CLINICAL TRIALS PROFILE FOR RITUXAN

Biosimilar Clinical Trials for RITUXAN

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.
NCT04555811 ↗	FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL	Recruiting	Masonic Cancer Center, University of Minnesota	Phase 1	2020-09-22	This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
NCT05065554 ↗	ACALA-R In Anti-MAG Neuropathy Mediated Neuropathy	Not yet recruiting	AstraZeneca	Phase 2	2021-11-01	In this research study, is combining a new treatment acalabrutinib with a standard treatment, rituximab or other CD20 antibody, to determine whether this combination is safe and effective for participants with Immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance ( IgM MGUS) or Waldenström macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: - Acalabrutinib - Rituximab or similar CD20 antibody
NCT05065554 ↗	ACALA-R In Anti-MAG Neuropathy Mediated Neuropathy	Not yet recruiting	Jorge J. Castillo, MD	Phase 2	2021-11-01	In this research study, is combining a new treatment acalabrutinib with a standard treatment, rituximab or other CD20 antibody, to determine whether this combination is safe and effective for participants with Immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance ( IgM MGUS) or Waldenström macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: - Acalabrutinib - Rituximab or similar CD20 antibody

All Clinical Trials for RITUXAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003204 ↗	Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1998-03-01	Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by rituximab or observation in treating patients who have stage III or stage IV low-grade non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which regimen of combination chemotherapy, with or without rituximab, is more effective for non-Hodgkin's lymphoma
NCT00003397 ↗	Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma	Completed	University of Maryland Greenebaum Cancer Center	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
NCT00003397 ↗	Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma	Completed	University of Maryland	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
NCT00003397 ↗	Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma	Completed	University of Maryland, Baltimore	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
NCT00003554 ↗	Rituximab in Treating Patients With Multiple Myeloma	Completed	The Cleveland Clinic	Phase 2	1998-11-01	RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them. PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed.

Clinical Trial Conditions for RITUXAN

Condition Name

Condition Name for RITUXAN
Intervention	Trials
Lymphoma	117
Leukemia	59
Chronic Lymphocytic Leukemia	53
Mantle Cell Lymphoma	39

Condition MeSH

Condition MeSH for RITUXAN
Intervention	Trials
Lymphoma	383
Lymphoma, Non-Hodgkin	167
Leukemia	149
Lymphoma, B-Cell	141

Clinical Trial Locations for RITUXAN

Trials by Country

Trials by Country for RITUXAN
Location	Trials
Australia	66
France	57
Germany	42
Poland	38
United Kingdom	32

Trials by US State

Trials by US State for RITUXAN
Location	Trials
Texas	194
New York	130
California	128
Ohio	106
Massachusetts	84

Clinical Trial Progress for RITUXAN

Clinical Trial Phase

Clinical Trial Phase for RITUXAN
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	14
Phase 3	64

Clinical Trial Status

Clinical Trial Status for RITUXAN
Clinical Trial Phase	Trials
Completed	298
Recruiting	103
Terminated	94

Clinical Trial Sponsors for RITUXAN

Sponsor Name

Sponsor Name for RITUXAN
Sponsor	Trials
National Cancer Institute (NCI)	183
M.D. Anderson Cancer Center	125
Genentech, Inc.	79

Sponsor Type

Sponsor Type for RITUXAN
Sponsor	Trials
Other	637
Industry	422
NIH	217

Clinical Trials Update, Market Analysis, and Projection for RITUXAN (Rituximab)

Last updated: October 26, 2025

Introduction

Rituximab, marketed as RITUXAN, is a monoclonal antibody developed by Genentech (a subsidiary of Roche) and approved by the U.S. Food and Drug Administration (FDA) in 1997. It targets CD20-positive B cells, making it a cornerstone in treating hematologic malignancies and autoimmune disorders. This analysis provides an updated overview of ongoing clinical trials, a comprehensive market assessment, and future growth projections for RITUXAN within the global pharmaceutical landscape.

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Clinical Trials Update

1. Ongoing and Recent Clinical Trials

Recent years have seen persistent research efforts to expand RITUXAN’s therapeutic applications and enhance its efficacy. According to ClinicalTrials.gov, over 150 registered trials evaluate RITUXAN across diverse indications, including hematology, oncology, autoimmune diseases, and combination therapies.

Significant studies include:

• Rituximab in Frontline Treatment of Chronic Lymphocytic Leukemia (CLL): Multiple phase III trials investigate combinations with chlorambucil or new targeted agents. Results consistently demonstrate improved progression-free survival (PFS), affirming RITUXAN’s role as a backbone in CLL therapy [1].

• Autoimmune Disorders: Several ongoing Phase II and III trials assess rituximab's use in rheumatoid arthritis (RA), especially in patients refractory to standard treatments, as well as in multiple sclerosis (MS) and autoimmune hematologic conditions. Recent data show promising effects in reducing disease activity and corticosteroid dependence [2].

• Novel Formulations & Bi-specific Constructs: Trials are exploring subcutaneous formulations to improve patient compliance, reducing infusion times and adverse reactions. Bi-specific antibodies combining rituximab with other targeting agents are under clinical investigation to overcome resistance issues [3].

2. Regulatory Approvals & Label Expansions

Anticipated updates include extensions of indications:

• Autoimmune Hemolytic Anemia (AIHA): Approved in certain regions for refractory AIHA based on recent positive trial outcomes.

