Drugs / CM082
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | 晚期肾细胞癌 | 2022-01-14 | “伏罗尼布片（CM082）拟用于与依维莫司联合，治疗既往接受过抗血管酪氨酸激酶抑制剂治疗失败的晚期肾细胞癌患者的上市许可申请获得受理。” bettapharma.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT04434326 | Jul → Oct 2021 | neoplasm | AnewPharma | Completed | No outcome recorded |
| Phase 1 | NCT04126668 | Dec 2019 → Jan 2020 | cancer | AnewPharma | Completed | No outcome recorded |
| Phase 1 | NCT04222842 | Dec 2019 → Dec 2021 | choroidal neovascularization | AnewPharma | Suspended | No outcome recorded |
| Phase 1 | NCT03792958 | Feb 2019 → Jun 2023 | cancer | AnewPharma | Unknown | No outcome recorded |
| Phase 1 | NCT03286244 | Mar 2018 → Aug 2019 | gastric cancer | AnewPharma | Unknown | No outcome recorded |
| Phase 1 | NCT02577458 | Sep 2015 → Mar 2018 | renal cell carcinoma | AnewPharma | Unknown | No outcome recorded |
| Phase 1 | NCT02452385 | Mar 2015 → Jun 2020 | age-related macular degeneration | AnewPharma | Suspended | No outcome recorded |
| Phase 1 | NCT01863485 | May 2013 → Oct 2014 | — | AnewPharma | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03904719 | Sep 2019 → Jun 2021 | small cell lung carcinoma | AnewPharma | Unknown | No outcome recorded |
| Phase 2 | NCT03848611 | Apr 2019 → Feb 2021 | non-small cell lung carcinoma | AnewPharma | Unknown | No outcome recorded |
| Phase 2 | NCT03710863 | Nov 2018 → Jan 2022 | age-related macular degeneration | AnewPharma | Unknown | No outcome recorded |
| Phase 2 | NCT03602547 | Jul 2018 → Jul 2019 | mucosal melanoma | AnewPharma | Unknown | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03095040 | Dec 2016 → Feb 2021 | renal cell carcinoma | AnewPharma | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | EyePoint Pharmaceuticals, Inc. | Results EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD eyepoint.bio ↗
DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD; primary endpoint not achieved in full dataset, confounded by this asymmetric cohort |
| 2025-11-19 | EyePoint Pharmaceuticals, Inc. | Results EyePoint Announces Positive Recommendation from Independent Data Safety Monitoring Committee for Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration eyepoint.bio ↗
The DSMC recommended that both the LUGANO and LUCIA trials continue as planned, with no modifications to the protocol. |
| 2022-10-02 | Betta Pharmaceuticals Co., Ltd. | Results 贝达药业伏罗尼布研究成果亮相2022美国眼科学会年会 bettapharma.com ↗
所有41例受试者的初步疗效结果显示，治疗12个月（第360±3天）后，相比于基线，受试者的视力增加7.7±10.00个字符。 |
| 2022-01-14 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业伏罗尼布片（CM082）上市申请获受理 bettapharma.com ↗
1月14日，贝达药业收到国家药品监督管理局签发的《受理通知书》（受理号：CXHS2200003国）， 伏罗尼布片（CM082）拟用于与依维莫司联合，治疗既往接受过抗血管酪氨酸激酶抑制剂治疗失败的晚期肾细胞癌患者的上市许可申请获得受理。 |
| 2020-04-27 | Betta Pharmaceuticals Co., Ltd. | Results 喜讯！贝达药业Vorolanib临床研究成果在《EBioMedicine》全文发表 bettapharma.com ↗
研究结果显示Vorolanib联合依维莫司治疗晚期肾癌具有良好的安全性。 |
| 2019-01-17 | Betta Pharmaceuticals Co., Ltd. | Regulatory 强强联手！贝达药业与君实生物的联合用药获临床批文 bettapharma.com ↗
批准开展用于既往未经治疗的局部进展或转移性黏膜黑色素瘤的临床试验。 |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | EyePoint Pharmaceuticals, Inc. | EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD eyepoint.bio ↗ |
| 2025-11-19 | EyePoint Pharmaceuticals, Inc. | EyePoint Announces Positive Recommendation from Independent Data Safety Monitoring Committee for Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration eyepoint.bio ↗ |
| 2022-10-02 | Betta Pharmaceuticals Co., Ltd. | 贝达药业伏罗尼布研究成果亮相2022美国眼科学会年会 bettapharma.com ↗ |
| 2022-01-14 | Betta Pharmaceuticals Co., Ltd. | 贝达药业伏罗尼布片（CM082）上市申请获受理 bettapharma.com ↗ |
| 2020-04-27 | Betta Pharmaceuticals Co., Ltd. | 喜讯！贝达药业Vorolanib临床研究成果在《EBioMedicine》全文发表 bettapharma.com ↗ |
| 2019-01-17 | Betta Pharmaceuticals Co., Ltd. | 强强联手！贝达药业与君实生物的联合用药获临床批文 bettapharma.com ↗ |
| 2018-08-04 | Betta Pharmaceuticals Co., Ltd. | 贝达药业控股子公司美国Xcovery宣布vorolanib（X-82）联合nivolumab用药临床试验患者入组 bettapharma.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CM082 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04434326 ↗ |
| Known as | vorolanib | “Vorolanib (X-82, CM082) is a multi-target tyrosine kinase inhibitor.” PMID 32335374 ↗ Apr 2020 |
| Known as | X-82 | “Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25mg BID/50mg QD/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or...” NCT04222842 ↗ |
| Action | Inhibit | “Vorolanib is a highly potent tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor.” PMID 36459768 ↗ Nov 2022 |
| Route | Oral | “taken orally once a day” NCT01863485 ↗ |