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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History