Tibsovo® is the commercial brand name of Ivosidenib Tablets, an oral selective mutant IDH1 inhibitor co-developed by CStone Pharmaceuticals and Servier. It selectively inhibits mutated isocitrate dehydrogenase 1 (IDH1) enzyme, reduces abnormal oncometabolite 2-hydroxyglutarate production, restores normal cellular differentiation of malignant tumor cells, and exerts targeted anti-tumor activity. This medicine is for oral administration only.
Main Indications
Treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) carrying IDH1 mutation;
First-line treatment for newly diagnosed acute myeloid leukemia in adult patients with IDH1 mutation who are ineligible for intensive chemotherapy;
Treatment of adult patients with unresectable or metastatic cholangiocarcinoma confirmed with IDH1 mutation after previous chemotherapy.
Clinical Research
Global multicenter Phase I/II pivotal registration trials demonstrated durable objective remission rate and prolonged overall survival for relapsed/refractory IDH1-mutant AML patients treated with ivosidenib monotherapy, achieving deep hematologic remission;
Phase III AGILE trial validated that combination of ivosidenib and azacitidine brought significant survival benefit for newly diagnosed IDH1-mutant AML patients unsuitable for intensive chemotherapy versus azacitidine monotherapy;
Registration clinical trials recruiting Chinese patients confirmed consistent anti-tumor efficacy and controllable safety profile compared with global trial population for both AML and cholangiocarcinoma indications;
Phase III ClarIDHy trial confirmed significant progression-free survival improvement for IDH1-mutant advanced cholangiocarcinoma patients receiving ivosidenib maintenance therapy.
Common Side Effects
Common adverse reactions include fatigue, leukocytosis, diarrhea, edema, nausea, hypokalemia, fever, joint pain, elevated liver enzymes;
Key serious adverse reaction is differentiation syndrome, which can be managed timely with corticosteroids and supportive treatment; most adverse events are grade 1–2 and manageable with symptomatic care or dose adjustment.
Approval Status in China
Tibsovo® (Ivosidenib Tablets, 0.25g per tablet, 60 tablets per box) was approved by NMPA in 2022 for relapsed/refractory IDH1-mutant acute myeloid leukemia; the indication for IDH1-mutant cholangiocarcinoma was approved in China in 2023, jointly commercialized by CStone Pharmaceuticals and Servier in mainland China.
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