Pronunciation: vo-rah-NEE-goh
Generic name: vorasidenib
Dosage form: tablets (10mg, 40mg)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Apr 30, 2025.

What is Voranigo?

Voranigo (vorasidenib) is a targeted treatment used for IDH-mutant glioma, a type of brain cancer. Voranigo is a once-daily tablet that helps delay tumor progression and extend the time before cancer progresses. Voranigo has been designed to cross the blood-brain barrier, allowing to reach and effectively treat tumors within the brain.

Astrocytoma and oligodendroglioma are a type of glioma, a tumor that develops from cells within the central nervous system (CNS). Mutations in the IDH1 and IDH2 genes produce  enzymes that helps tumors grow and survive. Vorasidenib works by blocking the mutant IDH1 and IDH2 enzymes, reducing tumor activity. 

Voranigo belongs to a class of drugs known as IDH1 and IDH2 inhibitors (isocitrate dehydrogenase inhibitors).

Voranigo FDA approval 

Voranigo FDA approval was granted on August 6, 2024, for the indication of grade 2 astrocytoma or oligodendroglioma containing susceptible IDH1 or IDH2 mutations, in patients 12 years and older who have had surgery, including biopsy, sub-total resection, or gross total resection.

The FDA approval was received after positive results from the INDIGO Phase 3 Trial (NCT04164901) published in The New England Journal of Medicine. Voranigo by Servier is the first and only FDA-approved targeted treatment for Grade 2 IDH-mutant glioma.

How well does Voranigo work?

Voranigo significantly extended progression-free survival, increased the time to the next anticancer intervention and decreased cancer tumor volume compared to placebo. 

The Voranigo Phase 3 INDIGO clinical trial  – Key Results

• Voranigo patients had a significantly extended progression-free survival of 27.7 months (median) compared to 11.1 months in the placebo group.
• Tumor volume decreased by 2.5% every 6 months in the Voranigo group, while the placebo group had a 13.9% mean increase over the same period.
• Disease progression at 14 months was 28% Voranigo group and 54% for the placebo group compared

Voranigo Benefits

• Progression-free survival was 16.6 months longer in the Voranigo-treated group compared to the placebo. This increase in PFS was statistically significant and clinically meaningful.
• Voranigo patients had a significant delay in the need for further anticancer treatment compared to the placebo group.
• Voranigo patients' tumor volume decreased compared to an increase in tumor volume in the placebo group.
  

Voranigo side effects

Common Voranigo side effects

The most common Voranigo side effects are:

• Tiredness (37%)
• COVID-19 (33%)
• Muscle or joint pain (26%)
• Diarrhea (25%)
• Seizures (16%)
• Constipation (13%)
• Abdominal pain (13%)
• Decreased appetite (9%)
• Changes in lab tests (Grade 3 or 4): Increased ALT, AST, GGT, and decreased neutrophils.

These common side effects occurred in 5% or more of patients who received Voranigo 40mg day in the Adverse Reactions (≥5%) in Patients Phase 3 INDIGO clinical trial INDIGO Trial.

Serious side effects

Liver Problems: Vorasidenib may cause serious changes in liver function. Regular blood tests are necessary. Contact your doctor if you experience:

• Yellowing of skin or eyes (jaundice)
• Dark, tea-colored urine
• Loss of appetite
• Pain in the upper right stomach area
• Extreme fatigue or weakness

Your doctor may adjust, pause, or stop treatment based on side effects.

Fertility Concerns: Voranigo may affect fertility in males and females. Talk to your doctor if this is a concern.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Related/similar drugs

Before Taking Voranigo

Tell your doctor if you:

• Have liver problems
• Have kidney problems or are on dialysis
• Smoke tobacco

Pregnancy

Voranigo can harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. 

Females who are able to become pregnant

• Your healthcare provider will do a pregnancy test before you start treatment with Voranigo.
• You should use effective nonhormonal birth control during treatment with these tablets and for 3 months after the last dose.
• Voranigo may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with this medicine.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with this medicine.

Males with female partners who can become pregnant

• You should use effective birth control during treatment with vorasidenib and for 3 months after the last dose.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with this medicine.

How Should I Take Voranigo?

Voranigo is taken once daily at the same time each day, with or without food.

Tablets should be swallowed whole with water; do not split, crush, or chew tablets.

Missed Dose

If missed by less than 6 hours, take it as soon as possible.

If missed by more than 6 hours, skip it and take the next dose at the usual time.

Vomiting

If vomiting occurs after taking Voranigo, do not take another dose—wait until the next scheduled dose.

​​Voranigo Dosing Information

Usual adult Voranigo dose:

• ​​Voranigo 40 mg orally once daily until disease progression or unacceptable toxicity.

Pediatric Patients (12+ Years):

• ≥40 kg: 40 mg orally once daily
• <40 kg: 20 mg orally once daily
• Continue until disease progression or unacceptable toxicity.

​​Voranigo is available as 10mg and 40mg tablets

Drug Interactions

Voranigo may interact with prescription and over-the-counter drugs, vitamins, and herbal supplements. Not all possible interactions are listed here.

CYP1A2 Inhibitors: Avoid concomitant use of strong and moderate CYP1A2 inhibitors.

CYP1A2 Inducers: Avoid concomitant use of moderate CYP1A2 inducers and smoking tobacco. 

Certain CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. 

Hormonal Contraception: If concomitant use cannot be avoided, use with nonhormonal contraception methods.

Tell your healthcare provider about all medications you take. Keep a medication list to show your doctor when starting a new drug.

​​Voranigo Package Insert 

Review the ​​Voranigo Package Insert for more detailed information about this medicine. The Voranigo Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Prescribing Information (PI) or FDA label.

Storage Information

• Store at room temperature (68°F–77°F / 20°C–25°C).
• Keep the desiccant canisters in the bottle—do not swallow them.
• Use the child-resistant cap and keep out of reach of children.

Ingredients

Active Ingredient: Vorasidenib

Inactive Ingredients: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, sodium lauryl sulfate

Tablet Coating: Hypromellose, lactose monohydrate, macrogol, titanium dioxide

Black Printing Ink: Black iron oxide, hypromellose, propylene glycol

Company

Voranigo Servier Pharmaceuticals LLC, Boston, MA 02210

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer