Tibsovo (ivosidenib)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Ivosidenib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ivosidenib
- Brand name
- Tibsovo
- Development code
- AG-120
- Drug class
- IDH1 inhibitor
- Manufacturer
- Servier
- How it's taken
- Oral tablets once daily, alone or with azacitidine
A once-daily pill for AML with a susceptible IDH1 mutation, approved in 3 AML settings: with azacitidine or alone for newly diagnosed AML in adults 75 or older or unfit for intensive chemotherapy, and alone for relapsed or refractory AML. In the AGILE trial, Tibsovo plus azacitidine tripled median survival compared with azacitidine alone. Tibsovo is also approved for IDH1-mutated MDS and cholangiocarcinoma, covered on a separate page.
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Where Ivosidenib fits
The IDH1-targeted alternative to venetoclax plus azacitidine for older or unfit adults, and 1 of 2 IDH1 inhibitors at relapse (the other is Rezlidhia). Trials are testing ivosidenib with intensive chemotherapy and in triplets with venetoclax and azacitidine.
How Ivosidenib works
About 6% to 10% of people with AML have an IDH1 mutation that makes the enzyme produce 2-hydroxyglutarate, a chemical that blocks blood cell maturation. Ivosidenib blocks the mutant IDH1 enzyme, 2-hydroxyglutarate levels drop, and the leukemia blasts resume maturing into functioning cells[1]. Azacitidine adds a second mechanism that reactivates silenced genes, and the 2 together produced far more remissions than azacitidine alone[2].
Mechanism: Oral inhibitor of mutant IDH1 that lowers 2-hydroxyglutarate and restores blast maturation
Side effects and safety
- QTc prolongation. ECGs and electrolytes are checked; the dose is reduced or held for QTc above 480 msec and stopped for life-threatening rhythm changes; avoid other QT-prolonging drugs and strong CYP3A4 inhibitors where possible.
- Guillain-Barre syndrome. New weakness, numbness or trouble breathing is checked at once; Tibsovo is stopped permanently if the syndrome is diagnosed.
- Noninfectious leukocytosis. White cells can rise as blasts mature and are brought down with hydroxyurea.
- Blood counts and chemistry before starting and at least weekly for the first month, every other week for the second month, then monthly
- ECG before starting, weekly for 3 weeks, then monthly
- Watch for new nerve symptoms
- Pregnancy test before starting
Tibsovo carries a boxed warning for differentiation syndrome in AML and MDS, which can be fatal; symptoms include fever, breathlessness, low oxygen, lung infiltrates, fluid around the lungs or heart, rapid weight gain or swelling, low blood pressure and kidney or liver problems, treated with steroids and monitoring[1]. Other warnings are QTc prolongation on the ECG and Guillain-Barre syndrome, a nerve disorder that requires stopping the drug permanently[1].
The most common side effects in AML (25% or more, including lab changes) were low white cells, diarrhea, low hemoglobin and platelets, high glucose, fatigue, raised alkaline phosphatase, swelling, low potassium, nausea, vomiting, low phosphate, decreased appetite, low sodium, leukocytosis, low magnesium, raised AST, joint pain, shortness of breath, high uric acid, abdominal pain, raised creatinine, mouth sores, rash, QT prolongation and differentiation syndrome[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ivosidenib
The dose is 500 mg (2 tablets of 250 mg) by mouth once a day, with or without food but not with a high-fat meal, until the leukemia progresses or side effects become unacceptable; in AML the label recommends at least 6 months of treatment if the disease is not progressing[1]. In newly diagnosed AML it is given with azacitidine 75 mg/m2 under the skin or by IV on days 1 to 7 of each 28-day cycle, or alone[1]. Tablets are swallowed whole; a vomited dose is not replaced.
Availability and cost
Only available as the brand-name product.
Help paying for Tibsovo
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Tibsovo Copay Program: eligible commercially insured patients pay as little as $0 per prescription; renewable for refills. Not valid for Medicaid, Medicare, Medigap, DoD, VA or TRICARE. No dollar cap is stated on the page.
For: private insurance · source - Bridge or quick-start supply
QuickStart Program: eligible new patients facing a coverage delay of 5 or more business days may receive a prescription with an option for a refill, 60 days in total, once a prior authorization has been submitted. A Bridge Program is also listed.
