Emalex Biosciences announced that the US Patent and Trademark Office issued a patent covering an Orally Disintegrating Tablet (ODT) formulation of ecopipam, an investigational D1 receptor antagonist in development for the treatment of Tourette syndrome.

The milestone comes as Emalex’s Expanded Access Program for ecopipam is enrolling up to 200 patients across the US, reflecting continued progress across the company’s development and access initiatives.

“Developing alternative dosage forms is a long-term effort that matters because how a medicine is delivered can be as important to patients as the medicine itself. This issued patent reflects our formulation approach supporting the ODT program, while our Expanded Access Program underscores our commitment to patients,” said Eric Messner, CEO, Emalex Biosciences.

Emalex plans to evaluate the ODT formulation through a development pathway that includes process development, scale-up, cGMP manufacturing, stability, and a first-in-human pharmacokinetic study, targeted for late 2026 or early 2027. Planned clinical work will assess the performance of low-dose ODT formulations compared with the immediate-release tablet, along with standard tolerability and palatability assessments.

The Expanded Access Program will enroll approximately 200 patients at sites across the US, providing a pathway for eligible patients who have exhausted approved treatment options to access ecopipam outside of clinical trials. Physicians may request ecopipam for patients who have been treated with an FDA-approved therapy for Tourette syndrome, including aripiprazole, haloperidol, pimozide or another D2 receptor antagonist, and who have experienced treatment failure, tolerability, safety concerns or lack access to approved medications.

Tourette syndrome is a chronic, childhood-onset neurodevelopmental disorder characterised by motor and vocal tics and is associated with significant morbidity that can disrupt school, work and social functioning. Despite available treatments, many patients continue to experience inadequate symptom control or tolerability challenges.

Participation in the Expanded Access Program requires physician oversight, FDA authorisation, and Institutional Review Board approval. Enrollment is limited, and eligibility is determined on a case-by-case basis.