Tibsovo® is the official global commercial brand name, and Tuoshuwo is its Chinese brand name co-developed by CSPC and Servier. It is an oral selective mutant IDH1 enzyme inhibitor. It targets mutated isocitrate dehydrogenase 1, blocking abnormal oncometabolite 2-HG accumulation, restoring normal cell differentiation and suppressing proliferation of IDH1-mutated malignant tumor cells.
Main Indications
Monotherapy for adult patients with relapsed or refractory acute myeloid leukemia (AML) carrying IDH1 mutation;
First-line single-agent treatment for newly diagnosed IDH1-mutated AML adult patients ineligible for intensive chemotherapy;
Treatment of unresectable or metastatic cholangiocarcinoma with confirmed IDH1 mutation after prior systemic chemotherapy.
Clinical Research
Global multicenter phase I/II AG120-C-001 pivotal trials fully validated durable complete remission and long-term survival benefit for multi-line pretreated IDH1-mutant AML patients;
Global phase III ClarIDHy registration trial confirmed significant progression-free survival improvement versus placebo for IDH1-mutant advanced cholangiocarcinoma;
Long-term open-label extension cohorts demonstrated sustained hematologic response and disease stabilization under continuous once-daily oral administration;
Dose-finding research verified balanced anti-tumor efficacy and liver safety profile of the 0.25g once-daily standard regimen;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for local IDH1-mutant AML and biliary tract cancer populations.
Common Side Effects
Common mild adverse reactions: Fatigue, nausea, diarrhea, leukocytosis, arthralgia and elevated bilirubin;
Laboratory abnormalities: Transient mild liver function test elevation, hyperbilirubinemia and leukocytosis;
Severe but uncommon risks: Differentiation syndrome, severe prolonged QT interval, severe hepatotoxicity and hypersensitivity reactions.
Approval Status in China
Original drug Tibsovo® (Chinese brand: Tuoshuwo) was officially approved for marketing in China in 2022, with the specification of 0.25g per tablet, 60 tablets per box. It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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