Ivosidenib is a Small Molecule owned by Les Laboratoires Servier, and is involved in 22 clinical trials, of which 8 were completed, 12 are ongoing, and 2 are planned.

Ivosidenib (AG-120) is an inhibitor of mutated form of isocitrate dehydrogenase 1 (isocitrate1). Mutated metabolic gene IDH1 has enzyme activity consistent with a cancer-causing gene or oncogene. It produces a metabolite, 2-hydroxyglutarate (2HG), which may contribute to the tumor formation and malignant progression. The drug candidate binds and inhibits the mutated form of isocitrate dehydrogenase 1 and may prove to be effective in the treatment of the conditions by checking the underlying cause of disease progression.

The revenue for Ivosidenib is expected to reach a total of $751m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Ivosidenib NPV Report.

Ivosidenib was originated by Agios Pharmaceuticals and is currently owned by Les Laboratoires Servier. Agios Pharmaceuticals and CStone Pharmaceuticals are the other companies associated in development or marketing of Ivosidenib.

Ivosidenib Overview

Ivosidenib (Tibsovo/ AG-120) acts as an anti-neoplastic agent. It is formulated as film-coated tablets for oral route of administration. Tibsovo is indicated for the treatment of relapsed or refractory acute myeloid leukemia in adults with a susceptible IDH1 mutation, and also for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. Tibsovo is indicated for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

AG-120 is under development for the treatment of myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML), clonal cytopenia of undetermined significance, advanced hematological malignancies including relapsed/primary refractory acute myeloid leukemia (AML), advanced solid tumors including glioma and chondrosarcoma. The drug candidate is administered through oral route. It acts by targeting isocitrate dehydrogenase 1.

CStone Pharmaceuticals Overview

CStone Pharmaceuticals is a biopharmaceutical company. It develops and commercializes immuno-oncology and precision medicine to address the unmet medical needs of cancer patients. The company’s pipeline product portfolio includes Ivosidenib (CS3010) for the treatment of acute myeloid leukemia (AML); CS1001 to treat solid tumors; Avapritinib (CS3007) for the treatment of liver diseases; CS1002, CS1003, CS3006, CS3003, CS3002 to treat solid tumors. CStone Pharmaceuticals operates clinical research institutions for developing anti-cancer drugs. The company has partnerships with Agios Inc, Blueprint Medicines Corp, and WuXi Biologics. CStone Pharmaceuticals is headquartered in Shanghai, China.

The company reported revenues of (Renminbi) CNY243.7 million for the fiscal year ended December 2021 (FY2021), a decrease of 76.5% over FY2020. The operating loss of the company was CNY1,917.9 million in FY2021, compared to an operating loss of CNY1,219.7 million in FY2020. The net loss of the company was CNY1,920.1 million in FY2021, compared to a net loss of CNY1,221 million in FY2020.

Quick View – Ivosidenib

Report Segments
  • Innovator (NME)
Drug Name
  • Ivosidenib
Administration Pathway
  • Oral
Therapeutic Areas
  • Hematological Disorders
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.