Drugs / Unecritinib
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04804904 | May → Jun 2021 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03019276 | Jul 2017 → Dec 2018 | cancer of unknown primary site | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04412564 | Aug 2020 → Mar 2021 | cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04306887 | Nov 2019 → Dec 2022 | anaplastic large cell lymphoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03972189 | Jul 2019 → Mar 2021 | non-small cell lung carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-11-28 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 2024年医保药品目录上新！正大天晴两款独家新药首次纳入 cttq.com ↗
根据目录，正大天晴2款独家新药——富马酸安奈克替尼胶囊（安柏尼）、枸橼酸依奉阿克胶囊（安洛晴）首次纳入国家医保目录，均为年内上市品种。 |
| 2024-04-30 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 创新突破！正大天晴首个国产ROS1靶向药获批上市 cttq.com ↗
4月30日，正大天晴收到国家药品监督管理局（NMPA）核准签发的《药品注册证书》，公司自主研发的1类创新药富马酸安奈克替尼胶囊（研发代号：TQ-B3101，商品名：安柏尼）获批上市，成为首个获批用于ROS1阳性的局部晚期或转移性非小细胞肺癌成人患者的国产靶向药。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-28 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 2024年医保药品目录上新！正大天晴两款独家新药首次纳入 cttq.com ↗ |
| 2024-04-30 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 创新突破！正大天晴首个国产ROS1靶向药获批上市 cttq.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Unecritinib | “Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial.” PMID 37385995 ↗ Jun 2023 |
| Known as | TQ-B3101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04804904 ↗ |
| Action | Inhibit | “a novel derivative of crizotinib and a multi-tyrosine kinase inhibitor targeting ROS1, ALK, and c-MET” PMID 37385995 ↗ Jun 2023 |
| Modality | Small molecule | — CHEMBL5314968 ↗ |
| Route | Oral | “administered orally” NCT03019276 ↗ |
| Target | ALK | “a novel derivative of crizotinib and a multi-tyrosine kinase inhibitor targeting ROS1, ALK, and c-MET” PMID 37385995 ↗ Jun 2023 |
| Target | MET | “a novel derivative of crizotinib and a multi-tyrosine kinase inhibitor targeting ROS1, ALK, and c-MET” PMID 37385995 ↗ Jun 2023 |
| Target | ROS1 | “a novel derivative of crizotinib and a multi-tyrosine kinase inhibitor targeting ROS1, ALK, and c-MET” PMID 37385995 ↗ Jun 2023 |