Acalabrutinib

Drug Profile

Acalabrutinib

Alternative Names: ACP-196

Latest Information Update: 09 Dec 2016

Price : $50

At a glance

  • Originator Acerta Pharma
  • Developer Acerta Pharma; Merck Sharp & Dohme
  • Class Antineoplastics; Benzamides; Heavy metals; Imidazoles; Pyrazines; Pyridines; Pyrrolidines; 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.

    Yes - Mantle-cell lymphoma
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Chronic lymphocytic leukaemia
  • Phase II Bladder cancer; Head and neck cancer; Mantle-cell lymphoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Rheumatoid arthritis
  • Phase I/II B cell lymphoma; B cell prolymphocytic leukaemia; Glioblastoma; Waldenstrom's macroglobulinaemia
  • Phase I Diffuse large B cell lymphoma; Follicular lymphoma; Multiple myeloma

Most Recent Events

  • 05 Dec 2016 Updated preliminary efficacy and adverse events data from a phase I/II trial in Chronic lymphocytic leukaemia presented at the 58th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2016)
  • 21 Nov 2016 Acerta Pharma plans a phase III trial for Mantle cell lymphoma (Combination therapy, First-line therapy, In the elderly) in USA, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Peru, Poland, Romania, Russia, South Korea, Spain, Taiwan, Ukraine and Vietnam (PO) (NCT02972840)
  • 27 Oct 2016 Phase-III clinical trials in Chronic lymphocytic leukaemia (Monotherapy, Second-line therapy or greater) in Spain (PO, Capsule) (EudraCT2015-004454-17)
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