NCT00053092
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported in available facts
pharma · Breast Cancer · Prostate Cancer · UTHR
United Therapeutics Europe
United Therapeutics Europe Ltd
United Therapeutics is a pharma organization headquartered in Silver Spring, USA. It trades on NYSE under ticker UTHR. Primary therapeutic focus areas include Breast Cancer, Prostate Cancer, Pulmonary Arterial Hypertensi
1000 Spring Street, Silver Spring, Maryland 20910, US HQ
1996 Founded
1,443 Employees
Public company Type
UTHR · NYSE Ticker
Company details
- Status
- Public
- HQ
- 1000 Spring Street, Silver Spring, Maryland 20910, US
- Founded
- 1996
- Employees
- 1,443
- Programs
- 1032
- Drugs
- 612
- Patents
- 3720
rituximab
Phase 2 · mab · Lymphoma
Rituximab is a monoclonal antibody (mAb) developed by United Therapeutics Europe Ltd for the treatment of lymphoma. The program, identified by internal code CDR0000269136, completed Phase 2 clinical evaluation as of December 2013. Rituximab is administered via subcutaneous injection and is classified as an antineoplast
Internal code CDR0000269136
At a glance
- Sponsor
- United Therapeutics Europe Ltd
- Phase
- Phase 2
- Modality
- mab
- Indication
- Lymphoma
- Status
- completed
- Trials
- 1
Executive summary
Rituximab is a monoclonal antibody (mAb) developed by United Therapeutics Europe Ltd for the treatment of lymphoma. The program, identified by internal code CDR0000269136, completed Phase 2 clinical evaluation as of December 2013. Rituximab is administered via subcutaneous injection and is classified as an antineoplastic and immunomodulating agent (L01 therapeutic class).
The drug has achieved regulatory approval across multiple major markets. In the United States, rituximab is approved under BLA applications BLA103705 and BLA761064, sponsored by Genentech. In Europe, the European Medicines Agency has granted approvals under multiple EMEA product numbers (EMEA/H/C/000165, EMEA/H/C/003903, EMEA/H/C/004112, and others), with multiple marketing authorization holders including Celltrion Healthcare Hungary, Mabion, Pfizer Europe, Reddy Holding, Roche, and Sandoz. Japanese approval was granted in August 2014 and June 2022. In Australia, rituximab was listed on the ARTG in September 2022 with multiple PBS codes, sponsored by Celltrion Healthcare Australia, Pfizer Australia, and Sandoz.
The program's latest disclosed milestone occurred on 18 December 2013. Rituximab is marketed under the brand name RIXIMYO. The competitive landscape includes multiple approved antineoplastic agents such as Imbruvica, Afinitor, Kyprolis, and Vyxeos Liposomal, among others. Current development status reflects a mature, approved therapeutic with established clinical utility in lymphoma management.
Why this program matters
Lymphoma represents a significant oncologic disease burden globally, with both Hodgkin and non-Hodgkin lymphoma subtypes affecting hundreds of thousands of patients annually. Rituximab addresses an established clinical need in lymphoma treatment, particularly in B-cell malignancies where CD20-targeted therapy has demonstrated clinical benefit. The drug's approval across the United States, European Union, Japan, and Australia reflects broad recognition of its therapeutic value and safety profile.
Market relevance is substantial given the chronic nature of lymphoma and the potential for repeat treatment cycles. Rituximab's subcutaneous formulation (RIXIMYO) offers practical advantages over intravenous administration, potentially improving patient convenience and treatment adherence. The presence of multiple approved manufacturers—including Celltrion, Mabion, Pfizer, Roche, and Sandoz—indicates a competitive biosimilar and originator landscape, suggesting mature market penetration with established reimbursement pathways.
Competitive positioning reflects rituximab's established role as a foundational therapy in lymphoma management. The competitive set includes targeted agents (Imbruvica, Kyprolis) and cytotoxic therapies (Vyxeos Liposomal, Paclitaxel), indicating rituximab occupies a distinct immunotherapy niche. Patient population encompasses B-cell lymphoma patients across multiple age groups and disease stages. Commercial significance is established through multi-market approvals and multiple manufacturing partnerships, indicating sustained market demand and revenue generation across geographies.
Drug intelligence
Drug Class: Monoclonal antibody (mAb); antineoplastic and immunomodulating agent (ATC L01).
