Drugs / TQB3454
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | IDH-mutant anaplastic astrocytoma | 2026-07-10 | “TQB3454（IDH1抑制剂）于7月10日获国家药监局药品审评中心（CDE）受理” cttq.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06139367 | Nov → Dec 2023 | bile duct carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04481607 | Aug 2020 → Dec 2022 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06218771 | Jul 2023 → Jun 2025 | acute myeloid leukemia, myelodysplastic syndrome | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05987358 | Sep 2023 → Dec 2026 expected | bile duct carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴两款1类创新药接连申报上市，TQB3454冲刺IDH1突变胆道癌精准治疗 cttq.com ↗
正大天晴自主研发的TQB3454（IDH1抑制剂）于7月10日获国家药监局药品审评中心（CDE）受理，拟用于治疗伴IDH1突变的晚期胆道癌（BTC）。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴两款1类创新药接连申报上市，TQB3454冲刺IDH1突变胆道癌精准治疗 cttq.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TQB3454 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04481607 ↗ |
| Known as | TQB3454 Tablets | “TQB3454 Tablets is a selective isocitrate dehydrogenase 1 (IDH1) mutation inhibitor” NCT06218771 ↗ |
| Action | Inhibit | “TQB3454 is a selective IDH1 mutant enzyme inhibitor.” NCT05987358 ↗ |
| Modality | Small molecule | “TQB3454 tablets is a small molecule oral drug.” NCT04481607 ↗ |
| Route | Oral | “TQB3454 tablets administered orally, once daily” NCT04481607 ↗ |
| Target | IDH1 | “TQB3454 is a selective IDH1 mutant enzyme inhibitor.” NCT05987358 ↗ |