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rituximab (Rituxirel / Toritz)

✓ Approved

Reliance Life Sciences Private Limited · MS4A1 · Monoclonal Antibodies

What is rituximab?

rituximab is a monoclonal antibodies developed by Reliance Life Sciences Private Limited. It is approved for therapeutic indications via injectable (others) or intracerebral/cerebroventricular injection or intravenous (iv) or subcutaneous injection.

Drug Profile

Brand NamesRituxirel, Toritz
CompanyReliance Life Sciences Private Limited
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetMS4A1
RouteInjectable (Others), Intracerebral/cerebroventricular Injection, Intravenous (IV), Subcutaneous Injection
StatusApproved

Mechanism of Action

Molecular Targets

rituximab acts on 1 molecular target:

MS4A1membrane spanning 4-domains A1 (S7, B1)
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Therapeutic Indications

rituximab is developed for 8 unique indications across 4 therapeutic areas.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-Hodgkin's lymphoma✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)B-cell lymphomaPreclinical
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Chronic lymphocytic leukaemiaPreclinical
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle cell lymphomaPreclinical

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Related Research Articles

PubMedJournal of neurology2026-10-16

Clinical phenotype and treatment response in AQP4-IgG-positive NMOSD and MOGAD: insights from the Italian I-MS&RD registry.

Tortorella Carla C, Cruciani Alessandro A, Patti Francesco F, Capobianco Marco M et al.

Neuromyelitis optica spectrum disorders (NMOSD) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) are rare entities distinct from multiple sclerosis. We leveraged the Italian Multiple Sclerosis and Related Disorders (I-MS&RD) Registry to characterise clinical and treatment features of AQP4-positive NMOSD and MOGAD, identify predictors of rituximab treatment response, and assess relapse outcomes across treatment classes. We identified 664 patients from 97 Italian centres: 406 with AQP4+ NMOSD and 258 with MOGAD. Demographic, clinical, and treatment characteristics were compared between groups. Time to first relapse was assessed according to treatment class, comparing monoclonal antibodies with other therapies. Predictors of relapse-free status were evaluated using multivariable logistic regression. Female sex was more common in AQP4+ NMOSD than in MOGAD patients (p < 0.001), whereas paediatric onset was more common in MOGAD (p < 0.001). Patients with AQP4+ NMOSD had greater disability at diagnosis than patients with MOGAD (p < 0.001). Rituximab was the most prescribed therapy. Treatment with monoclonal antibodies was associated with longer relapse-free survival in AQP4+ NMOSD (log-rank p = 0.021), but not in MOGAD. In AQP4+ NMOSD patients treated with rituximab, male sex and myelitis at onset were independently associated with a lower likelihood of remaining relapse-free (OR 0.37, 95% CI 0.14-0.94; p = 0.038 and OR 0.36, 95% CI 0.15-0.83; p = 0.017, respectively). In contrast, among rituximab-treated patients with MOGAD, optic neuritis at onset was the only predictor of relapse-free status at follow-up (OR 0.20, 95% CI 0.04-0.90; p = 0.038). This nationwide, large-scale analysis, derived from the newly established I-MS&RD Registry, characterises a large Italian cohort of patients with AQP4+ NMOSD and MOGAD, identifies clinically relevant predictors of response to rituximab, and provides real-world evidence on treatment-associated relapse outcomes in these two disorders.

PubMedJournal of clinical medicine2026-10-16

Cranial MRI Findings in Rheumatoid Arthritis Patients Treated with Rituximab: Prevalence, Patterns, and Clinical Correlates.

Coşkun Belkıs Nihan BN, Özpar Rıfat R, Lermi Nihal N, Güllü Gizem G et al.

