Drugs / Iruplinalkib
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06436885 | Feb 2024 → Dec 2025 | non-small cell lung carcinoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05716126 | Apr → Dec 2020 | — | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07330076 | Jan 2026 → Dec 2030 expected | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06282536 | Mar 2024 → Jun 2025 overdue | — | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04641754 | Mar 2019 → Dec 2020 | non-small cell lung carcinoma | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04632758 | Jun 2019 → Dec 2024 | non-small cell lung carcinoma | Qilu Pharmaceutical Co., Ltd. | Unknown | Met primary |
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 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iruplinalkib | “Iruplinalkib (WX-0593) is a new-generation, potent ALK tyrosine kinase inhibitor (TKI) that has been found to have systemic and central nervous system (CNS) efficacy in...” PMID 38280448 ↗ Jan 20245“Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT).” PMID 36829154 ↗ Feb 2023 |
| Known as | WX-0593 | “Iruplinalkib (WX-0593) is a new-generation, potent ALK tyrosine kinase inhibitor (TKI) that has been found to have systemic and central nervous system (CNS) efficacy in...” PMID 38280448 ↗ Jan 20242“Iruplinalkib (WX-0593) is an anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor.” PMID 36829154 ↗ Feb 2023 “Volunteer will receive a single oral dose of 120 mg \[14C\]Iruplinalkib (WX-0593) as a solution on Day 1” NCT05716126 ↗ |
| Action | Inhibit | “potent ALK tyrosine kinase inhibitor (TKI)” PMID 38280448 ↗ Jan 2024 |
| Route | Oral | “Patients received iruplinalkib 180 mg orally once daily for a 21-day cycle with a 7-day lead-in phase at 60 mg orally once daily.” PMID 36829154 ↗ Feb 2023 |
| Target | ALK | “potent ALK tyrosine kinase inhibitor (TKI)” PMID 38280448 ↗ Jan 2024 |