Parathyroid hormone - Shire

Drug Profile

Parathyroid hormone - Shire

Alternative Names: 423562; ALX 111; Natpar; Natpara; NPSP-795; NPSP558; Parathyroid hormone (1-84) - Shire; PREOS; Preotact; PTH (1-84); PTH 1-84; Recombinant human parathyroid hormone-1-84; rhPTH (1-84); rhPTH-1-84; SB-423562; SHP-635

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator NPS Pharmaceuticals
  • Developer National Institutes of Health (USA); NPS Pharmaceuticals; Shire; Takeda Pharmaceuticals International GmbH
  • Class Calcium regulators; Osteoporosis therapies; Peptide hormones
  • Mechanism of Action Calcium-sensing receptor antagonists; Osteogenesis stimulants; Parathyroid hormone receptor agonists
  • Orphan Drug Status

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

    Yes - Hypoparathyroidism
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hypoparathyroidism; Postmenopausal osteoporosis
  • Phase II Hypocalcaemia
  • Discontinued Osteoporosis

Most Recent Events

  • 24 Feb 2017 Updated adverse events data from the phase III REPLACE trial in Hypoparathyroidism released by Shire
  • 23 Feb 2017 CHMP recommends approval of Shire's Parathyroid hormone for Hypoparathyroidism (Adjunctive treatment) in European Union
  • 07 Oct 2016 Preregistration for Hypoparathyroidism (Adjunctive treatment) is ongoing in European Union (SC)
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