Drugs / UX-GIP001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07244328 | Nov 2025 → Nov 2028 expected | epilepsy | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07572812 | May 2026 → Jul 2029 expected | epilepsy | Shanghai UniXell Biotechnology Co., Ltd | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Shanghai UniXell Biotechnology Co., Ltd | Regulatory 跃赛生物癫痫细胞治疗药物UX-GIP001注射液荣获美国FDA“快速通道资格”认定！ unixell.com ↗
公司新闻 6月2日，跃赛生物自主研发的癫痫细胞治疗药物UX-GIP001注射液正式获得美国食品药品监督管理局（FDA）授予的快速通道资格（Fast Track Designation）。 |
| 2026-04-08 | Shanghai UniXell Biotechnology Co., Ltd | Regulatory 【全球首创·中美双批】直击癫痫！跃赛生物iPSC药物UX-GIP001获批临床 unixell.com ↗
UX-GIP001注射液，获得了中国国家药品监督管理局药品审评中心（CDE）的临床试验默示许可。 |
| 2026-03-13 | Shanghai UniXell Biotechnology Co., Ltd | Regulatory 全球首款｜跃赛生物癫痫细胞治疗药物UX-GIP001获FDA IND批准开展临床研究 unixell.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Shanghai UniXell Biotechnology Co., Ltd | 跃赛生物癫痫细胞治疗药物UX-GIP001注射液荣获美国FDA“快速通道资格”认定！ unixell.com ↗ |
| 2026-04-08 | Shanghai UniXell Biotechnology Co., Ltd | 【全球首创·中美双批】直击癫痫！跃赛生物iPSC药物UX-GIP001获批临床 unixell.com ↗ |
| 2026-03-13 | Shanghai UniXell Biotechnology Co., Ltd | 全球首款｜跃赛生物癫痫细胞治疗药物UX-GIP001获FDA IND批准开展临床研究 unixell.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | UX-GIP001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07572812 ↗ |
| Known as | UX-GIP001 Injection | “UX-GIP001 Injection (Human GABAergic Interneuron Progenitor Cells Injection)” NCT07244328 ↗ |
| Modality | Cell therapy | “a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP)” NCT07244328 ↗ |
| Route | Other | “via stereotactic neurosurgery” NCT07244328 ↗ |