CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases

Active Indication

Multiple SclerosisMultiple sclerosis relapseMultiple Sclerosis, Primary Progressive+ [5]

Inactive Indication

Follicular LymphomaHashimoto's EncephalitisLupus Nephritis+ [2]

Originator Organization

Genentech, Inc.

Biogen Idec Ltd.

Active Organization

Hoffmann-La Roche, Inc.

Roche Holding AG

Hoffmann-La Roche Ltd.

+ [6]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (28 Mar 2017),

Multiple sclerosis relapseMultiple Sclerosis, Primary Progressive

RegulationFast Track (US)

Gene Sequence

Sequence Code 31212L

Source: *****

Sequence Code 42721H

Source: *****

106

Clinical Trials associated with Ocrelizumab

NCT06700343 / Not yet recruitingPhase 3

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

Start Date31 Jan 2025

Sponsor / Collaborator

Amgen, Inc.

NCT06675955 / Not yet recruitingPhase 3

An Open-Label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program

The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.

Start Date09 Dec 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT06677710 / Not yet recruitingPhase 1

A Phase 1B Study of IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Refractory Primary and Secondary Progressive Multiple Sclerosis

This is an open label, Phase 1b, multiple ascending dose, and dose-expansion study of IDP-023 administered in combination with interleukin-2 (IL-2) and ocrelizumab to evaluate the safety, tolerability, and biologic activity on autoreactive immune cells in patients with refractory progressive multiple sclerosis.

Start Date01 Nov 2024

Sponsor / Collaborator

Indapta Therapeutics, Inc.Startup

100 Clinical Results associated with Ocrelizumab

100 Translational Medicine associated with Ocrelizumab

100 Patents (Medical) associated with Ocrelizumab

1,256

Literatures (Medical) associated with Ocrelizumab

01 Feb 2025·JOURNAL OF NEUROIMMUNOLOGY

Elevated frequencies of activated memory B cells in multiple sclerosis are reset to healthy control levels after B cell depletion with Ocrelizumab

Article

Author: O'Dell, Samantha ; Obeidat, Ahmed Z ; Gurski, Cody J ; Fenton, Kaylan ; Hajiyeva, Zivar ; Veltri, Anthony J ; Dittel, Bonnie N

In multiple sclerosis (MS) the B cell depleting drug ocrelizumab has shown high efficacy in reducing inflammatory activity. Its mechanism of action is unclear due to B cell subset complexity and unknown roles in pathogenesis. Here, we comprehensively phenotyped and quantitated peripheral blood B cell subsets before and after ocrelizumab infusion to gain insight into the fate of B cell subsets with pathogenic potential. Peripheral blood B cells were collected from treatment naïve patients at baseline and months one, three, and six following the first course of ocrelizumab treatment; at 6 months following the second treatment cycle; ∼14 months following their last infusion; and from healthy controls. Flow cytometry combined with cluster analysis was used to track depletion and repletion of naïve, memory, and antibody secreting cells. By month one, naïve B cells were depleted, but a small subset of memory B cells were retained with no depletion of antibody secreting cells. Uniform manifold approximation and projection for dimension reduction analysis of flow cytometry data revealed two non-class switched naïve clusters and two class switched memory clusters. One class switched cluster was activated in MS patients but largely absent in healthy controls. Both memory B cell subsets underwent depletion after a single six-month course of ocrelizumab treatment after which their proportions were reset to heathy control levels. These observations suggest that activated class-switched memory B cells could serve as a biomarker of recent or ongoing MS disease activity to guide redosing.

01 Feb 2025·TALANTA

A liquid chromatography - Tandem mass spectrometry method for determination of ocrelizumab in serum of patients with multiple sclerosis

Article

Author: Grundmann, Milan ; Hradilek, Pavel ; Matlak, Patrik ; Brozmanova, Hana ; Kacirova, Ivana ; Sistik, Pavel ; Moskorova, Denisa

