Austedo (deutetrabenazine) / Teva - LARVOL DELTA

New Developments in the Treatments of Psychosis (WFSBP 2025) - "Objective: Despite the discovery of chlorpromazine over 70 years ago and substantial pharmacologic advances, postsynaptic dopamine blockade has remained the sole mechanism of action of approved drugs for schizophrenia... Newly/recently approved agents include vesicular monoamine transporter-2 inhibitors valbenazine and deutetrabenazine for tardive dyskinesia and, possibly, residual positive symptoms; olanzapine/samidorphan combination, lumateperone, new formulations, including subcutaneous injections, and ultra-long-acting injectable antipsychotics. Agents in development that have at least one positive phase 1B, 2 or 3 trial include the trace amine-associated receptor-1 (TAAR1) ulotaront, M1/M4 muscarinic agonist xanomeline plus peripherally restricted anticholinergic trospium, the M4 muscarinic positive allosteric modulator emraclidine, as well as multiple other muscarinic receptor modulators for total psychopathology, methylated amisulpride (LB-102), and evenamide, a..."

CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P4 trial • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Vesicular monoamine transport inhibitors: current uses and future directions. (PubMed, Lancet) - "VMAT2 inhibitors, such as tetrabenazine, deutetrabenazine, and valbenazine, show therapeutic efficacy in managing hyperkinetic movement disorders, including Huntington's disease, tardive dyskinesia, and Tourette's syndrome. Recent studies have provided further structural insights into VMAT2 inhibition mechanisms, paving the way for the development of inhibitors with enhanced potency and selectivity. Leveraging pharmacogenetics for precision medicine and exploring VMAT2 inhibition in broader therapeutic contexts could revolutionise treatment frameworks for neurological and psychiatric conditions."

Journal • Review • CNS Disorders • Huntington's Disease • Mental Retardation • Movement Disorders • Psychiatry • Tourette Syndrome

Teva’s Innovative Portfolio Fuels 10th Consecutive Quarter of Growth in Q2 2025; Increases 2025 Revenue Outlook for Key Innovative Products and EPS, and Reaffirms All Other Components (GlobeNewswire) - "AJOVY revenues in our United States segment in the second quarter of 2025 were $63 million, an increase of 53% compared to the second quarter of 2024, mainly due to an increase in sales allowance due to a non-recurring item in the second quarter of 2024 and growth in volume in the second quarter of 2025....AUSTEDO revenues in our United States segment in the second quarter of 2025 were $495 million, an increase of 22%, compared to $407 million in the second quarter of 2024....UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the second quarter of 2025 were $54 million, an increase of 120% compared to the second quarter of 2024, mainly due to growth in volume....COPAXONE revenues in our United States segment in the second quarter of 2025 were $62 million, a decrease of 23% compared to the second quarter of 2024, mainly due to market share erosion and competition."

Sales • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders. (PubMed, Tremor Other Hyperkinet Mov (N Y)) - "Of the 359 prescriptions for VMAT2 inhibitors, 94% included tetrabenazine, 4.6% deutetrabenazine, and 1.4% valbenazine. Our study suggests that VMAT2 inhibitors are effective for treating pediatric hyperkinetic movement disorders. Furthermore, this study provides insights into barriers to access to these drugs by pediatric patients."

Journal • Real-world evidence • Huntington's Disease • Movement Disorders • Pediatrics

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025 (European Medicines Agency) - "On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Austedo, intended for the treatment of adults with moderate to severe tardive dyskinesia. The applicant for this medicinal product is TEVA GmbH. Austedo will be available as 12 mg, 24 mg, 30 mg, 36 mg, 42 mg and 48 mg prolonged-release tablets."

