NDAORALTABLETPriority Review
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
TIBSOVO (ivosidenib) by R-Pharm US is isocitrate dehydrogenase 1 inhibitors [moa]. Approved for isocitrate dehydrogenase 1 inhibitor [epc]. First approved in 2018.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIBSOVO (ivosidenib) is an oral isocitrate dehydrogenase 1 (IDH1) inhibitor approved in 2018 for IDH1-mutated malignancies including acute myeloid leukemia, myelodysplastic syndromes, and cholangiocarcinoma. It works by selectively inhibiting the mutant IDH1 enzyme, which drives cancer cell proliferation in genetically defined tumor populations. The drug addresses a niche but clinically important patient segment with actionable IDH1 mutations.
$0.296MPart D
Peak13.1 years to LOETIBSOVO is at peak lifecycle with modest Part D claims (11 in 2023), indicating a specialized, limited population reach requiring precision oncology commercial strategies.
Mechanism of Action
Isocitrate Dehydrogenase 1 Inhibitors
Pharmacologic Class:
Isocitrate Dehydrogenase 1 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.
Started Sep 2026
60 enrolled
Acute Myeloid Leukemia
A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia
Started Jan 2026
45 enrolled
Acute Myeloid Leukemia
Ivosidenib as Post-HSCT Maintenance for AML
Started Jan 2026
75 enrolled
IDH1 MutationAcute Myeloid Leukemia (AML)Hematopoietic Stem Cell Transplant (HSCT)
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
Started Jan 2026
0Low Grade Glioma of Brain
Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma
Started Nov 2025
40 enrolled
CholangiocarcinomaIDH Mutation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.