Rezlidhia (olutasidenib)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Olutasidenib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Olutasidenib
- Brand name
- Rezlidhia
- Development code
- FT-2102
- Drug class
- IDH1 inhibitor
- Manufacturer
- Rigel Pharmaceuticals
- How it's taken
- Oral capsule twice daily on an empty stomach
A capsule taken twice a day on an empty stomach for adults whose IDH1-mutated AML has relapsed or never responded. Approved December 1, 2022 as the second IDH1 inhibitor; about 1 in 3 trial patients reached a complete remission, and those remissions lasted a median of about 26 months.
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Where Olutasidenib fits
One of 2 IDH1 inhibitors for relapsed disease. Its trial reported longer remissions than ivosidenib's single-arm study, but the 2 drugs have not been compared directly and the patient groups differed.
How Olutasidenib works
Like ivosidenib, olutasidenib blocks the mutated IDH1 enzyme so that it stops producing 2-hydroxyglutarate, the chemical that holds leukemia blasts in an immature state; the blasts then mature and normal blood production can recover[1]. It is a chemically distinct molecule from ivosidenib and is given twice rather than once a day.
Mechanism: Oral inhibitor of mutant IDH1 that lowers 2-hydroxyglutarate and restores blast maturation
Side effects and safety
- Hepatotoxicity. Liver enzyme rises are common; tests before starting, every 2 weeks for 2 months, monthly for the rest of the first year, and the dose is interrupted, reduced or stopped by grade.
- Noninfectious leukocytosis. In 25%; hydroxyurea is used to lower the white count and may signal differentiation syndrome.
- Liver function tests on the schedule above
- Blood counts and chemistry before starting and at least every 2 weeks for 2 months
- Watch for differentiation syndrome throughout treatment
Rezlidhia carries a boxed warning for differentiation syndrome, which occurred in 16% of trial patients (grade 3 or 4 in 8%, fatal in 1%) as early as 1 day and as late as 18 months after starting; it is treated with steroids, hydroxyurea for a rising white count, and hospital monitoring[1]. The other warning is liver toxicity: liver tests are checked before starting, every 2 weeks for 2 months, then monthly for a year, and the drug is held or stopped for rises[1].
The most common side effects were nausea (38%), fatigue (36%), joint pain (28%), constipation (26%), leukocytosis (25%), fever (24%), mouth sores (23%), diarrhea (20%), abdominal pain, swelling and vomiting, along with raised liver enzymes[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 Olutasidenib
The dose is 150 mg (one capsule) by mouth twice a day, at least 1 hour before or 2 hours after a meal, about 12 hours apart, until the leukemia progresses or side effects become unacceptable; the label recommends at least 6 months of treatment if the disease is not progressing[1]. Capsules are swallowed whole; a missed dose is taken only if at least 8 hours remain before the next one.
Availability and cost
Only available as the brand-name product.
Help paying for Rezlidhia
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
Rezlidhia Copay Assistance: eligible patients with commercial insurance pay as little as $0 per prescription dispense. Eligibility requirements apply.
For: private insurance · source - Insurance and case manager help
RIGEL ONECARE case managers connect with your insurance plan and care team, determine eligibility for copay and financial assistance programs and help with enrollment. Call 1-833-RIGELOC, Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Rezlidhia.com mentions financial assistance beyond the copay program without describing it; no free-drug terms are listed until Rigel publishes them.
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 | 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 You are here | 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
Study 2102-HEM-101 (NCT02719574), a single-arm trial, treated 147 adults with relapsed or refractory IDH1-mutated AML. Complete remission or complete remission with partial count recovery was reached by 35% (51/147), with complete remission in 32%; the median duration of response was 25.9 months and the median time to response 1.9 months.
Among 86 patients who needed transfusions at the start, 34% became transfusion independent, and 11% of patients went on to a transplant[1]. Response was lower (17%) in people with the R132H form of the mutation[1].
Development history
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Olutasidenib
▸What is Olutasidenib (Rezlidhia)?
A capsule taken twice a day on an empty stomach for adults whose IDH1-mutated AML has relapsed or never responded. Approved December 1, 2022 as the second IDH1 inhibitor; about 1 in 3 trial patients reached a complete remission, and those remissions lasted a median of about 26 months.
▸How does Olutasidenib work?
Like ivosidenib, olutasidenib blocks the mutated IDH1 enzyme so that it stops producing 2-hydroxyglutarate, the chemical that holds leukemia blasts in an immature state; the blasts then mature and normal blood production can recover[1]. It is a chemically distinct molecule from ivosidenib and is given twice rather than once a day.
▸What are the side effects of Olutasidenib?
Rezlidhia carries a boxed warning for differentiation syndrome, which occurred in 16% of trial patients (grade 3 or 4 in 8%, fatal in 1%) as early as 1 day and as late as 18 months after starting; it is treated with steroids, hydroxyurea for a rising white count, and hospital monitoring[1]. The other warning is liver toxicity: liver tests are checked before starting, every 2 weeks for 2 months, then monthly for a year, and the drug is held or stopped for rises[1]. The most common side effects were nausea (38%), fatigue (36%), joint pain (28%), constipation (26%), leukocytosis (25%), fever (24%), mouth sores (23%), diarrhea (20%), abdominal pain, swelling and vomiting, along with raised liver enzymes[1].
▸How is Olutasidenib taken?
The dose is 150 mg (one capsule) by mouth twice a day, at least 1 hour before or 2 hours after a meal, about 12 hours apart, until the leukemia progresses or side effects become unacceptable; the label recommends at least 6 months of treatment if the disease is not progressing[1]. Capsules are swallowed whole; a missed dose is taken only if at least 8 hours remain before the next one.
▸Is Olutasidenib FDA approved?
Yes, Olutasidenib (Rezlidhia) is FDA approved (2022) 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.
- Rigel Pharmaceuticals via openFDA · 2025-11-05. Rezlidhia (olutasidenib) capsules prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%224a0c7c8b-b95f-455d-9600-b7351e4397fe%22
- FDA. Rezlidhia approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215814
- Rigel Pharmaceuticals. Support and resources: RIGEL ONECARE. https://www.rezlidhia.com/support-and-resources/