Phase 3 study of S-888711 in thrombocytopenic patients with chronic liver disease
Phase of Trial: Phase III
Latest Information Update: 26 Feb 2018
At a glance
- Drugs Lusutrombopag (Primary)
- Indications Thrombocytopenia
- Focus Adverse reactions; Therapeutic Use
- Acronyms L-PLUS1
- Sponsors Shionogi
- 26 Feb 2018 Based on L-PLUS1 and L-PLUS2 studies, New Drug Application (NDA) for lusutrombopag (S-888711), has been accepted for filing and has been granted Priority Review by the U.S. Food & Drug Administration (FDA), and the European Medicines Agency has validated for review Marketing Authorization Application (MAA).
- 25 Sep 2017 According to a Shionogi media release, based on the results from the L-PLUS1 and L-PLUS2 Phase 3 studies, Shionogi has initiated rolling submission of a New Drug Application to the FDA.
- 25 Mar 2015 New trial record