CPI 613

Drug Profile

CPI 613

Alternative Names: Bylantra; CPI-613

Latest Information Update: 17 Jan 2017

Price : $50

At a glance

  • Originator Cornerstone Pharmaceuticals; Stony Brook University
  • Developer Cornerstone Pharmaceuticals; National Cancer Institute (USA); Wake Forest University School of Medicine
  • Class Antineoplastics; Carboxylic acids; Coenzymes; Fatty acids; Small molecules; Thiophenes
  • Mechanism of Action Ketoglutarate dehydrogenase complex inhibitors; Pyruvate dehydrogenase complex inhibitors
  • Orphan Drug Status

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

    Yes - Myelodysplastic syndromes; Acute myeloid leukaemia; Pancreatic cancer
  • 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 II Myelodysplastic syndromes; Pancreatic cancer; Small cell lung cancer; Solid tumours
  • Phase I/II Cancer
  • Phase I Acute myeloid leukaemia; Biliary cancer; Colorectal cancer; Haematological malignancies; Hodgkin's disease; Non-Hodgkin's lymphoma

Most Recent Events

  • 06 Jan 2017 Cornerstone Pharmaceutical suspends enrolment in a phase I/II trial in Pancreatic cancer (Combination therapy) in USA (NCT00907166)
  • 28 Dec 2016 Cornerstone Pharmaceuticals withdraws a phase IIa trial for Acute myeloid leukaemia and Myelodysplastic syndrome (Second-line therapy or greater) before enrolment in USA (IV) (NCT01520805)
  • 01 Dec 2016 Cornerstone Pharmaceuticals completes a phase I/II trial in Cancer (Late-stage disease, Metastatic disease) in USA and Canada (NCT00741403)
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