CLINICAL TRIALS PROFILE FOR RUXIENCE

Biosimilar Clinical Trials for RUXIENCE

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

All Clinical Trials for RUXIENCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04189588 ↗	Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine	Completed	TerSera Therapeutics	Phase 2	2020-03-25	This study is designed to compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
NCT04189588 ↗	Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine	Completed	JDP Therapeutics, Inc.	Phase 2	2020-03-25	This study is designed to compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
NCT04189588 ↗	Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine	Completed	TerSera Therapeutics LLC	Phase 2	2020-03-25	This study is designed to compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
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.
NCT04688788 ↗	Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis	Recruiting	Aalborg University Hospital	Phase 3	2021-04-28	The DanNORMS study is phase 3 non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.
NCT04688788 ↗	Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis	Recruiting	Aarhus University Hospital	Phase 3	2021-04-28	The DanNORMS study is phase 3 non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.
NCT04688788 ↗	Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis	Recruiting	Danske Regioner	Phase 3	2021-04-28	The DanNORMS study is phase 3 non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.

Clinical Trial Conditions for RUXIENCE

Condition Name

Condition Name for RUXIENCE
Intervention	Trials
Chronic Lymphocytic Leukemia	3
Small Lymphocytic Lymphoma	2
Autoimmune Diseases of the Nervous System	1
Multiple Sclerosis	1

Condition MeSH

Condition MeSH for RUXIENCE
Intervention	Trials
Leukemia	5
Lymphoma	5
Leukemia, Lymphoid	4
Leukemia, Lymphocytic, Chronic, B-Cell	3

Clinical Trial Locations for RUXIENCE

Trials by Country

Trials by Country for RUXIENCE
Location	Trials
United States	18
Belgium	5
Japan	2
Denmark	2
Netherlands	1

Trials by US State

Trials by US State for RUXIENCE
Location	Trials
California	3
New York	2
Missouri	2
Minnesota	2
Texas	2

Clinical Trial Progress for RUXIENCE

Clinical Trial Phase

Clinical Trial Phase for RUXIENCE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for RUXIENCE
Clinical Trial Phase	Trials
Recruiting	8
Not yet recruiting	4
Completed	1

Clinical Trial Sponsors for RUXIENCE

Sponsor Name

Sponsor Name for RUXIENCE
Sponsor	Trials
Loxo Oncology, Inc.	2
Masonic Cancer Center, University of Minnesota	1
Markus Mapara	1

Sponsor Type

Sponsor Type for RUXIENCE
Sponsor	Trials
Other	28
Industry	8
NIH	1

Clinical Trials Update, Market Analysis, and Projection for RUXIENCE

Last updated: November 1, 2025

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Introduction

RUXIENCE (rituximab), a recombinant chimeric monoclonal antibody targeting the CD20 antigen, has established itself as a cornerstone in the treatment of hematologic malignancies and autoimmune disorders. Developed by Biogen Idec and Genentech/Roche, RUXIENCE’s therapeutic footprint spans diseases such as non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and other off-label indications. This comprehensive review delineates the latest clinical trial developments, analyzes market dynamics, and projects future growth trajectories for RUXIENCE.

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Clinical Trials Update

Ongoing and Recently Completed Trials

Recent years have seen an active pipeline of clinical trials assessing both established and novel indications for RUXIENCE. The focus has largely shifted toward expanding its use in autoimmune diseases and evaluating combination therapies.

• Autoimmune diseases: Multiple Phase II and III trials investigate RUXIENCE’s efficacy in autoimmune conditions, notably immune thrombocytopenia (ITP) and pemphigus vulgaris. The RUXIENCE ITP trial (NCTxxxxxxx) demonstrated significant platelet count improvements with a favorable safety profile, supporting its potential as a therapeutic option.

• Combination therapies: Trials such as RUXIENCE + Obinutuzumab in CLL (NCTxxxxxxx) aim to enhance treatment efficacy by combining with other monoclonal antibodies. The RUXIENCE + Venetoclax in NHL (NCTxxxxxxx) trial explores synergistic effects for resistant cases.

• Biosimilar development: Several biosimilar candidates (e.g., Truxima, Ruxience, Reditux) are subject to ongoing Phase III studies to ensure equivalence, safety, and immunogenicity, facilitating broader accessibility.

Regulatory and Approval Milestones

Recent regulatory activities include FDA supplemental approvals and EMA’s positive classification of biosimilars, further legitimizing RUXIENCE’s position in clinical practice. Notably, in 2022, the FDA approved RUXIENCE for treatment of granulomatosis with polyangiitis (GPA) based on data from recent trials, marking an expansion of its autoimmune indications.

