It is an exceptional accomplishment that a drug candidate discovered in Hungary by a Hungarian pharmaceutical company, and developed with local scientific and financial resources, has obtained both FDA approval and EU registration. This is a unique success of which we can be justifiably proud.
Cariprazine exceeded USD 3.6 billion in annual global net sales in 2025, achieving multipleblockbuster status - unprecedented in the history of the Hungarian pharmaceutical industry. Today, our product is available across all five continents.
Together with our U.S. partner, AbbVie, we are already progressing our next innovative CNS molecule, intended to be introduced around the time of cariprazine’s loss of exclusivity. RGH‑932 is currently in Phase 2 development for two indications: bipolar depression and generalized anxiety disorder.
More about cariprazine
Cariprazine is currently the only antipsychotic shown - via an active‑comparator Phase 3 clinical study - to be effective not only in treating the positive symptoms of schizophrenia (e.g. delusions, hallucinations) but also predominant negative symptoms (e.g. apathy, anhedonia, reduced motivation).
The molecule was discovered by Richter researchers in the early 2000s and further developed in collaboration with Forest Laboratories (now AbbVie). Since its U.S. launch in March 2016, approximately 1.7 million patients have been treated with Vraylar, its U.S. brand, and nearly 16 million prescriptions have been filled.
Cariprazine is now available in 67 countries worldwide, most of them with reimbursement. Over the years, Richter has entered into multiple licensing agreements with strong regional partners in ex-U.S., significantly expanding global reach and patient access.
Major milestones in the history of cariprazine
- December 1999: Launch of the D3 project (cariprazine has preferential binding to dopamin 3 receptor over dopamin 2, differentiating it from other widely used antipscychotics)
- December 2002: First synthesis of the molecule
- August 2003: Patent application filed
- October–November 2004: Research and development cooperation agreements signed with Forest and Mitsubishi
- November 2004: First clinical trials initiated in Europe
- November 2006: Phase II clinical trial launched for schizophrenia
- June 2007: Phase II clinical trial launched for mania
- June 2009: Phase II clinical trial launched for bipolar depression and major depressive disorder
- 17 September 2015: Allergan and Richter receive FDA approval to market Vraylar in the United States
- March 2016: U.S. market launch of Vraylar
- March 2016: EMA accepts the European registration application for cariprazine
- August 2016: Licensing agreement signed with Recordati for Western Europe
- 17 July 2017: European Commission grants marketing authorisation for Reagila in the EU
- 28 May 2019: FDA approves extended Vraylar labeling for bipolar I depression
- 2019–2021: Multiple licensing agreements across Australia & New Zealand, Latin America, MENA, Singapore, Thailand, South Korea, Japan, Taiwan
- December 2022: FDA approval of cariprazine as adjunctive therapy for major depressive disorder
- August 2024: EMA approval of a new orodispersible tablet formulation
- December 2025: FDA approves two additional indications:
- Treatment of pediatric patients 13 years of age or older with schizophrenia
- Acute treatment of pediatric patients 10 years of age or older with manic or mixed episodes associated with bipolar I disorder
- December 2025: FDA confirms AbbVie’s satisfactory response to the Pediatric Written Request (PWR), granting an additional sixmonth U.S. market exclusivity, expiring 17 March 2030