Drugs / OPC-61815
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | pulmonary edema | 2021-03-22 | “an NDA (New Drug Application) has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval of OPC-61815” otsuka.co.jp ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT05439148 | Jun → Sep 2022 | — | Otsuka Beijing Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT04182958 | Nov → Dec 2019 | — | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03510663 | May → Jul 2018 | congestive heart failure | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT03962101 | Jun 2019 → Jun 2020 | congestive heart failure | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03772041 | Jan 2019 → Jul 2020 | congestive heart failure | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT03254108 | Nov 2017 → Apr 2018 | congestive heart failure | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-03-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Has Filed an Application in Japan for Regulatory Approval of OPC-61815, a V -Receptor Antagonist for the Treatment of Cardiac Edema2 otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an NDA (New Drug Application) has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval of OPC-61815 for the treatment of cardiac edema. |
| 2020-10-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Positive Top-Line Results in Phase 3 Trial of OPC-61815, a V -Receptor Antagonist for the Treatment of Cardiac Edema2 otsuka.co.jp ↗
The trial outcomes showed non-inferiority of OPC-61815 versus tolvaptan 15mg tablet in the primary endpoint of change in body weight from baseline at the final dose. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-03-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Has Filed an Application in Japan for Regulatory Approval of OPC-61815, a V -Receptor Antagonist for the Treatment of Cardiac Edema2 otsuka.co.jp ↗ |
| 2020-10-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Positive Top-Line Results in Phase 3 Trial of OPC-61815, a V -Receptor Antagonist for the Treatment of Cardiac Edema2 otsuka.co.jp ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OPC-61815 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03772041 ↗ |
| Route | Intravenous | “intravenous administration” NCT03254108 ↗ |