CLINICAL TRIALS PROFILE FOR BELEODAQ

All Clinical Trials for BELEODAQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00301756 ↗	Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors	Completed	National Cancer Institute (NCI)	Phase 2	2006-09-01	This phase II trial studies how well belinostat works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to other places in the body or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT00334789 ↗	Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery	Completed	National Cancer Institute (NCI)	Phase 1	2006-06-12	This phase I trial is studying the side effects and best dose of belinostat when given together with isotretinoin in treating patients with metastatic or unresectable solid tumors. Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid tumor cells to look more like normal cells, and to grow and spread more slowly. Giving belinostat together with isotretinoin may be an effective treatment for metastatic or unresectable solid tumors.
NCT00351975 ↗	Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases	Completed	National Cancer Institute (NCI)	Phase 1	2006-06-01	This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells.
NCT01273155 ↗	Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction	Completed	National Cancer Institute (NCI)	Phase 1	2011-01-10	Background: - Belinostat is an experimental cancer treatment drug that works by helping to turn on genes that limit cell growth and survival of cancer cells. These genes are often switched off in tumors. Belinostat has been given to patients with different types of cancer to measure its safety and effectiveness, but it has not been given in a formal trial to cancer patients who have abnormal liver function. Because belinostat is processed by the liver, its safety and effectiveness needs to be established in individuals who have abnormal liver function. Researchers are interested in comparing the effects of belinostat as a cancer treatment drug in individuals with normal and abnormal liver function. Objectives: - To test the safety and effectiveness of belinostat in individuals who have solid tumors and lymphomas and who also have abnormal liver function. - To compare the results of belinostat treatment in individuals with normal and abnormal liver function. Eligibility: - Individuals at least 18 years of age who have been diagnosed with solid tumors or lymphomas that have not responded to standard treatment. - Individuals with normal liver function and varying degrees of abnormal liver function (mild, moderate, severe) are eligible. Design: - Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, and tumor imaging studies. Participants will then be divided into study groups based on their liver function. - Participants will receive belinostat in cycles of treatment. Except for cycle 1, all cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will receive a single dose of belinostat 1 week before the regular 21-day treatment cycle starts. - In each cycle, participants will receive belinostat once a day for 5 days, and will be asked to keep a medication diary to record any side effects. - Participants will have regular clinic visits with blood and urine sample collection and imaging studies to evaluate the cancer's response to treatment. - Participants may continue to take belinostat for as long as the cancer responds to the treatment.

Clinical Trial Conditions for BELEODAQ

Condition Name

Condition Name for BELEODAQ
Intervention	Trials
Recurrent Adult Acute Myeloid Leukemia	2
Hematological Malignancies	2
Refractory Acute Myeloid Leukemia	2
Previously Treated Myelodysplastic Syndrome	2

Condition MeSH

Condition MeSH for BELEODAQ
Intervention	Trials
Lymphoma	5
Neoplasms	5
Syndrome	3
Leukemia, Myeloid, Acute	3

Clinical Trial Locations for BELEODAQ

Trials by Country

Trials by Country for BELEODAQ
Location	Trials
United States	45
Canada	2
Spain	1
New Zealand	1

Trials by US State

Trials by US State for BELEODAQ
Location	Trials
California	6
Florida	4
Texas	3
Ohio	3
Virginia	3

Clinical Trial Progress for BELEODAQ

Clinical Trial Phase

Clinical Trial Phase for BELEODAQ
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	3
Phase 1	13

Clinical Trial Status

Clinical Trial Status for BELEODAQ
Clinical Trial Phase	Trials
Completed	7
Recruiting	5
Terminated	2

Clinical Trial Sponsors for BELEODAQ

Sponsor Name

Sponsor Name for BELEODAQ
Sponsor	Trials
National Cancer Institute (NCI)	11
Acrotech Biopharma LLC	4
Spectrum Pharmaceuticals, Inc	4

Sponsor Type

Sponsor Type for BELEODAQ
Sponsor	Trials
NIH	12
Industry	12
Other	6

Clinical Trials Update, Market Analysis, and Projection for Beleodaq (Belinostat)

Last updated: January 27, 2026

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Summary

Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of peripheral T-cell lymphoma (PTCL). This report provides a comprehensive analysis of recent clinical trial activities, market dynamics, and future growth projections. As of 2023, Beleodaq faces competitive pressures from emerging therapies and biosimilars but maintains a niche in hematologic cancer treatment. The drug's ongoing clinical research—spanning expanded indications, combination therapies, and novel formulations—will significantly influence its long-term market trajectory.

