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MedsAcross

Molecule

Valbenazine

Also known as valbenazine tosylate
Available on requestOrphanNeurology
Presentations
7
Brands
2
Manufacturers
1
Available from stock
0

Valbenazine is a vesicular monoamine transporter 2 inhibitor indicated for the treatment of adults with - tardive dyskinesia. It is available as capsules and kits for oral use. MedsAcross supplies Valbenazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Vesicular Monoamine Transporter 2 Inhibitor, Vesicular Monoamine Transporter 2 Inhibitors
ATC classification
N07XX13 Valbenazine · Other nervous system medicines, subgroup N07X, subgroup N07XX
US FDA first approval
11 April 2017
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Capsule, Kit
Identifiers
UNII 54K37P50KHRxCUI 1918219CAS 1025504-45-3DrugBank DB11915Q27089118

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia. - chorea associated with Huntington’s disease. INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. - chorea associated with Huntington’s disease.

Source: US FDA prescribing information

How it works

The mechanism of action of valbenazine for the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

Source: US FDA prescribing information

Dosing overview

Tardive dyskinesia: The initial dosage is 40 mg once daily. After one week, increase the dose to the recommended dosage of 80 mg once daily. Chorea associated with Huntington’s disease: The initial dosage is 40 mg once daily. Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily. 40 mg or 60 mg once daily may be considered depending on response and tolerability. Can be taken with or without food. INGREZZA SPRINKLE may be opened and sprinkled over soft food (do not use milk or drinking water). INGREZZA SPRINKLE may be swallowed whole with water. Do not crush or chew. The recommended dosage for patients with moderate or severe hepatic impairment is 40 mg once daily. The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily.

Source: US FDA prescribing information

Contraindications

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported with use of INGREZZA. Known hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (depression and suicidal ideation and behavior in patients with huntington’s disease vmat2): inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Depression and suicidal ideation and behavior in patients with Huntington’s disease. Hypersensitivity, including angioedema may occur. Discontinue if this occurs. Somnolence/sedation: May impair patient’s ability to drive or operate hazardous machinery. QT Prolongation: May cause an increase in QT interval. Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease Hypersensitivity Reactions Somnolence and Sedation QT Prolongation Neuroleptic Malignant Syndrome (NMS) Parkinsonism Most common adverse reaction (≥5% and twice the rate of placebo): - Tardive dyskinesia: somnolence. - Chorea associated with Huntington’s disease: somnolence/lethargy/sedation, urticaria, rash, insomnia.

Source: US FDA prescribing information

Interactions

Dose adjustments due to drug interactions: Factors Dose Adjustments for INGREZZA and INGREZZA SPRINKLE Use of MAOIs with INGREZZA or INGREZZA SPRINKLE Avoid concomitant use with MAOIs. Use of strong CYP3A4 inducers with INGREZZA or INGREZZA SPRINKLE Concomitant use is not recommended. Use of strong CYP3A4 inhibitors with INGREZZA or INGREZZA SPRINKLE Recommended dosage is 40 mg once daily. Use of strong CYP2D6 inhibitors with INGREZZA or INGREZZA SPRINKLE Recommended dosage is 40 mg once daily.

Source: US FDA prescribing information

Storage

Storage INGREZZA: Store at 15°C to 30°C (59°F to 86°F). INGREZZA SPRINKLE: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

7 presentations of Valbenazine, sorted by availability.

MedicineManufacturerRegisterAvailability
Ingrezza kitOralNeurocrine BiosciencesUS FDAAvailable on request
Ingrezza 40 mg capsuleOralNeurocrine BiosciencesUS FDAAvailable on request
Ingrezza 60 mg capsuleOralNeurocrine BiosciencesUS FDAAvailable on request
Ingrezza 80 mg capsuleOralNeurocrine BiosciencesUS FDAAvailable on request
INGREZZA Sprinkle 40 mg capsuleOralNeurocrine BiosciencesUS FDAAvailable on request
INGREZZA Sprinkle 60 mg capsuleOralNeurocrine BiosciencesUS FDAAvailable on request
INGREZZA Sprinkle 80 mg capsuleOralNeurocrine BiosciencesUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 11 April 2017Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Valbenazine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Valbenazine available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Valbenazine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Valbenazine have?

The catalogue lists 2 brand names for Valbenazine, including Ingrezza, INGREZZA Sprinkle.

Is Valbenazine approved by the US FDA?

Yes. The US FDA first approved Valbenazine on 11 April 2017, according to Drugs@FDA.

Does Valbenazine need cold chain shipping?

No listed presentation of Valbenazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Valbenazine in?

Valbenazine is classified under ATC code N07XX13 (Valbenazine).

References

  1. INGREZZA prescribing information (Neurocrine Biosciences). U.S. National Library of Medicine, DailyMed. Retrieved 17 April 2026

Request Valbenazine for export supply

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