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Zoledronic acid - Novartis

Drug Profile

Zoledronic acid - Novartis

Alternative Names: Aclasta; AK-156; CGP-42446A; Reclast; ZOL-446; zoledronate; Zometa

Latest Information Update: 30 Oct 2021

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At a glance

  • Originator Novartis
  • Developer Asahi Kasei Pharma Corp; Novartis; UNICANCER
  • Class Antineoplastics; Bisphosphonates; Calcium regulators; Imidazoles; Osteoporosis therapies; Small molecules
  • Mechanism of Action Bone resorption factor inhibitors; Geranyltranstransferase inhibitors; Osteoclast inhibitors
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Marketed Bone metastases; Corticosteroid-induced osteoporosis; Fracture; Male osteoporosis; Malignant hypercalcaemia; Mesothelioma; Multiple myeloma; Osteitis deformans; Postmenopausal osteoporosis
  • Registered Osteoporosis
  • Phase II Breast cancer
  • Discontinued Osteogenesis imperfecta; Osteosarcoma; Rheumatoid arthritis

Most Recent Events

  • 25 May 2021 Novartis and University of Sheffield completes the phase III AZURE trial in Breast cancer (Adjuvant therapy) in USA, Spain, Australia, Ireland, Portugal, Taiwan, Thailand and the United Kingdom, before May 2021 (ISRCTN79831382) (NCT00072020)
  • 30 Mar 2021 No development reported - Phase-III for Corticosteroid-induced osteoporosis (In adolescents, In children) in United Kingdom, Australia, Belgium, Canada, Germany, Hungary, Finland, Italy, Romania, Russia, Poland, South Africa (IV)
  • 05 Mar 2018 Novartis Pharmaceuticals completes a phase III trial in Corticosteroid-induced osteoporosis (In adolescents, In children) Australia, Canada, Finland, Romania, Italy, Russia, South Africa, Germany, Hungary, Belgium, Poland and the UK (IV) (EudraCT2008-001252-52) (NCT00799266)
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