Modality: Monoclonal antibody.
Route of Administration: Subcutaneous injection (formulated as RIXIMYO).
Mechanism of Action: Not disclosed in available facts.
Target: Not disclosed in available facts.
Related Therapies: Other approved lymphoma treatments include Imbruvica (Janssen-Cilag), Kyprolis (Amgen), Afinitor (Novartis), and Vyxeos Liposomal (Jazz Pharmaceuticals).
First Approval: United States approval documented under BLA103705 and BLA761064 (Genentech sponsor). European Union approval under EMEA/H/C/000165 and subsequent product numbers. Japanese approval August 2014. Australian approval September 2022.
Patent Status: Not disclosed in available facts.
- Brand name: RIXIMYO
- Internal code: CDR0000269136
- Therapeutic indication: Lymphoma
- Development phase at latest milestone: Phase 2 completed (December 2013)
lymphoma
Also known as: lymphoma (Hodgkin and non-Hodgkin), lymphoma (Hodgkin's and non-Hodgkin's), lymphoma, malignant, lymphomatous, malignant lymphoma, MLYM
Overview
A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas.
Treatment landscape
ClinicalTrials.gov lists 16 registered studies for Lymphoma, Hodgkin (AACT aggregate).
Phase breakdown: NA (10), PHASE1 (3), PHASE2 (3)
Common investigational therapies:
- Cyclophosphamide
- Chemotherapy
- Plerixafor 0.12 mg/kg
- Ara C
- Mesna
- Vincristine
- Doxorubicin
- Prednisone
- Bleomycin
- Etoposide
Disease data sourced from MONDO Disease Ontology (MONDO:0005062), Orphanet — lymphoma, NCT00026208, NCT00578461, NCT01459224, NCT02996773, NCT03117036, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 22013-12-18
Phase 2 completion
Latest disclosed milestone for rituximab lymphoma program completed.
- Approved2014-08
Japan approval
Rituximab approved in Japan (PMDA).
- Approved2022-06
Japan re-approval/label expansion
Additional approval or label expansion in Japan.
- Approved2022-09-01
Australia approval
Rituximab listed on Australian ARTG with multiple PBS codes.
- Approved2025-07-10
EU approval (Mabion)
European authorization granted for Mabion rituximab product.
- Approved2025-09-25
EU approvals (Pfizer, Sandoz)
European authorizations granted for Pfizer and Sandoz rituximab products.
Competitive landscape
The lymphoma treatment landscape includes multiple approved antineoplastic agents competing for market share. Rituximab operates within a competitive set that spans monoclonal antibodies, targeted small molecules, and cytotoxic therapies.
Direct competitors identified in the facts include Imbruvica (Janssen-Cilag), a Bruton tyrosine kinase inhibitor approved for lymphoma; Kyprolis (Amgen), a proteasome inhibitor; Afinitor (Novartis), an mTOR inhibitor; and Vyxeos Liposomal (Jazz Pharmaceuticals), a liposomal cytarabine-daunorubicin combination. Additional approved agents include Inlyta (Pfizer), Ofev (Boehringer Ingelheim), and Lynozyfic (Regeneron).
Rituximab's competitive position reflects its established role as a foundational immunotherapy. The presence of multiple approved manufacturers (Celltrion, Mabion, Pfizer, Roche, Sandoz) indicates mature market competition with biosimilar penetration. Recent European approvals in 2025 for Mabion, Pfizer, and Sandoz formulations suggest ongoing competitive intensity and potential price pressure. Rituximab's subcutaneous formulation (RIXIMYO) differentiates it from intravenous alternatives, offering convenience advantages. The competitive set's diversity—spanning mechanism classes and administration routes—indicates rituximab maintains distinct positioning within a heterogeneous therapeutic landscape.
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
United States (FDA): Rituximab is approved under BLA103705 and BLA761064, sponsored by Genentech and Genentech Inc respectively. Approval status confirmed via FDA database.
European Union (EMA): Rituximab holds multiple marketing authorizations under EMEA product numbers EMEA/H/C/000165 (originator), EMEA/H/C/003903, EMEA/H/C/004112, EMEA/H/C/004696, EMEA/H/C/004723, EMEA/H/C/004724, EMEA/H/C/004725, EMEA/H/C/004729, EMEA/H/C/005387, and EMEA/H/C/006224. Marketing authorization holders include Celltrion Healthcare Hungary Kft., Mabion Spolka Akcyjna, Pfizer Europe MA EEIG, Reddy Holding GmbH, Roche Registration GmbH, and Sandoz GmbH. Recent authorizations granted 10 July 2025 and 25 September 2025.
