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CLINICAL TRIALS PROFILE FOR ZOLINZA

All Clinical Trials for Zolinza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00121225 ↗	Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma	Completed	National Cancer Institute (NCI)	Phase 2	2005-09-01	This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT00127101 ↗	An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)	Terminated	Merck Sharp & Dohme Corp.	Phase 1	2005-09-01	This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.
NCT00128102 ↗	Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-06-30	The goal of this study is to assess the efficacy and safety of an oral investigational drug suberoylanilide hydroxamic acid (vorinostat, MK-0683) compared to placebo, in the treatment of participants with advanced malignant pleural mesothelioma who have failed at least one prior chemotherapy regimen. The primary hypotheses are the following: (1) vorinostat improves overall survival (OS) compared to placebo (2) vorinostat is generally safe and well tolerated.
NCT00132002 ↗	Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2005-06-01	This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
NCT00132028 ↗	Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2005-09-01	This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT00132067 ↗	Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer	Completed	Gynecologic Oncology Group	Phase 2	2005-10-01	This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Conditions for Zolinza

Condition Name

Condition Name for Zolinza
Intervention	Trials
Lymphoma	11
Unspecified Adult Solid Tumor, Protocol Specific	10
Recurrent Adult Acute Myeloid Leukemia	10
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	8

Condition MeSH

Condition MeSH for Zolinza
Intervention	Trials
Lymphoma	35
Leukemia	26
Lymphoma, Non-Hodgkin	21
Leukemia, Myeloid, Acute	20

Clinical Trial Locations for Zolinza

Trials by Country

Trials by Country for Zolinza
Location	Trials
United States	545
Canada	33
Australia	8
Japan	6
Germany	2

Trials by US State

Trials by US State for Zolinza
Location	Trials
Texas	43
California	35
Pennsylvania	30
New York	27
Maryland	25

Clinical Trial Progress for Zolinza

Clinical Trial Phase

Clinical Trial Phase for Zolinza
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	2
Phase 2	53

Clinical Trial Status

Clinical Trial Status for Zolinza
Clinical Trial Phase	Trials
Completed	91
Terminated	30
Active, not recruiting	21

Clinical Trial Sponsors for Zolinza

Sponsor Name

Sponsor Name for Zolinza
Sponsor	Trials
National Cancer Institute (NCI)	81
Merck Sharp & Dohme Corp.	39
M.D. Anderson Cancer Center	19

Sponsor Type

Sponsor Type for Zolinza
Sponsor	Trials
Other	165
NIH	86
Industry	63

Zolinza (Vorinostat): Clinical Trials, Market Analysis, and Projections

Introduction to Zolinza (Vorinostat)

Zolinza, also known as vorinostat, is a histone deacetylase (HDAC) inhibitor used primarily in the treatment of cutaneous T-cell lymphoma (CTCL) and other hematological malignancies. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are ongoing or have recently been completed to evaluate the efficacy and safety of vorinostat in various indications.

• Multiple Myeloma: A Phase I trial is evaluating the combination of vorinostat with lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma. This study aims to assess the clinical effectiveness and side effects of this combination therapy[1].
• Other Indications: Trials sponsored by organizations such as the Prospect Creek Foundation, Oregon Health and Science University, and the OHSU Knight Cancer Institute are exploring the use of vorinostat in different phases and for various cancer types[2].

Safety and Efficacy

Clinical trials have shown that vorinostat is effective in treating CTCL, but it also comes with significant side effects. Common adverse reactions include hyperglycemia, thrombocytopenia, anemia, and fatigue. Severe adverse reactions such as pulmonary embolism, squamous cell carcinoma, and anemia have also been reported[4].

Mechanism of Action

Vorinostat belongs to the class of HDAC inhibitors, which work by inhibiting the histone deacetylase enzymes. This inhibition leads to the accumulation of acetylated histones, resulting in the modulation of gene expression. This mechanism is particularly effective in treating cancers by inducing cell cycle arrest and apoptosis in cancer cells[2].

Market Analysis

Current Market Position

Vorinostat is one of the leading HDAC inhibitors in the market, primarily due to its approval for the treatment of CTCL and its availability in oral form. Merck’s vorinostat (Zolinza) holds a significant market share in the HDAC inhibitor segment, largely because it lacks a therapeutically equivalent version in the United States[3].

