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Evobrutinib - Merck Serono

Drug Profile

Evobrutinib - Merck Serono

Alternative Names: M-2951; MSC-2364447; MSC2364447C

Latest Information Update: 14 May 2024

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At a glance

  • Originator Merck Serono
  • Developer EMD Serono; Merck Serono
  • Class Amines; Anti-inflammatories; Antirheumatics; Phenyl ethers; Piperidines; Pyrimidines; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Multiple sclerosis
  • No development reported Encephalomyelitis
  • Discontinued Rheumatoid arthritis; Systemic lupus erythematosus

Most Recent Events

  • 29 Apr 2024 EMD Serono and Merck terminate the phase III evolutionRMS 1 trial in Multiple sclerosis in USA, Ukraine, United Kingdom, Taiwan, Spain, Serbia, Russia, Poland, Netherlands, South Korea, Mexico, Italy, Israel, India, Hungary, Hong Kong, Germany, Georgia, France, Finland, Estonia, Croatia, Czech Republic, Colombia, Canada, Bulgaria, Bosnia-Herzegovina, Belgium, Australia, Austria, Argentina (PO), due to the results of EVOLUTION clinical trials, which showed that evobrutinib did not meet its primary endpoint (NCT04338022) (EudraCT2019-004972-20)
  • 26 Apr 2024 EMD Serono and Merck terminate a phase II trial in Multiple sclerosis in Ukraine, Serbia, Russia, Poland, Bulgaria, Ukraine, Spain, Solvakia and Czech Republic (PO), due to the results of EVOLUTION clinical trials, which showed that evobrutinib did not meet its primary endpoint (NCT02975349) (EudraCT2016-001448-21)
  • 19 Mar 2024 Merck terminates phase-III evolutionRMS 2 trial in Multiple sclerosis (Treatment-experienced) in USA, Belarus, Brazil, Bulgaria, Canada, France, Germany, Greece, India, Italy, Latvia, Lithuania, Malaysia, Moldova, Norway, Philippines, Poland, Portugal, Puerto Rico , Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine (PO) due to evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies (NCT04338061)
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