A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant Salmon Calcitonin (rsCT) Compared to Salmon Calcitonin (sCT) Nasal Spray in Postmenopausal Osteoporotic Women

Trial Profile

A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant Salmon Calcitonin (rsCT) Compared to Salmon Calcitonin (sCT) Nasal Spray in Postmenopausal Osteoporotic Women

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Oct 2015

At a glance

  • Drugs Calcitonin (Primary) ; Calcitonin (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ORACAL
  • Sponsors Tarsa Therapeutics
  • Most Recent Events

    • 19 Oct 2015 According to a Tarsa Therapeutics media release, the NDA for TBRIA (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the US FDA in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016.
    • 26 Jul 2012 Results were published in the Journal of Bone and Mineral Research, according to an Unigene Laboratories media release.
    • 17 Jul 2012 Results published in the Journal of Bone and Mineral Research.
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