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Ontamalimab - Takeda

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Drug Profile

Ontamalimab - Takeda

Alternative Names: PF-00547659; PF-547659; SHP-647; TAK-647

Latest Information Update: 10 Jul 2025

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At a glance

  • Originator Pfizer
  • Developer Takeda
  • Class Anti-inflammatories; Hepatoprotectants; Monoclonal antibodies
  • Mechanism of Action Inflammation mediator inhibitors; MADCAM1 protein inhibitors
  • Orphan Drug Status

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

    Yes - Ulcerative colitis; Crohn's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Non-alcoholic steatohepatitis
  • Discontinued Crohn's disease; Ulcerative colitis

Most Recent Events

  • 06 Jul 2025 Takeda terminates a phase-I clinical trials in Non-alcoholic steatohepatitis in USA due to strategic shift and reprioritization of clinical programs (SC) (NCT07052682)
  • 13 Dec 2023 Takeda completes the phase III trial in Crohn's Disease in US, Argentina, Australia, Austria, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Turkey, Ukraine, and United Kingdom (NCT03283085)
  • 13 Dec 2023 Takeda completes the phase III trial in Ulcerative Colitis in US, Argentina, Australia, Austria, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Turkey, Ukraine, and United Kingdom (NCT03283085)

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