ecopipam (EBS-101) / Teva - LARVOL DELTA

Long-Term Safety and Effect of Ecopipam, a Selective Dopamine D1 Receptor Antagonist, in Children, Adolescents, and Adults With Tourette Syndrome (MDS Congress 2026) - No abstract available

Clinical • CNS Disorders • Movement Disorders • Tourette Syndrome

Safety and Effect of Ecopipam During the First 8 Weeks of Treatment for Tourette Syndrome: A Post Hoc Analysis (MDS Congress 2026) - No abstract available

Clinical • Retrospective data • CNS Disorders • Movement Disorders • Tourette Syndrome

Presence of Common Psychiatric Diagnoses Did Not Impact the Efficacy or Safety of Ecopipam in Individuals With Tourette Syndrome (MDS Congress 2026) - No abstract available

Clinical • CNS Disorders • Movement Disorders • Psychiatry • Tourette Syndrome

Receptor Selectivity Profile and Clinical Significance of Ecopipam and Its Metabolites as a Potential Therapy for Tourette Syndrome (MDS Congress 2026) - No abstract available

Clinical • CNS Disorders • Movement Disorders • Tourette Syndrome

Efficacy and Safety of Ecopipam for Tourette Syndrome: A Meta analysis of Controlled Trials (MDS Congress 2026) - No abstract available

Retrospective data • CNS Disorders • Movement Disorders • Tourette Syndrome

Efficacy and safety of ecopipam for Tourette syndrome: An updated systematic review and meta-analysis of randomized controlled trials. (PubMed, Ther Adv Psychopharmacol) - "Short-term randomized evidence suggests that ecopipam reduces tic severity. Evidence concerning insomnia and long-term psychiatric and metabolic safety remains insufficient, requiring larger independent trials with longer follow-up."

Journal • Retrospective data • CNS Disorders • Developmental Disorders • Insomnia • Movement Disorders • Pain • Psychiatry • Sleep Disorder • Tic Disorders • Tourette Syndrome

Teva Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ecopipam, with a targeted action (PDUFA) date late in the first quarter of 2027. (Teva Press Release) - "The NDA acceptance for ecopipam is supported by positive Phase 2b and 3 data."

FDA approval • FDA filing • Priority review • Tourette Syndrome

EBS-101-TD-391: A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: Emalex Biosciences Inc. | Trial completion date: Mar 2027 ➔ Feb 2028 | Trial primary completion date: Dec 2026 ➔ Feb 2028

Trial completion date • Trial primary completion date • Movement Disorders • Tourette Syndrome

Contemporary Perspectives on Neurobiology and Treatment of Tic Disorders: A Narrative Review. (PubMed, J Korean Acad Child Adolesc Psychiatry) - "Pharmacotherapies are reserved for patients with significant functional impairment, whereas novel targeted agents, such as ecopipam, and innovative neuromodulation modalities, including adaptive deep brain stimulation, offer promising avenues for circuit-specific modulation. Thus, integrating advanced neurobiological frameworks with expanding therapeutic alternatives underscores the definitive shift toward precision medicine in tic management."

Journal • Endocrine Cancer • Movement Disorders • Tic Disorders • Tourette Syndrome

Teva Submits NDA for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Tourette Syndrome (GlobeNewswire) - "The NDA submission is supported by positive Phase 3 data recently published in JAMA Neurology, which showed that ecopipam significantly delayed time to relapse compared with placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period."

FDA filing • Tourette Syndrome

Teva Pharmaceutical Industries…announced the closing of Teva’s acquisition of Emalex Biosciences, strengthening its late-stage pipeline with ecopipam and further advancing its Pivot to Growth strategy (GlobeNewswire) - "U.S. NDA submission is anticipated in the second half of 2026."

FDA filing • M&A • Tourette Syndrome

Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Neurol) - P3 | "Adverse events primarily affected the central nervous system. ClinicalTrials.gov Identifier: NCT05615220."