For: private insurance, Medicare, Medicaid, TRICARE · source - Free medicine program
Patient Assistance Program provides Tibsovo to uninsured and underinsured patients who meet eligibility criteria; the doctor's office faxes the enrollment form to 1-844-409-1143.
For: no insurance, underinsured · source - Insurance and case manager help
Patient Experience Managers at 1-800-813-5905, Monday to Friday, 8 AM to 8 PM ET, help with insurance and program enrollment.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The existing `ivosidenib` (cholangiocarcinoma) record points at tibsovo.com; this AML record uses the ServierONE Tibsovo page, which loaded on October 19, 2026. Servier customer service is 1-800-807-6124.
How the targeted AML pills compare, by mutation
AML has 19 FDA-approved medicines, counting the 3 older chemotherapy drugs. This chart covers the 8 that target a specific gene change, because the result of your mutation test decides which of them could apply to you. Chemotherapy (7+3, Vyxeos), Venclexta, Mylotarg, Onureg, Daurismo and the APL drugs are described on the drug pages instead. Several of these drugs are only approved after relapse, and all of the FLT3, IDH and menin drugs can cause differentiation syndrome, so your leukemia doctor will weigh the mutation, your point in treatment and your heart and liver tests.
Acute Myeloid Leukemia has 8 FDA-approved treatments: Rydapt (midostaurin, approved 2017); Vanflyta (quizartinib, approved 2023); Xospata (gilteritinib, approved 2018); Tibsovo (ivosidenib, approved 2018); Rezlidhia (olutasidenib, approved 2022); Idhifa (enasidenib, approved 2017); Revuforj (revumenib, approved 2024); Komzifti (ziftomenib, approved 2025). Rydapt is typically used as newly diagnosed, with intensive chemotherapy.
| Drug | Mutation it targets | When it is approved | How it's taken | How often | Given with | FDA approved |
|---|---|---|---|---|---|---|
Rydapt midostaurin | FLT3 (ITD or TKD) | Newly diagnosed, with intensive chemotherapy | Oral capsule | Twice daily on days 8 to 21 of each chemotherapy cycle | 7+3 induction and high-dose cytarabine consolidation (hospital-based chemotherapy) | 2017 |
Vanflyta quizartinib | FLT3-ITD only | Newly diagnosed, with intensive chemotherapy, then maintenance | Oral tablet | Once daily, with chemotherapy and then up to 36 months of maintenance | 7+3 induction and cytarabine consolidation, then alone as maintenance (not after transplant) | 2023 |
Xospata gilteritinib | FLT3 (ITD or TKD) | Relapsed or refractory | Oral tablets | Once daily | Taken alone | 2018 |
Tibsovo ivosidenib You are here | IDH1 | Newly diagnosed (older or unfit) and relapsed or refractory | Oral tablets | Once daily | With azacitidine or alone (newly diagnosed, 75+ or unfit); alone at relapse | 2018 |
Rezlidhia olutasidenib | IDH1 | Relapsed or refractory | Oral capsule | Twice daily on an empty stomach | Taken alone | 2022 |
Idhifa enasidenib | IDH2 | Relapsed or refractory | Oral tablet | Once daily | Taken alone | 2017 |
Revuforj revumenib | KMT2A rearrangement (any acute leukemia) or NPM1 mutation (AML) | Relapsed or refractory (NPM1: after other options) | Oral tablets | Twice daily | Taken alone; adults and children 1 year and older | 2024 |
Komzifti ziftomenib | NPM1 mutation | Relapsed or refractory, after other options | Oral capsules | Once daily on an empty stomach | Taken alone; adults only | 2025 |
This chart is for education only and is not medical advice. Approval dates, indications and warnings come from each drug's FDA prescribing information and Drugs@FDA. None of these drugs has been compared head to head with another in the same column, and trial results are not comparable across different studies. A leukemia specialist who has your mutation report will know which, if any, applies to you and whether a clinical trial would fit better.
