Drugs / Ensartinib
Ensartinib
also known as
X-396 · Ensacove · Ensartinib dihydrochloride · Ensartinib Hydrochloride · Ensatinib · X-396 DIHYDROCHLORIDE · X-396 HCl
Small molecule targets ALK, MET, ROS1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ENSACOVE | — | 2024-12-18 | fda.gov ↗ |
Trials 35 · a red edge is where a trial was stopped
| 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 220 trials | ||||||
| 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 | NCT06779539 | Jan 2025 → Jun 2028 expected | non-small cell lung carcinoma | West China Hospital | 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 | 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 | NCT05186506 | Jan 2022 → Dec 2025 overdue | non-small cell lung carcinoma | Sichuan University | Not yet 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 |
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02767804 | Jun 2016 → Dec 2025 overdue | non-small cell lung carcinoma | Xcovery Holdings, Inc. | Active not recruiting | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05665283 Comparator | Nov 2022 → Jan 2023 | — | Xcovery Holdings, Inc. | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 39 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 | Ensatinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05186506 ↗ |
| 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 |