Drugs / tibremciclib
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05316259 | Apr → Aug 2022 | — | Betta Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03791112 | Jul 2019 → Dec 2025 overdue | cancer | Betta Pharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05433480 | May 2022 → Dec 2023 | breast cancer | Betta Pharmaceuticals Co., Ltd. | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | Betta Pharmaceuticals Co., Ltd. | Results 贝达药业泰瑞西利I期临床研究在《ESMO Open》发表 bettapharma.com ↗
在Ib期阶段，42例患者达到PR，ORR为53.8%，DCR为87.2%，中位无进展生存期（PFS） 17.0个月，中位缓解持续时间（DOR） 25.5 个月。 |
| 2023-06-05 | Betta Pharmaceuticals Co., Ltd. | Results ASCO 2023 | 贝达药业BPI-16350确认的ORR高达60.5%！有望成为HR+/HER2-晚期转移性乳腺癌患者新的治疗选择 bettapharma.com ↗
在B阶段，46例患者中，43例至少进行过一次疗效评估，DCR为97.7%（42/43），确认的ORR高达60.5%（26/43），中位PFS尚未达到。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | Betta Pharmaceuticals Co., Ltd. | 贝达药业泰瑞西利I期临床研究在《ESMO Open》发表 bettapharma.com ↗ |
| 2023-06-05 | Betta Pharmaceuticals Co., Ltd. | ASCO 2023 | 贝达药业BPI-16350确认的ORR高达60.5%！有望成为HR+/HER2-晚期转移性乳腺癌患者新的治疗选择 bettapharma.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tibremciclib | “Tibremciclib (BPI-16350) is a novel potent selective inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6).” PMID 40403388 ↗ May 2025 |
| Known as | BPI-16350 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05433480 ↗ |
| Action | Inhibit | “novel potent selective inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6)” PMID 40403388 ↗ May 2025 |
| Modality | Small molecule | — CHEMBL5314545 ↗ |
| Route | Oral | “BPI-16350 capsules administered orally” NCT03791112 ↗ |
| Target | CDK4 | “novel potent selective inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6)” PMID 40403388 ↗ May 2025 |