Clozapine is the only approved treatment for patients with treatment-resistant schizophrenia (TRS) but response rates remain at 50 – 60%1. Evenamide, a sodium channel blocker, has shown efficacy in a phase II trial to significantly reduce symptom severity with good tolerability as an add-on to existing antipsychotics in TRS patients2. A phase III program is recently approved to investigate the efficacy of the drug as add-on therapy in over 1000 TRS patients, including those on clozapine3. Upon completion, this landmark program is anticipated to provide high-level evidence for evenamide as the first add-on therapy for TRS, enhancing the current treatment landscape.
References
1. Flanagan RJ, et al. Br Med Bull. 2020;135(1):73-89. 2. Singh R, et al. Int J Neuropsychopharmacol. 2024;27(2):pyae005. 3. Newron announces approval for pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with treatment-resistant schizophrenia (TRS) [Internet]. Newron Pharmaceuticals. 2025 [cited 2025 May 15].
