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subcutaneous Rituximab
subcutaneous Rituximab is a Small molecule drug developed by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. It is currently in Phase 2 development. Also known as: MABTHERA.
Rituximab is a subcutaneous antibody that binds to the B-lymphocyte antigen CD20. It is used to treat conditions such as Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Leukemia, Lymphocytic, Chronic, B-Cell.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | subcutaneous Rituximab |
|---|---|
| Also known as | MABTHERA |
| Sponsor | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
- Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma (PHASE2)
- Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma (PHASE2)
- Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL (PHASE3)
- Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma (PHASE2)
- A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (PHASE3)
- A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- subcutaneous Rituximab CI brief — competitive landscape report
- subcutaneous Rituximab updates RSS · CI watch RSS
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea portfolio CI
Frequently asked questions about subcutaneous Rituximab
What is subcutaneous Rituximab?
Who makes subcutaneous Rituximab?
Is subcutaneous Rituximab also known as anything else?
What development phase is subcutaneous Rituximab in?
Related
- Manufacturer: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea — full pipeline
- Also known as: MABTHERA
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing