A leading US KOL states that brilaroxazine shows placebo-like extrapyramidal symptoms (EPS) at week 4, potentially differentiating it from risperidone which cannot achieve this1.
Reviva plans to initiate the RECOVER-2 Phase 3 trial for brilaroxazine in schizophrenia in H1 2026 following FDA recommendation for additional efficacy and safety data2.
Brilaroxazine demonstrates broad-spectrum efficacy across schizophrenia symptom domains, including negative symptoms, with a well-tolerated safety profile in over 900 subjects24.
Phase 3 RECOVER trial data shows low EPS and akathisia, mild weight gain (1.52 kg pooled), reductions in prolactin levels, and improvements in sexual function over 1 year4.
New publication highlights speech latency as an objective vocal biomarker for brilaroxazine's effect on negative symptoms, reinforcing efficacy35.
Sources:
1. https://firstwordhealthtech.com
2. https://www.biospace.com/press-releases/reviva-announces-regulatory-update-regarding-the-development-of-brilaroxazine-for-the-treatment-of-schizophrenia
3. https://www.sahmcapital.com/news/content/reviva-pharmaceuticals-reports-phase-3-success-for-brilaroxazine-in-treating-schizophrenia-negative-symptoms-2026-01-08
4. https://revivapharma.com/wp-content/uploads/2025/07/2025-07-RS-Reviva-RVPH-Investor-Presentation.pdf