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ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function?

MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK.and 2.5 million people worldwide.
Without disease modifying treatment (DMT),the majority of people with MS (pwMS) will develop significant disability within 10 years of onset, and 50% will require wheelchair assistance within 20 years. convenient, highly effective and CNS penetrant DMT for patients with relapsing multiple sclerosis (pwRMS) administered in short (8-10 days/year over 2 years) treatment courses.
It effectively depletes B cells, particularly Memory B cells, a likely key mechanism of disease control in MS. Cladribine is the investigational product in this study as it not currently used to treat patients with an EDSS of 6.5 - 8.5. This is a multi-centre, randomised double-blind placebo-controlled phase IIb to test cladribine tablets (MAVENCLAD®) (3.5mg/kg over 24 months) for safety, efficacy, and cost effectiveness, and to advance mechanistic understanding of its action in people with advanced MS (pwAMS).

Start Date25 Jun 2021

Sponsor / Collaborator

Queen Mary University of London

[+3]

100 Clinical Results associated with Merck Serono Ltd.

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0 Patents (Medical) associated with Merck Serono Ltd.

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182

Literatures (Medical) associated with Merck Serono Ltd.

08 Apr 2025·Neurology

Oral Cladribine Capsules for Generalized Myasthenia Gravis: Design of the Actively Recruiting Phase 3 MyClad Study (P1-11.013)

Author: Mantegazza, Renato ; Howard, James F. ; Nolting, Axel ; Cutter, Gary ; Gopalakrishnan, Sathej ; Palace, Jacqueline ; Jack, Dominic ; Alexandri, Nektaria ; Kaminski, Henry ; O’Connor, Kevin ; Rejdak, Konrad ; Meisel, Andreas ; Dimachkie, Mazen ; Le Bolay, Claire ; Javor, Andrija

01 Apr 2025·Clinical and Translational Science

Effect of Cladribine Tablets on the Pharmacokinetics of a Combined Oral Contraceptive in Pre‐Menopausal Women With Relapsing Multiple Sclerosis

Article

Author: Hellwig, Kerstin ; Galazka, Andrew ; Bytyqi, Afrim ; Krebs‐Brown, Axel ; Vetter, Claudia ; Dong, Jennifer Q. ; Venkatakrishnan, Karthik ; Nolting, Axel ; Gaikwad, Sumedh ; Jack, Dominic ; Hermann, Robert

ABSTRACTThis study assessed the effect of cladribine tablets (CladT) on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in pre‐menopausal women with relapsing multiple sclerosis. It was a randomized, double‐blind, two‐period, two‐sequence crossover study to assess steady‐state plasma PK (area under the concentration–time curve and peak concentration) of COC (ethinylestradiol [EE] 30 μg and levonorgestrel [LNG] 150 μg) when co‐administered with CladT or placebo. Participants received 2 weeks of active CladT treatment per course (Weeks 1 and 5 per year) to have a cumulative dose of 3.5 mg/kg over 2 years as per label. Of the 24 randomized participants, 23 completed the study. The results showed that the concentration–time profiles as well as PK parameters of EE and LNG in the plasma were similar when co‐administered with CladT or placebo. Analysis of variance confirmed the bioequivalence of EE and LNG in COC when co‐administered with either CladT or placebo. All participants were adequately exposed to cladribine. Repeat‐dose administration of CladT had no apparent effect on serum luteinizing hormone, follicle‐stimulating hormone, progesterone, or sex hormone‐binding globulin concentrations during concomitant treatment with COC. Co‐administration with COC did not change the known safety and tolerability profile of CladT and did not alter the PK of EE or LNG in a COC during the study. Therefore, the concomitant use of CladT is not expected to decrease the efficacy of COCs containing EE and LNG.Trial Registration: EudraCT Number: 2018‐001015‐70.

10 Feb 2025·Journal of Clinical Oncology

Avelumab in combination with axitinib (Ave + Axi) for first-line (1L) treatment of advanced renal cell carcinoma (aRCC): A systematic literature review (SLR) of real-world effectiveness and safety.

Author: Sharma, Aniket ; Elsada, Ahmed ; Taneja, Ankush ; Fontrier, Anna-Maria ; Kearney, Mairead ; Alexopoulos, Stamatia ; Roskell, Neil

100 Deals associated with Merck Serono Ltd.

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100 Translational Medicine associated with Merck Serono Ltd.

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Pipeline

Pipeline Snapshot as of 18 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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