SUSMED,Inc.

SUSMED, a Japanese company that develops therapeutic apps and clinical trial support systems, announced on September 16 that a drug tested in a clinical trial using its blockchain-based system has received domestic manufacturing and marketing approval. According to the company's research, this is the world's first drug approval based on the results of a corporate-sponsored clinical trial that used blockchain. The approved drug is Uekix Tablets, indicated for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea syndrome, among other conditions. Viatris Pharmaceuticals obtained the approval, and SUSMED provided the system for the domestic clinical trial. SUSMED's SourceDataSync uses blockchain technology for data verification, checking whether records of patients' conditions and drug effects match the original records at medical institutions, with the aim of reducing manual confirmation work and data entry at medical institutions while maintaining the reliability of the records. Leading up to this approval, SUSMED conducted verification under the government's regulatory sandbox program, and in December 2020 received a response from the Ministry of Health, Labour and Welfare that blockchain-based data verification could replace conventional work. This was followed by a trial that began in November 2022, and in January 2023 the system was adopted for a trial in a different target disease. The key point this time is that a technology still in the verification stage was used in a clinical trial that led to drug approval, and SUSMED says that a separate comparative study showed a reduction in man-hours for clinical trial confirmation work and other tasks.