A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis
Phase of Trial: Phase III
Latest Information Update: 03 Oct 2017
At a glance
- Drugs Sirolimus (Primary)
- Indications Posterior uveitis
- Focus Registrational; Therapeutic Use
- Acronyms SAKURA Study 1
- Sponsors Santen Incorporated
- 25 Apr 2017 According to a Santen Pharmaceutical media release, based on the on the the data from the SAKURA Program (SAKURA-1 and SAKURA-2 studies) the FDA has accepted the NDA of Sirolimus and as per the Prescription Drug User Fee Act (PDUFA) set an action date of 24 December 2017 to complete its review.
- 15 Dec 2016 Status changed from active, no longer recruiting to completed.
- 28 Nov 2016 According to a Santen Pharmaceutical media release, based on the on the totality of the data from the SAKURA Program (SAKURA-1 and SAKURA-2 studies) the company plans to file a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History