Drug Profile


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

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Calistoga Pharmaceuticals
  • Developer Calistoga Pharmaceuticals; Gilead Sciences
  • 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 Myelofibrosis; Pancreatic cancer
  • Discontinued Allergic rhinitis; Solid tumours

Most Recent Events

  • 28 Jul 2017 Gilead Sciences and Boehringer Ingelheim terminates a phase Ib/II trial for Chronic lymphocytic leukaemia (Combination therapy, Second-line therapy or greater) in USA (PO) (NCT02538614)
  • 22 Jun 2017 Efficacy and adverse events data from a terminated phase II trial in Chronic lymphocytic leukaemia were presented at the 22nd Congress of the European Haematology Association (EHA-2017)
  • 10 Jan 2017 Dana-Farber Cancer Institute and Gilead Sciences terminates patient enrolment in a phase II trial for Waldenstrom's macroglobulinaemia due to safety issues from trials in CLL (Second-line therapy or greater) in USA (NCT02439138)
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