{"id":"valbenazine","brandName":"Ingrezza","genericName":"valbenazine","companyId":"neurocrine","companyName":"Neurocrine","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Valbenazine (Ingrezza), marketed by Neurocrine, is the first FDA-approved drug for the treatment of tardive dyskinesia, a condition characterized by involuntary movements. Its key strength lies in being the only approved therapy specifically for this indication, providing a unique market position. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.","enrichmentLevel":3,"visitCount":0,"mechanism":{"target":"Potassium voltage-gated channel subfamily H member 2, Synaptic vesicular amine transporter, Synaptic vesicular amine transporter"},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["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. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. • Increases the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease ( 5.1 ) • Balance risks of depression, and suicidal ideation and behavior with the clinical need for treatment of chorea when considering the use of INGREZZA or INGREZZA SPRINKLE ( 5.1 ) • Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior ( 5.1 ) • Inform patients, caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician ( 5.1 ) • Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 )"],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"2719 reports"},{"date":"","signal":"SOMNOLENCE","source":"FDA FAERS","actionTaken":"2412 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1646 reports"},{"date":"","signal":"TREMOR","source":"FDA FAERS","actionTaken":"1539 reports"},{"date":"","signal":"TARDIVE DYSKINESIA","source":"FDA FAERS","actionTaken":"1471 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"1104 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"930 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"912 reports"},{"date":"","signal":"DROOLING","source":"FDA FAERS","actionTaken":"881 reports"},{"date":"","signal":"THERAPEUTIC PRODUCT EFFECT DECREASED","source":"FDA FAERS","actionTaken":"858 reports"}],"drugInteractions":[{"drug":"Monoamine Oxidase Inhibitors (MAOIs)","severity":"major","mechanism":"Concomitant use of INGREZZA or INGREZZA SPRINKLE with MAOIs may increase the concentration of monoamine neurotransmitters in synapses.","management":"Avoid concomitant use of INGREZZA or INGREZZA SPRINKLE with MAOIs, or within 14 days of discontinuing therapy with an MAOI.","clinicalEffect":"Potentially leading to increased risk of adverse reactions such as serotonin syndrome, or attenuated treatment effect of INGREZZA or INGREZZA SPRINKLE."},{"drug":"Strong CYP3A4 Inhibitors","severity":"major","mechanism":"Concomitant use of INGREZZA or INGREZZA SPRINKLE with strong CYP3A4 inhibitors increased the exposure (C max and AUC) to valbenazine and its active metabolite compared with the use of INGREZZA or INGREZZA SPRINKLE alone.","management":"Reduce INGREZZA or INGREZZA SPRINKLE dose when INGREZZA or INGREZZA SPRINKLE is coadministered with a strong CYP3A4 inhibitor.","clinicalEffect":"Increased exposure of valbenazine and its active metabolite may increase the risk of exposure-related adverse reactions."},{"drug":"Strong CYP2D6 Inhibitors","severity":"major","mechanism":"Concomitant use of INGREZZA or INGREZZA SPRINKLE with strong CYP2D6 inhibitors increased the exposure (C max and AUC) to valbenazine’s active metabolite compared with the use of INGREZZA or INGREZZA SPRINKLE alone.","management":"Reduce INGREZZA or INGREZZA SPRINKLE dose when INGREZZA or INGREZZA SPRINKLE is coadministered with a strong CYP2D6 inhibitor.","clinicalEffect":"Increased exposure of active metabolite may increase the risk of exposure-related adverse reactions."},{"drug":"Strong CYP3A4 Inducers","severity":"major","mechanism":"Concomitant use of INGREZZA or INGREZZA SPRINKLE with a strong CYP3A4 inducer decreased the exposure of valbenazine and its active metabolite compared to the use of INGREZZA or INGREZZA SPRINKLE alone.","management":"Concomitant use of strong CYP3A4 inducers with INGREZZA or INGREZZA SPRINKLE is not recommended.","clinicalEffect":"Reduced exposure of valbenazine and its active metabolite may reduce efficacy."}],"commonSideEffects":[{"effect":"Somnolence (somnolence, fatigue, sedation)","drugRate":"10.9","_validated":true,"placeboRate":"4.2"},{"effect":"Anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention)","drugRate":"5.4","_validated":true,"placeboRate":"4.9"},{"effect":"Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder)","drugRate":"4.1","_validated":true,"placeboRate":"2.2"},{"effect":"Headache","drugRate":"3.4","_validated":true,"placeboRate":"2.7"},{"effect":"Akathisia (akathisia, restlessness)","drugRate":"2.7","_validated":true,"placeboRate":"0.5"},{"effect":"Vomiting","drugRate":"2.6","_validated":true,"placeboRate":"0.6"},{"effect":"Nausea","drugRate":"2.3","_validated":true,"placeboRate":"2.1"},{"effect":"Arthralgia","drugRate":"2.3","_validated":true,"placeboRate":"0.5"}],"contraindications":["INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.","Known hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE."],"specialPopulations":{},"discontinuationRates":[{"trial":"Tardive Dyskinesia Variable and Fixed Dose Placebo-Controlled Trial","drugArm":"3%","placeboArm":"2%","commonReason":""},{"trial":"Chorea Associated with Huntington’s Disease 14-week Placebo-Controlled Study","drugArm":"8%","placeboArm":"6%","commonReason":""}],"seriousAdverseEvents":[]},"trials":["NCT03732534","NCT05206513","NCT01688037","NCT07111988","NCT02581865","NCT02256475","NCT05654870","NCT02405091","NCT02679079","NCT01916993","NCT04400331","NCT03698331","NCT05207085","NCT04102579","NCT01910480","NCT03325010","NCT03444038","NCT05053321","NCT02274558","NCT02879578","NCT03530293","NCT06312189","NCT06107829","NCT05110157","NCT07105111","NCT02736955","NCT01733121","NCT05157100","NCT06771323","NCT05859698","NCT03891862","NCT01267188","NCT01393600"],"indications":{"approved":[{"id":"valbenazine-tardive-dyskinesia","name":"Tardive Dyskinesia","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults","diagnosticRequired":null,"brandNameForIndication":"Ingrezza"},{"id":"valbenazine-chorea-associated-with-hunting","name":"Chorea Associated with Huntington’s Disease","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults","diagnosticRequired":null,"brandNameForIndication":"Ingrezza"}],"offLabel":[],"pipeline":[]},"commercial":{"revenueYear":2024,"annualRevenue":1900,"revenueSource":"Verified: Neurocrine 10-K","revenueCurrency":"USD","revenueConfidence":"verified"},"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT03732534","phase":"Phase 2","title":"Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette 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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. Closely monitor patients for the emergence or worsening o","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:19:08.092807+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:19:17.579260+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Synaptic vesicular amine transporter inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:19:17.160579+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:20:27.706345+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2364639/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:19:16.819622+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS 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 [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) ] Somnolence and Sedation [see Warnings and Precautions ( 5.3 )] QT Prolongation [see Warnings and Precautions ( 5.4 )] Neurole","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:19:44.220250+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:19:49.205076+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA209241, NDA218390","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:19:08.092813+00:00"}},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T01:20:39.681950+00:00","fieldsConflicting":0,"overallConfidence":0.95},"crossReferences":{"chemblId":"CHEMBL2364639"},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}