Drug Profile


Alternative Names: Absorb; Affinitor; Affinitor Dispersible; Afinitor; Afinitor Disperz; Certican; Esprit BVS; Promus; Promus Element; Promus Premier; RAD; RAD-001; SDZ RAD; Synergy; Votubia; Xience nano; Xience Prime; Xience V; Xience Xpedition; Zortress

Latest Information Update: 16 Jan 2017

Price : $50

At a glance

  • Originator Novartis; University of Michigan Comprehensive Cancer Center
  • Developer Abbott Laboratories; Assistance Publique Hopitaux de Paris; Boston Scientific Corporation; Dana-Farber Cancer Institute; Hannover Medical School; Italian Trials in Medical Oncology; National Cancer Institute (USA); New York University School of Medicine; Novartis; Sarcoma Alliance for Research through Collaboration; SCRI Development Innovations; University of California at San Francisco; University of Sydney; University of Texas M. D. Anderson Cancer Center; Yale University
  • Class Antineoplastics; Macrolides; Polyenes
  • Mechanism of Action B cell inhibitors; Immunosuppressants; MTOR protein inhibitors; T lymphocyte inhibitors
  • Orphan Drug Status

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

    Yes - Astrocytoma; Angiomyolipoma
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Angiomyolipoma; Astrocytoma; Breast cancer; Coronary artery restenosis; Heart transplant rejection; Kidney disorders; Liver transplant rejection; Neuroendocrine tumours; Renal cell carcinoma; Renal transplant rejection
  • Preregistration Partial epilepsies
  • Phase III Autosomal dominant polycystic kidney disease; Diffuse large B cell lymphoma; Hepatocellular carcinoma; Myocardial infarction
  • Phase II Cognition disorders; Endometrial cancer; Endometrial hyperplasia; Germ cell and embryonal neoplasms; Glioma; Head and neck cancer; Hodgkin's disease; Neurofibromatoses; Neurofibromatosis 2; Non-small cell lung cancer; Pancreatic cancer; Plexiform neurofibroma
  • Phase I/II Acute lymphoblastic leukaemia; Colorectal cancer; Oesophageal cancer
  • Phase I Cervical cancer; Multiple myeloma; Non-Hodgkin's lymphoma; Prostate cancer; Solid tumours; Tuberous sclerosis
  • No development reported Mantle-cell lymphoma; Mesothelioma
  • Discontinued Gastric cancer; Gastrointestinal stromal tumours; Pulmonary fibrosis; Rheumatoid arthritis

Most Recent Events

  • 02 Jan 2017 M.D. Anderson Cancer Center and Novartis plan a phase II trial for Endometrial cancer (Recurrent, Combination therapy, Second-line therapy or greater, Late-stage disease) in USA (NCT03008408)
  • 16 Dec 2016 Preregistration for Partial epilepsies (In children, In adolescents, In adults) in European Union before December 2016 (PO)
  • 16 Dec 2016 The CHMP adopts a positive opinion for everolimus for the treatment Partial epilepsies associated with tuberous sclerosis complex
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