Drugs / WX-0593
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03389815 | Sep 2017 → Jun 2020 | non-small cell lung carcinoma | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05765877 | Mar 2023 → Mar 2027 expected | non-small cell lung carcinoma | Pingping Song | Recruiting | No outcome recorded |
| Phase 2 | NCT05351320 | Apr 2022 → Apr 2026 | non-small cell lung carcinoma | Jinming Yu | Unknown | No outcome recorded |
| Phase 2 | NCT05801107 | Oct 2021 → Jul 2023 | non-small cell lung carcinoma | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-02-26 | Qilu Pharmaceutical Co., Ltd. | Regulatory 国家“重大新药创制”科技重大专项成果分享暨启欣可®（伊鲁阿克片）一线适应症上市新闻发布会圆满举行 qilu-pharma.com ↗
齐鲁制药历时十年自主研发的肺癌治疗重磅药物伊鲁阿克片获批新适应症，新适应症覆盖全线ALK阳性晚期非小细胞肺癌患者。 |
| 2022-02-24 | Qilu Pharmaceutical Co., Ltd. | Results 国产新一代ALK抑制剂——齐鲁制药伊鲁阿克临床数据国际首次发布 qilu-pharma.com ↗
递增阶段和扩展阶段的整体ORR分别为59.3% (32/54)和56.6% (56/99)。 |
| 2021-07-28 | Qilu Pharmaceutical Co., Ltd. | Regulatory 齐鲁制药1类新药依鲁奥克片上市申请获受理 qilu-pharma.com ↗
7月24日，CDE官网显示，齐鲁制药1类新药依鲁奥克片的上市申请已获国家药监局受理。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-02-26 | Qilu Pharmaceutical Co., Ltd. | 国家“重大新药创制”科技重大专项成果分享暨启欣可®（伊鲁阿克片）一线适应症上市新闻发布会圆满举行 qilu-pharma.com ↗ |
| 2022-02-24 | Qilu Pharmaceutical Co., Ltd. | 国产新一代ALK抑制剂——齐鲁制药伊鲁阿克临床数据国际首次发布 qilu-pharma.com ↗ |
| 2021-07-28 | Qilu Pharmaceutical Co., Ltd. | 齐鲁制药1类新药依鲁奥克片上市申请获受理 qilu-pharma.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | WX-0593 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03389815 ↗ |
| Known as | Iruplinalkib | “WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI).” PMID 35087031 ↗ Jan 2022 |
| Action | Inhibit | “tyrosine kinase inhibitor (TKI)” PMID 35087031 ↗ Jan 2022 |
| Modality | Small molecule | “highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI)” PMID 35087031 ↗ Jan 2022 |
| Route | Oral | “highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI)” PMID 35087031 ↗ Jan 2022 |
| Target | ALK | “highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI)” PMID 35087031 ↗ Jan 2022 |
| Target | ROS1 | “highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI)” PMID 35087031 ↗ Jan 2022 |