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New Drugs Online Report for bitopertin
Generic Name:
Trade Name:  
Synonym: RO4917838, RG1678, GLYT-1 
Entry Type: Licence extension / variation  
Development and Regulatory status
UK: Discontinued 
EU: Discontinued 
US: Discontinued 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Mar 15. Reported as discontinued for Schizophrenia in all regions. [10] 
31/03/2015 12:39:12
Oct 14: Bitopertin for schizophrenia no longer listed in Roche pipeline [9]. 
19/12/2014 10:05:37
Apr 14: The PIII study TwiLyte for sub-optimally controlled symptoms did not meet primary end points. MoonLyte has been discontinued after futility analyses. NightLyte will continue [7] 
16/04/2014 09:39:14
Feb 14: Filing still anticipated 2015 [5] 
24/02/2014 11:18:31
Dec 12: Filings will not be until 2015 [4]. 
05/03/2013 14:36:21
Jun 12: EU & US filings estimated to be 2014 [3]. 
04/09/2012 11:27:36
PIII [1,2]. 
06/03/2012 17:04:57
Trial or other data
Q2 14: Bitopertin 10mg dose arm met primary endpoint in NIGHTLYTE. Further steps are under evaluation [8]. 
12/09/2014 16:06:14
Q4 10: First pts enrolled in each of 3 PIII studies to assess the safety & efficacy of bitopertin (each involving approx 600 pts) with suboptimally controlled symptoms of schizophrenia treated with antipsychotics. One (NIGHTLYTE; NCT01235559) is a 12-week, randomised, double-blind, parallel group trial, followed by a 40-week double-blind, parallel group, placebo-controlled period. Patient recruitment is underway in the US, Bulgaria, China, Czech Republic, Italy & Japan. The 2 other studies have a similar design - MOONLYTE (NCT01235520) & TWILYTE (NCT01235585) [1,2]. 
06/03/2012 17:11:44
Evidence Based Evaluations
NHSC  http://www.nhsc-healthhorizons.org.uk/files/downloads/1848/2235.774408e0.Bitopertin_June12.pdf 
Available only to registered users
BNF Category:
Drugs used in psychoses and related disorders (04.02)
Pharmacology: Glycine transporter-1 (GlyT1) inhibitor, first in class  
Epidemiology: Incidence pf schizophrenia is approximately 15.2 per 100,000 person-years and prevalence of approximately 7.2 per 1,000 persons. Most commonly starts in adolescence and early 20s, and in young people aged 10-18 schizophrenia accounts for 24.5% of all psychiatric admissions. [6]  
Indication: Schizophrenia 
Additional Details: sub-optimally controlled symptoms, + antipsychotics 
Method(s) of Administration
Company Information
Name: Roche 
US Name: Roche 
Further Information
Anticipated commissioning route (England) CCG 
High cost drug list? Awaiting Update
Implications Available only to registered users