Drugs / Condoliase
Condoliase
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | lumbar disk disease | 2026-09-09 | “response letter (CRL)* concerning Seikagaku’s biologics license application (BLA) in the U.S. for SI-6603 (generic name: condoliase)” seikagaku.co.jp ↗ |
| Rejected (CRL) | US (FDA) | — | lumbar disk disease | 2025-03-11 | “letter (CRL)* concerning Seikagaku’s biologics license application (BLA) in the U.S. for SI-6603 (generic name: condoliase)” seikagaku.co.jp ↗ |
| Filed | Japan (PMDA) | — | lumbar disk disease | 2014-01-30 | “Seikagaku Submits New Drug Application for SI-6603 in Japan for Treatment of Lumbar Disc Herniation” seikagaku.co.jp ↗ |
| Filed | US (FDA) | — | lumbar disk disease | — | “In March 2026 the Company resubmitted to U.S. Food and Drug Administration (FDA) a biologics license application (BLA) for SI-6603.” seikagaku.co.jp ↗ “Seikagaku submitted a Biologics License Application (BLA) for SI-6603 in March 2024, which was accepted for filing by the U.S.” seikagaku.co.jp ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01282606 | Dec 2007 → Aug 2012 | lumbar disk disease | Seikagaku Corporation | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00634946 | Jan 2008 → Nov 2009 | lumbar disk disease | Seikagaku Corporation | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT03607838 | Nov 2018 → Aug 2022 | lumbar disk disease | Seikagaku Corporation | Completed | Met primary |
| Phase 3 | NCT02421601 | Mar 2015 → Feb 2018 | intervertebral disk degenerative disorder, lumbar disk disease | Seikagaku Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01941563 | Sep 2013 → Nov 2015 | intervertebral disk degenerative disorder, lumbar disk disease | Seikagaku Corporation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | Seikagaku Corporation | Regulatory Seikagaku Announces Receipt of a Complete Response Letter Concerning the Biologics License Application in the U.S. for SI-6603 seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today (September 9, U.S. time) that it has received from the U.S. Food and Drug Administration (FDA) a complete response letter (CRL)* concerning Seikagaku’s biologics license application (BLA) in the U.S. for SI-6603 (generic name: condoliase), filed in March 2026. |
| 2026-03-10 | Seikagaku Corporation | Regulatory Seikagaku Announces Resubmission of Application to Obtain Approval in the U.S. for SI-6603 seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today that it has resubmitted to the U.S. Food and Drug Administration (FDA) a biologics license application (BLA) for SI-6603 (generic name: condoliase), a potential treatment for lumbar disc herniation. |
| 2025-03-12 | Seikagaku Corporation | Regulatory Seikagaku Announces Receipt of a Complete Response Letter Concerning the Biologics License Application in the U.S. for SI-6603 (Generic Name: Condoliase) seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today (March 11, U.S. time) that it has received from the U.S. Food and Drug Administration (FDA) a complete response letter (CRL)* concerning Seikagaku’s biologics license application (BLA) in the U.S. for SI-6603 (generic name: condoliase), a treatment that reduces leg pain associated with lumbar disc herniation. |
| 2024-04-09 | Seikagaku Corporation | Results Seikagaku Announces an Academic Conference Presentation on SI-6603 by Licensee Ferring Pharmaceuticals Inc. seikagaku.co.jp ↗
A single intradiscal injection of SI-6603 demonstrated significantly greater improvement in leg pain vs. sham at Week 13 in a registrational Phase 3 clinical trial |
| 2023-05-26 | Seikagaku Corporation | Results Seikagaku Announces the Topline Results from a Phase III Clinical Study (Additional Study) in the U.S. for SI-6603, a Treatment for Lumbar Disc Herniation seikagaku.co.jp ↗
SI-6603 showed statistically significant improvement compared to the control group in worst leg pain reduction at 13 weeks after injection, the primary endpoint of the study. |
| 2018-05-22 | Seikagaku Corporation | Regulatory Seikagaku and Kaken Announce the Listing in the National Health Insurance Drug Price List and Launch Date of HERNICORE 1.25 Units for Intradiscal Injection in Japan, Indicated for Treatment of Lumbar Disc Herniation seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) and Kaken Pharmaceutical Co. Ltd. (Tokyo, Japan; “Kaken”) announced today that HERNICORE® 1.25 units for intradiscal injection (generic name: condoliase) has been listed in the National Health Insurance drug price list. |
| 2018-03-23 | Seikagaku Corporation | Regulatory Seikagaku Announces New Drug Application Approval of HERNICORE 1.25 Units for Intradiscal Injection in Japan, Indicated for Treatment of Lumbar Disc Herniation. seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today that the Japanese Ministry of Health, Labour and Welfare (“MHLW”) has approved the New Drug Application (“NDA”) of HERNICORE® 1.25 units for intradiscal injection (generic name: condoliase, development code: SI-6603) in Japan, indicated for the treatment of lumbar disc herniation. |
| 2017-11-07 | Seikagaku Corporation | Results Seikagaku Announces the Results of SI-6603 Phase III Clinical Trials in the U.S., Indicated for Treatment of Lumbar Disc Herniation seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today that in a U.S. Phase III clinical trial, SI-6603 (generic name: Condoliase), demonstrated the expected pharmacologic effect but failed to meet its primary endpoint, change in worst leg pain at week thirteen (13). |
| 2014-06-05 | Seikagaku Corporation | Results Seikagaku Announces Results of Phase III Clinical Trial in Japan for SI-6603, Indicated for Treatment of Lumbar Disc Herniation seikagaku.co.jp ↗
The change from baseline in the VAS score of worst leg pain at 13 weeks after administration was significantly greater in the SI-6603 group (p=0.001), indicating marked improvement in the leg pain. |
| 2014-01-30 | Seikagaku Corporation | Regulatory Seikagaku Submits New Drug Application for SI-6603 in Japan for Treatment of Lumbar Disc Herniation seikagaku.co.jp ↗
Seikagaku Corporation (Tokyo, Japan) hereby announces that it has submitted a new drug application (NDA) for SI-6603 (generic name: condoliase), indicated for the treatment of lumbar disc herniation, to the Ministry of Health, Labour and Welfare of Japan. |
| 2013-08-07 | Seikagaku Corporation | Results Seikagaku Announces Top-Line Results from a Phase III Clinical Trial for SI-6603, Indicated for Treatment of Lumbar Disc Herniation, in Japan seikagaku.co.jp ↗
Compared to the placebo, SI-6603 demonstrated significant improvement in lower limb pain at 13 weeks after the administration, the primary endpoint of the trial. |
| 2010-12-14 | Seikagaku Corporation | Results Seikagaku announces on top-line results from phase II/III clinical trial in Japan of SI-6603, indicated for treatment on lumbar disc herniation seikagaku.co.jp ↗
SI-6603 demonstrated significant improvement in the pain compared to the placebo. |
All press releases naming this drug 22 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | condoliase | “SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain.” PMID 39168360 ↗ Aug 2024 |
| Known as | Condoliasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107876 ↗ |
| Known as | Hernicore | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107876 ↗ |
| Known as | SI-6603 | “The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.” NCT01941563 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL2107876 ↗ |
| Route | Other | “SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.” NCT00634946 ↗ |