CHMP • CNS Disorders

A narrative review of Phase III and IV clinical trials for the pharmacological treatment of Tourette's syndrome in children, adults, and older adults. (PubMed, Medicine (Baltimore)) - "Deutetrabenazine (TEV-50717) showed limited efficacy compared to placebo. Other medications, including Clonidine, Guanfacine, Levetiracetam, Ondansetron, Topiramate, D-serine, and Riluzole, demonstrated varying levels of effectiveness, though some require further validation...Aripiprazole stands out as the most effective therapy, though further research is needed for other medications. Continued advancements in pharmacological interventions offer promise for improving the management of TS and enhancing the quality of life for affected individuals."

Journal • P3 data • Review • CNS Disorders • Developmental Disorders • Movement Disorders • Psychiatry • Tourette Syndrome

TD-AIDD: Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities (clinicaltrials.gov) - P4 | N=25 | Not yet recruiting | Sponsor: University Hospitals Cleveland Medical Center

New P4 trial • Behavior Disorders • CNS Disorders • Developmental Disorders • Mental Retardation • Movement Disorders • Psychiatry

Teva Reaffirms “Pivot to Growth” Strategy Progress with Launch of Acceleration Phase at 2025 Innovation and Strategy Day (Teva Press Release) - "AUSTEDO: Expected to exceed $2.5 billion in sales by 2027 and exceed $3 billion by 2030. AJOVY: A globally established brand with presence across 43 countries and expected launches in 3 additional countries this year....duvakitug (anti-TL1A): A potentially best-in-class treatment for inflammatory bowel disease, with potential expansion into additional indications with peak sales potential of up to $2-$5 billion. DARI: A dual-action rescue inhaler for asthma, that could address a significant unmet need as a first ICS/SABA combination for both adult and pediatric patient populations, with peak sales potential of ~$1 billion....emrusolmin: A potential first-in-class treatment for Multiple System Atrophy (MSA), a rare and fatal neurodegenerative disease that currently has no approved treatments, with peak sales potential of more than $2 billion. TEV-‘408...with peak sales potential of more than $1 billion."

Launch • Sales projection • Asthma • Crohn's disease • Huntington's Disease • Inflammatory Bowel Disease • Migraine • Multiple System Atrophy

Assessing Real-World Dosing Patterns for Vesicular Monoamine Transporter-2 Inhibitors (VMAT2i), Valbenazine and Deutetrabenazine, Among Patients with Tardive Dyskinesia (TD) in a Nationwide US Claims Database (ISPOR 2025) - "Persistent patients taking valbenazine experienced fewer month-to-month dose changes than deutetrabenazine patients, potentially representing a simpler treatment regimen for patients and providers. Additionally, over one-quarter of persistent deutetrabenazine patients on either formulation did not attain therapeutic dosing."

Claims database • Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders

Indirect Treatment Comparison for Early Efficacy of VMAT2 Inhibitors for Tardive Dyskinesia and Chorea Associated with Huntington's Disease (ISPOR 2025) - "OBJECTIVES: Two vesicular monoamine transporter 2 (VMAT2) inhibitors, valbenazine and deutetrabenazine, are approved for both tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). Favorable improvements were found with valbenazine versus deutetrabenazine during early treatment for both TD and HD-chorea. Magnitude of effect and time needed to reach an effective dose are important considerations when choosing a medication to treat the hyperkinetic movement disorders of TD or HD-chorea."

Clinical • Huntington's Disease • Movement Disorders

Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved (Teva Press Release) - "AUSTEDO – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an increase of 39% in local currency terms compared to Q1 2024; increasing 2025 full-year revenue outlook from ~$1.9-2.05 billion to $1.95-2.05 billion. AJOVY – global revenues of $139 million in Q1 2025, an increase of 26% in local currency terms compared to Q1 2024. Reaffirming $600M 2025 revenue outlook. UZEDY continues strong momentum – global revenues of $39 million in Q1 2025."

Sales • CNS Disorders • Huntington's Disease • Migraine • Schizophrenia

Unique and overlapping mechanisms of valbenazine, deutetrabenazine, and vitamin E for tardive dyskinesia. (PubMed, Schizophrenia (Heidelb)) - "Pharmacological experiments should be conducted to verify and further explore these results. The findings offer a theoretical basis for further pharmacological investigation and a resource for TD drug screening."

