Last reviewed · How we verify
Xenazine
At a glance
| Generic name | Xenazine |
|---|---|
| Also known as | tetrabenazine |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: DEPRESSION AND SUICIDALITY XENAZINE can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of XENAZINE must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should
Common side effects
- Sedation/somnolence
- Insomnia
- Fatigue
- Depression
- Akathisia
- Anxiety/anxiety aggravated
- Fall
- Nausea
- Upper respiratory tract infection
- Irritability
- Balance difficulty
- Parkinsonism/bradykinesia
Serious adverse events
- Any extrapyramidal event
- Extrapyramidal event (bradykinesia, parkinsonism, extrapyramidal disorder, hypertonia)
- Dysphagia
- Aspiration pneumonia
Key clinical trials
- Xenazine in Late Dyskinetic Syndrome With Neuroleptics (PHASE3)
- Effect of Tetrabenazine on Stroop Interference in HD (PHASE4)
- Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease (PHASE3)
- Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements
- A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine) (PHASE4)
- Alternatives for Reducing Chorea in Huntington Disease (PHASE3)
- Excessive Crying in Children With Cerebral Palsy and Communication Deficits (PHASE4)
- A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette's Syndrome (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |