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rituximab (Usmal / BCD020 / AcellBia)

✓ Approved

Grupo Biotoscana · MS4A1 · Monoclonal Antibodies

What is rituximab?

rituximab is a monoclonal antibodies developed by Grupo Biotoscana. It is approved for therapeutic indications via injectable (others) or intracerebral/cerebroventricular injection or intravenous (iv) or subcutaneous injection.

Drug Profile

Brand NamesUsmal, BCD020, AcellBia
CompanyGrupo Biotoscana
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetMS4A1
RouteInjectable (Others), Intracerebral/cerebroventricular Injection, Intravenous (IV), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Grupo Biotoscana

Mechanism of Action

Molecular Targets

rituximab acts on 1 molecular target:

MS4A1membrane spanning 4-domains A1 (S7, B1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

rituximab is developed for 7 unique indications across 4 therapeutic areas.

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

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Related Research Articles

PubMedOpen medicine (Warsaw, Poland)2026-09-20

Glucocorticoids combined with rituximab treatment for IgG4-related tubulointerstitial nephritis with diabetic nephropathy: a case report.

Wang Tianshu T, Zhang Jingjing J, Xu Yaguang Y

IgG4-related disease is a chronic immune-mediated disorder featuring elevated serum IgG4 levels and the tissue infiltration of IgG4-positive plasma cells. Kidney involvement in IgG4-related disease, known as IgG4-related kidney disease, most commonly manifests as tubulointerstitial nephritis. A 55-year-old male presented with acute kidney injury (creatinine=816 μmol/L), severe anemia, lymphadenopathy, and high IgG4 levels (13.89 g/L). Renal MRI and Chest CT showed diffuse renal abnormalities and mediastinal lymphadenopathy. Renal biopsy confirmed IgG4-related tubulointerstitial nephritis, complicated by IgA nephropathy and diabetic nephropathy. Initial glucocorticoid treatment was prescribed followed by 1.8 g rituximab consolidation therapy. Over 32 months follow-up, the patient's renal function significantly improved (creatinine 215 μmol/L) and his serum IgG4 levels normalized (0.89 g/L). This success of this case suggests that combination therapy may be a reasonable option in selected cases, and underscores the importance of an early diagnosis, pathological confirmation, and standardized immunosuppressive therapy for improving the outcomes in IgG4-related kidney disease.

PMID 42763610
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PubMedCase reports in critical care2026-09-20

Pan-Neurofascin Antibody-Associated Nodopathy: A Critical Guillain-Barré Syndrome Mimic in the Differential Diagnosis-Report of Two Cases.

Nemethova Andrea A, De Ridder Willem W, Baar Ingrid I, Alonso-Jimenez Alicia A

Guillain-Barré syndrome (GBS) is an acute autoimmune polyradiculoneuropathy typically characterized by an ascending sensorimotor deficit with potential involvement of bulbar and respiratory muscles that may necessitate intensive care admission and mechanical ventilation. Standard treatment includes supportive care, management of complications such as weakness, immobility, respiratory failure, autonomic dysfunction and pain, along with early initiation of immunotherapy-either intravenous immunoglobulin (IVIg) or plasma exchange (PE). However, lack of significant clinical improvement following immunotherapy should prompt consideration of alternative diagnoses, including pan-neurofascin antibody-positive autoimmune nodopathy (panNF + AN). In this report, we present two patients presenting with a severe GBS-like neuropathy. Initial treatment with IVIg resulted in either no response or only transient, mild improvement, followed by rapid clinical deterioration to near-complete tetraplegia, respiratory failure, and autonomic and cranial nerve involvement. Both patients were unresponsive to further treatment with a second course of IVIg, PE and corticosteroids. Subsequent diagnostic evaluation revealed the presence of pan-neurofascin antibodies, confirming panNF + AN. This prompted initiation of treatment with rituximab, which resulted in sustained and complete clinical recovery in both cases. A transient or mild clinical response-or an initial lack of response-to standard GBS-treatment followed by rapid and severe deterioration in cases initially presenting as GBS should be considered a red flag warranting evaluation for AN-associated antibodies. Recognition of this important GBS mimic is critical, as it requires an alternative treatment approach with rituximab, which has been associated excellent clinical outcomes.

PMID 42763515
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PubMedClinical drug investigation2026-09-20

Real-World Treatment Patterns, Healthcare Resource Use, and Costs in Patients with Follicular Lymphoma, Waldenström Macroglobulinemia, and Marginal Zone Lymphoma: A Claims-Based Study in the USA.

Garg Mahek M, Satija Ambika A, Song Yan Y, Meade Benjamin B et al.

Indolent non-Hodgkin's lymphomas (NHL) are associated with relapses necessitating recurrent treatment and lifelong care. However, contemporary real-world evidence of the disease burden among patients with indolent NHLs remains limited. This study describes treatment patterns, healthcare resource use (HRU), and costs among patients with follicular lymphoma (FL), Waldenström macroglobulinemia (WM), and marginal zone lymphoma (MZL) in the USA. Adults with newly diagnosed FL, WM, and MZL were identified in claims data (October 2015-June 2021). The study period spanned from the index date (first observed diagnosis code) until end of continuous enrollment or data availability. Treatment patterns were described during the study period by lines of therapy (LOTs). HRU and costs per-patient-per-month (PPPM) were described overall and by LOTs. This study included 2805 patients with FL, 791 with WM, and 2207 with MZL with a median follow-up of > 20 months each. Bendamustine-based therapies and rituximab monotherapy were most common. In later lines, bendamustine-based therapies declined while rituximab monotherapy and ibrutinib-based therapies increased. Mean all-cause total costs were US $12,402, US $8445, and US $9580 PPPM for patients with FL, WM, and MZL, respectively. Disease-related medical costs constituted > 50% of all-cause total costs, with most hospitalization costs being disease-related. In FL, HRU and costs tended to increase by LOT, driven by FL-related hospitalizations. Trends in HRU and costs across LOTs were less clear for WM and MZL. Our study suggests that indolent NHLs are associated with a significant economic burden that tends to increase across LOTs in FL, highlighting the need for better therapeutic options.