Journal • Movement Disorders • DRD2 • NOS3 • SLC6A3 • TLR4

Huntington's disease treatment drug 'Austedo' expands indication for 'tardive dyskinesia' [Google translation] (HIT News) - "HanDok Teva...announced on the 25th that its Austedo tablet (ingredient: deutetrabenazine) received approval from the Ministry of Food and Drug Safety on the 9th for the indication of 'improving symptoms of tardive dyskinesia (TD)'....Austedo confirmed its therapeutic efficacy and safety in patients with tardive dyskinesia through two phase 3 clinical trials, 'AIM-TD' and 'ARM-TD.'"

Korea approval • CNS Disorders

The effect of deuterated PLK1 inhibitor on its safety and efficacy in vivo. (PubMed, Front Oncol) - "The FDA's approval of deutetrabenazine, the first deuterium-labeled drug, demonstrated an improved safety profile compared to its non-deuterated counterpart, tetrabenazine. The deuterated PR00012 demonstrated an improved safety profile and slightly enhanced efficacy compared to its non-deuterated counterpart, NMS-P937. This study provides a foundation for further clinical trials investigating the treatment of various cancers."

Journal • Preclinical • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Deutetrabenazine treatment outcomes with doses above U.S. Food and Drug Administration maximum approved doses in Huntington's disease chorea: A dual-site analysis. (PubMed, J Huntingtons Dis) - "The median total maximum chorea score in the Unified HD Rating Scale was 13 (IQR 9-19) and 13 (IQR 7-18) at baseline and follow-up, respectively. Median PDC was 0.99 (IQR 0.94-1.00); two patients discontinued therapy due to AEs.ConclusionsDeutetrabenazine >48 mg daily appears safe and well tolerated in patients with uncontrolled HD chorea, though no significant change in total maximal chorea score was found."

FDA event • Journal • Huntington's Disease • Movement Disorders • Psychiatry

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders (AAN 2025) - "Of 347 prescriptions for VMAT2 inhibitors, 94% were prescribed tetrabenazine, 4.6% deutetrabenazine and 1.4% valbenazine. Our study suggests that VMAT2 inhibitors are effective and safe for treating pediatric hyperkinetic movement disorders. While adverse effects were common, most were mild and improved with dosage reduction or transitioning to deutetrabenazine or valbenazine. Furthermore, this study provides insight into barriers to pediatric access."

Clinical • Real-world • Real-world evidence • Movement Disorders • Pediatrics

Effect Sizes of Once-daily Valbenazine for Tardive Dyskinesia: A Post-hoc Analysis of KINECT® 3 Data (AAN 2025) - P3 | "Effect sizes have been reported for common neuropsychiatric medications relative to placebo, including antidepressants for major depressive episodes (d=0.4), antipsychotics for schizophrenia (d=0.5), deutetrabenazine for TD (d=0.6), and levodopa for Parkinson's disease (d=0.9).Design/Cohen's d effect sizes for valbenazine in TD were calculated using Abnormal Involuntary Movement Scale (AIMS) data from KINECT® 3 (NCT02274558), a 6-week phase 3 study with valbenazine (40 or 80 mg) versus placebo. Based on AIMS data from KINECT 3, meaningful effect sizes were detected as early as Week 2 with a large effect size noted for valbenazine 80 mg by Week 6."

Retrospective data • CNS Disorders • Depression • Huntington's Disease • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Cost Trends of New-To-Market Neurologic Medications: An Insurance Claims Database Analysis. (PubMed, Neurology) - "NTM medications for neurologic conditions have substantial and increasing individual and societal costs, which was not observed for older generic medications. These data suggest a need for policies to limit the financial burden of NTM medications on patients with neurologic conditions."

