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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

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

Enrollment Status: Recruiting

Publish Date: April 08, 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)

A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

Enrollment Status: Recruiting

Publish Date: April 06, 2026

Intervention Type: Drug

Study Phase: Phase 1

Summary: The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle ...

A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)

Enrollment Status: Recruiting

Publish Date: April 03, 2026

Intervention Type: Drug

Study Phase: Phase 3

Summary: This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be adminis...

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The allosteric IDH1 inhibitor ivosidenib overcomes chemoresistance in intrahepatic cholangiocarcinoma models expressing wild-type IDH1.

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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