Ocrelizumab is a second generation recombinant humanized IgG1 monoclonal antibody used for the treatment of multiple sclerosis that selectively target B cells expressing the CD20 antigen. This study aimed to develop and validate a UPLC-MS/MS method for quantification of ocrelizumab in human serum, which can be used in clinical applications for therapeutic drug monitoring. The analysis of ocrelizumab was performed using a bottom-up approach on a liquid chromatography coupled to tandem mass spectrometry detection. The method involved immunoglobulin precipitation with cold methanol followed by peptide digestion with trypsin. The resulting specific peptides were separated on an Acquity UPLC BEH C18 column at 55 °C using gradient elution. The method was validated according to European Medicines Agency (EMEA) guidelines and demonstrated intra- and inter-assay precision with coefficients of variation ranging from 1.6 % to 6.1 % and accuracies between 90.2 % and 107.2 %. Stability testing, including autosampler, long-term and freeze-thaw stability, showed no more than 15 % variation. The method was successfully applied to 169 patient samples, revealing ocrelizumab concentrations ranging from 0.5 to 21.8 mg/L in patients on 6-month dosing regimen and 20.5-65.0 mg/L in 16 patients receiving an initial two-week dose of 300 mg. The newly developed UPLC-MS/MS method met all criteria for accuracy, precision and stability, confirming its suitability for clinical use in monitoring ocrelizumab levels in multiple sclerosis patients.

01 Jan 2025·Multiple Sclerosis and Related Disorders

Hypogammaglobulinemia and severe infections in Multiple Sclerosis patients on anti-CD20 agents: A multicentre study

Article

Author: Falzone, F ; Santangelo, M ; Franceschini, A ; Poma, N ; Cardi, M ; De Napoli, G ; Vitetta, F ; Ferri, C ; Pesci, I ; Panzera, I ; Camilli, F ; Immovilli, P ; Zini, C ; Smolik, K ; Montepietra, S ; Granella, F ; Mancinelli, L ; Ferraro, D ; Simone, A M ; Foschi, M ; Baldi, E ; Guareschi, A ; Fiore, A ; Lugaresi, A ; Surcinelli, A ; Piscaglia, M G ; Bazzurri, V

BACKGROUND:

Hypogammaglobulinemia (HG) is a known side effect of treatment with anti-CD20 monoclonal antibodies, and it is associated with the risk of infections.

OBJECTIVES:

Aim of this retrospective multicentre study was to assess the frequency of HG in Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disorder patients treated with Ocrelizumab or Rituximab and its association with the occurrence of severe infections (SI). Furthermore, predictors of HG and SI were sought.

METHODS:

We included 556 patients (190M, 366F, mean age: 47 years) with a mean follow-up of 28 months (range 12-90 months).

RESULTS:

IgG HG occurred in 20% and IgM HG in 34% of patients. At multivariable analysis, the risk of IgG HG was influenced by an older age (≥50 years) (OR 1.64, 95%CI: 1.06-2.54, p=0.027), and by the number of treatment cycles (OR: 1.20, 95%CI: 1.09-1.33, p<0.001). A total of 25 SI occurred (100 person-years rate: 1.8), with a disease phenotype other than relapsing-remitting (OR 1.50, 95%CI: 1.02-2.20; p=0.039) and IgG HG (OR 2.65, 95%CI: 1.15-6.12; p=0.022) increasing its risk.

CONCLUSIONS:

IgG and IgM HG occurred in a considerable proportion of patients. IgG HG increased the risk of SI, which were, nevertheless, relatively infrequent. Our results highlight the importance of monitoring immunoglobulin levels during treatment with anti-CD20 agents, to personalize treatment strategies.

148

News (Medical) associated with Ocrelizumab

17 Dec 2024

·www.businesswire.com

Indapta Therapeutics Secures $22.5 Million to Advance Clinical Trials of Innovative Cancer and Autoimmune Treatments