Journal • Reimbursement • US reimbursement • Amyloidosis • Amyotrophic Lateral Sclerosis • Cardiac Amyloidosis • CNS Disorders • Duchenne Muscular Dystrophy • Genetic Disorders • Huntington's Disease • Hypotension • Migraine • Movement Disorders • Muscular Dystrophy • Myasthenia Gravis • Pain • Rare Diseases

Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD (clinicaltrials.gov) - P1 | N=36 | Terminated | Sponsor: Fundacion Huntington Puerto Rico | Not yet recruiting ➔ Terminated; The study was terminated prematurely due to the lack of availability of the study drug.

Trial termination • Gastrointestinal Disorder • Genetic Disorders • Huntington's Disease • Movement Disorders

Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database. (PubMed, BMC Pharmacol Toxicol) - "This research has yielded initial safety insights into the practical use of deutetrabenazine, validating established adverse reactions and uncovering further possible risks. These findings present essential safety considerations for physicians when prescribing deutetrabenazine for the clinical treatment."

Adverse events • Journal • P4 data • Real-world evidence • Retrospective data • CNS Disorders • Depression • Fatigue • Huntington's Disease • Insomnia • Movement Disorders • Psychiatry • Sleep Disorder • Suicidal Ideation

A narrative review of phase III and IV clinical trials for the pharmacological treatment of Huntington's disease in adults. (PubMed, Medicine (Baltimore)) - "The medications used in phase III and IV trials are minocycline, valbenazine, deutetrabenazine, tominersen, pridopidine (phase III), and memantine (phase IV)...Current medications aim to manage HD symptoms, potentially improving outcomes and reducing disease progression risks. The growing emphasis on specific approaches reflects a better understanding of HD's diverse symptoms, presenting opportunities for more effective and personalized treatment strategies."

Journal • P3 data • Review • CNS Disorders • Genetic Disorders • Huntington's Disease • Movement Disorders • Psychiatry

The Huntington's disease drug pipeline: a review of small molecules and their therapeutic targets. (PubMed, Prog Mol Biol Transl Sci) - "Two small molecules, Tetrabenazine and Deutetrabenazine, are approved for managing chorea associated with HD, and several others are under clinical trials. The emphasis is placed on detailing their structural design, therapeutic effects, and specific mechanisms of action. Additionally, exploring key drivers implicated in HD pathogenesis offers valuable insights, as a foundational principle for designing prospective anti-HD therapeutic leads."

Journal • Review • CNS Disorders • Huntington's Disease • Movement Disorders

Teva Delivers Second Consecutive Year of Growth; Announces Strong Financial Results in Fourth Quarter and Full Year 2024, Led by Generics Performance and Innovative Portfolio Growth (GlobeNewswire) - "Duvakitug (Anti-TL1A) positive Phase 2B results announced and initiation of Phase 3 program is expected in 2025...AJOVY revenues in our United States segment in the fourth quarter of 2024 were $63 million, an increase of 11% compared to the fourth quarter of 2023...AUSTEDO revenues in our United States segment in the fourth quarter of 2024 increased by 27%, to $518 million, compared to $408 million in the fourth quarter of 2023...UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the fourth quarter of 2024 were $43 million...COPAXONE revenues in our United States segment in the fourth quarter of 2024 were $63 million, a decrease of 13% compared to the fourth quarter of 2023, mainly due to market share erosion and competition, partially offset by a reduction in sales allowance."

Commercial • New P3 trial • CNS Disorders • Crohn's disease • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

Safety and Efficacy of Deutetrabenazine at High versus Lower Daily Dosages in the ARC-HD Study to Treat Chorea in Huntington Disease. (PubMed, CNS Drugs) - P3 | "In this open-label, long-term study, some participants received deutetrabenazine dosing > 48 mg/d to achieve adequate chorea control. There was no new safety concern or incremental change in the safety profile between dosages of ≤ 48 mg/d and > 48 mg/d. These results include dosages that have not been approved for clinical use, however, they increase our understanding of safety and tolerability of deutetrabenazine doses."

Journal • CNS Disorders • Genetic Disorders • Huntington's Disease • Movement Disorders • Psychiatry