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Abaloparatide - Ipsen/Radius Health

Drug Profile

Abaloparatide - Ipsen/Radius Health

Alternative Names: Abaloparatide patch; Abaloparatide-SC; Abaloparatide-TD; BA-058; BA-058-SC; BA-058-TD; BIM-44058; Eladynos; ITM-058; PTHrP; Synthetic human parathyroid hormone 37-70 analogue - Ipsen; TYMLOS

Latest Information Update: 12 Aug 2019

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At a glance

  • Originator 3M Drug Delivery Systems; Biomeasure Inc; Ipsen
  • Developer Radius; Radius Health Inc.; Teijin Pharma
  • Class Calcium regulators; Osteoporosis therapies; Peptide hormones
  • Mechanism of Action Osteogenesis stimulants; Parathyroid hormone receptor type 1 agonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Postmenopausal osteoporosis

Highest Development Phases

  • Marketed Postmenopausal osteoporosis
  • Phase III Male osteoporosis

Most Recent Events

  • 05 Aug 2019 Phase-III clinical trials in Postmenopausal osteoporosis in USA (Transdermal) (NCT04064411)
  • 01 Oct 2018 Radius Health receives approval from the US FDA for sNDA to include data from the ACTIVExtend trial
  • 24 Jul 2018 The Committee for Medicinal Products for Human Use (CHMP) of EMA issues negative trend vote on the re-examination of abaloparatide for treatment of Postmenopausal osteoporosis
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