We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Tibsovo
Published
Product name
Tibsovo
Active ingredient
Ivosidenib
Submission type
New Chemical Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Tibsovo (ivosidenib) was approved for the following therapeutic use:
Tibsovo is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.
How this medicine works
Ivosidenib is a small molecule inhibitor of R132-mutated isocitrate dehydrogenase 1 (IDH1) enzymes. Through a gain of neomorphic function, the mutant IDH1 converts alpha-ketoglutarate (α-KG) to 2- hydroxyglutarate (2-HG). As 2-HG competitively inhibits α-KG-dependent enzymes, including histone and deoxyribonucleic acid (DNA) demethylases, its accumulation leads to widespread epigenetic dysregulation. Ivosidenib inhibited selected IDH1 mutants (R132C, R132L, R132G, R132H and R132S) at much lower concentrations than wild-type IDH1 in vitro.