Drugs / XNW4107
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04801043 | Mar → Oct 2021 | bacterial infectious disease | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04787562 | Feb → Oct 2021 | bacterial infectious disease | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04482569 | Jul 2020 → Feb 2021 | bacterial infectious disease | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05204368 | Mar 2023 → Jun 2025 | acute pyelonephritis | Evopoint Biosciences Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT05204563 | Jul 2022 → Sep 2024 | bacterial pneumonia | Evopoint Biosciences Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-12-18 | Evopoint Biosciences Inc. | Regulatory 信诺维新药福诺巴坦（XNW4107）提交Pre-NDA申请，为HABP/VABP患者带来新希望 evopointbio.com ↗
苏州信诺维医药科技股份有限公司（简称“信诺维”或“公司”）今日宣布，其在研1类新药——福诺巴坦/亚胺培南/西司他丁，已于近日向国家药品监督管理局药品审评中心（CDE）提交了Pre-NDA申请，其有望成为全球首款广谱且对三大碳青霉烯耐药革兰阴性杆菌（CRO）具有强大抗菌活性的新型β-内酰胺类/β-内酰胺酶抑制剂（BL/BLI）药品。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-12-18 | Evopoint Biosciences Inc. | 信诺维新药福诺巴坦（XNW4107）提交Pre-NDA申请，为HABP/VABP患者带来新希望 evopointbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | XNW4107 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05204368 ↗ |
| Route | Intravenous | “given as intravenous (IV) infusion” NCT04482569 ↗ |