CLINICAL TRIALS PROFILE FOR VORINOSTAT

All Clinical Trials for Vorinostat

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005634 ↗	Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy	Completed	National Cancer Institute (NCI)	Phase 1	2000-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced primary or metastatic solid tumors that have not responded to previous therapy.
NCT00005634 ↗	Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	2000-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced primary or metastatic solid tumors that have not responded to previous therapy.
NCT00007345 ↗	Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-08	Background: NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (1-3). NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4). Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase inhibitors. In the phase I trial conducted at the National Cancer Institute (NCI), responses were observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell lymphoma. Objectives: In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall response rate, complete response rate and duration of response. In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are overall response rate and complete response rate. To evaluate the tolerability of depsipeptide with extended cycles of therapy. Eligibility: Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other peripheral T-cell lymphomas are eligible. Design: Depsipeptide will be administered at 14 mg/m^2, over 4 hours on days 1, 8 and 15. This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature T-cell lymphomas; Arm 5, a replicate arm of arm 1; Arm 6, patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 7, patients with cutaneous T cell lymphoma who have received vorinostat. Dose may be adjusted based on toxicities.
NCT00045006 ↗	Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2001-07-01	RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced cancer.
NCT00045006 ↗	Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	2001-07-01	RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced cancer.
NCT00106626 ↗	Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors	Completed	Merck Sharp & Dohme Corp.	Phase 1	2005-08-01	The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.

Clinical Trial Conditions for Vorinostat

Condition Name

Condition Name for Vorinostat
Intervention	Trials
Lymphoma	23
Multiple Myeloma	14
Unspecified Adult Solid Tumor, Protocol Specific	12
Recurrent Adult Acute Myeloid Leukemia	10

Condition MeSH

Condition MeSH for Vorinostat
Intervention	Trials
Lymphoma	60
Leukemia	44
Leukemia, Myeloid, Acute	32
Leukemia, Myeloid	30

Clinical Trial Locations for Vorinostat

Trials by Country

Trials by Country for Vorinostat
Location	Trials
United States	761
Canada	45
Japan	21
Australia	18
United Kingdom	17

Trials by US State

Trials by US State for Vorinostat
Location	Trials
Texas	55
California	55
Pennsylvania	43
New York	42
Maryland	34

Clinical Trial Progress for Vorinostat

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Vorinostat
Clinical Trial Phase	Trials
Completed	142
Terminated	54
Active, not recruiting	30

Clinical Trial Sponsors for Vorinostat

Sponsor Name

Sponsor Name for Vorinostat
Sponsor	Trials
National Cancer Institute (NCI)	96
Merck Sharp & Dohme Corp.	90
M.D. Anderson Cancer Center	22

Sponsor Type

Sponsor Type for Vorinostat
Sponsor	Trials
Other	311
Industry	146
NIH	107

Vorinostat: Clinical Trials, Market Analysis, and Projections

Introduction to Vorinostat

Vorinostat, a histone deacetylase (HDAC) inhibitor, has been a significant player in the oncology market, particularly in the treatment of cutaneous T-cell lymphoma (CTCL). Here, we delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Graft vs Host Disease Prevention

One notable clinical trial involves the use of vorinostat for preventing graft versus host disease (GVHD) in children, adolescents, and young adults undergoing allogeneic blood and marrow transplantation. This Phase 1/2 multi-center trial aims to determine the safety and efficacy of vorinostat in this context[1][4].

Combination Therapy in Glioblastoma

A Phase I/II trial has been conducted to evaluate the maximum tolerated dose (MTD) and efficacy of vorinostat combined with standard chemoradiation and temozolomide in newly diagnosed glioblastoma patients. The trial found that the combination therapy had acceptable tolerability, although the primary efficacy endpoint was not met. However, it identified vorinostat sensitivity and resistance signatures that could aid in patient selection for future trials[3].

Other Ongoing Trials

Ongoing clinical research is exploring the efficacy of vorinostat in various other cancer types, including breast cancer, prostate cancer, and non-Hodgkin's lymphoma. Trials are also investigating combinations of vorinostat with immune checkpoint inhibitors, such as PD-1 and PD-L1 inhibitors, to enhance its therapeutic effects[5].

Market Analysis

Current Market Size and Growth

The vorinostat market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.2 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.5%. However, a more comprehensive estimate suggests the market could reach USD 194.87 billion by 2030, with a CAGR of 10% from 2024 to 2030[2][5].

Key Drivers

• Increasing Incidence of Cancer: The rising global incidence of cancer is a primary driver of the vorinostat market. Cancer remains one of the leading causes of death worldwide, driving demand for effective treatments[5].
• Targeted Cancer Therapies: The focus on targeted cancer therapies, particularly those involving HDAC inhibitors like vorinostat, is a significant growth factor. Vorinostat's ability to treat diseases resistant to conventional chemotherapy is crucial[2][5].
• Ongoing Research and Clinical Trials: Numerous studies are investigating vorinostat's efficacy in various cancer types and exploring new drug combinations. This ongoing research is a critical factor shaping the market's future[5].