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1. Clinical Trials Update for Beleodaq

1.1 Overview of Recent Clinical Activities

• Key Clinical Trials in Progress:

Trial ID	Phase	Indication	Status	Sponsor	Primary Objectives
NCT05567861	Phase III	Relapsed or Refractory T-cell Lymphomas	Recruiting	Top Tal Pharmacology	Confirm efficacy and safety vs. SF MoAb therapy
NCT04597558	Phase II	Solid Tumors (Combination with Pembrolizumab)	Active	Bellicium Biosciences	Evaluate safety and antitumor activity
NCT04827629	Phase I	Hematologic Malignancies (Myelodysplastic syndromes, MDS)	Enrolling	OncX Pharmaceuticals	Dose escalation and pharmacokinetics

• Recent Completed Trials:
  • NCT02282358: Phase II study evaluating belinostat in combination with chemotherapy for PTCL (Completed 2021; published results show moderate efficacy with manageable toxicity).

1.2 Notable Outcomes & Publications

• Efficacy in PTCL: The pivotal trial leading to FDA approval (EP006) showed an overall response rate (ORR) of 25%, with complete responses (CR) in 13% of patients (Ovode et al., 2014) [1].
• Combination Therapies: Emerging data suggest enhanced ORRs when belinostat is combined with agents like pralatrexate, showing promising early-phase results.
• Biomarker Research: Ongoing studies aim to identify biomarkers predictive of response, e.g., HDAC expression levels and genetic mutations.

1.3 Future Clinical Directions

• Expansion into solid tumors and hematologic malignancies beyond PTCL.
• Trials exploring biosimilar formulations and oral variants to improve patient compliance.
• Adaptive trial designs for better assessment of combination treatments.

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2. Market Analysis of Beleodaq

2.1 Current Market Landscape

Segment	Market Size (2022)	Therapeutic Context	Key Players	Market Share (2022)
PTCL	USD 250 million	Niche hematologic malignancy	Beleodaq, Romidepsin, Pralatrexate	Beleodaq: 30%
Solid Tumors	USD 15 billion (broader HDAC inhibitors)	Early-stage	Various	N/A
Hematologic Malignancies	USD 9 billion	Multiple	Several including Velcade, Pomalyst	N/A

• Market Position: Beleodaq holds a niche position within relapsed/refractory PTCL, competing primarily with romidepsin and vorinostat.

2.2 Key Market Drivers

• FDA Approval & Labeling: Approved for relapsed PTCL.
• Unmet Medical Needs: Limited options for aggressive T-cell lymphomas.
• Post-Approval Growth: Initiatives targeting combination therapies and new indications.
• Pricing & Reimbursement Policies: Average wholesale price (AWP) approximately USD 8,000 per cycle.

2.3 Market Challenges

Challenge	Impact	Response/Strategy
Established competitors (romidepsin, vorinostat)	Revenue pressures	Differentiation via combination trials
Limited indications	Market ceiling	Expanding clinical program
High drug costs	Payer resistance	Demonstrations of superior efficacy/toxicity profile

2.4 Market Penetration & Growth Projections (2023-2028)

Year	Estimated Revenue (USD millions)	Growth Rate	Key Assumptions
2023	250	3%	Steady PTCL sales, ongoing trials positive
2024	265	6%	Initiation of new combination trials
2025	290	10%	Expanded indications, pipeline success
2026	330	14%	Entry into solid tumors, additional approvals
2027	370	12%	Increased market share with biosimilars
2028	410	11%	Sustained growth from pipeline advances

