What began as an early research initiative in 1999 has since become one of the most significant achievements in the history of the Hungarian pharmaceutical industry. Working alongside its U.S. partner – originally Forest Laboratories, later Actavis, Allergan, and today AbbVie – Richter scientists played a leading role in bringing this molecule from concept to global therapy. Cariprazine was first synthesized in 2002, entered clinical trials in 2004, and received U.S. marketing approval in 2015, followed by approval in Europe in 2017.
Over the past decade, cariprazine has expanded its indications beyond manic or mixed episodes associated with type I bipolar disorder and schizophrenia to include for the treatment of depressive episodes associated with bipolar I disorder (2019) and adjunctive treatment for major depressive disorder (2022) in the USA. It remains the only antipsychotic of its kind to demonstrate efficacy in both the positive and negative symptoms of schizophrenia.
Since its launch in the United States in 2016, cariprazine has become available in 70 countries, making a meaningful difference for patients and families across the globe. Its success stands as a milestone not only for Gedeon Richter, but also for Hungarian innovation, as it is the first original Hungarian-developed medicine to reach the U.S. market in more than a century.
“Cariprazine represents the very best of Hungarian scientific ingenuity and international collaboration,” said Gábor Orbán, CEO of Gedeon Richter. “As we look back on ten years of impact, we are proud to have created an original product that is now available worldwide and has already helped nearly 2 million patients globally, and we remain committed to developing new therapies that address unmet medical needs.”
Facts and figures about cariprazine
- 18 years of R&D, including 13 years of clinical development
- More than 50 clinical trials
- More than 10,500 people participated in clinical trials
- Studies on 4 continents (America, Europe, Asia, Africa), at approximately 1,600 trial sites.
- Data from the first documentation submitted in the United States (schizophrenia and bipolar mania): 4,500 files, 1,200,000 pages;
- Initial documentation submitted in the EU (schizophrenia, including dominant negative symptoms): 1,100 files, 110,000 pages
- Global publications: more than 100 articles, around 500 posters and more than 25 oral presentations at international events.
- According to 2024 data, the drug was the 55st best-selling drug in the world.
- In 2020, the drug became a so-called “blockbuster,” exceeding $1 billion in sales, which have since continued to grow, surpassing the $3 billion mark in 2024.
- The drug has already been prescribed to nearly 2 million patients worldwide.
About Gedeon Richter Plc.
Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.7bn and sales of EUR 2.2bn in 2024, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com
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