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Research Report
TQB-3454: A Strategic Analysis of an Investigational IDH1 Inhibitor for Biliary Tract and Hematologic Malignancies
I. Executive Summary
TQB-3454 is an orally administered, small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (IDH1), under development by the prominent China-based pharmaceutical company, Chia Tai Tianqing Pharmaceutical Group (CTTQ). The drug is positioned at a critical juncture in its clinical development, with the most advanced program being a pivotal Phase 3 trial for the treatment of advanced biliary tract cancer (BTC) harboring an IDH1 mutation. This indication represents a well-defined area of unmet medical need with a validated therapeutic target.
The mechanism of action of TQB-3454 is definitively established as the targeted inhibition of the mutant IDH1 enzyme. This action is designed to block the production of the oncometabolite D-2-hydroxyglutarate (2-HG), thereby reversing the epigenetic dysregulation that drives oncogenesis in certain malignancies. Despite the existence of conflicting information in some public-facing, third-party databases which erroneously describe the drug as a PI3K/AKT/mTOR pathway inhibitor, the overwhelming body of evidence from clinical trial designs, regulatory filings, and multiple authoritative databases confirms its identity as an IDH1 inhibitor.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/07/22 | Phase 1 | UNKNOWN |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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