• Combination Therapies: Regulatory bodies are reviewing data on RITUXAN combined with novel agents such as Ibrutinib or Venetoclax in hematological malignancies, which may lead to label extensions.

3. Safety & Efficacy Trends

Clinical data affirm RITUXAN’s established safety profile. While infusion reactions and immunosuppression-related infections remain concerns, ongoing trials aim to optimize dosing schedules and mitigate adverse events.

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Market Analysis

1. Market Size and Revenue

The global rituximab market was valued at approximately $8.9 billion in 2022 and is projected to reach $16.2 billion by 2030, growing at a compound annual growth rate (CAGR) of around 8.1%. The key drivers include expanding indications, biosimilar entrants, and increasing adoption of targeted biologics.

2. Market Segmentation

• Hematological Malignancies: The largest segment, driven by lymphoma and CLL treatment. RITUXAN remains the standard first-line therapy, with an estimated 60-65% market share among monoclonal antibodies targeting B-cell cancers.

• Autoimmune Diseases: Growing usage in RA, MS, and vasculitis, constituting roughly 25% of the revenue share. Increasing prevalence of autoimmune conditions and improved efficacy data bolster future growth.

• Biosimilars Impact: Since patent expiration in 2018 in the U.S. and Europe, several biosimilar versions (e.g., Truxima, Ruxience, and Ritemvia) have entered markets, exerting price pressures but also expanding access.

3. Geographic Market Analysis

• North America: Dominates, accounting for over 45% of the market, driven by high healthcare spending, extensive clinical infrastructure, and established treatment protocols.

• Europe: Second-largest market, with a CAGR similar to North America, boosted by regulatory approvals and expanding indications.

• Asia-Pacific: Fastest-growing region due to increasing healthcare infrastructure, rising autoimmune disease prevalence, and local manufacturing, with forecasts indicating a CAGR of over 10%.

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Market Projections and Future Outlook

1. Drivers of Growth

• Expanded Indications: Ongoing trials and regulatory approvals in autoimmune conditions and rare diseases will broaden RITUXAN’s application spectrum.

• Biologic and Biosimilar Competition: While biosimilars exert downward pressure on prices, they also facilitate greater access, especially in low- and middle-income countries.

• Combination Therapies and Personalized Medicine: Integration with novel agents enhances efficacy and could set new treatment standards, fostering premium pricing for specialized regimens.

• Digitalization & Manufacturing Advances: Improved manufacturing efficiencies and real-world data collection will optimize supply chains and patient management.

2. Challenges and Risks

• Pricing Pressures: Biosimilar entry continues to threaten margins, particularly in mature markets.

• Safety Concerns: Long-term safety, especially regarding immunosuppression and infection risk, remains under surveillance, potentially affecting prescribing patterns.

• Regulatory Variability: Delays or restrictions in emerging markets could hinder global expansion.

3. Future Market Trends

• Market Growth: Estimated to sustain a CAGR of 7-8% through 2030, driven mainly by autoimmune disease applications and new combination protocols.

• Innovation Pipeline: Bi-specific antibodies and novel delivery systems could revolutionize RITUXAN’s administration and efficacy, enabling potential premium pricing and longer-term market growth.

• Pipeline Integration: The integration of RITUXAN with CAR-T cell therapies and other cell-based treatments might position it as part of multi-modality regimens, expanding usage.

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Key Takeaways

• Strong Clinical Trial Portfolio: RITUXAN remains a pivotal therapy for hematologic cancers and autoimmune disorders, with numerous ongoing trials enhancing its application scope and optimizing its efficacy profile.

• Market Expansion & Competition: While biosimilars have increased price competition, RITUXAN’s proven efficacy and expanding indications sustain its market presence.

• Growth Forecast: The rituximab market is poised for steady growth, driven by emerging indications, combination therapies, and expanding geographies, with an expected CAGR of approximately 7-8% through 2030.

• Innovation & Adoption Potential: Advances in formulation, personalized medicine, and combination strategies offer opportunities for increased market share and improved patient outcomes.

• Regulatory & Safety Considerations: Monitoring ongoing safety data and regulatory developments remains crucial for long-term planning.

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FAQs

1. What are the primary indications for RITUXAN today?
RITUXAN is primarily approved for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

2. How have biosimilars impacted RITUXAN’s market?
Biosimilars introduced since 2018 have intensified price competition, leading to revenue declines in certain markets but also broader access and market expansion in developing regions.

3. Are there promising new clinical applications for rituximab?
Yes. Trials exploring rituximab’s use in autoimmune hematologic conditions, such as autoimmune hemolytic anemia, and in combination with novel agents for resistant cancers, show promising results.

4. How is the safety profile of RITUXAN influencing its use?
While generally well-tolerated, risks like infusion reactions and immunosuppression persist. Ongoing research aims to mitigate these issues, influencing prescribing protocols.

5. What is the outlook for RITUXAN’s future market share?
With ongoing clinical advancements, expanded indications, and increasing adoption worldwide, RITUXAN’s market share is expected to remain significant, though it faces stiff competition from biosimilars and emerging therapies.

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References

[1] ClinicalTrials.gov. (2023). List of ongoing trials involving Rituximab.
[2] European League Against Rheumatism. (2022). Rituximab in autoimmune disorders.
[3] Roche. (2022). RITUXAN formulation and biosimilar development updates.