Emalex Biosciences has secured a US patent for an orally disintegrating tablet formulation of ecopipam for Tourette syndrome as it advances development and patient access.

The patent, issued by the US Patent and Trademark Office, covers a novel orally disintegrating tablet (ODT) formulation of ecopipam, an investigational dopamine D1 receptor antagonist being developed for the treatment of Tourette syndrome.

The approval adds protection around Emalex’s formulation strategy as the company prepares further clinical development steps, including a first-in-human pharmacokinetic study expected in late 2026 or early 2027.

Eric Messner said: “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.”

The company is developing the ODT version alongside its existing immediate-release tablet, with planned studies set to compare low-dose ODT formulations against the current oral form. These studies are expected to assess pharmacokinetics, tolerability and palatability.

Orally disintegrating formulations are designed to dissolve in the mouth without the need for water, which may offer an alternative for patients who have difficulty swallowing conventional tablets. This is particularly relevant in paediatric and neurodevelopmental conditions such as Tourette syndrome.

Alongside formulation development, Emalex is progressing an Expanded Access Program in the US, with enrolment of up to 200 patients. The programme is intended for individuals who have exhausted available treatment options or cannot tolerate currently approved therapies.

Physicians can request access to ecopipam for patients previously treated with approved therapies including aripiprazole, haloperidol and pimozide, or other dopamine D2 receptor antagonists, who have experienced treatment failure or tolerability issues.

Tourette syndrome is a chronic neurodevelopmental disorder that typically begins in childhood and is characterised by motor and vocal tics. The condition can significantly affect daily functioning, including education, employment and social interaction.

Although several treatments are available, many patients experience limited efficacy or adverse effects, highlighting the need for alternative therapeutic approaches. Unlike currently approved treatments that primarily target dopamine D2 receptors, ecopipam selectively targets D1 receptors, representing a different mechanism of action under investigation.

Participation in the Expanded Access Program requires regulatory and ethics approvals, with eligibility determined on a case-by-case basis.

The patent marks a step in supporting both the formulation development of ecopipam and broader efforts to expand treatment options for patients with Tourette syndrome.