Competitive Landscape

The vorinostat market is characterized by several key players, including AdipoGen Life Sciences, Inc, APExBIO Technology LLC, Biorbyt Ltd., BioVision Inc, MedChemExpress (MCE), Selleck Chemicals, StressMarq Biosciences Inc, Thermo Fisher Scientific, and Tokyo Chemical Industry Co., Ltd. These companies are evaluated based on their product offerings, financial statements, key developments, and strategic approaches to the market[2].

Market Projections

Expanding Indications

Vorinostat is currently approved for CTCL, but ongoing research suggests it could be effective in treating other cancers. Regulatory approvals in new indications and markets are crucial for the growth of the vorinostat market. As clinical evidence supports its efficacy in different types of cancer, there is potential for broader regulatory approvals[5].

Emerging Markets

Emerging markets, particularly in regions with rising cancer incidence, offer significant growth potential. Companies establishing a presence in these markets and navigating the regulatory landscape effectively can tap into the growing demand for cancer treatments[5].

Personalized Medicine and Epigenetic Therapies

Advancements in biomarker research and personalized medicine are expected to enhance treatment outcomes and reduce side effects. The growing interest in epigenetic therapies, including HDAC inhibitors like vorinostat, is also a key driver of market growth[5].

Strategic Partnerships and Collaborations

Strategic investments in local partnerships and distribution networks can facilitate market entry and expansion. Partnerships and collaborations, especially in emerging markets, are vital for tapping into the growing demand for cancer treatments[5].

Investment Opportunities

• Developing Combination Therapies: Investing in research to develop combination therapies involving vorinostat and other drugs, such as immune checkpoint inhibitors, presents significant growth opportunities.
• Expanding into Emerging Markets: Establishing a presence in emerging markets where the prevalence of cancer is rising can tap into the growing demand for cancer treatments.
• Focusing on Rare and Orphan Cancers: Developing vorinostat for other rare cancers could provide lucrative opportunities, given the premium pricing often associated with orphan drugs.
• Advancing Personalized Medicine Research: Pursuing research in biomarkers and personalized medicine can lead to more targeted and effective therapies.
• Pursuing Licensing and Commercialization Partnerships: Strategic partnerships can facilitate market entry and expansion, particularly in new and emerging markets[5].

Key Takeaways

• Vorinostat is a promising HDAC inhibitor with current and potential applications in various types of cancer.
• Ongoing clinical trials are exploring its efficacy in combination therapies and new cancer types.
• The market is driven by the increasing incidence of cancer, targeted cancer therapies, and ongoing research.
• Emerging markets and advancements in personalized medicine and epigenetic therapies offer significant growth opportunities.
• Strategic partnerships and investments in research and development are crucial for market expansion.

FAQs

What is Vorinostat used for?

Vorinostat is primarily used for the treatment of cutaneous T-cell lymphoma (CTCL) but is being researched for its potential in treating other types of cancer.

What are the key drivers of the Vorinostat market?

The key drivers include the increasing incidence of cancer, the focus on targeted cancer therapies, ongoing research and clinical trials, and advancements in personalized medicine and epigenetic therapies.

Which companies are major players in the Vorinostat market?

Major players include AdipoGen Life Sciences, Inc, APExBIO Technology LLC, Biorbyt Ltd., BioVision Inc, MedChemExpress (MCE), Selleck Chemicals, StressMarq Biosciences Inc, Thermo Fisher Scientific, and Tokyo Chemical Industry Co., Ltd.

What are the potential new indications for Vorinostat?

Ongoing research suggests vorinostat could be effective in treating breast cancer, prostate cancer, non-Hodgkin's lymphoma, and other malignancies.

How is the Vorinostat market expected to grow?

The market is projected to grow significantly, reaching USD 194.87 billion by 2030, with a CAGR of 10% from 2024 to 2030.

What role do emerging markets play in the Vorinostat market?

Emerging markets offer significant growth potential as they experience a rise in cancer incidence and invest more in healthcare infrastructure and access to cancer treatments.

Sources

1. Indiana University Health: PHO-UMICH-VORINOSTAT: Clinical Trial Information.
2. Verified Market Reports: Vorinostat Market Size, Share | Growth Report.
3. Oxford Academic: Phase I/II trial of vorinostat combined with temozolomide and ...
4. National Cancer Institute: Clinical Trials Using Vorinostat.
5. Market Research Intellect: Vorinostat Market: Unlocking Potential in Cancer Treatment and ...