SEP 14 2026
Seikagaku — SI-6603
for knee osteoarthritis
FDA issued a Complete Response Letter for the BLA for SI-6603, a hyaluronidase inhibitor for knee osteoarthritis.
About
Osteoarthritis is a degenerative joint disease where the breakdown of cartilage and bone causes pain, stiffness, and swelling, often in the knees, which can limit daily activities. SI-6603 is a drug designed to inhibit the enzyme hyaluronidase, which breaks down a key lubricating substance in the joint. By blocking this enzyme, the treatment may help preserve joint lubrication and potentially slow the progression of symptoms.
Pivotal trial
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.
Source: ClinicalTrials.gov