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Brand Name

Tibsovo

Generic Name

Ivosidenib

View Brand Information

FDA approval date: October 19, 2021

Classification: Isocitrate Dehydrogenase 1 Inhibitor

Form: Tablet

What is Tibsovo (Ivosidenib)?

TIBSOVO is an isocitrate dehydrogenase-1 inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Approved To Treat

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Related Clinical Trials

A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation

Enrollment Status: Recruiting

Publish Date: June 18, 2026

Intervention Type: Drug

Study Phase: Phase 2

Summary: This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).

Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS

Who is this study for: Adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome

Enrollment Status: Recruiting

Publish Date: June 12, 2026

Intervention Type: Drug

Study Drugs: Ivosidenib, Liposomal Daunorubicin, Liposomal Cytarabine

Study Phase: Phase 2

Summary: This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing th...

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT

Enrollment Status: Recruiting

Publish Date: June 10, 2026

Intervention Type: Drug

Study Phase: Phase 3

Summary: This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)

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Related Latest Advances

Subclonal IDH1/2 Mutations as a Targetable Vulnerability in Vascular Tumors.

Journal: bioRxiv : the preprint server for biology

Published: May 25, 2026

MechAInistic: An LLM-guided Multi-Agent System for Reasoning over Genome-Scale Constraint-Based Metabolic Models.

Journal: bioRxiv : the preprint server for biology

Published: May 25, 2026

Long-term (74-month) efficacy and safety of ivosidenib and azacitidine in an elderly patient with mutated IDH1 acute myeloid leukemia: insights from a case report.

Journal: Postgraduate medicine

Published: May 11, 2026

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Brand Information

TIBSOVO (ivosidenib)

WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution

1DOSAGE FORMS AND STRENGTHS

Tablets: 250 mg as a blue oval-shaped film-coated tablet debossed "IVO" on one side and "250" on the other side.

2CONTRAINDICATIONS

None.

3ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Differentiation Syndrome in AML and MDS
QTc Interval Prolongation
Guillain-Barré Syndrome

3.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

4DESCRIPTION

TIBSOVO (ivosidenib) is an inhibitor of isocitrate dehydrogenase 1 (IDH1) enzyme. The chemical name is (2

The molecular formula is C

TIBSOVO (ivosidenib) is available as a film-coated 250 mg tablet for oral administration. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet coating includes FD&C blue #2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.

5PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

6PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Carton

NDC 72694-617-60

TIBSOVO

250 mg

Dispense the enclosed

Swallow tablets whole. Do not split,

1 Bottle containing 60 tablets

Rx only

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Carton