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.

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
Lung Adenocarcinoma	1

Condition MeSH

Condition MeSH for ZIEXTENZO
Intervention	Trials
Lymphoma	6
Lymphoma, B-Cell	4
Lymphoma, Large B-Cell, Diffuse	3
Lymphoma, Follicular	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
Illinois	7
Florida	7
Missouri	7
California	6
Washington	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
Bayer	1

Sponsor Type

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

ZIEXTENZO (pegfilgrastim): Clinical Trial Update, Market Analysis, and Projection

Last updated: May 8, 2026

What is ZIEXTENZO and where does it sit in the pegfilgrastim landscape?

ZIEXTENZO is a biosimilar to Neulasta (pegfilgrastim), targeting prevention of chemotherapy-induced neutropenia and febrile neutropenia in patients receiving myelosuppressive anti-cancer therapy. The product is administered as a subcutaneous injection and is built on the pegfilgrastim mechanism (G-CSF analog) that supports neutrophil recovery after chemotherapy.

Competitive context

• Reference product: Neulasta and related formulations (including on-body injector variants).
• Biosimilar class includes: multiple pegfilgrastim biosimilars launched across major markets, competing primarily on acquisition cost, formulary placement, and administration pathway fit (manual injection versus on-body device workflows).

Key market drivers

• High and stable utilization in oncology regimens that require G-CSF prophylaxis.
• Formulary and budget pressure from patent-expired biologics and ongoing substitution of reference with biosimilars.
• Hospital procurement behavior that favors predictable contracting, tendering, and low administration friction.

What is the latest clinical trial and evidence profile for ZIEXTENZO?

No actionable, dated clinical trial update set can be produced from the information available in this prompt alone. A complete clinical-trials update requires verifiable identifiers (trial registries, protocol names, study dates, endpoints, and results) tied specifically to ZIEXTENZO, not the pegfilgrastim class.

Result: The response cannot include a complete and accurate ZIEXTENZO-specific clinical-trial update without underlying, citable trial data.

How big is the pegfilgrastim biosimilar market and where does ZIEXTENZO compete?

Addressable use case

ZIEXTENZO competes in the segment of oncology supportive care where G-CSF prophylaxis is used to reduce:

• Severe neutropenia
• Febrile neutropenia
• Treatment delays and dose reductions associated with neutropenia risk

Where competition happens

Pricing and share capture are driven by:

• Formulary adoption at hospital networks
• Tender outcomes for biosimilar supply
• Switching policies (reference-to-biosimilar and between biosimilars)
• Clinical equivalence acceptance by oncology and hematology service lines

Market shares and growth mechanics (projection structure)

A credible projection model for ZIEXTENZO requires:

• Current brand-level share of pegfilgrastim biosimilars in each geography
• Sequencing of launches by biosimilar cohorts
• Net price vs list price and contract intensity
• Uptake curves by infusion center versus outpatient clinics
• Retention through subsequent tenders

Result: A numeric, market-share-grade projection cannot be produced with accuracy from this prompt alone.

What revenue and volume projection can be stated for ZIEXTENZO?

A complete market projection requires at least one of the following:

• Actual sales/units data for ZIEXTENZO (quarterly or annual)
• Public biosimilar market forecasts with ZIEXTENZO-specific positioning
• Published guidance from the marketer tied to ZIEXTENZO

Result: No accurate ZIEXTENZO revenue and unit projections can be stated without those data inputs.

What business signals matter for investors and R&D planners?

Even without numeric forecasts, the following are the decision-grade signals that determine outcomes for pegfilgrastim biosimilars such as ZIEXTENZO:

1. Formulary wins
   • Evidence of tier placement and automatic substitution rules in large oncology networks.
2. Tender performance
   • Relative competitiveness in multi-year procurement contracts.
3. Switching cadence
   • Rate of reference-to-biosimilar conversion and biosimilar-to-biosimilar switching after tenders.
4. Supply reliability
   • Ability to maintain contracted volumes without backorders (affects retention).
5. Administration pathway fit
   • Hospital workflow preference (single injection scheduling) and coordination with infusion calendars.
6. Lifecycle management
   • Expansion of label or studies supporting additional clinical settings.

These indicators are observable in payer contracting and hospital formularies, not in mechanism-level reasoning.

Key Takeaways

• ZIEXTENZO is a pegfilgrastim biosimilar positioned in chemotherapy supportive care to prevent neutropenia and febrile neutropenia.
• A ZIEXTENZO-specific clinical trials update cannot be produced accurately from the information provided in the prompt.
• A ZIEXTENZO-specific market analysis and numeric projections cannot be produced accurately without sales/market-share inputs tied to ZIEXTENZO.
• Decision-grade evaluation should focus on formulary adoption, tender outcomes, switching cadence, supply reliability, and workflow fit.

FAQs

1) Is ZIEXTENZO approved for prevention of febrile neutropenia?
It is positioned for prevention of chemotherapy-induced neutropenia and febrile neutropenia as part of supportive oncology care.

2) How do pegfilgrastim biosimilars gain share in hospitals?
Through formulary placement, tender contracts, substitution policies, and retention driven by consistent supply and predictable administration workflows.

3) What clinical evidence format matters most for biosimilar acceptance?
Comparable efficacy and safety evidence aligned to the reference pegfilgrastim product, typically supported by biosimilar analytical similarity and at least one clinical comparative study.

4) What drives pegfilgrastim biosimilar pricing?
Hospital contracting pressure, competitive tender dynamics among biosimilars, and reimbursement incentives that reward lower net acquisition cost.

5) What is the fastest route to revenue for a pegfilgrastim biosimilar?
Large-network formulary adoption paired with multi-year tender commitments that lock in volume.

References

[1] No cited sources were provided in the prompt.