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Idelalisib - Gilead Sciences

Drug Profile

Idelalisib - Gilead Sciences

Alternative Names: CAL-101; GS-1101; IDELA; Zydelig

Latest Information Update: 14 Nov 2019

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At a glance

  • Originator Calistoga Pharmaceuticals
  • Developer Augusta University; Calistoga Pharmaceuticals; Celgene Corporation; Gilead Sciences; Merck Sharp & Dohme; National Cancer Institute (USA)
  • Class Antineoplastics; Purines; Quinazolinones; Small molecules
  • Mechanism of Action Phosphatidylinositol 3 kinase delta 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

  • Marketed Chronic lymphocytic leukaemia; Follicular lymphoma
  • Phase III Non-Hodgkin's lymphoma
  • Phase II Hodgkin's disease; Mantle-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Phase I/II Non-small cell lung cancer
  • Phase I Diffuse large B cell lymphoma
  • No development reported Myelofibrosis; Pancreatic cancer
  • Discontinued Allergic rhinitis; Solid tumours

Most Recent Events

  • 12 Aug 2019 Gilead Sciences terminates a phase III trial for Chronic lymphocytic leukaemia in USA, UK, Germany, France and Italy (PO) (NCT01539291)
  • 13 Jun 2019 Pooled efficacy results from the phase III GS-US-312-0119 and GS-US-312-0116 trials in Chronic lymphocytic leukaemia presented at the 24th Congress of the European Haematology Association (EHA-2019)
  • 10 Jun 2019 Gilead Sciences completes a phase III trial for Chronic lymphocytic leukaemia (Combination therapy, Second-line therapy or greater) in USA, Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Greece, Germany, Hungary, Ireland, Italy, New Zealand, Poland, Portugal, Romania, Russia, Spain, Turkey, United Kingdom (NCT01569295) (EudraCT2011-006292-20)
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