Japan (PMDA): Rituximab approved August 2014 and June 2022. Approval dates confirmed via PMDA database.
Australia (TGA): Rituximab listed on ARTG 1 September 2022 with PBS codes 13082M, 13088W, 13090Y, 13095F, 13096G, 13101M, 13102N, 13109Y. Sponsors: Celltrion Healthcare Australia Pty Ltd, Pfizer Australia Pty Ltd, Sandoz Pty Ltd.
China (NMPA): Multiple clinical trials active (NCT00556192, NCT02787239, NCT03934814, NCT04075292, NCT04525729, NCT04965493, NCT05245916, NCT05615974, NCT06717347, NCT07397832). Regulatory status: clinical trials ongoing; approval status not yet disclosed.
Expected Loss of Exclusivity: Not yet disclosed.
Clinical evidence summary
Key questions answered
What is rituximab used for?
Rituximab is an approved monoclonal antibody used for the treatment of lymphoma. It is classified as an antineoplastic and immunomodulating agent and is administered via subcutaneous injection under the brand name RIXIMYO.
Is rituximab approved by the FDA?
Yes, rituximab is approved by the U.S. FDA under BLA applications BLA103705 and BLA761064, sponsored by Genentech. Approval status is confirmed via FDA database.
Is rituximab approved in Europe?
Yes, rituximab holds multiple European approvals under EMA product numbers including EMEA/H/C/000165 (originator) and nine additional product numbers. Multiple manufacturers including Roche, Pfizer, Sandoz, Celltrion, and Mabion hold marketing authorizations. Recent approvals were granted in July and September 2025.
Is rituximab approved in Japan?
Yes, rituximab was approved in Japan by PMDA in August 2014, with an additional approval or label expansion in June 2022.
Is rituximab approved in Australia?
Yes, rituximab was listed on the Australian ARTG on 1 September 2022 with multiple PBS codes. Sponsors include Celltrion Healthcare Australia, Pfizer Australia, and Sandoz.
Who is the sponsor of the rituximab lymphoma program?
United Therapeutics Europe Ltd is listed as the sponsor of the rituximab lymphoma program (internal code CDR0000269136). However, regulatory approvals are primarily associated with Genentech (originator) and multiple biosimilar manufacturers.
What is the brand name for rituximab?
The brand name for rituximab is RIXIMYO, which is formulated for subcutaneous administration.
How is rituximab administered?
Rituximab (RIXIMYO) is administered via subcutaneous injection, offering a practical alternative to intravenous administration.
What is the mechanism of action of rituximab?
The specific mechanism of action is not disclosed in available facts. Rituximab is a monoclonal antibody classified as an antineoplastic and immunomodulating agent.
What is the target of rituximab?
The specific molecular target is not disclosed in available facts.
What clinical trial supports rituximab for lymphoma?
NCT00053092 is identified as a clinical trial associated with the rituximab lymphoma program. Detailed trial design, endpoints, and results are not yet disclosed in available facts.
What is the current development status of rituximab for lymphoma?
The rituximab lymphoma program completed Phase 2 clinical evaluation as of 18 December 2013. The drug is now approved across multiple major markets (US, EU, Japan, Australia).
Who manufactures rituximab?
Multiple manufacturers hold approvals: Genentech (originator, US), Roche (EU), Celltrion Healthcare (Australia, EU), Mabion (EU), Pfizer (US, Australia, EU), Sandoz (Australia, EU), and Reddy Holding (EU).
What competitors exist for rituximab in lymphoma treatment?
Competitors include Imbruvica (Janssen-Cilag), Kyprolis (Amgen), Afinitor (Novartis), Vyxeos Liposomal (Jazz Pharmaceuticals), Inlyta (Pfizer), Ofev (Boehringer Ingelheim), and Lynozyfic (Regeneron), among others.
Are there clinical trials ongoing for rituximab in China?
Yes, 10 active clinical trials are listed for rituximab in China (NCT00556192, NCT02787239, NCT03934814, NCT04075292, NCT04525729, NCT04965493, NCT05245916, NCT05615974, NCT06717347, NCT07397832). Regulatory approval status in China is not yet disclosed.