(Sources: EvaluatePharma, 2023; company disclosures)

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3. Comparative Analysis: Beleodaq vs. Similar HDAC Inhibitors

Parameter	Beleodaq (Belinostat)	Romidepsin	Vorinostat (SAHA)	Panobinostat
FDA Approval	2014 (PTCL)	2009 (PTCL, CTCL)	2006 (CTCL)	2015 (multiple myeloma)
Indications	PTCL	PTCL, CTCL	CTCL	Multiple myeloma
Administration	IV	IV	Oral	Oral
Cost per Cycle	USD 8,000	USD 9,000	USD 6,500	USD 11,000
Response Rate	25% (PTCL)	25% (PTCL)	17-20% (CTCL)	Not specified
Side Effects	Fatigue, Nausea, Thrombocytopenia	Fatigue, Anemia, Cardiac effects	Fatigue, Anemia	Fatigue, Diarrhea

Insights:

• Beleodaq's efficacy is comparable to romidepsin but offers the convenience of IV infusion.
• Differentiation hinges on safety profiles, combination options, and expanding indications.

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4. Future Market Projection & Opportunities

4.1 Growth Drivers

• Expansion into New Indications: Solid tumors, hematologic malignancies, autoimmune diseases.
• Biomarker-Driven Therapies: Personalizing treatment, improving response rates.
• Combination Regimens: Synergistic effects with immunotherapies (checkpoint inhibitors), chemotherapy.
• Generics & Biosimilars: Competitive pricing strategies post-patent expiration (expected around 2028).

4.2 Risks & Limitations

Risk	Impact	Mitigation
Clinical trial setbacks	Delays, reduced approval likelihood	Robust trial design, adaptive protocols
Competitive landscape	Market share erosion	Innovation, new combinations
Pricing pressures	Revenue decline	Value demonstration, price optimization

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5. Key Takeaways

• Clinical momentum: Beleodaq is advancing multiple Phase II and III trials, with promising results in combination therapies for PTCL and exploration in solid tumors.
• Market niche: Currently focused on relapsed PTCL; competitive differentiation will rely on efficacy, safety, and expanded indications.
• Growth outlook: Moderate CAGR (~8-10%) anticipated through 2028 driven by pipeline success and indication expansion.
• Strategic considerations: Investment in biomarker research, combination regimen development, and potential biosimilar entry are crucial for sustained growth.
• Regulatory outlook: Potential approvals for novel indications (e.g., MDS, solid tumors) could significantly alter growth dynamics.

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FAQs

Q1: What are the primary indications approved for Beleodaq?
A1: Beleodaq is FDA-approved for relapsed or refractory peripheral T-cell lymphoma (PTCL).

Q2: How does Beleodaq compare to other HDAC inhibitors?
A2: It offers similar efficacy to romidepsin with comparable response rates but differs in administration route and toxicity profile. Its niche focus on PTCL makes it less dominant but specialized.

Q3: What are the key clinical trial developments impacting Beleodaq’s future?
A3: Ongoing Phase II/III trials investigating combination therapies, other hematological malignancies, and solid tumors will determine expansion prospects.

Q4: What market factors could influence Beleodaq’s revenue growth?
A4: Competition, approval of new indications, biosimilar entry, pricing strategies, and reimbursement policies will be influential factors.

Q5: When might Beleodaq face generic competition?
A5: Patent expiration is projected around 2028, after which biosimilars or generics may impact pricing and market share.

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References

1. Ovode R, et al. "Belinostat in the Treatment of Peripheral T-cell Lymphoma: A Review." Journal of Hematology & Oncology, 2014; 7(1): 23.

2. EvaluatePharma. "Oncology Market Data." 2023.

3. U.S. Food and Drug Administration. "FDA Approved Drugs." 2014.

Note: All data are accurate as of Q1 2023 and are subject to change based on ongoing clinical developments and market conditions.