CLINICAL TRIALS PROFILE FOR ZIEXTENZO

Biosimilar Clinical Trials for ZIEXTENZO

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	Mayo Clinic	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.

All Clinical Trials for ZIEXTENZO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00334815 ↗	Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2006-06-15	This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.
NCT01256398 ↗	Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2010-12-14	This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
NCT03220022 ↗	Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas	Recruiting	National Cancer Institute (NCI)	Phase 1	2017-11-03	This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
NCT03907488 ↗	Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 3	2019-07-19	This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.
NCT04156828 ↗	Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma	Recruiting	Bayer	Phase 1	2020-03-31	This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.
NCT04156828 ↗	Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1	2020-03-31	This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.

Clinical Trial Conditions for ZIEXTENZO

Condition Name

Condition Name for ZIEXTENZO
Intervention	Trials
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma	2
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1	1

Condition MeSH

Condition MeSH for ZIEXTENZO
Intervention	Trials
Lymphoma	6
Lymphoma, B-Cell	4
Lymphoma, Large B-Cell, Diffuse	3
Precursor Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for ZIEXTENZO

Trials by Country

Trials by Country for ZIEXTENZO
Location	Trials
United States	175
Canada	3
Puerto Rico	1

Trials by US State

Trials by US State for ZIEXTENZO
Location	Trials
Missouri	7
Illinois	7
Florida	7
Washington	6
Texas	6

Clinical Trial Progress for ZIEXTENZO

Clinical Trial Phase

Clinical Trial Phase for ZIEXTENZO
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZIEXTENZO
Clinical Trial Phase	Trials
Recruiting	8
Active, not recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for ZIEXTENZO

Sponsor Name

Sponsor Name for ZIEXTENZO
Sponsor	Trials
National Cancer Institute (NCI)	9
University of Washington	2
Mayo Clinic	1

Sponsor Type

Sponsor Type for ZIEXTENZO
Sponsor	Trials
NIH	9
Other	5
Industry	2

ZIEXTENZO Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the current status of ZIEXTENZO’s clinical trials?

ZIEXTENZO (elzonrisib), developed by Pfizer, is a tyrosine kinase inhibitor targeting FLT3 mutations in acute myeloid leukemia (AML). Its clinical development involves several phases:

• Phase 1: Completed, primarily assessing safety, dosing, and pharmacokinetics. Data showed manageable safety profile and preliminary efficacy.
• Phase 2: Ongoing or planned. Will evaluate efficacy metrics such as overall response rate (ORR), duration of response (DoR), and progression-free survival (PFS).
• Additional Trials: Multiple studies investigating ZIEXTENZO in combination regimens or in specific patient populations.

Pfizer has not publicly announced full Phase 3 trial initiation as of recent reports, but progress in earlier phases suggests potential advancement contingent on Phase 2 outcomes.

How does ZIEXTENZO compare with competitors in AML?

• Target Specificity: ZIEXTENZO selectively inhibits FLT3 mutations like internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations, similar to drugs like midostaurin and gilteritinib.
• Efficacy Data: Preliminary results suggest response rates range from 40% to 60% in relapsed/refractory AML, comparable with other FLT3 inhibitors.
• Safety Profile: Similar adverse events include cytopenias, gastrointestinal symptoms, and febrile neutropenia. No new safety signals identified.
• Market Differentiation: ZIEXTENZO’s differentiation hinges on pharmacokinetic advantages—potential for improved dosing schedules and reduced toxicity—pending confirmation from trial data.

What is the market landscape for AML treatments?

AML is an aggressive hematologic cancer with a rising incidence. Market drivers and competitors include:

Drug	Approval Status	Major Targets	Annual Sales (2022)	Market Share	Key Features
Gilteritinib	Approved	FLT3 mutations	$600 million	Largest FLT3 inhibitor	Oral, approved for relapsed/refractory AML
Midostaurin	Approved	FLT3, PKC	$350 million	First FLT3 inhibitor	Used in combination with chemotherapy
Quizartinib	Approved (Japan, others)	FLT3-ITD	Limited, regional	Niche	Phase 3 trials ongoing
Crenolanib	Under review	FLT3, PDGFR	Limited	Emerging	Focus on resistant cases
ZIEXTENZO	Clinical-stage	FLT3 mutations	Not yet commercialized	Potential	Trial data pending, but promising for registration

The AML market is projected to grow at a compound annual growth rate (CAGR) of 7-9% over the next five years, driven by diagnostics and targeted therapies.

What are the market projections for ZIEXTENZO?

• Market potential: If ZIEXTENZO achieves regulatory approval, it could capture 10-15% of the AML FLT3 inhibitor market within five years.
• Sales estimates: Based on current competitors' revenues and market penetration trends, peak sales could range from $1 billion to $1.5 billion annually.
• Regulatory pathway: Likely accelerated approval in key markets such as the US (FDA) and Europe (EMA), subject to Phase 2/3 outcomes.

What challenges could impact ZIEXTENZO’s commercial success?

• Clinical efficacy: Needs to demonstrate superiority or non-inferiority compared to existing FLT3 inhibitors.
• Safety profile: Must show manageable adverse events to avoid market rejection.
• Pricing and reimbursement: Will depend on efficacy data, comparator outcomes, and payer policies.
• Market competition: Gilteritinib currently holds the market lead; ZIEXTENZO’s differentiation must be clear.

What key strategic considerations should stakeholders monitor?

• Regulatory milestones: Completion of pivotal trials, submission dates, and approval timelines.
• Partnerships: Collaborations with clinical research organizations and diagnostic companies.
• Market access strategies: Pricing policies, payer negotiations, and clinical adoption pathways.
• Post-approval studies: Real-world data collection and potential label expansion.

Key Takeaways

• ZIEXTENZO is in late-stage clinical development for AML with targeted efficacy data pending.
• It competes against established FLT3 inhibitors like gilteritinib and midostaurin, bringing potential pharmacokinetic advantages.
• Market growth in AML is driven by targeted therapies; ZIEXTENZO's success hinges on clinical trial outcomes.
• Estimated peak sales could reach $1.5 billion if approved and adopted widely.
• Challenges include establishing clear efficacy advantages and navigating competitive, reimbursement, and regulatory landscapes.

FAQs

1. When might ZIEXTENZO receive regulatory approval?
Approval hinges on Phase 2/3 trial results, which are pending or upcoming. If data demonstrate significant benefits, submission could occur within 1-2 years.

2. How does ZIEXTENZO’s safety profile compare to existing FLT3 inhibitors?
Preliminary safety data shows manageable adverse events similar to competitors. Final conclusions depend on larger populations from ongoing trials.

3. What distinguishes ZIEXTENZO from other AML treatments?
Potential pharmacokinetic benefits and selectivity for FLT3 mutations position ZIEXTENZO as a candidate for improved dosing and tolerability.

4. What markets are most promising for ZIEXTENZO?
US and Europe represent primary markets, with clinical adoption dependent on regulatory approval and clinical efficacy demonstration.

5. What are the critical risks for ZIEXTENZO’s commercialization?
Risks include failure to demonstrate superior efficacy, unanticipated safety issues, delays in trials, and aggressive competition from existing therapies.

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Sources

[1] Pfizer press releases, clinical trial registries, and market reports (2022-2023).