Background/Objectives: Neurological manifestations in rheumatoid arthritis (RA) are common, yet the clinical relevance of central nervous system (CNS) abnormalities detected on neuroimaging remains uncertain. We aimed to determine the prevalence and patterns of cranial magnetic resonance imaging (MRI) findings in RA patients treated with rituximab (RTX) and to assess whether these abnormalities are associated with disease-specific mechanisms or with age- and comorbidity-related factors. Methods: In this retrospective observational study, 84 RA patients who received RTX and had available pre-treatment cranial MRI underwent systematic evaluation. Imaging findings were classified by an experienced neuroradiologist blinded to clinical data and dichotomized as normal or abnormal, and white matter hyperintensities were graded semiquantitatively using a Fazekas-type scale. Factors independently associated with abnormal MRI were assessed by multivariable logistic regression. Results: Cranial MRI abnormalities were identified in 60 patients (71.5%), predominantly as nonspecific white matter hyperintensities (48 patients, 57.1%). In multivariable analysis, older age (adjusted odds ratio [aOR] 1.16 per year, 95% CI 1.08-1.25) and the presence of comorbidities (aOR 5.36, 95% CI 1.49-19.23) were independently associated with abnormal imaging (p < 0.001 and p = 0.010, respectively), whereas no association was found with disease duration, seropositivity, or extra-articular involvement. Imaging findings remained stable over time in the majority of the 39 patients (46.4%) who underwent follow-up imaging. Conclusions: Cranial MRI abnormalities are highly prevalent in RA and were associated primarily with age and comorbidity burden rather than with RA-specific inflammation; however, in the absence of a control group, we cannot determine whether their prevalence exceeds that of a comparable non-RA population. No treatment-related demyelinating disease or progressive multifocal leukoencephalopathy was observed, but the study was not designed to assess drug safety, and these findings should be interpreted as the absence of an observed imaging signal rather than as evidence of the neurological safety of rituximab. Cranial neuroimaging in RA should therefore be interpreted cautiously and in clinical context.

PubMedDiagnostics (Basel, Switzerland)2026-10-16

Prostatic Involvement in Granulomatosis with Polyangiitis: A Case Report and Scoping Review.

Kulski Jakub J, Miszewski Kevin K, Kałwak Oliwia O, Miszewska Laura L et al.

Background and Clinical Significance: Granulomatosis with polyangiitis (GPA) is a systemic antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis that typically affects the respiratory tract and kidneys. Prostatic involvement is rare and may mimic infection or malignancy, delaying diagnosis. We report a case of exceptionally extensive urogenital destruction and provide a scoping review of prostatic involvement in GPA published since the last comprehensive review in 2019. Case Presentation: A 60-year-old man underwent repeated antibiotic courses and urological procedures for sterile, antibiotic-refractory prostatic and periurethral necrosis, initially attributed to infection or malignancy. Imaging showed a contiguous necrotising process extending from the prostatic fossa to the urethra, bladder trigone, penile base, and left upper urinary tract. With concurrent sinonasal and mastoid disease, karyorrhectic necrosis on histology, and low-titre ANCA positivity, GPA was diagnosed and treated with glucocorticoids and cyclophosphamide followed by rituximab, with regression of active disease but persistent structural sequelae. A PRISMA-ScR-guided search of PubMed, Scopus, Web of Science and Embase (24 August 2026) identified post-2019 reports of prostatic involvement in GPA. Fifteen publications plus the present case yielded 16 cases for structured extraction. Mean age at first prostatic manifestation was 55.1 years, and the mean reported interval to diagnosis was 4 months. Prostatic abscess was the most frequently reported imaging finding. PR3-ANCA positivity (13/16) and pulmonary involvement (13/16) were reported most often; renal involvement was reported in 4/16 cases and death in 4/16. Rituximab was reported more often than cyclophosphamide (10/16 vs. 7/16). Conclusions: Reports of prostatic involvement published from 2019 onward appear broadly consistent with the profile described in the last comprehensive review. These proportions, however, describe a small, publication-selected case series and are not estimates of the characteristics, prognosis or treatment response of prostatic involvement in GPA. Prostatic involvement may extend contiguously into the urethra, bladder, penile structures and upper urinary tract; the present case is one of the most extensive examples identified in this review. Sterile, antibiotic-refractory urogenital lesions, especially with extra-urogenital disease, low-titre or discordant ANCA serology, should prompt consideration of GPA before irreversible anatomical loss.

PubMedJournal of clinical medicine2026-10-16

From Rescue Therapy to Mechanism-Based Sequencing in Refractory Myasthenia Gravis: A Narrative Review with an Illustrative Clinical Case.

