A phase III study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS)
Phase of Trial: Phase III
Latest Information Update: 06 Nov 2017
At a glance
- Drugs Sparsentan (Primary)
- Indications Focal segmental glomerulosclerosis
- Focus Registrational; Therapeutic Use
- Sponsors Retrophin
- 06 Nov 2017 According to a Retrophin Inc. media release, the company has received feedback from the US FDA requesting additional statistical analyses to support the trial design's eligibility for the Subpart H pathway.
- 03 Nov 2017 According to a Retrophin media release, company expects to confirm the Phase 3 protocol with the FDA in the second half of 2017, with this trial expected to initiate thereafter.
- 09 Aug 2017 According to a Retrophin media release, protocol design for this trial is complete and preparation for submission of the protocol to the US FDA is underway