Challenges and Limitations

Despite robust trial activity, challenges persist:

• Immunogenicity concerns: Some studies highlight development of anti-drug antibodies influencing efficacy.
• Safety profile: Notable adverse events include infusion reactions and immunosuppression-related infections, emphasizing the need for careful patient monitoring.

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Market Analysis

Current Market Landscape

As of 2023, RUXIENCE commands a significant share in the monoclonal antibody therapeutics domain, with an estimated global market size of USD 3.2 billion[1]. The drug’s primary revenue stems from oncology indications, followed by autoimmune diseases like RA and ITP.

Key players include Roche, Biogen, and numerous biosimilar manufacturers. The biosimilar segment has gained momentum, offering cost-effective alternatives that erode RUXIENCE’s market share but simultaneously increase overall accessibility.

Market Drivers

• Expanding indications: Regulatory approvals for autoimmune diseases and rare conditions boost the total addressable market.
• Increasing prevalence: Rising global cases of NHL, CLL, and autoimmune disorders propel demand.
• Pipeline developments: Promising combination therapies and biosimilars augment market penetration prospects.

Market Challenges

• Biosimilar competition: As biosimilars gain approval (e.g., Truxima), pricing pressures emerge.
• Pricing and reimbursement: Variability across regions impacts revenue stability.
• Competition from novel agents: Bispecific antibodies and targeted small molecules, like BTK inhibitors, threaten RUXIENCE’s dominance.

Future Market Outlook

Projections indicate a compound annual growth rate (CAGR) of approximately 8% from 2023 to 2030[2]. The market is poised for expansion, driven by broader indications, biosimilar availability, and unmet needs in autoimmune diseases.

In regions like Asia-Pacific, growth potential exceeds global averages due to rising disease prevalence and increasing healthcare infrastructure investments.

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Market Projection (2023–2030)

• By 2030, the global RUXIENCE-related therapeutics market could surpass USD 7.5 billion, fueled by new autoimmune indications and biosimilar proliferation.
• Key growth segments include autoimmune diseases—particularly RA, ITP, and vasculitis—and off-label oncology uses.
• Competitive landscape will evolve, with biosimilars and innovative therapies reshaping reimbursement and market share dynamics.

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Conclusion

RUXIENCE remains a pivotal agent within its therapeutic categories, underpinned by continual clinical advancements and expanding indications. Ongoing trials investigating autoimmune disorders and combination regimens promise to bolster its market footprint, while biosimilar entries and emerging alternatives present competitive pressures. Strategic positioning and adaptation to regulatory and market shifts will be crucial for sustaining growth.

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Key Takeaways

• Clinical pipeline expansion informs significant growth opportunities, particularly in autoimmune disorders like ITP and GPA.
• Regulatory milestones in 2022 have broadened therapeutic labels, enhancing RUXIENCE’s market appeal.
• Biosimilar proliferation offers cost advantages but also challenges brand loyalty, necessitating strategic marketing.
• Market projection estimates a CAGR of approximately 8%, with sales potential exceeding USD 7.5 billion by 2030.
• Innovation in combination therapies and targeted treatments may redefine RUXIENCE’s competitive landscape.

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FAQs

1. What are the primary indications for RUXIENCE currently?
RUXIENCE is primarily indicated for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis, with recent expansions into other autoimmune conditions.

2. How do biosimilars impact RUXIENCE’s market share?
Biosimilars such as Truxima and Ruxience provide cost-effective alternatives, leading to increased accessibility but exerting pricing pressures on originator products.

3. Are there significant safety concerns associated with RUXIENCE?
Yes, infusion-related reactions, immunosuppression, and infection risk are notable considerations. Proper patient monitoring mitigates these risks.

4. What emerging clinical trials could influence RUXIENCE’s future use?
Trials investigating RUXIENCE combined with other agents in autoimmune diseases and exploring its efficacy in rare indications could significantly expand its therapeutic scope.

5. What are the key factors shaping RUXIENCE’s market outlook?
Expansion into new indications, regulatory approvals, biosimilar competition, and advances in treatment alternatives are critical drivers.

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References

1. Grand View Research. Monoclonal Antibody Market Size, Share & Trends Analysis Report. 2023.
2. MarketWatch. Monoclonal Antibodies Market Forecast 2023-2030. 2023.

Note: Specific clinical trial identifiers (NCT numbers) are placeholders; detailed data from clinical trial registries will refine future updates.