Ilves Aleksandr A, Nikitin Vera V

Refractory acetylcholine receptor antibody-positive generalized myasthenia gravis (AChR-Ab-positive gMG) is clinically heterogeneous, and evidence on how to select a therapeutic mechanism after incomplete response to a previous targeted class remains limited. This narrative review synthesizes guidelines, randomized trials, extension studies, meta-analyses, observational evidence, and emerging translational data identified through targeted searches updated to 21 June 2026, with a final bibliographic check through 10 August 2026. We examine conventional immunosuppression, rescue therapy, B-cell and B-lineage depletion, terminal complement inhibition, and neonatal Fc receptor (FcRn) inhibition as interventions acting at different levels of the pathogenic cascade. We propose a framework in which prior response, nonresponse, intolerance, corticosteroid dependence, respiratory vulnerability, and rescue-therapy dependence are interpreted as mechanistic clues rather than as a fixed treatment ladder. An illustrative case of severe refractory AChR-Ab-positive gMG showed incomplete control after conventional immunosuppression, rituximab, thymectomy, and terminal complement inhibition, with reproducible but transient benefit from plasma exchange. This pattern supported a mechanistic rationale for FcRn inhibition, although overlapping treatments and single-case design preclude causal attribution. Mechanism-based sequencing should be viewed as structured decision support rather than a validated algorithm. Prospective switching studies and predictive biomarkers are needed to optimize individualized treatment sequencing.

PubMedKidney3602026-10-15

Rituximab-Belimumab Sequential Therapy in Refractory Minimal Change Disease.

Li Yifan Y, Ai Yuxin Y, Cheng Jinbo J, Huang Yinghui Y

Frequent relapses and steroid dependence remain challenging in minimal change disease (MCD). Rituximab depletes B cells, yet post-treatment B-cell Activating Factor (BAFF) elevation may drive disease relapse. Sequential rituximab followed by belimumab (a BAFF inhibitor) has shown benefit in lupus, but its role in MCD is unknown. A 14-year-old male with biopsy-proven MCD and acute kidney injury failed multiple immunosuppressants, including two courses of rituximab (the first induced a 6-month remission, whereas the second failed despite B-cell depletion). After another relapse, he received single-dose rituximab followed by belimumab, achieving complete remission and maintaining relapse-free for 57 months.This case suggests that sequential rituximab-belimumab therapy may offer durable remission in MCD patients who are refractory to conventional immunosuppressive regimens.

PubMedRevista da Associacao Medica Brasileira (1992)2026-10-15

A comparative analysis of semiannual versus annual rituximab maintenance in patients with refractory idiopathic inflammatory myopathies: a retrospective longitudinal real-world study.

Serrano Rodrigo Lorenzetti RL, Souza Fernando Henrique Carlos de FHC, Miossi Renata R, Faria Marlise Sítima Mendes Simões MSMS et al.

The aim of this study was to explore the real-world effectiveness of semiannual versus annual rituximab maintenance administration in patients with refractory idiopathic inflammatory myopathies. In this single-center, retrospective longitudinal study (2010-2025), 45 adults with refractory idiopathic inflammatory myopathies received two initial rituximab infusions (1 g on days 0 and 15). Maintenance rituximab was administered every 6 months (semiannual group, n=14) or every 12 months (annual group, n=31). Baseline immunosuppressive therapy was maintained, and glucocorticoid tapering was guided by clinical and laboratory parameters. Outcomes at months 6-12 and 18-24 included the need for rescue therapies: intravenous methylprednisolone (3 g total) and immunoglobulin (2 g/kg), or prednisone dose escalation. Baseline demographics, refractory idiopathic inflammatory myopathies subtypes, rituximab indications (cutaneous, muscular, articular, and/or pulmonary activity), and peri- rituximab medications (within 2 months before/after infusion) did not differ significantly between groups (p>0.05). No statistically significant differences in the frequency of rescue therapy use at 6-12 and 18-24 months were detected between the two regimens. Intragroup analysis demonstrated significant reductions in relapse rates and rescue therapy requirements over time (p<0.05), suggesting improvement in both cohorts. In this exploratory cohort, no statistically significant differences were detected between semiannual and annual rituximab maintenance regimens with respect to clinical outcomes, although numerically higher relapse rates were observed in the annual group. These findings suggest that extended rituximab intervals may be feasible in resource-limited settings, but further prospective studies are needed to confirm these observations.

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