PMID 42763362
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PubMedCureus2026-09-20

Otologic Manifestations and Peripheral Facial Nerve Palsy As the Initial Presentation of Granulomatosis With Polyangiitis: A Case Report.

Hamdar Alex A, Chelly Reda R, Charlier Liza L, David Ngongang Ouandji A NOA et al.

Granulomatosis with polyangiitis (GPA) is a rare antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis that predominantly affects the upper and lower respiratory tracts and the kidneys. Although otolaryngological manifestations are common, isolated otologic symptoms as the initial presentation are rare and may delay diagnosis. We report the case of a 65-year-old man who initially presented with refractory bilateral otitis media associated with progressive mixed hearing loss, vestibular dysfunction, and subsequent peripheral facial nerve palsy. Initial temporal bone imaging was unremarkable, showing only middle ear and mastoid effusion. Further investigations revealed ANCA positivity and bilateral necrotizing pulmonary opacities on chest CT, leading to the diagnosis of GPA. Treatment with rituximab and corticosteroids resulted in marked improvement of hearing, vestibular symptoms, and facial nerve function. This case highlights the importance of considering GPA in patients with refractory otologic disease, particularly when associated with severe otalgia, sensorineural hearing loss, vertigo, or facial nerve palsy. Early recognition of these atypical manifestations and prompt multidisciplinary management are essential to prevent irreversible organ damage and improve clinical outcomes.

PMID 42763551
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PubMedGenes & diseases2026-09-20

LAMA5 pathogenic variant uncovers a novel autoantigen in membranous nephropathy.

Xiao Han H, Yin Hui H, Shi Yulu Y, Zhou Xindi X et al.

Membranous nephropathy is a leading cause of nephrotic syndrome, driven by autoantibodies targeting podocyte antigens. Although antibodies against PLA2R and THSD7A account for the majority of cases, a substantial fraction of patients remain seronegative, implying the existence of additional, unidentified autoantigens. Here, we report the identification of two novel compound heterozygous mutations in LAMA5 encoding Laminin α5, in a pediatric patient with severe nephrotic syndrome. Whole-exome sequencing revealed c.1355A>T (p.N452I) and c.9770A>G (p.N3257S) variants, with structural modeling indicating that p.N452I induces a conformational change in Laminin α5. This altered conformation enhanced its binding to Collagen IV networks, resulting in thickening of the glomerular basement membrane and the creation of a neo-epitope recognized by conformation-specific IgG1/IgG3 autoantibodies. These autoantibodies activated the classical complement pathway, triggering podocyte injury. A knock-in mouse model harboring the Lama5 N457I mutation recapitulated the human phenotype, exhibiting proteinuria, glomerular basement membrane thickening, and glomerular IgG deposits. Notably, rituximab treatment in the patient led to the disappearance of anti-Laminin α5 autoantibodies and sustained clinical remission. Our findings establish Laminin α5 as a novel genetic autoantigen in membranous nephropathy and suggest that screening for anti-Laminin α5 antibodies may help identify patients who could benefit from B-cell-targeted therapies.

PMID 42763546
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PubMedFrontiers in medicine2026-09-19

Clinical scenarios of suboptimal response to rituximab in relapsing ANCA-associated vasculitis.

Prieto-González Sergio S, Romich Ellen E, Merkel Peter A PA, Jayne David R W DRW et al.

Rituximab is effective for induction and maintenance of remission in relapsing ANCA-associated vasculitis (AAV), but some patients do not achieve complete remission or experience relapse despite treatment. We aimed to describe the frequency, characteristics, and outcomes of patients with suboptimal response to rituximab within the RITAZAREM trial. Post hoc descriptive analysis, including patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) treated with rituximab for induction (N = 188) and those receiving rituximab maintenance (N = 85). Three scenarios of suboptimal response were examined: (i) failure to achieve protocol-defined remission at month 4 (n = 6); (ii) incomplete remission at month 4, defined as BVAS/WG = 1 (n = 10); and (iii) relapse during rituximab maintenance (n = 13). Data were summarized descriptively. Time to relapse from month 4 in patients with BVAS/WG = 1 versus BVAS/WG = 0 was explored using Kaplan-Meier analysis. Six of 188 patients (3%) did not achieve protocol-defined remission by month 4, 10 (5%) had residual low-grade disease activity (BVAS/WG = 1), and 13 of 85 patients (15%) receiving rituximab maintenance relapsed within 24 months during maintenance treatment. All patients with BVAS/WG = 1 at month 4 had a history of PR3-ANCA positivity and ear/nose/throat (ENT) baseline manifestations. Relapse occurred more frequently in this subgroup than in patients with BVAS/WG = 0, and time-to-relapse analysis showed shorter relapse-free survival, although interpretation is limited by the small sample size. Most first relapses were minor, and some patients subsequently experienced additional relapses, including major relapses. In this exploratory and hypothesis-generating analysis, a small subset of patients with relapsing AAV showed suboptimal outcomes with rituximab. Residual disease activity at month 4, particularly in patients with PR3-ANCA positivity and ENT involvement, may represent a clinical subgroup associated with an increased frequency of earlier relapse, although this observation requires confirmation.

PMID 42761370
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