Competitive Landscape

The competitive landscape for HDAC inhibitors is dynamic, with new drugs and therapies emerging. While vorinostat remains a key player, other HDAC inhibitors like chidamide (Epidaza) from Shenzhen Chipscreen Biosciences are gaining traction due to their approval for a wide range of indications and lower costs[3].

Market Projections

The global epigenetic drugs and diagnostics market, which includes HDAC inhibitors like vorinostat, is projected to reach $19.7 billion by 2031, growing at a CAGR of 17.3%. The hematologic neoplasms segment, where vorinostat is most clinically successful, continues to drive the market. However, there is a trend towards diversification into non-oncology indications such as HIV infection, muscular dystrophies, and neurodegenerative diseases[3].

Regional Market Insights

The market for epigenetic drugs, including vorinostat, is spread across various regions:

• North America: This region is expected to remain a significant market due to advanced healthcare infrastructure and high adoption rates of new therapies.
• Europe: European markets are also substantial, driven by regulatory approvals and reimbursement policies.
• Asia Pacific: This region is anticipated to grow rapidly, especially with the approval and manufacturing licenses of drugs like chidamide in countries such as China and India[5].

Patent and Generic Entry

Vorinostat is protected by five US patents, but the earliest estimated date for generic entry is based on the expiration of these patents and regulatory exclusivities. However, factors such as new patent filings, patent extensions, and early generic licensing can influence the actual generic entry date[2].

Key Takeaways

• Clinical Trials: Ongoing trials are exploring the efficacy of vorinostat in combination therapies for multiple myeloma and other indications.
• Safety and Efficacy: Vorinostat is effective but comes with significant side effects, necessitating careful monitoring.
• Market Position: Vorinostat holds a significant market share in the HDAC inhibitor segment due to its approval and lack of therapeutically equivalent versions.
• Market Projections: The global epigenetic drugs market is expected to grow substantially, driven by hematologic neoplasms and diversification into non-oncology indications.
• Regional Insights: North America, Europe, and the Asia Pacific are key regions for the market growth of vorinostat.

FAQs

What is the primary indication for Zolinza (vorinostat)?

Zolinza is primarily indicated for the treatment of cutaneous T-cell lymphoma (CTCL).

What are the common side effects of Zolinza?

Common side effects include hyperglycemia, thrombocytopenia, anemia, and fatigue. Severe side effects can include pulmonary embolism, squamous cell carcinoma, and anemia[4].

What is the mechanism of action of Zolinza?

Zolinza works by inhibiting histone deacetylase enzymes, leading to the accumulation of acetylated histones and modulation of gene expression[2].

What is the projected market size for epigenetic drugs by 2031?

The global epigenetic drugs and diagnostics market is projected to reach $19.7 billion by 2031, growing at a CAGR of 17.3%[3].

When can we expect generic versions of Zolinza to enter the market?

The earliest estimated date for generic entry is based on patent expirations and regulatory exclusivities, but actual entry may be influenced by various factors such as new patent filings and early generic licensing[2].

Sources

1. Dana-Farber Cancer Institute. A Phase I Trial Evaluating the Safety and Efficacy of Vorinostat (Zolinza®) + RVD (Lenalidomide {Revlimid®} + Bortezomib {Velcade®} + Dexamethasone) for Patients with Newly Diagnosed Multiple Myeloma. [Online]. Available: https://www.dana-farber.org/clinical-trials/10-126
2. DrugPatentWatch. ZOLINZA Drug Patent Profile. [Online]. Available: https://www.drugpatentwatch.com/p/tradename/ZOLINZA
3. iHealthcareAnalyst. Global Epigenetic Drugs and Diagnostics Market $19.7 Billion by 2031. [Online]. Available: https://www.ihealthcareanalyst.com/epigenetics-drugs-market-forecast-demand-cancer-heart-diseases-diabetes-mental-illnesses-treatment/
4. Merck. ZOLINZA (vorinostat) Capsules. [Online]. Available: https://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_pi.pdf
5. iHealthcareAnalyst. Epigenetics Drugs Market and Forecast 2024-2031. [Online]. Available: https://www.ihealthcareanalyst.com/report/epigenetic-products-market/