Rexulti
Author: Stephanie Yip
Publisher: Datamonitor Healthcare
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Drug Overview
Rexulti (brexpiprazole) is Otsuka’s latest atypical antipsychotic, approved simultaneously in the US for schizophrenia and major depressive disorder in July 2015. The drug acts similarly to Abilify (aripiprazole; Otsuka/Lundbeck), displaying partial agonism of dopamine receptors in the central nervous system.
In November 2011, Otsuka announced that it had signed a long-term agreement with Lundbeck for the development and commercialization of central nervous system products in both companies’ pipelines. Rexulti was one of Otsuka’s key assets in the deal. In return for $200m upfront, with a potential final deal value of $1.8bn, Lundbeck gained co-development and co-promotion rights to Rexulti and a depot formulation of Abilify. Lundbeck also offered Otsuka the same rights for up to three of its compounds after Phase IIb clinical trials.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Rexulti : Depression
17 Rexulti : Bipolar disorder
22 Rexulti : Schizophrenia
LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Rexulti for depression
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Rexulti for depression
15 Figure 3: Rexulti sales for depression across the US, Japan, and five major EU markets, by country, 2017–26
21 Figure 4: Rexulti for bipolar disorder – SWOT analysis
26 Figure 5: Rexulti for schizophrenia – SWOT analysis
27 Figure 6: Datamonitor Healthcare’s drug assessment summary of Rexulti for schizophrenia
28 Figure 7: Datamonitor Healthcare’s drug assessment summary of Rexulti for schizophrenia
30 Figure 8: Rexulti sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Rexulti drug profile
6 Table 2: Approval history of Rexulti for depression in the US
7 Table 3: Late-phase trials of Rexulti for depression
9 Table 4: Rexulti ongoing Phase III trials in depression
11 Table 5: Rexulti for depression – SWOT analysis
18 Table 6: Rexulti drug profile
19 Table 7: Rexulti Phase III trials in bipolar mania
21 Table 8: Rexulti Phase IV trial in bipolar depression
23 Table 9: Rexulti drug profile
24 Table 10: Rexulti pivotal trial data in schizophrenia
31 Table 11: Rexulti sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017–26
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