Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent
January 6, 2026 – Clinical Trials, Drug Discovery, Other, Pharmaceutical – Newron Pharmaceuticals, antipsychotic therapies, biopharma, neurology, schizophrenia
- EP4615820 – “Crystalline Forms of Evenamide” is expected to extend asset exclusivity in EU into 2044
- Evenamide is currently being investigated in Newron’s global
- ENIGMA-TRS Phase III development program, enrolling at least 1,000 schizophrenia patients with topline results expected in Q4-2026
- Evenamide is a first-in-class glutamate modulator with a novel mechanism of action for patients who do not respond adequately, or are resistant to, existing antipsychotic therapies
- ENIGMA-TRS program aims to establish evenamide as the first approved add-on therapy for treatment resistant schizophrenia (TRS), a patient population with high morbidity and mortality.
6 January 2026 — Milan, Italy and New Jersey, US — Newron Pharmaceuticals, a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that the European Patent Office (EPO) has issued the decision to grant an additional patent covering its lead development compound, evenamide. This composition of matter patent EP4615820 claims crystalline forms of evenamide, processes for their preparation, and their uses. The patent has a scheduled term of 2044.
“This European Patent Office decision is evidence of our comprehensive strategy to continuously strengthen the intellectual property protecting our key assets,” stated Elena Barbanti, Newron’s Senior Director Intellectual Property (IP).
Stefan Weber, Newron’s CEO, added: “This is an important milestone for Newron and a testament to the outstanding work of our IP team.
We expect this new patent will extend the exclusivity runway for evenamide, supporting our efforts to maximize its therapeutic and commercial potential. This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately, or are resistant to, existing antipsychotic therapies, in our assessment constituting the vast majority of patients suffering from schizophrenia.”
Newron has completed the entry into national phases for counterpart patent applications to EP4615820in all key countries. This new composition of matter patent adds to the current extensive IP protection around evenamide.
About Newron Pharmaceuticals
Newron is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com
