Abaloparatide - Ipsen/Radius Health

Drug Profile

Abaloparatide - Ipsen/Radius Health

Alternative Names: 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: 03 Apr 2018

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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

  • 02 Apr 2018 Phase-III clinical trials in Male osteoporosis in USA (SC)
  • 22 Mar 2018 CHMP of EMA issues negative trend vote on the benefit-risk balance for abaloparatide for treatment of Postmenopausal osteoporosis and adopts a negative opinion on MAA
  • 22 Mar 2018 Radius Health intends to appeal against negative opinion of CHMP on MAA for abaloparatide for treatment of Postmenopausal osteoporosis
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