A bioequivalence study in healthy subjects for PF-708
Phase of Trial: Phase I
Latest Information Update: 09 Aug 2017
At a glance
- Drugs Teriparatide (Primary)
- Indications Osteoporosis
- Focus Pharmacokinetics; Registrational
- 09 Aug 2017 According to a Pfenex media release, the company expects to submit the new drug application (NDA) in the third quarter of 2018 to the FDA.
- 15 Mar 2017 Status changed from active, no longer recruiting to completed, according to a Pfenex media release.
- 15 Mar 2017 According to a Pfenex media release, this study, along with the phase III study (profile 271298), is anticipated to satisfy the filing requirements for PF708 through the 505(b)(2) regulatory pathway.