Drugs / ORITINIB
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04808648 | Apr → Jun 2021 | — | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04810533 | May 2020 → Mar 2021 | — | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03973632 | Jul → Dec 2019 | — | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03618043 | Sep 2018 → Dec 2019 | cancer | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03603262 | Apr 2018 → Dec 2019 | non-small cell lung carcinoma | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03823807 | Mar 2019 → Dec 2020 | non-small cell lung carcinoma | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06080776 | May 2023 → Feb 2028 expected | non-small cell lung carcinoma | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04239833 | Jan 2020 → Jan 2022 | non-small cell lung carcinoma | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-06-19 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Regulatory 圣和药业1类创新药圣瑞沙 ® 获NMPA批准上市 sanhome.com ↗
国家药品监督管理局（NMPA）官方网站公示，南京圣和药业股份有限公司自主研发的化学1类创新药品种「甲磺酸瑞厄替尼片」（受理号：CXHS2101058）获得NMPA批准上市。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-06-19 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | 圣和药业1类创新药圣瑞沙 ® 获NMPA批准上市 sanhome.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ORITINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068561 ↗ |
| Known as | SH-1028 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03603262 ↗ |
| Action | Inhibit | “SH-1028 is a new third-generation EGFR tyrosine kinase inhibitors (TKI)” PMID 36813747 ↗ Feb 2023 |
| Modality | Small molecule | — CHEMBL6068561 ↗ |
| Route | Oral | “Patients received SH-1028 at five oral dose levels” PMID 36813747 ↗ Feb 2023 |
| Target | EGFR | “SH-1028 is a new third-generation EGFR tyrosine kinase inhibitors (TKI)” PMID 36813747 ↗ Feb 2023 |