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Dactolisib - resTORbio

Drug Profile

Dactolisib - resTORbio

Alternative Names: BEZ-235; Dactolisib-tosylate; NVP-BEZ-235; NVP-BEZ235-ANA; NVP-BEZ235-NX; RTB-101

Latest Information Update: 05 Nov 2019

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At a glance

  • Originator Novartis
  • Developer Memorial Sloan-Kettering Cancer Center; Novartis; resTORbio
  • Class 3-ring heterocyclic compounds; Acetonitriles; Antineoplastics; Antivirals; Benzenesulfonates; Imidazoles; Nitriles; Quinolines; Small molecules
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; 3 phosphoinositide dependent protein kinase 1 inhibitors; Apoptosis stimulants; Immunostimulants; MTOR protein 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

  • Phase III Respiratory tract infections
  • Phase II Influenza virus infections
  • Phase I/II Parkinson's disease
  • Phase I Heart failure; Urinary tract infections
  • Discontinued Breast cancer; Glioblastoma; Haematological malignancies; Non-small cell lung cancer; Pancreatic cancer; Perivascular epithelioid cell tumours; Prostate cancer; Renal cell carcinoma; Solid tumours

Most Recent Events

  • 02 Oct 2019 Efficcay, safety and pharmacodynamics data from a phase IIb trial in Respiratory tract infections released by resTORbio
  • 07 Jul 2019 Phase-III clinical trials in Respiratory tract infections (In the elderly, Prevention) in Canada, USA (PO) (NCT04139915)
  • 07 Jul 2019 Phase-III clinical trials in Respiratory tract infections (In the elderly, Prevention) in United Kingdom and Germany (PO) (EudraCT2019-002014-39)
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