HOUSTON & SEATTLE--( BUSINESS WIRE )--Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation cell therapies for the treatment of cancer and autoimmune diseases, announced today it has closed a $22.5 million round of new financing to accelerate the clinical development of its differentiated allogeneic Natural Killer (NK) cell therapy. Current investors RA Capital Management, LP, Leaps by Bayer, the impact investment arm of Bayer AG, Vertex Ventures HC, Pontifax, and the Myeloma Investment Fund, the venture philanthropy subsidiary of the Multiple Myeloma Research Foundation, completed the round. "This funding will enable us to generate significant additional data in our ongoing trial of IDP-023 in cancer as well as initial data from our first trial in autoimmune disease," said Mark Frohlich, Indapta’s CEO. "Preliminary results of IDP-023 in cancer are encouraging and we look forward to initiating our Phase 1 trial for multiple sclerosis in Q1 2025. This financing, together with our recently announced collaboration with Sanofi, highlights the promise of our differentiated platform.” Advancing Clinical Trials of Lead Product IDP-023 Indapta has completed enrollment in the safety run-in portion of the Phase 1 clinical trial of IDP-023 in Non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma (MM), in which patients received up to three doses of IDP-023 without and with interleukin (IL)-2. As presented at the Society for Immunotherapy of Cancer meeting , the mean maximum decrease in serum M-protein or light chain was 73% in responding myeloma patients with relapsed/refractory disease, with three patients achieving a reduction of 84% or greater. Enrollment of cohorts receiving IDP-023 in combination with monoclonal antibodies targeting CD20 or CD38 is underway. In August, Indapta announced FDA clearance of its IND of IDP-023 in combination with ocrelizumab in progressive MS . The company’s approach is highly differentiated from other cellular approaches to autoimmune diseases, with at least three different mechanisms that can address the biology of the disease: 1) by combining with a B cell targeting antibody like ocrelizumab, IDP-023 can deplete B cells more effectively than antibody alone; 2) g-NK cells are capable of targeting autoreactive T and B cells that are known to upregulate HLA-E; and 3) given their inherent anti-viral activity, g-NK cells can potentially address the EBV viral reservoir that contributes to the disease pathogenesis. About Indapta Therapeutics Indapta is a privately-held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers as well as autoimmune diseases. The company’s proprietary robust platform of naturally-occurring g-NK cells is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit www.indapta.com .

Cell TherapyImmunotherapyPhase 1INDDrug Approval

19 Nov 2024

·medcitynews.com

Merck Gets a Shot of Confidence From Pivotal Test of SubQ Injectable Keytruda - MedCity News

Keytruda, a Merck cancer immunotherapy that has become the world’s top-selling medication, is administered as an intravenous infusion over the course of 30 minutes. The pharmaceutical giant now has results from a pivotal clinical trial showing an experimental injectable version of Keytruda dosed in minutes was roughly comparable to the IV-administered drug. Merck now plans to discuss these results with regulators, laying the groundwork for potential submissions seeking approvals of the more patient-friendly subcutaneous version. Injectable Keytruda could improve access to the product with a version that’s less burdensome to both patients and clinicians. For Merck, an injectable formulation would help the company hold on to some market share and revenue that will be lost when biosimilar versions of the drug become available. In pursuing an injectable version of its blockbuster cancer drug, Merck is taking the same strategy as some other pharmaceutical companies that also face looming biosimilar competition. Pembrolizumab, brand name Keytruda, belongs to a class of immunotherapies called checkpoint inhibitors. The drug is an antibody designed to block PD-1, a protein on immune cells that keep those cells from recognizing and targeting tumors. Antibodies drugs are typically administered as IV infusions. Merck developed the injectable version of Keytruda with enzyme technology that enables intravenous drugs to be administered as injections. This technology, called Hybrozyme, comes from South Korea-based Alteogen. Consumer / Employer Health Executives on Digital Transformation in Healthcare Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. By MedCity News The results announced Tuesday are from an open-label Phase 3 test enrolled about 378 adults with advanced non-small cell lung cancer. Keytruda was evaluated as a first-line treatment. Patients were randomly assigned to receive injectable Keytruda in combination with chemotherapy or IV-infused Keytruda and chemotherapy. Both drug regimens were administered every six weeks. The main goal was to assess pharmacokinetics (PK) — how the drug distributed in the body. Without releasing specific figures, Merck said injectable Keytruda met the two main PK goals of the study, demonstrating exposure in the body that was no worse than the IV-infused formulation of the drug during the first dosing cycle and at the Keytruda’s trough concentration measured at the drug’s steady state. On secondary goals of efficacy and safety, Merck said the subcutaneous formulation was consistent with the IV formulation. Merck said these results, plus data from ongoing analyses, will be presented at an unspecified upcoming medical meeting and shared with regulatory authorities worldwide. “It is very encouraging to see positive Phase 3 results evaluating this fixed-dose combination of subcutaneous pembrolizumab, which was administered, on average, in approximately two to three minutes and has the potential to improve the patient experience as well as increase access for patients and healthcare providers compared to intravenous administration,” Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said in a prepared statement. Keytruda accounted for $21.6 billion in revenue through the first three quarters of 2024, a 17.6% increase compared to the same period in the prior year. It’s far and away Merck’s largest product by revenue and also the top-selling medication in the world. Keytruda drug faces patent expiration in 2028. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech Merck isn’t the only company that has turned to Alteogen’s technology as a way to try to compete against biosimilars. Earlier this month, Daiichi Sankyo secured rights to use the technology to develop a subcutaneous version of Enhertu, a blockbuster antibody drug conjugate cancer therapy that is commercialized in partnership with AstraZeneca. But Alteogen also has alliances with companies that are developing biosimilars. Sandoz has global rights to use the Alteogen technology to develop a subcutaneous version of an unspecified biosimilar in its portfolio. That deal includes an option for Sandoz to license the technology for two additional products. Roche has already received FDA approvals for new injectable formulations of two of its blockbuster products. In September, the FDA approved an injectable version of the pharma giant’s cancer immunotherapy Tecentriq. That approval was followed by a regulatory nod for an injectable formulation of multiple sclerosis drug Ocrevus. Both Roche products were developed with Enhanze, a Halozyme drug delivery technology that enables biologic drugs to be administered as injections.

