Drugs / Ensartinib
Ensartinib
also known as
X-396 · Ensacove · Ensartinib dihydrochloride · Ensartinib Hydrochloride · X-396 DIHYDROCHLORIDE · X-396 HCl
Small molecule targets ALK, MET, ROS1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | non-small cell lung carcinoma | 2018-12-26 | “公司申报的盐酸恩莎替尼（X-396）用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的药品注册申请获得国家药品监督管理局受理。” bettapharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ENSACOVE | — | 2024-12-18 | fda.gov ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06492525 | Jul → Oct 2024 overdue | — | Betta Pharmaceuticals Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04837716 | Mar 2021 → Sep 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03804541 | Dec 2018 → Jun 2019 | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03510611 | Mar → Aug 2018 | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02959619 | Mar 2017 → Oct 2019 | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07354061 | Mar 2026 → Mar 2028 expected | non-small cell lung carcinoma | Tang-Du Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07448116 | Jan 2026 → Feb 2029 expected | cancer | Betta Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02898116 | May → Aug 2017 | non-small cell lung carcinoma | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/2 | NCT01625234 | Jun 2012 → Sep 2020 | non-small cell lung carcinoma | Xcovery Holdings, Inc. | Completed | No outcome recorded |
| Phase 219 trials · 1 met primary | ||||||
| Phase 2 | NCT07235306 | Dec 2025 → Jan 2031 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06772610 | Mar 2025 → Mar 2029 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06762327 | Feb 2025 → Dec 2026 expected | cancer | Nanjing First Hospital, Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06780839 | Jan 2025 → Jan 2029 expected | non-small cell lung carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06779539 | Jan 2025 → Jun 2028 expected | non-small cell lung carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05380024 | Aug 2022 → Dec 2023 | non-small cell lung carcinoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05491811 | Aug 2022 → Aug 2024 overdue | non-small cell lung carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05241028 | May 2022 → Feb 2027 expected | non-small cell lung carcinoma | Hebei Medical University Fourth Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05178511 | Dec 2021 → Jul 2023 | — | Li Zhang, MD | Unknown | No outcome recorded |
| Phase 2 | NCT03737994 | Jul 2019 → Jul 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03753685 | Apr 2019 → Jun 2025 overdue | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Fudan University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04415320 | Mar 2019 → Dec 2020 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Unknown | 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 | NCT03608007 | Jun 2018 → Mar 2020 | lung cancer | Betta Pharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03213652 | Apr 2018 → Sep 2025 overdue | Ewing sarcoma/peripheral primitive neuroectodermal tumor, Langerhans cell histiocytosis, Wilms tumor, ependymoma +9 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03420508 | Jan 2018 → Jan 2027 expected | melanoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03215693 | Sep 2017 → Mar 2020 | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03155620 | Jul 2017 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, conventional osteosarcoma +13 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT06955325 | May 2025 → Dec 2030 expected | non-small cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05341583 | May 2022 → Jun 2025 overdue | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Recruiting | Met primary |
| Phase 3 | NCT02767804 | Jun 2016 → Dec 2025 overdue | non-small cell lung carcinoma | Xcovery Holdings, Inc. | Active not recruiting | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07671560 | Jul 2026 → Dec 2028 expected | — | Qiming Wang | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06785584 | Feb → Dec 2025 overdue | non-small cell lung carcinoma | Fujian Medical University Union Hospital | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04146571 | — | non-small cell lung carcinoma | Xcovery Holdings, Inc. | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05665283 Comparator | Nov 2022 → Jan 2023 | — | Xcovery Holdings, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Xcovery Holdings, Inc. | Regulatory Betta Pharmaceuticals Announces NMPA Approval of Ensartinib for Adjuvant Treatment of ALK-Positive NSCLC in China xcovery.com ↗