Clinical • Journal • P3 data • CNS Disorders • Fatigue • Insomnia • Mood Disorders • Movement Disorders • Pain • Pediatrics • Psychiatry • Sleep Disorder • Tourette Syndrome

Ecopipam, a Dopamine D1 Receptor Antagonist: Pharmacokinetics, Mass Balance, and Metabolism in Healthy Volunteers. (PubMed, Clin Transl Sci) - "Ecopipam is primarily metabolized to ecopipam glucuronide, with only 10.5% metabolized to EBS-101-40853. The long half-life of plasma radioactivity was attributed to previously uncharacterized metabolites that each accounted for < 10% of radioactivity and were considered not clinically relevant."

Journal • PK/PD data • Movement Disorders • Tourette Syndrome

Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: William Ondo, MD | Unknown status ➔ Completed

Trial completion • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

Efficacy and Safety of Ecopipam in Treatment of Tourette Syndrome: A Systematic Review and Meta-analysis with GRADE Assessment (AAN 2026) - "Conclusions Ecopipam demonstrates potential efficacy at reducing tics in TS patients while also having a favorable safety profile. However, because of the small sample size and restricted number of included studies, additional follow-up research is required."

Retrospective data • Review • CNS Disorders • Developmental Disorders • Insomnia • Movement Disorders • Sleep Disorder • Tourette Syndrome

Receptor Selectivity Profile and Clinical Significance of Ecopipam and Relevant Metabolites: A Potential New Treatment for Tourette Syndrome (TS) (AAN 2026) - "Conclusions Ecopipam demonstrated selectivity for D1Rs over ~98 off-target receptors, ion channels, enzymes, and transporters. These data are consistent with the clinical profile of the drug in the TS patient population."

Clinical • Movement Disorders • Tourette Syndrome

Exposure-response (ER) and Clinical Trial Simulations for Efficacy of Ecopipam in Adults and Pediatrics with Tourette’s Syndrome (TS) (AAN 2026) - "Clinical trial simulations showed that the probability of successfully demonstrating efficacy (active-placebo ≥ 20%) and clinically meaningful benefit for ecopipam is ≥ 90% if an RCT was conducted in adult and pediatric patients with TS. Conclusions PopPK, E-R, and clinical trial simulations add to the weight of evidence for the efficacy of ecopipam in pediatrics and adults with TS."

Clinical • Pediatrics • Tourette Syndrome

Efficacy and Safety of Ecopipam for Tourette Syndrome: Results from a Phase 3, Double-blind, Placebo-controlled, Randomized Withdrawal Trial (AAN 2026) - "This study demonstrated that ecopipam maintained clinically meaningful improvements in TS symptoms; was generally well-tolerated, with AEs primarily affecting the CNS; and did not cause weight gain, dyslipidemia, or drug-induced movement disorders."

Clinical • P3 data • Dyslipidemia • Insomnia • Metabolic Disorders • Mood Disorders • Movement Disorders • Sleep Disorder • Tourette Syndrome

Plain Language Summary of a Phase 2b Randomized Controlled Trial of Ecopipam and Its 12-Month Open-Label Extension in Children and Adolescents With Tourette Syndrome. (PubMed, Ther Adv Neurol Disord) - "The studies tested if ecopipam could safely improve symptoms and quality of life in children and adolescents with Tourette syndrome. Please note that ecopipam is not currently approved to treat Tourette syndrome."

Journal • P2b data • Review • Movement Disorders • Tic Disorders • Tourette Syndrome

The Effect of Uridine Diphosphate-Glucuronosyltransferase Inhibition on the Pharmacokinetics of Ecopipam and Its Metabolites. (PubMed, Clin Transl Sci) - "This open-label, fixed-sequence study evaluated the effect of mefenamic acid (UGT1A9 inhibitor) and divalproex sodium extended release (ER; general UGT inhibitor) on the pharmacokinetics (PK) of ecopipam and its metabolites. Divalproex sodium ER increased the Cmax (66%) and AUCinf (2.1×) of ecopipam, increased the Cmax (40%) and AUCinf (86%) of EBS-101-40853, and decreased the Cmax of ecopipam glucuronide and EBS-101-40853 glucuronide (23% and 32%, respectively). Inhibition of ecopipam metabolism indicated that ecopipam dose adjustments may be needed when administered with UGT inhibitors."

