There have been new developments in the expansion of drug indications in Japan as well, allowing many diabetic patients with complications to benefit.
Approval of New Drug Indication: In April 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan approved an extension of the label for the diabetes drug TWYMEEG® (Imeglimin), allowing it to be used for the treatment of patients with type 2 diabetes and moderate to severe renal impairment.
Clinical value: This approval allows TWYMEEG® to be used in patients with type 2 diabetes who have kidney disease, especially the elderly, who often face limited treatment options. This approval is based on the results of the Phase 4 TWINKLE study, which confirmed the safety and tolerability of the drug in such patients.