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SEP 9 2026
CRL · 20 DAYS AGO

Seikagaku Corporation — Hernicore (condoliase) $4548.T

for radicular leg pain associated with lumbar disc herniation

BLA · Standard Review

About

Lumbar disc herniation happens when the cushion between two spinal bones bulges or tears, pressing on nearby nerves and causing back pain, leg pain, numbness, and disability. Hernicore (condoliase) is a bacterial enzyme injected once into the disc, where it breaks down chondroitin sulfate, the gel-like material that gives the disc's soft center its bulk. Softening that core may lower pressure on the pinched nerve root and could ease radicular leg pain without surgery.

Pivotal trial

NCT03607838 Phase 3 completed NCT03607838

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Source: ClinicalTrials.gov

Also in development