Clinical ResultImmunotherapyPhase 3Drug Approval

13 Nov 2024

·www.prnewswire.com

75+ Key Companies Charting New Frontiers in Multiple Sclerosis Therapeutic Space | DelveInsight

Multiple sclerosis (MS) is a chronic neurological disorder affecting the central nervous system (CNS), particularly the brain, spinal cord, and optic nerves. Continuous research has led to new drug developments, particularly disease-modifying therapies (DMTs) that slow MS progression. Monoclonal antibodies, oral therapies, and infusion treatments are among the most promising options and drives the multiple sclerosis market. LAS VEGAS, Nov. 13, 2024 /PRNewswire/ -- DelveInsight's ' Multiple Sclerosis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline multiple sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the multiple sclerosis pipeline domain. Key Takeaways from the Multiple Sclerosis Pipeline Report DelveInsight's multiple sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for multiple sclerosis treatment. Key multiple sclerosis companies such as Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Promising multiple sclerosis pipeline therapies such as GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. In October 2024, Immunic, Inc. reported favorable results from the non-binding interim futility analysis of its Phase 3 ENSURE trial, which is evaluating its lead candidate, vidofludimus calcium (IMU-838), a nuclear receptor-related 1 (Nurr1) activator, for the treatment of relapsing multiple sclerosis (RMS). In October 2024, Immunic, Inc. announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned. In September 2024, Roche, secured FDA approval for an injectable form of its blockbuster multiple sclerosis treatment, Ocrevus, reducing patient treatment time and potentially helping the company stay ahead of increasing competition. In September 2024, Sanofi announced the outcomes of Phase III clinical trials of its investigational oral brain-penetrant BTK inhibitor, tolebrutinib, aimed at treating multiple sclerosis (MS). These studies, namely HERCULES, GEMINI 1, and GEMINI 2, have provided mixed results, with the HERCULES trial meeting its primary endpoint while the GEMINI trials did not. The HERCULES study focused on the efficacy and safety of tolebrutinib in individuals with non-relapsing secondary progressive MS (nrSPMS) compared to a placebo. In August 2024, Abata Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101's Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase I study is imminent. In August 2024, TG Therapeutics announced that the FDA has cleared an investigational new drug (IND) application submitted by TG Therapeutics for azercabtagene zapreleucel (azer-cel), an investigational allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, for a phase 1 clinical trial in patients with progressive multiple sclerosis (MS). In January 2024, Kyverna Therapeutics, Inc. announced it received fast-track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of multiple sclerosis (MS). Request a sample and discover the recent advances in multiple sclerosis treatment drugs @ Multiple Sclerosis Pipeline Report The multiple sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage multiple sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the multiple sclerosis clinical trial landscape. Multiple Sclerosis Overview Multiple sclerosis is a chronic autoimmune disorder that affects the central nervous system, leading to the deterioration or permanent damage of myelin, the protective sheath surrounding nerve fibers. While the exact cause of multiple sclerosis remains unclear, it is believed to involve a combination of genetic predisposition, environmental factors, and possibly viral infections. Common symptoms of multiple sclerosis include fatigue, difficulty walking, numbness or tingling in the limbs, muscle weakness, and vision