Clinical trial results
AGILE (NCT03173248) randomized 146 adults with newly diagnosed IDH1-mutated AML who were unfit for intensive chemotherapy to ivosidenib plus azacitidine or placebo plus azacitidine. Event-free survival favored the combination (hazard ratio 0.35, 95% CI 0.17 to 0.72), median overall survival was 24.0 months against 7.9 months (hazard ratio 0.44, 95% CI 0.27 to 0.73, p=0.0010), and complete remission was 47% against 15%[1][2].
In relapsed or refractory AML, the single-arm Study AG120-C-001 (NCT02074839) treated 174 adults; complete remission was 24.7% with a median duration of 10.1 months, a further 8.0% had complete remission with partial count recovery, and 12% went on to a transplant[1]. A 28-patient cohort of newly diagnosed unfit patients treated with ivosidenib alone supports the monotherapy indication[1].
Development history
Ivosidenib was discovered by Agios Pharmaceuticals and is now marketed by Servier. The FDA approved it for relapsed or refractory IDH1 AML on July 20, 2018, for newly diagnosed unfit patients as a single agent on May 2, 2019, in combination with azacitidine on May 25, 2022, and for relapsed or refractory IDH1 MDS on October 24, 2023; the cholangiocarcinoma approval came in August 2021[3].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Ivosidenib
▸What is Ivosidenib (Tibsovo)?
A once-daily pill for AML with a susceptible IDH1 mutation, approved in 3 AML settings: with azacitidine or alone for newly diagnosed AML in adults 75 or older or unfit for intensive chemotherapy, and alone for relapsed or refractory AML. In the AGILE trial, Tibsovo plus azacitidine tripled median survival compared with azacitidine alone. Tibsovo is also approved for IDH1-mutated MDS and cholangiocarcinoma, covered on a separate page.
▸How does Ivosidenib work?
About 6% to 10% of people with AML have an IDH1 mutation that makes the enzyme produce 2-hydroxyglutarate, a chemical that blocks blood cell maturation. Ivosidenib blocks the mutant IDH1 enzyme, 2-hydroxyglutarate levels drop, and the leukemia blasts resume maturing into functioning cells[1]. Azacitidine adds a second mechanism that reactivates silenced genes, and the 2 together produced far more remissions than azacitidine alone[2].
▸What are the side effects of Ivosidenib?
Tibsovo carries a boxed warning for differentiation syndrome in AML and MDS, which can be fatal; symptoms include fever, breathlessness, low oxygen, lung infiltrates, fluid around the lungs or heart, rapid weight gain or swelling, low blood pressure and kidney or liver problems, treated with steroids and monitoring[1]. Other warnings are QTc prolongation on the ECG and Guillain-Barre syndrome, a nerve disorder that requires stopping the drug permanently[1]. The most common side effects in AML (25% or more, including lab changes) were low white cells, diarrhea, low hemoglobin and platelets, high glucose, fatigue, raised alkaline phosphatase, swelling, low potassium, nausea, vomiting, low phosphate, decreased appetite, low sodium, leukocytosis, low magnesium, raised AST, joint pain, shortness of breath, high uric acid, abdominal pain, raised creatinine, mouth sores, rash, QT prolongation and differentiation syndrome[1].
▸How is Ivosidenib taken?
The dose is 500 mg (2 tablets of 250 mg) by mouth once a day, with or without food but not with a high-fat meal, until the leukemia progresses or side effects become unacceptable; in AML the label recommends at least 6 months of treatment if the disease is not progressing[1]. In newly diagnosed AML it is given with azacitidine 75 mg/m2 under the skin or by IV on days 1 to 7 of each 28-day cycle, or alone[1]. Tablets are swallowed whole; a vomited dose is not replaced.
▸Is Ivosidenib FDA approved?
Yes, Ivosidenib (Tibsovo) is FDA approved (2018) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Servier Pharmaceuticals via openFDA · 2025-12-22. Tibsovo (ivosidenib tablets) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2265d254c0-67ad-42c4-b972-ad463b755b2d%22
- New England Journal of Medicine · 2022-04-21. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. https://pubmed.ncbi.nlm.nih.gov/35443108/
- FDA. Tibsovo approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211192
- Servier Pharmaceuticals. Support for TIBSOVO (ivosidenib). https://www.servierone.com/patient/financial-support/tibsovo