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
Breast Cancer	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	776
Canada	45
Japan	21
Australia	18
United Kingdom	17

Trials by US State

Trials by US State for VORINOSTAT
Location	Trials
Texas	56
California	56
Pennsylvania	44
New York	42
Washington	34

Clinical Trial Progress for VORINOSTAT

Clinical Trial Phase

Clinical Trial Phase for VORINOSTAT
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	3
Phase 4	1

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)	97
Merck Sharp & Dohme Corp.	90
M.D. Anderson Cancer Center	22

Sponsor Type

Sponsor Type for VORINOSTAT
Sponsor	Trials
Other	317
Industry	151
NIH	109

Vorinostat: Clinical Trials Update, Market Analysis, and Forecast

Last updated: February 20, 2026

What are the current clinical trial activities for Vorinostat?

Vorinostat (brand name Zolinza) is an HDAC inhibitor approved by the FDA for the treatment of cutaneous T-cell lymphoma (CTCL). It is under ongoing investigation for various cancer indications, including hematological malignancies and solid tumors.

Active Clinical Trials

As of March 2023, over 20 clinical trials involving Vorinostat are registered globally on ClinicalTrials.gov. These trials target multiple cancer types, including non-small cell lung cancer (NSCLC), multiple myeloma, and relapsed/refractory acute myeloid leukemia (AML).

Trial Phase	Number	Focus Area	Status
Phase 1	7	Dose escalation, safety, pharmacokinetics	Ongoing
Phase 2	9	Efficacy in specific cancers (e.g., multiple myeloma, AML)	Ongoing/Recruiting
Phase 3	2	Confirmatory studies, combination therapies	Not yet active
Phase 4	3	Post-marketing surveillance	Not documented

Key Trials

• NCT02703547: Evaluates Vorinostat combined with bortezomib in multiple myeloma patients (Phase 1/2). Results pending.
• NCT03137913: Assesses Vorinostat plus pembrolizumab in relapsed or refractory solid tumors (Phase 1/2). Active recruitment.
• NCT04556577: Investigates Vorinostat in combination with chemotherapy for AML (Phase 2). Expected completion in 2024.

How does the market for Vorinostat currently stand?

Market Size and Revenue

The global HDAC inhibitors market, driven by drugs like Vorinostat, reached approximately USD 300 million in 2022. Vorinostat accounts for roughly 20% of this segment, which was valued at USD 60 million in 2022. The drug is marketed primarily in the US, with limited penetration other regions.

Competitive Landscape

The HDAC inhibitor market comprises several drugs:

• Vorinostat (Zolinza): Approved for CTCL, in research for other cancers.
• Romidepsin (Istodax): Approved for CTCL and peripheral T-cell lymphoma.
• Belinostat (Beleodaq): Approved for peripheral T-cell lymphoma.
• Panobinostat (Farydak): Approved for multiple myeloma.

The market is dominated by Romidepsin and Belinostat, with Vorinostat maintaining niche positioning for specific indications.

Regulatory and Commercial Challenges

• Limited indications restrict market expansion.
• Side effect profile impacts patient tolerability.
• Competition from newer, targeted agents with better efficacy profiles.

What is the forecast for Vorinostat’s market over the next five years?

Market Growth Drivers

• Clinical trials demonstrating efficacy in new indications.
• Potential expansion into hematological cancers.
• Increasing approval of combination therapies involving Vorinostat.

Market Projections

Year	Predicted Revenue (USD million)	Growth Rate	Assumptions
2023	65	8%	Continued use in CTCL, ongoing trials
2024	71	9%	New combination trial approvals
2025	78	10%	Expanded indications, global licensing
2026	85	9%	Market penetration increases
2027	92	8%	Regulatory approvals in additional regions

The CAGR for Vorinostat's segment is projected at approximately 8.5% through 2027, driven by pipeline developments and broader clinical adoption.

Key Takeaways

• Vorinostat remains primarily approved for CTCL, with active research into leukemia, lung, and other cancers.
• Over 20 clinical trials investigate its efficacy and safety profile.
• The global HDAC inhibitor market was estimated at USD 300 million in 2022; Vorinostat accounts for roughly 20%.
• Market expansion depends on successful trial outcomes, new indication approvals, and competition with newer HDAC inhibitors.
• Revenue forecast suggests moderate growth, with upward potential from pipeline progress and geographic expansion.

FAQs

1. What are Vorinostat’s primary approved indications?
   Vorinostat is approved in the US for cutaneous T-cell lymphoma (CTCL).

2. Are there new indications under clinical development for Vorinostat?
   Yes, clinical trials explore its use in AML, non-small cell lung cancer, and combination therapies for various cancers.

3. What challenges limit Vorinostat’s market growth?
   Efficacy limitations, adverse effects, competition from targeted therapies, and restricted approved indications.

4. How does Vorinostat compare to other HDAC inhibitors?
   Vorinostat is earlier in the market, with a narrower approved scope, and faces competition from Romidepsin and Belinostat, which have broader indications.

5. What is the outlook for Vorinostat's future sales?
   Moderate growth driven by pipeline success and potential indication expansions. Growth is expected to stabilize without new major approvals.

References

[1] ClinicalTrials.gov. (2023). Clinical Trials for Vorinostat. https://clinicaltrials.gov/ct2/results?cond=&term=Vorinostat&cntry=&state=&city=&dist=

[2] MarketsandMarkets. (2022). HDAC Inhibitors Market. https://www.marketsandmarkets.com/Market-Reports/hdac-inhibitors-market-146266689.html

[3] FDA. (2006). FDA approves Zolinza for cutaneous T-cell lymphoma. https://www.fda.gov/news-events/press-announcements/fda-approves-zolinza-cutaneous-t-cell-lymphoma

[4] GlobalData. (2023). Oncology Pipeline Tracker. https://www.globaldata.com/pipeline-tracker/