Journal • PK/PD data • Movement Disorders • Tourette Syndrome

Pharmacological manipulation of binge-like eating in male and female rats. (PubMed, Pharmacol Biochem Behav) - "The amphetamine prodrug lisdexamfetamine (0.1875-1.5 mg/kg IP), which is used to treat binge eating disorder in humans, suppressed intake of all foods in both sexes, with the greatest effects on chocolate. Co-administration of dopamine receptor antagonists with varying selectivity profiles (ecopipam, haloperidol, flupenthixol) reversed the suppressive effects of LDX on binge-like intake of chocolate, with haloperidol and flupenthixol producing more robust effects. The final group of studies characterized the effects of two commonly prescribed drugs for weight-loss that have been suggested as treatment options for binge eating disorder (bupropion and naltrexone). These drugs, alone and in combination, suppressed binge-like intake of chocolate. Taken together, these findings contribute to the development of animal models of BLE, which can potentially foster the development of treatments for binge eating disorder."

Journal • Preclinical • Binge Eating Disorder • CNS Disorders

The Effect of Ecopipam on the Pharmacokinetics of Concomitant Medications. (PubMed, Clin Transl Sci) - "Cohort 3 received an oral solution containing microdoses of dabigatran (P-gp), pitavastatin (OATP1B1), rosuvastatin (BCRP, OATP, and P-gp), atorvastatin (BCRP, OATP, P-gp, and CYP3A4), and midazolam...Steady-state ecopipam administration increased dextromethorphan exposure (> 100-fold); decreased the AUCinf of midazolam, omeprazole, and dabigatran by 44.2%, 44.1%, and 37.9%, respectively; and decreased unconjugated bilirubin (UGT1A1) by 19.5%...There were no changes in caffeine, bupropion, or pitavastatin exposure. Ecopipam is a strong inhibitor of CYP2D6 and weak inducer of CYP3A4, CYP2C19, P-gp, and UGT1A1. Ecopipam did not inhibit CYP3A4, CYP2C19, CYP2B6, CYP1A2, UGT1A1, P-gp, or OATP1B1 and did not induce OATP1B1 or CYP2B6."

Journal • PK/PD data • Movement Disorders • Tourette Syndrome • CYP1A2 • CYP2C19 • CYP3A4 • UGT1A1

QUESTIONS THAT MAKE YOU TIC: A TOURETTE'S DISORDER AND RELATED DISORDERS UPDATE (AACAP 2025) - "Cathy L. Budman, MD, will provide an overview of TD pharmacology and focus on new, promising interventions, including ecopipam and gemlapodect. This Symposium highlights novel, practical, clinically relevant advances in TD and related disorders' conceptualization and treatment interventions.TICD, TRIC, NI"

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Inflammation • Mental Retardation • Movement Disorders • Psychiatry • Tic Disorders • Tourette Syndrome

Efficacy of Ecopipam on Motor and Phonic Tics in Tourette's Disorder: Data From a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial (AACAP 2025) - "Ecopipam significantly improved both motor and phonic tics in children, adolescents, and adults with TD and was generally well tolerated.TD"

Clinical • P3 data • CNS Disorders • Fatigue • Insomnia • Mood Disorders • Movement Disorders • Pediatrics • Psychiatry • Sleep Disorder • Tourette Syndrome

Update on Pharmacology in Tourette's Disorder (AACAP 2025) - "There are only 3 pharmacological interventions FDA-approved for TD: pimozide, haloperidol, and aripiprazole, and as such, most treatments are used off-label...She will also describe recent trials that did not meet their primary end points (eg, deutetrabenazine, nabiximols), but may still hold promise for certain individuals/subgroups with TD... There is a great need for new medications for TD that are as effective for tics as antipsychotics, but without the potential short and long-term side effects associated with typical and atypical antipsychotics. Recently, new medications currently in Phase IIb and III trials are showing great promise!.TD, TICD, PPC"

CNS Disorders • Mental Retardation • Movement Disorders • Psychiatry • Tourette Syndrome