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A Phase 3 Study of Oral PTH (1-34) for the Treatment of Osteoporosis for the treatment of osteoporosis in comparison with subcutaneous FORTEO (teriparatide, Eli Lilly)

Trial Profile

A Phase 3 Study of Oral PTH (1-34) for the Treatment of Osteoporosis for the treatment of osteoporosis in comparison with subcutaneous FORTEO (teriparatide, Eli Lilly)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2023

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At a glance

  • Drugs Teriparatide (Primary) ; Teriparatide (Primary)
  • Indications Osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Entera Bio
  • Most Recent Events

    • 14 Nov 2023 According to an Entera Bio media release, the company is prepared to initiate a pivotal phase 3 study in post-menopausal women with high-risk osteoporosis and no prior fracture.
    • 12 May 2022 According to an Entera Bio media release, company and the FDA agreed upon the production and specifications of the drug components and final product for the Phase 3 study. The Company looks forward to providing further updates related to its productive discussions with the Food and Drug Administration (FDA) in the near term.
    • 17 Feb 2022 According to an Entera Bio media release, data from this trial will be presented at the Aegis Capital Corp. Virtual Conference.

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