Genet Pharma's Lyophilized Nellonemdaz Injectable Wins U.S. Patent

Securing Technology for Rapid Reconstitution and Long-Term Stability

Genet Pharma announced on December 5 that it has received a notice of patent registration from the United States Patent and Trademark Office (USPTO) for the lyophilized powder injectable formulation and manufacturing process of its multi-target neuroprotective agent 'Nellonemdaz,' which is being developed as a treatment for stroke.

Multi-target Neuroprotective Agent 'Nellonemdaz'. Genet Pharma

This patent covers technology that demonstrates the excellent reconstitution and long-term stability of the lyophilized Nellonemdaz formulation. It is notable for resolving formulation stability issues that occurred with conventional lyophilization processes.

Previously, Genet Pharma secured a patent from the USPTO in August 2023 for combination therapy with Nellonemdaz and recanalization treatment, as well as a patent in June 2025 for reducing cerebral hemorrhage in patients undergoing recanalization therapy. With this new patent for the lyophilized formulation, Genet Pharma now holds a total of three U.S. patents related to Nellonemdaz. This latest patent is considered a core intellectual property (IP) asset for future global licensing and commercialization.

Nellonemdaz is the world's first dual pharmacological neuroprotective agent, developed with support from the Ministry of Science and ICT and Gyeonggi Province. It works by blocking glutamate neurotoxicity during the acute phase and inhibiting neuronal cell death during the subacute phase, thereby substantially reducing brain damage.

Domestic clinical trials have confirmed the efficacy of Nellonemdaz in stroke patients who underwent rapid recanalization therapy and in cardiac arrest patients who received hypothermia treatment. Notably, among stroke patients who received the drug and underwent thrombectomy within 60 minutes of arriving at the emergency room, there was a significant and more than fourfold improvement in disability compared to placebo.

Based on the results of completed phase 2/3 clinical trials in Korea, Genet Pharma is preparing for a multinational phase 3 global stroke clinical trial involving the United States, Canada, Australia, China, and other countries. In July, the company received approval for its Investigational New Drug (IND) application from the Ministry of Food and Drug Safety.

Recanalization therapy (thrombolytics and thrombectomy) is currently the only standard treatment for stroke. However, in most cases, neuronal cell death continues even after recanalization, resulting in disability or death. Nellonemdaz, as a dual-mechanism neuroprotective agent that addresses this unmet medical need, has demonstrated superior neuroprotective effects compared to other drugs in both animal models and clinical trials, positioning it as a potential game-changer in stroke treatment.

Genet Pharma CEO Kwak Byungjoo stated, "With this registration, the number of U.S. patents for Nellonemdaz has increased to three, giving new momentum to our global commercialization strategy. As soon as we finalize the selection of our global manufacturing partner, we will swiftly initiate the multinational phase 3 clinical trial."

This content was produced with the assistance of AI translation services.