DUBLIN — September 21, 2026
Alkermes announced positive topline results from a Phase 1b proof-of-concept study of ALKS 7290, an investigational oral orexin 2 receptor (OX2R) agonist being developed for attention-deficit hyperactivity disorder (ADHD). In adults with ADHD, ALKS 7290 demonstrated dose-dependent, clinically meaningful improvements in ADHD symptoms on exploratory measures including the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression-Severity Scale (CGI-S) after 14 days of treatment. The findings represent the first clinical evidence reported for an orexin receptor agonist in ADHD and support continued evaluation of ALKS 7290 in the company’s ongoing Phase 2 program.
ALKS 7290 Shows Improvements in ADHD Symptom Measures
The Phase 1b study enrolled 50 adults with ADHD who were randomized to receive split doses of ALKS 7290 at 20 mg or 50 mg daily, or placebo, for 14 days following a two-week washout of existing ADHD medications. At Day 14, median AISRS scores declined by 14.0 points with the 20 mg dose and 19.0 points with the 50 mg dose from baseline. Improvements were observed across both inattentive and hyperactivity/impulsivity domains and began as early as Day 6. On the CGI-S scale, median scores declined by 1.0 point with 20 mg and 2.0 points with 50 mg, indicating improvements in overall clinician-rated disease severity.
Phase 1b Findings Support Central Activity and Tolerability
ALKS 7290 was generally well tolerated across the tested doses, with no serious treatment-emergent adverse events reported among participants with ADHD. Most adverse events were mild, with insomnia, pollakiuria, dizziness, changes in sustained attention, urinary urgency and constipation among the most frequently reported events. No clinically significant findings were observed in hepatic or renal laboratory parameters, vital signs or ECGs, and no participants receiving ALKS 7290 discontinued treatment. Exploratory EEG biomarkers and cognitive performance assessments also demonstrated treatment-related effects across domains including processing speed, information processing, working memory and attention.
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Alkermes Advances ALKS 7290 Into Phase 2
Alkermes has initiated a Phase 2 study of ALKS 7290 in adults with ADHD, with the first participant dosed in September 2026 and approximately 312 participants expected to enroll. The randomized study (NCT07755410) is evaluating once-daily and split-dose regimens against placebo, with change from baseline in AISRS total score at Week 4 as the primary endpoint. Data are expected in 2027. ALKS 7290 forms part of Alkermes’ broader strategy to explore the potential of orexin biology beyond hypersomnolence disorders, including neurological conditions characterized by impairments in attention, cognition and related functions
Source :Cue Biopharma press release
