Tibsovo (Ivosidenib)

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 Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

Enrollment Status: Recruiting

Publish Date: October 09, 2025

Intervention Type: Drug

Study Phase: Phase 3

Summary: Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resect...

Phase 1b/2 Study of Oral Decitabine/Cedazuridine (ASTX727) and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib

Who is this study for: Patients with relapsed or refractory acute myeloid leukemia

Enrollment Status: Recruiting

Publish Date: October 09, 2025

Intervention Type: Drug

Study Drugs: Decitabine, Cedazuridine, Enasidenib, Ivosidenib, Venetoclax

Study Phase: Phase 1/Phase 2

Summary: This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slo...

Phase Ib/II Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies

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

Enrollment Status: Recruiting

Publish Date: October 03, 2025

Intervention Type: Drug

Study Drugs: Azacitidine, Ivosidenib, Venetoclax

Study Phase: Phase 1/Phase 2

Summary: This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work ...

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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