Alkermes’ orexin agonist shows early promise in ADHD

Alkermes reported positive Phase 1b proof-of-concept results for ALKS 7290, an investigational oral orexin-2 receptor agonist for adult ADHD.

The small randomized study involved 50 adults treated for 14 days. Median ADHD symptom scores fell by 14 points with 20 mg and 19 points with 50 mg on the 54-point AISRS scale, from a baseline of about 39.

Improvements were also seen on the Clinical Global Impression-Severity scale, and some benefits appeared as early as day six.

ALKS 7290 was generally well tolerated; reported adverse events included insomnia, dizziness, urinary symptoms and constipation. No serious treatment-emergent adverse events were reported.

The study was not designed or powered to establish statistical efficacy, so the findings remain preliminary and require confirmation in larger trials.

Alkermes has begun a Phase 2 trial of roughly 312 adults, testing three dosing regimens over four weeks, with results expected in 2027. Pediatric studies may follow if adult safety data are sufficient.

The potential commercial significance is substantial:
orexin agonists have primarily been associated with sleep disorders, while ADHD could provide a much larger market. Alkermes is also developing the orexin agonist alixorexton for sleep disorders.