Adalvo announces plans to submit the DCP for Cariprazine Capsules in October 2025, expanding its CNS pipeline with a targeted product addressing unmet needs in schizophrenia treatment.
Based on the reference brand Reagila®, Cariprazine is indicated for the treatment of schizophrenia in adult patients.
Notably, it is the only approved antipsychotic with proven superiority over another second-generation antipsychotic (Risperidone), positioning it as a differentiated therapy in a competitive but underserved market.
According to IQVIA, global sales of Cariprazine reached $4.5 million in 2024, with a 3Y CAGR of 32%, indicating steady growth potential as markets prepare for generic entry.
Based on this successful development, we expect to be amongst the first companies to be ready for launch on Day-1 in the major markets.
With a clearly defined regulatory pathway and a focused execution strategy, Adalvo continues to build a CNS portfolio centered on therapeutic relevance, high-barrier execution, and commercial readiness.
To explore licensing or partnership opportunities, contact the Adalvo team.