Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats newly diagnosed AML. Sold as Tibsovo. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ivosidenib (sold as Tibsovo), first approved Jul 20, 2018, with 4 new uses approved and 0 published complete response letters.
First approved: Jul 20, 2018
Applications: 1
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $326M
Orphan exclusivity until: Oct 24, 2030
First approved in the EU: May 4, 2023
First approved in Japan: Mar 27, 2025
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 80 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Tibsovo, new ingredientA drug with a new active ingredient indicated for the treatment of IDH1 mutation-positive acute myeloid leukemia. · Nihon Servier Co., Ltd. · Mar 27, 2025
Clinical Trials
51 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
