Drugs / DICLOFENAC ETALHYALURONATE
DICLOFENAC ETALHYALURONATE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | osteoarthritis | 2020-01-06 | “submitted a new drug application (“NDA”) for manufacturing and marketing approval for ONO-5704/SI-613 (“the Product”) in Japan” seikagaku.co.jp ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03209362 | Oct 2017 → Aug 2018 | osteoarthritis, knee | Seikagaku Corporation | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2021-03-23 | Seikagaku Corporation | Regulatory Ono and Seikagaku Announce a Manufacturing and Marketing Approval in Japan for JOYCLU 30mg Intra-articular Injection, a Joint Function Improvement Agent, for the Indication of Osteoarthritis (Knee Joint and Hip Joint) seikagaku.co.jp ↗
Ono Pharmaceutical Co., Ltd. (Osaka, Japan; “Ono”) and Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today that Seikagaku has obtained from the Ministry of Health, Labour and Welfare (MHLW) a manufacturing and marketing approval in Japan for JOYCLU® 30mg Intra-articular Injection |
| 2021-03-23 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono and Seikagaku Announce a Manufacturing and Marketing Approval in Japan for JOYCLU® 30mg Intra-articular Injection, a Joint Function Improvement Agent, for the Indication of Osteoarthritis (Knee Joint and Hip Joint) ono-pharma.com ↗ |
| 2020-06-11 | Seikagaku Corporation | Results Ono and Seikagaku Announce the Results from a Phase III Clinical Study in Japan of ONO-5704/SI-613 in Patients with Knee Osteoarthritis Presented at an Academic Conference seikagaku.co.jp ↗
ONO-5704/SI-613 group also demonstrated a statistically significant difference (-5.6 mm) compared to placebo group in mean change from baseline to 24 weeks after the initial administration (p=0.001). |
| 2020-01-06 | Seikagaku Corporation | Regulatory Ono and Seikagaku Submit a New Drug Application for Manufacturing and Marketing Approval for ONO-5704/SI-613 for the Treatment of Osteoarthritis in Japan seikagaku.co.jp ↗
Ono Pharmaceutical Co., Ltd. (Osaka, Japan; “Ono”) and Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today that the companies have submitted a new drug application (“NDA”) for manufacturing and marketing approval for ONO-5704/SI-613 (“the Product”) in Japan, for the treatment of osteoarthritis (knee joint, hip joint and ankle joint). |
| 2019-02-19 | Seikagaku Corporation | Results Ono and Seikagaku Announce the Topline Results from Phase III Confirmatory Study of ONO-5704/SI-613 in Patients with Knee Osteoarthritis in Japan seikagaku.co.jp ↗
ONO-5704/SI-613 demonstrated a statistically significant improvement in WOMAC (a knee pain evaluation index) scores, a primary endpoint of the Study, compared with a placebo at twelve weeks after the initial injection (three injections every four weeks). |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DICLOFENAC ETALHYALURONATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297231 ↗ |
| Known as | Etalhialuronato de diclofenaco | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297231 ↗ |
| Known as | Etalhyaluronate de diclofenac | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297231 ↗ |
| Known as | SI-613 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03209362 ↗ |