U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome
Rhea-AI Summary
Teva (NYSE: TEVA) announced that the U.S. FDA has accepted the New Drug Application and granted Priority Review for ecopipam (EBS-101), a first-in-class selective D1 receptor antagonist for pediatric Tourette syndrome, with a targeted PDUFA action date in late Q1 2027.
According to Teva, ecopipam, which has Orphan Drug designation, could become the first new treatment for pediatric Tourette syndrome in over 10 years and the first novel mechanism of action in more than 50 years. The NDA is supported by Phase 2b and Phase 3 data showing statistically significant tic reduction and a 53% decreased relapse risk over 12 weeks versus placebo, with no clinically meaningful changes in weight, metabolic, ECG, movement-disorder, or psychiatric measures and a generally well-tolerated safety profile.
Positive
- FDA Priority Review granted for ecopipam NDA in pediatric Tourette syndrome with a targeted PDUFA date in late Q1 2027
- Ecopipam has Orphan Drug designation from the FDA for pediatric Tourette syndrome, targeting a population of 200,000 or fewer patients
- Phase 2b trial showed statistically significant tic reduction on YGTSS-TTS at Week 12 vs placebo with P = 0.01
- Phase 3 randomized withdrawal study showed a 53% decreased relapse risk over 12 weeks vs placebo (p=0.008)
- Across Phase 2b, OLE and Phase 3, no clinically meaningful changes observed in weight, BMI, vitals, metabolic labs, ECG, movement-disorder scales, or psychiatric measures
- D1AMOND Phase 2b and Phase 3 program enrolled over 350 participants across more than 70 sites in North America and Europe, supporting the NDA with multi-center data
Negative
- Ecopipam remains an investigational therapy and is not yet approved; commercial use depends on the FDA decision expected in late Q1 2027
- Common adverse events in pediatric Tourette patients on ecopipam included headache, insomnia, fatigue, somnolence, tics, anxiety, nausea and restlessness
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 20 | NDA acceptance | Positive | -0.3% | FDA accepted Teva’s NDA for once-monthly olanzapine extended-release injectable suspension. |
| Dec 09 | NDA submission | Positive | +0.8% | Teva submitted an NDA for investigational once-monthly olanzapine injectable treatment. |
| Sep 20 | Phase 3 safety data | Positive | +2.8% | SOLARIS reported no post-injection delirium or sedation syndrome through Week 56. |
| Sep 09 | Fast Track designation | Positive | +2.0% | FDA granted Fast Track designation to Teva’s investigational multiple-system-atrophy treatment. |
| May 30 | Phase 3 clinical data | Positive | +2.9% | Teva presented positive Phase 3 SOLARIS efficacy and safety findings. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial announcements aligned positively in four of five events, while one NDA acceptance diverged.
Key Terms
new drug application regulatory
pdufa regulatory
priority review regulatory
orphan drug designation regulatory
open-label extension clinical
randomized withdrawal trial clinical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation
- NDA acceptance is supported by positive Phase 3 data, which were published in JAMA Neurology, and Phase 2b data
- If approved, ecopipam would be the first new treatment option indicated for pediatric patients with Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years1
PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today 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. Ecopipam is a first-in-class investigational therapy for the treatment of pediatric patients with Tourette syndrome. This milestone advances Teva’s Pivot to Growth strategy by utilizing the company’s expertise in neuroscience to support patients, particularly in areas where there is high unmet need.
Tourette syndrome is a debilitating neuro-developmental condition impacting approximately 100,000 children and adolescents nationwide.2 Only half of these patients are treated with prescription medication for this condition, and only 20-30 percent remain on therapy after one year. Despite the current treatment options available, many patients continue to experience inadequate control or treatment-limiting side effects.3 This patient experience underscores the urgent need for new prescription drug options and reinforces Teva’s commitment to expanding access to innovative neuroscience treatments for underserved patient populations.3
“Ecopipam’s NDA acceptance is an important milestone that advances Teva’s Pivot to Growth strategy and brings us closer to addressing the unmet needs of children and their families affected by Tourette syndrome,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years, offering patients and families a long-awaited new treatment option.”
The NDA acceptance for ecopipam is supported by positive Phase 2b and 3 data. In the Phase 2b study, patients receiving ecopipam experienced a reduction in tic severity, with statistically significant and clinically meaningful improvement in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) vs. placebo at Week 12 (P = 0.01).4 Durability of efficacy was shown in participants who subsequently enrolled in a Phase 2b open-label extension (OLE) study.5
The Phase 3 randomized withdrawal study, recently published in JAMA Neurology,6 further demonstrated maintenance of efficacy with ecopipam. For the primary endpoint, pediatric ecopipam responders compared to placebo had a
Across the Phase 2b, Phase 2b OLE and Phase 3 clinical trials, no clinically meaningful changes were observed across the following areas with ecopipam use:4,5,6,7
- Body weight and Body Mass Index (BMI) Z-Score
- Vitals and laboratory measures, including metabolic parameters
- Electrocardiogram (ECG) measurements
- Drug-induced movement disorders (DIMD) as measured by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS) or Extrapyramidal Symptom Rating Scale (ESRS)
- Measures of psychiatric comorbidities
Ecopipam was generally well-tolerated and the most common adverse events in pediatric patients with Tourette syndrome were headache, insomnia, fatigue, somnolence, tics, anxiety, nausea and restlessness.4,5,6
Teva remains deeply committed to advancing this clinical program and, if approved, delivering a long-awaited new treatment option to pediatric patients with Tourette syndrome who have historically relied on treatment options primarily developed for other conditions.
About Tourette Syndrome
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.2 For people living with Tourette syndrome, symptoms can be frequent, visible, and disruptive, affecting everyday life.2
About Ecopipam and Its Clinical Program
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.
Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.
The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.4 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.5 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.6 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam and additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” “Other Information” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
- U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology.
- CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025.
- Tomczak KK et al. High Rates of Discontinuation of D2 Receptor Antagonists as Treatment of Tourette Syndrome in Children: A Retrospective Database Analysis American Academy of Neurology (AAN) Annual Meeting Poster, 2025.
- Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574
- Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091.
- Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431
- Data on file.
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