This regulatory approval applies to China. |
| 2026-03-25 | Betta Pharmaceuticals Co., Ltd. | Results 2026 EBMT 丨贝达药业恩沙替尼治疗复发/难治性ALK阳性淋巴瘤研究成果亮相 bettapharma.com ↗
所有患者的总缓解率 (ORR) 和疾病控制率 (DCR) 均为100%（其中完全缓解7例 [77.8%]；部分缓解2例 [22.2%]），详见图1和表2。 |
| 2025-09-23 | Betta Pharmaceuticals Co., Ltd. | Results 2025 ESMO丨恩沙替尼术后辅助治疗研究数据将首次披露 bettapharma.com ↗
近期，恩沙替尼用于ALK阳性非小细胞肺癌术后辅助治疗的药物临床试验期中数据分析显示阳性结果，达到预设的主要研究终点。 |
| 2021-09-02 | Xcovery Holdings, Inc. | Results Ensartinib published phase 3 global trial results in the journal of JAMA Oncology Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase−Positive Non–Small Cell Lung Cancer A Randomized Clinical Trial xcovery.com ↗ |
| 2021-01-28 | Xcovery Holdings, Inc. | Results Ensartinib updated the efficacy and quality of life data at the World Conference on Lung Cancer (WCLC) World Wide Virtual Event, January 28-31, 2021 Dr. Yi-long Wu presented the poster titled “Quality-of-life outcomes and subgroup analysis in a phase 3 randomized study of ensartinib vs. crizotinib in anaplastic lymphoma kinase (ALK)-positive NSCLC patients: EXALT3” xcovery.com ↗ |
| 2020-08-10 | Betta Pharmaceuticals Co., Ltd. | Results 恩沙替尼一线数据全球惊艳亮相 全线守护ALK阳性患者 bettapharma.com ↗
结果显示，接受恩沙替尼治疗的 ALK 阳性非小细胞肺癌（ NSCLC ）患者，其中位无进展生存期（ mPFS ）显著长于接受克唑替尼治疗的患者。 |
| 2019-09-02 | Betta Pharmaceuticals Co., Ltd. | Results 佳音再传！盐酸恩沙替尼药品注册临床试验最新数据彰显更好疗效 bettapharma.com ↗
在疗效性方面，恩沙替尼整体ORR为52.6%，疾病控制率为87.8%，中位PFS为11.2个月，颅内ORR为71.4%，颅内病灶控制率达95.2%。 |
| 2018-12-27 | Betta Pharmaceuticals Co., Ltd. | Regulatory 重大喜讯！国家药监局受理盐酸恩莎替尼新药注册申请 bettapharma.com ↗
公司申报的盐酸恩莎替尼（X-396）用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的药品注册申请获得国家药品监督管理局受理。 |
| 2017-12-20 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达新药项目开启全球首个ALK抑制剂在黑色素瘤中的探索性研究 bettapharma.com ↗
该试验由著名的纪念斯隆-凯特琳癌症中心（MSKCC）向美国食品药品管理局提交临床研究申请（IND 137434），获批进行Ensartinib（X-396）在具有ALK突变的晚期恶性黑色素瘤患者中的Ⅱ期研究，由纪念斯隆-凯特琳癌症中心的研究员、黑色素瘤及免疫治疗领域的医学博士Alexander Shoushtari主导。 |
| 2017-11-05 | Betta Pharmaceuticals Co., Ltd. | Regulatory 6载同行，一路非凡——凯美纳上市6周年学术峰会在广州举行 bettapharma.com ↗
特别值得一提的是，公司正在开发的Ensartinib（X-396），在2016年获批进行I、II、III期临床试验的基础上，今年又获批进入国际多中心Ⅲ期临床研究。 |
| 2017-06-05 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业治疗肺癌新药获得国际多中心临床试验批文 今后有望在全球同步上市 bettapharma.com ↗
6月2日，贝达药业股份有限公司发布公告：公司控股子公司美国Xcovery Holding Company LLC开发的治疗肺癌新药X-396胶囊获得国家食品药品监督管理总局（CFDA）批准进入国际多中心临床研究。 |
All press releases naming this drug 12 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ensartinib | “To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is...” NCT03608007 ↗32“Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive Non-small Cell Lung Cancer(NSCLC): An Exploratory Analysis” NCT07671560 ↗ “oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed.” NCT04415320 ↗ |
| Known as | Ensacove | ChEMBL registry synonym — accepted as the source's own label CHEMBL4113131 ↗ |
| Known as | Ensartinib dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4113131 ↗ |
| Known as | Ensartinib Hydrochloride | “Drug: Ensartinib Hydrochloride” NCT05665283 ↗ |
| Known as | X-396 | “This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers.” NCT01625234 ↗6“oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed.” NCT03753685 ↗ “X-396 (ensartinib)” NCT02767804 ↗ |
| Known as | X-396 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4113131 ↗ |
| Known as | X-396 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL4113131 ↗ |
| Action | Inhibit | “a potent anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI)” PMID 29563138 ↗ Mar 2018 |
| Modality | Small molecule | “Ensartinib, an oral tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK)” PMID 34473194 ↗ Nov 2021 |
| Route | Oral | “the investigational drug will be given as a once or twice daily oral dose” NCT01625234 ↗ |
| Target | ALK | “a potent anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI)” PMID 29563138 ↗ Mar 2018 |