problems, which can vary significantly among individuals and may evolve over time. Diagnosis typically involves a combination of neurological examinations, magnetic resonance imaging (MRI) to detect lesions in the brain and spinal cord, and sometimes lumbar puncture to analyze cerebrospinal fluid for inflammatory markers. While there is no cure for multiple sclerosis, treatment options aim to manage symptoms, reduce the frequency and severity of relapses, and slow disease progression. This may include disease-modifying therapies (DMTs), corticosteroids for acute exacerbations, and symptomatic treatments such as physical therapy, pain management, and lifestyle modifications. Early diagnosis and a tailored treatment plan are crucial for improving the quality of life for those living with multiple sclerosis. Find out more about multiple sclerosis treatment drugs @ Drugs for Multiple Sclerosis Treatment A snapshot of the Multiple Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging multiple sclerosis pipeline therapies @ Multiple Sclerosis Clinical Trials Multiple Sclerosis Therapeutics Assessment The multiple sclerosis pipeline report proffers an integral view of the multiple sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Multiple Sclerosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunomodulators, MHC class II gene modulators, Agammaglobulinaemia tyrosine kinase inhibitors, Dihydroorotate dehydrogenase inhibitors, Nuclear receptor subfamily 4 group A member 2 agonists, CD20 antigen inhibitors, Energy metabolism stimulants; Immunomodulators, Lysine-specific demethylase 1 inhibitors, Monoamine oxidase B inhibitors, Protein-arginine deiminase inhibitors, Immunostimulants Key Multiple Sclerosis Companies: Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Key Multiple Sclerosis Pipeline Therapies:GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. Dive deep into rich insights for new drugs for multiple sclerosis treatment, visit @ Multiple Sclerosis Drugs Table of Contents For further information on the multiple sclerosis pipeline therapeutics, reach out @ Multiple Sclerosis Treatment Drugs Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key multiple sclerosis companies including Immune Response BioPharma, Inc., Clene Nanomedicine, Genzyme, ImStem Biotechnology, Rho, Inc., Bristol-Myers Squibb, TG Therapeutics, Inc., Hoffmann-La Roche, Atara Biotherapeutics, Immunic AG, Celgene, Anokion SA, Sanofi, Actelion, Biogen, Supernus Pharmaceuticals, Inc., GeNeuro SA, HuniLife Biotechnology, Inc., Emerald Health Pharmaceuticals, RemeGen Co., Ltd., Antisense Therapeutics, Biocad, AB Science, Genentech, Novartis, Pipeline Therapeutics, ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, Mapi Pharma, f5 Therapeutics, Autobahn Therapeutics, AstraZeneca, ZyVersa Therapeutics, RedHill Biopharma, Gossamer Bio, Sarepta Therapeutics, BrainStorm Cell Limited, CytoDyn, Pear Therapeutics, Solstice Neurosciences, ProJenX, among others. Multiple Sclerosis Epidemiology Forecast Multiple Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted multiple sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Relapsing Multiple Sclerosis Pipeline Relapsing Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key relapsing multiple sclerosis companies, including ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, among others. Relapsing-Remitting Multiple Sclerosis Pipeline Relapsing-Remitting Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMS companies, including TG Therapeutics, Novartis, Sanofi, Cinnagen, Polpharma Biologics, Immunic, Mapi Pharma, Biocad, Apimeds, Genentech (Roche), Merck, Immune Response BioPharma, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, Emerald Health Pharmaceuticals, GlaxoSmithKline, RedHill Biopharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultFast TrackCell TherapyImmunotherapy

