Japan-based Shionogi & Co., Ltd. (Tokyo: 4507) announced a continued partnership with the ALS/MND Natural History Consortium to access longitudinal, clinic-based real-world data on amyotrophic lateral sclerosis patients, with a focus that includes post-market data on its approved therapy edaravone (RADICAVA ORS). The collaboration centers on the Consortium’s NeuroBANK platform, a patient-centered observational registry supported by the Neurological Clinical Research Institute at Massachusetts General Hospital, which has enrolled more than 4,500 ALS patients across 18 multidisciplinary clinics in the US, Europe, and Israel. Financial terms were not disclosed.

NeuroBANK collects standardized longitudinal clinical data during routine care visits, capturing disease progression across diverse patient populations without imposing significant additional burden on participants. Shionogi’s interest in the dataset extends to understanding how edaravone — an antioxidant free-radical scavenger approved by the US FDA in May 2022 as an oral suspension — performs in real-world clinical settings outside the controlled conditions of registrational trials. The US FDA granted edaravone Orphan Drug Exclusivity in 2024, recognizing the oral suspension formulation’s contribution to patient care relative to the previously available intravenous route.

The current partnership directly follows a structurally comparable arrangement that Mitsubishi Tanabe Pharma America struck with the ALS/MND Natural History Study Consortium in June 2023, when Mitsubishi Tanabe held commercial rights to Radicava in the US. Shionogi acquired all global rights to the edaravone franchise — including Radicava ORS and intravenous Radicava — from Tanabe Pharma Corporation in a transaction valued at USD 2.5 billion announced in December 2025, making this Consortium partnership a logical extension of that commercial footprint into evidence generation. More than 22,800 people with ALS in the US have been treated with edaravone across both formulations, providing a substantial real-world patient base from which the NeuroBANK registry can draw longitudinal observations.

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