Drugs / ORIN1001
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04643769 | Feb 2021 → Dec 2025 | idiopathic pulmonary fibrosis | Orinove, Inc. | Suspended | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05154201 | Jul 2020 → Jan 2023 | — | Orinove, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03950570 | May 2019 → Jan 2023 | metastatic neoplasm | Orinove, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-06-16 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma’s Innovative Drug ORIN1001 Receives U.S. FDA Fast Track Designation, Marking a Milestone for the treatment of Triple-negative Breast Cancer fosunpharma.com ↗
ORIN1001 has received Fast Track designation (FTD) from U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed, refractory and metastatic breast cancer (including triple-negative breast cancer [TNBC]). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-06-16 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Fosun Pharma’s Innovative Drug ORIN1001 Receives U.S. FDA Fast Track Designation, Marking a Milestone for the treatment of Triple-negative Breast Cancer fosunpharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ORIN1001 | “ORIN1001 will be administered as a table as a monotherapy in the dose escalation phase in patients with advanced solid tumors or in combination with Abraxane in patients with...” NCT03950570 ↗ |
| Route | Oral | “Oral ORIN1001” NCT03950570 ↗ |