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.
NCT01583777 ↗	Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer	Completed	Acrotech Biopharma LLC	Phase 1	2013-09-01	The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy.
NCT01583777 ↗	Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer	Completed	Spectrum Pharmaceuticals, Inc	Phase 1	2013-09-01	The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy.

Clinical Trial Conditions for Beleodaq

Condition Name

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

Condition MeSH

Condition MeSH for Beleodaq
Intervention	Trials
Neoplasms	5
Lymphoma	5
Lymphoma, Non-Hodgkin	3
Syndrome	3

Clinical Trial Locations for Beleodaq

Trials by Country

Trials by Country for Beleodaq
Location	Trials
United States	45
Canada	2
New Zealand	1
Spain	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
Not yet recruiting	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

Beleodaq (belinostat): Clinical Trials Update and Market Outlook

Last updated: April 28, 2026

What is Beleodaq and what is its current clinical posture?

Beleodaq is belinostat, an HDAC (histone deacetylase) inhibitor. Commercial and regulatory positioning is anchored in its approved indication for relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least one prior therapy.

Where is Beleodaq in the clinical trial landscape right now?

A complete, current “trial-by-trial” update (by study ID, status, NCT number, enrollment, endpoints, timelines, and readout dates) requires up-to-date trial registries and sponsor disclosures. The prompt does not provide that dataset, and producing it without verified, traceable sources would risk inaccuracy.

What is the approved market scope and how does adoption typically play out?

Beleodaq’s commercial addressable market is limited by:

• Indication specificity: relapsed or refractory PTCL after prior therapy.
• Treatment-line constraint: patients often transition quickly to alternative regimens or clinical trials, which compresses sustainable annual scripts versus broader oncology launches.
• Competitive class dynamics: HDAC inhibitor use is constrained by efficacy comparisons, sequencing, and toxicity tolerance in heavily pretreated lymphoma.

How do you frame market analysis for Beleodaq without trial-by-trial data?

For an actionable market projection, the relevant levers are:

• Treated-prevalence of relapsed/refractory PTCL in target geographies.
• Share-of-therapy for HDAC inhibitors in that setting.
• Conversion of uptake into durable revenue streams (formulary position, reimbursement stability, and patient retention per course of therapy).
• Erosion from label expansion (if any) or from new entrants that displace HDAC inhibitor sequencing.

With the absence of current, validated claims about ongoing studies, label expansion, or new efficacy readouts, a numerical forecast would be speculative.

Market analysis (structure you can underwrite)

The market can be modeled in a standard oncology commercial framework:

Module	Inputs required for a defensible projection	Decision use
Addressable patient volume	Relapsed/refractory PTCL treated population per geography	Sets ceiling demand
Therapy penetration	Beleodaq share among eligible regimens	Determines uptake
Treatment duration and dosing intensity	Median cycles, dose modifications, discontinuation	Converts patients to units and revenue
Pricing and net-to-gross	List price, discounts, rebates, reimbursement access	Converts units to revenue
Competitive displacement	Evidence-driven sequencing changes	Adjusts share over time

What is the practical investment and R&D takeaway for Beleodaq?

For Beleodaq, the critical business question is whether any new clinical readouts drive:

• A credible incremental efficacy or tolerability profile that changes sequencing in PTCL, or
• A credible expansion into additional lymphoma subtypes or earlier lines with sufficient uptake to overcome limited current label scope.

Absent verified “trial update” data for the current period, the only defensible conclusion is that market trajectory is governed by maintenance of existing uptake and any formally documented label or evidence changes.

Clinical and commercial risk factors that move projections

Key factors that compress or extend Beleodaq’s revenue runway include:

• Efficacy benchmarking in relapsed/refractory PTCL versus modern combination regimens.
• Sequencing shifts based on emerging standards (and payers’ treatment pathways).
• Safety and tolerability in a heavily pretreated, comorbidity-loaded population.
• Access friction (prior authorization, formulary exclusions).
• Competing HDAC inhibitor and non-HDAC modalities that reduce eligible demand.

Projections: what can be stated without fabricated numbers

A projection can be stated directionally, but not quantitatively, without current trial status and market metrics. The defensible directional view is:

• Beleodaq’s market is likely to remain narrow because its approved indication is narrow.
• Revenue growth, if it occurs, depends on label expansion or practice-changing outcomes with measurable uptake impact.
• Without evidence of new practice-changing outcomes in PTCL, the revenue trend is typically flat-to-declining in mature, niche oncology brands due to competitive sequencing and limited patient pools.

Key Takeaways

• Beleodaq (belinostat) is positioned for relapsed or refractory PTCL after prior therapy, which constrains addressable demand.
• A rigorous “clinical trials update” and any numeric market projection require verified trial registry and commercial datasets for the current period; generating them without those inputs would risk incorrect business decisions.
• Beleodaq’s revenue trajectory is primarily driven by evidence that changes PTCL sequencing and by access and penetration in a small, specific patient population.

FAQs

1. What does Beleodaq treat?
   It is approved for relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least one prior therapy.

2. Why is Beleodaq’s market limited versus broader oncology drugs?
   The label is narrow (relapsed/refractory PTCL, post-prior therapy), which caps treated prevalence and eligibility.

3. What would most likely drive revenue growth for Beleodaq?
   Practice-changing clinical evidence that expands label scope or alters PTCL treatment sequencing enough to increase uptake.

4. What are the biggest commercial risks for belinostat?
   Competitive displacement, lack of incremental efficacy in sequencing, and access and reimbursement barriers.

5. Can a numeric market forecast be produced reliably from this request?
   Not from the information provided here, because a correct forecast requires current, sourced data on trials, label status, uptake, pricing, and patient volumes.

References

1. FDA. Beleodaq (belinostat) prescribing information.
2. ClinicalTrials.gov. Belinostat (Beleodaq) search results and study records.