Tibsovo
Tibsovo ingredients
| Active ingredient | Strength |
|---|---|
| Ivosidenib | 250 mg/1 |
What Tibsovo is used for
The FDA lists the approved uses on the official label (below). In the EU, ivosidenib is approved as Tibsovo for:
Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1). Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Tibsovo
- Generic name
- Ivosidenib
- Made by
- Servier Pharmaceutical LLC
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Isocitrate Dehydrogenase 1 Inhibitor
- FDA approval
- New drug application (NDA) NDA211192
- On the US market since
- 2021
Official information
- Tibsovo prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Ivosidenib)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Tibsovo?
Tibsovo (Ivosidenib) is a cancer medicine made by Servier Pharmaceutical LLC, approved by the US FDA.
What are the ingredients of Tibsovo?
Tibsovo contains Ivosidenib (250 mg/1).
Is Tibsovo approved in Europe?
The same active substance is approved in the EU as Tibsovo.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA