Drug Overview
Geodon contains ziprasidone, a dopamine (D2) and serotonin (5-HT2) antagonist developed and marketed by Pfizer. Geodon initially launched in the US in 2001 for the treatment of schizophrenia. It subsequently gained approval for bipolar disorder indications in the US and EU in August 2004 and October 2005, respectively.
In March 2011, Meiji Seika Kaisha acquired exclusive rights to develop and commercialize ziprasidone in Japan, with RaQualia Pharma being eligible for developmental milestones and royalties on commercial sales. RaQualia Pharma announced in March 2015 that it had initiated a Phase III trial in Japan studying Geodon for the treatment of schizophrenia. Datamonitor Healthcare believes that the companies are focusing on development for schizophrenia first before pursuing bipolar disorder.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Geodon : Bipolar disorder
LIST OF FIGURES
15 Figure 1: Geodon for bipolar disorder – SWOT analysis
16 Figure 2: Datamonitor Healthcare’s drug assessment summary for Geodon in bipolar disorder
17 Figure 3: Datamonitor Healthcare’s drug assessment summary for Geodon in bipolar disorder
LIST OF TABLES
5 Table 1: Geodon bipolar disorder indication approvals
6 Table 2: Geodon drug profile
8 Table 3: Overview of key clinical trial data for Geodon in bipolar disorder
10 Table 4: Treatment-emergent adverse reactions in ≥5% of Geodon-treated adult patients with bipolar mania in double-blind, placebo-controlled trials
12 Table 5: Geodon ongoing late-phase clinical trials as a therapy in children and adolescents with bipolar I disorder
14 Table 6: Overview of key clinical trial data for Geodon in bipolar depression