Drugs / AZD3759
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07620951 | Jul 2026 | central nervous system cancer, lung cancer | Alpha Biopharma (Jiangsu) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT07361705 | Jan 2026 → Apr 2028 expected | — | Alpha Biopharma (Jiangsu) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT02228369 | Nov 2014 → Aug 2017 | lung cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03360929 | Oct 2017 → Nov 2020 | non-small cell lung carcinoma | LYZZ Alpha Holding Ltd | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT07551414 | May 2026 → May 2027 expected | neoplastic meningitis, non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03574402 | Jul 2018 → Dec 2022 | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Unknown | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03653546 | Oct 2018 → Jul 2022 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Alpha Biopharma (Jiangsu) Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-11-20 | Alpha Biopharma (Jiangsu) Co., Ltd. | Regulatory 全球首个针对肺癌脑转移的EGFR-TKI——佐利替尼（泽瑞尼®）获批上市 alphabiopharma.com ↗
2024年11月20日 ，国家药品监督管理局（NMPA）官方网站公示，国家药监局批准晨泰医药申报的1类创新药盐酸佐利替尼片（商品名：泽瑞尼 ® ）上市。 |
| 2024-10-12 | Alpha Biopharma (Jiangsu) Co., Ltd. | Results CELL子刊发文：佐利替尼一线治疗非小细胞肺癌脑转移带来生存获益 alphabiopharma.com ↗
与对照组相比，佐利替尼的中位 PFS 明显更长（ 9.6 个月对 6.9 个月；风险比 [HR] 为 0.719 ； 95% 置信区间 [CI] 为 0.580–0.893 ； p = 0.0024 ）。 |
| 2023-06-10 | Alpha Biopharma (Jiangsu) Co., Ltd. | Results 周清教授专访 | ASCO 2023 < EVEREST > 研究数据发布 alphabiopharma.com ↗
EVEREST研究中400多例一线脑转移患者数据证实了AZD3759对照一代EGFR-TKI取得了整体（9.6月vs 6.9月）和颅内PFS （15.2月vs 8.3月）的显著获益 和OS获益趋势（数据尚未成熟）。 |
| 2023-01-30 | Alpha Biopharma (Jiangsu) Co., Ltd. | Regulatory 晨泰医药提交全球首款治疗伴CNS转移EGFR敏感突变NSCLC药物上市申请并获CDE正式受理 alphabiopharma.com ↗
上海，2023年1月 30 日 —— 创新药物提供者晨泰医药宣布，其获得国家重大新药创制专项支持的1类新药“佐利替尼”（Zorifertinib）——专为治疗伴中枢神经系统（CNS）转移的晚期EGFR敏感突变非小细胞肺癌患者的新一代EGFR-TKI药物，已提交新药上市申请（NDA）并获得国家药品监督管理局药品审评中心（Center for Drug Evaluation，CDE）正式受理。 |
| 2016-04-14 | AstraZeneca | Results AstraZeneca showcases breadth of Oncology portfolio at AACR 2016 Annual Meeting astrazeneca.com ↗
Anti-tumor activities of AZD3759, a novel EGFR inhibitor with excellent penetration cross central nervous system (CNS), in pre-clinical animal models |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-20 | Alpha Biopharma (Jiangsu) Co., Ltd. | 全球首个针对肺癌脑转移的EGFR-TKI——佐利替尼（泽瑞尼®）获批上市 alphabiopharma.com ↗ |
| 2024-10-12 | Alpha Biopharma (Jiangsu) Co., Ltd. | CELL子刊发文：佐利替尼一线治疗非小细胞肺癌脑转移带来生存获益 alphabiopharma.com ↗ |
| 2023-06-10 | Alpha Biopharma (Jiangsu) Co., Ltd. | 周清教授专访 | ASCO 2023 < EVEREST > 研究数据发布 alphabiopharma.com ↗ |
| 2023-01-30 | Alpha Biopharma (Jiangsu) Co., Ltd. | 晨泰医药提交全球首款治疗伴CNS转移EGFR敏感突变NSCLC药物上市申请并获CDE正式受理 alphabiopharma.com ↗ |
| 2016-04-14 | AstraZeneca | AstraZeneca showcases breadth of Oncology portfolio at AACR 2016 Annual Meeting astrazeneca.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AZD3759 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03574402 ↗ |
| Known as | [14C]Zorifertinib | “This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety...” NCT07620951 ↗ |
| Known as | zorifertinib | “Zorifertinib (AZD3759), an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with high blood-brain barrier penetration capability, demonstrated promising...” PMID 39389055 ↗ Oct 20244“Zorifertinib (AZD3759), an EGFR-tyrosine kinase inhibitor (TKI) with high blood-brain barrier penetration” PMID 38666433 ↗ Apr 2024 |
| Action | Inhibit | “AZD3759 is a novel EGFR tyrosine kinase inhibitor with high capability to penetrate the blood-brain barrier.” PMID 29056570 ↗ Oct 2017 |
| Modality | Small molecule | “an EGFR-tyrosine kinase inhibitor (TKI)” PMID 38666433 ↗ Apr 2024 |
| Route | Oral | “Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291” NCT02228369 ↗ |
| Target | EGFR | “AZD3759 is a novel EGFR tyrosine kinase inhibitor with high capability to penetrate the blood-brain barrier.” PMID 29056570 ↗ Oct 2017 |