Cariprazine is currently the only antipsychotic that has been shown to be effective in treating not only the positive symptoms of schizophrenia (eg. delusions or hallucinations) but also predominant negative symptoms (eg. apathy, anhedonia and decreased drive).
The cariprazine molecule was discovered by Richter researchers in the early 2000s and was further developed in collaboration with Forest Laboratories (later Actavis, Allergan, then Abbvie). Since its launch in March 2016, more than 400,000 patients have been treated with it and more than 3 million prescriptions have been made in the US. The antipsychotic is already available in 36 countries worldwide, in 22 of them, including Hungary, with price subsidy. Recently, Richter has also entered into a number of licensing agreements with local partners that will make cariprazine available on major markets around the world.
Drug of the Year 2019
Major milestones in the history of cariprazine
- December 1999: the D3 project is launched, initially for another indication
- December 2002: the molecule is first synthesized
- August 2003: patent application is filed
- October-November 2004: Forest and Mitsubishi research cooperation agreements signed
- November 2004: first clinical trials launched in Europe
- November 2006: launch of a phase II clinical trial in the schizophrenia indication
- June 2007: launch of a Phase II clinical trial in the mania indication
- June 2009: launch of a Phase II clinical trial in the bipolar depression and major depression indication
- On 17 September 2015, Allergan and Richter receives approval from the US Food and Drug Administration (FDA) to market Vraylar in the United States
- March 2016: market entry with Vraylar in the US
- March 2016: the EMA accepts the registration application for cariprazine
- August 2016: Richter and Recordati sign a licensing agreement to distribute Cariprazine in Western Europe
- 17 July 2017, Richter receives a marketing authorisation from the European Commission for the marketing of Reagila in the EU
- May 28, 2019: FDA approves the extended Summary of Product Characteristics for VRAYLAR for the treatment of depressive episodes associated with bipolar I disorder
- May 2019-March 2020: various license agreements (Australia and New Zealand, Latin America, MENA region, Singapore, Thailand, South Korea)
Publications
Complete list of cariprazine publications with hyperlinks
Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial
Published: Lancet, March 2017
Quality-adjusted life year difference in patients with predominant negative symptoms of schizophrenia treated with cariprazine and risperidone
Published: Journal of Comparative Effectiveness Research, May 2017