A single, randomized, open label, active-controlled, non-inferiority bioequivalence pivotal study of TYMLOS to treat patients with postmenopausal osteoporosis.
Phase of Trial: Phase I
Latest Information Update: 01 Mar 2018
At a glance
- Drugs Abaloparatide (Primary) ; Abaloparatide
- Indications Postmenopausal osteoporosis
- Focus Registrational; Therapeutic Use
- Sponsors Radius Health Inc.
- 01 Mar 2018 According to a Radius media release, company expects to initiate this pivotal trial in mid-2019.
- 01 Mar 2018 According to a Radius media release, based on the results of this study, FDA has agreed to provide an approval for Abaloparatide-Transdermal Patch (TD) to treat patients with postmenopausal osteoporosis .
- 02 Nov 2017 The company has scheduled a meeting with the FDA in January 2018 to align on a regulatory pathway for this trial, as reported in a Radius media release.