100 Deals associated with Ocrelizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D05218	Ocrelizumab	L04AA36	DB11988

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis	AU	Roche Holding AG	13 Jul 2017
Multiple sclerosis relapse	US	Genentech, Inc.	28 Mar 2017
Multiple Sclerosis, Primary Progressive	US	Genentech, Inc.	28 Mar 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Chronic Progressive	Phase 3	US	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	BA	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	BR	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CA	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CO	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CR	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CZ	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	DK	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	EG	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	FR	Hoffmann-La Roche, Inc.	28 May 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03085810 (ENSEMBLE, Pubmed \| Neurology)	Phase 3	Multiple Sclerosis, Relapsing-Remitting First line serum neurofilament light chain (NfL)	678	Ocrelizumab 600 mg	qadthpucrf(vmffavxrdt) = iigfeutfnh ndapqmukgi (afosxypmwv )	Positive	24 Dec 2024
NCT04075266 (OPERETTA 1, CTgov)	Phase 2	Multiple Sclerosis, Relapsing-Remitting	23	ocrelizumab (Body Weight < 40 kg)	ypsctpxkub(tfyuztnijl) = rgexyjilrl lwtgwxnani (ensjthdfwp, gzoxurfhho - hopvvdkqpt) View more	-	08 Nov 2024
				ocrelizumab (Body Weight ≥ 40 kg)	ypsctpxkub(tfyuztnijl) = rofgrgfikz lwtgwxnani (ensjthdfwp, mytoxswjdj - sviyjeuonl) View more
NCT04966338 (Pubmed) Manual	Phase 3	Multiple sclerosis relapse	170	Xacrel	jbhmfjefgz(kbmuoqqjaw) = equivalent ibxjvsbqby (xjhdvzqwfg ) View more	Similar	22 Oct 2024
				Ocrevus
NCT04877457 (CELLO, CTgov)	Phase 4	Radiologically isolated syndrome	3	ocrelizumab (Ocrelizumab)	hxhxekcrac(czesnhrdas) = wcdhcbdaoy oqudeuylpg (crixjjbbwz, wkjokrrlbt - ofclqlgffj) View more	-	09 Oct 2024
				Placebo (Placebo)	hxhxekcrac(czesnhrdas) = vzbxuayqst oqudeuylpg (crixjjbbwz, pklcotufwc - yosknmswcu) View more
EAN2024	Not Applicable	-	-	ocrelizumab (Treatment-naive patients (TN))	onpshiglky(umufnyelja) = Adverse events (AEs) occurred in 56.7/100 patient years (PY) in TN-patients (88.7/100PY in pwPMST â‰¥3); 22.9/100PY were classified as System Organ Class (SOC) âInfections and infestationsâ (32.3/100PY in pwPMST â‰¥3) mkcqgaivai (fxsnmirkpq ) View more	-	28 Jun 2024
				ocrelizumab (Patients with â‰¥1 prior MS-specific therapies (pwPMST))
NCT02688985 (CTgov)	Phase 3	Multiple Sclerosis, Primary Progressive \| Multiple sclerosis relapse	131	Antihistamine+Methyloprednisolone+Ocrelizumab (RMS Cohort Arm 1: Ocrelizumab + LP)	bdkdhmiyvf(ubodxsnckr) = sfbwjpxucu flakuzchyn (rclhihygig, crpeldydkx - qbtpnivinp) View more	-	04 Jun 2024
				Antihistamine+Methyloprednisolone+Ocrelizumab (RMS Cohort Arm 2: Ocrelizumab + LP)	bdkdhmiyvf(ubodxsnckr) = aalvhsrzmk flakuzchyn (rclhihygig, mxenuliofo - vgzhvbrabk) View more
NCT03972306 (OCARINA I, AAN2024)	Phase 1	Multiple Sclerosis	131	Ocrelizumab SC 920mg	awmnszimwe(aghhnmqvcn) = vzhrlmylwx fynflrrmdy (okigxtasxh ) View more	Positive	09 Apr 2024
				Ocrelizumab IV 600mg	awmnszimwe(aghhnmqvcn) = jhznegtbbd fynflrrmdy (okigxtasxh ) View more
NCT03085810 (ENSEMBLE, AAN2024)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	301	Ocrelizumab	muteezoabg(iztsyomqwi) = nwpsrakprs ktzwjksodz (osbojhccku )	Positive	09 Apr 2024
				Interferon β-1a/-1b, Glatiramer Acetate, Dimethyl Fumarate, Teriflunomide	muteezoabg(iztsyomqwi) = ejvxfcgvoc ktzwjksodz (osbojhccku )
NCT03085810 (ENSEMBLE, AAN2024)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	678	Ocrelizumab 600 mg	tkgrnmiyvr(gujnecbwcd) = cveodirlnp ypscfwbvsw (faetxapldo )	Positive	09 Apr 2024
AAN2024	Not Applicable	Multiple Sclerosis	-	Ocrelizumab exposure	pmamgwsvfn(fbztrjswez) = wkgcpelviq rguuuyskhe (ghdmdujzad ) View more	Positive	09 Apr 2024

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