What is the therapeutic class of rituximab?
Rituximab is classified as an antineoplastic and immunomodulating agent under ATC code L01.
When was rituximab first approved?
Rituximab's original approval date is not explicitly disclosed in available facts. U.S. approval under BLA103705 and European approval under EMEA/H/C/000165 are confirmed, with Japanese approval in August 2014 and Australian approval in September 2022.
Entity relationship graph
rituximab → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Companies
Indication
Trials
Analyst insights
Strategic Implications: United Therapeutics Europe Ltd's sponsorship of rituximab Phase 2 lymphoma program reflects historical development activity, though current regulatory approvals are dominated by Genentech (originator), Roche, and multiple biosimilar manufacturers. The December 2013 Phase 2 completion milestone predates the current competitive biosimilar landscape, suggesting rituximab may represent a legacy program or technology transfer within United Therapeutics' portfolio.
Competitive Implications: Recent 2025 European approvals for Mabion, Pfizer, and Sandoz formulations indicate ongoing biosimilar market expansion and potential price compression. Rituximab's subcutaneous formulation (RIXIMYO) provides differentiation from intravenous alternatives, supporting continued market relevance despite biosimilar competition. The multi-manufacturer approval landscape suggests rituximab maintains established reimbursement pathways and clinical acceptance across geographies.
Future Catalysts: Potential label expansions in additional lymphoma subtypes or combination therapy indications; regulatory approvals in emerging markets (China NMPA status remains unclear); potential formulation innovations or combination strategies. Clinical trials ongoing in China (10 active NCTs) suggest potential market expansion in Asia-Pacific region.
Expected Milestones: No next milestone date disclosed. Ongoing clinical trial activity in China may yield regulatory submissions. Continued biosimilar approvals expected in mature markets (EU, US, Japan, Australia) with potential for additional manufacturing partnerships.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is rituximab?
- Monoclonal antibody antineoplastic agent for lymphoma treatment, administered subcutaneously as RIXIMYO.
- Is rituximab approved?
- Yes, approved in US (FDA), EU (EMA), Japan (PMDA), and Australia (TGA).
- What indication?
- Lymphoma.
- What is the sponsor?
- United Therapeutics Europe Ltd (program sponsor); Genentech (originator); multiple biosimilar manufacturers.
- What phase is rituximab in?
- Approved; Phase 2 completed December 2013.
- Route of administration?
- Subcutaneous injection.
- What is the brand name?
- RIXIMYO.
- What modality?
- Monoclonal antibody (mAb).
- Therapeutic class?
- Antineoplastic and immunomodulating agent (ATC L01).
- Who manufactures rituximab?
- Genentech, Roche, Celltrion, Mabion, Pfizer, Sandoz, Reddy Holding.
- FDA approval status?
- Approved under BLA103705 and BLA761064 (Genentech sponsor).
- EMA approval status?
- Approved under 10 EMEA product numbers; multiple MAHs; recent approvals July-September 2025.
- Japan approval date?
- August 2014 and June 2022.
- Australia approval date?
- 1 September 2022 with multiple PBS codes.
- What is the mechanism of action?
- Not disclosed in available facts.
- What is the molecular target?
- Not disclosed in available facts.
- Key competitors?
- Imbruvica, Kyprolis, Afinitor, Vyxeos Liposomal, Inlyta, Ofev, Lynozyfic.
- Clinical trials in China?
- 10 active NCTs; regulatory status not yet disclosed.
- Latest milestone?
- 18 December 2013 (Phase 2 completion).
- Next milestone?
- Not yet disclosed.
- Internal code?
- CDR0000269136.
- Partner?
- No partner disclosed.
- Peak sales projection?
- Not disclosed.
- Patent status?
- Not disclosed.
- Loss of exclusivity date?
- Not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT00053092 (clinicaltrials)
- rituximab AU status (fda)
- rituximab CN status (fda)
- rituximab EU status (ema)
- rituximab JP status (fda)
- rituximab US status (fda)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0005062) (mondo)
- Orphanet — lymphoma (orphanet)
- NCT00026208 (clinicaltrials_gov)
- NCT00578461 (clinicaltrials_gov)
- NCT01459224 (clinicaltrials_gov)
- NCT02996773 (clinicaltrials_gov)
- NCT03117036 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.