Drug Profile


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

Latest Information Update: 02 Nov 2017

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At a glance

  • Originator Calistoga Pharmaceuticals
  • Developer Augusta University; Calistoga Pharmaceuticals; Gilead Sciences; Merck Sharp & Dohme
  • 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 Myelofibrosis; Pancreatic cancer
  • Discontinued Allergic rhinitis; Solid tumours

Most Recent Events

  • 17 Oct 2017 Gilead Sciences completes a phase I trial in (Chronic lymphocytic leukaemia, Follicular lymphoma and Non-Hodgkin's lymphoma (Second-line therapy or greater, Monotherapy) in Japan (PO) (NCT02242045)
  • 20 Sep 2017 Phase-I/II clinical trials in Non-small cell lung cancer (Combination therapy, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT03257722)
  • 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)
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