market?

North America dominates the bexarotene market, holding an active share of around 47%.

Sources

1. MS Society: "Trial shows myelin repair in humans is possible"
2. We Market Research: "Bexarotene Market Report | Size, Share, Growth and Statistics"
3. PubMed: "Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results"
4. MS Trust: "Bexarotene"
5. Market Research Intellect: "Bexarotene API Market Size, Scope And Forecast Report"

Last updated: 2024-12-31