Alkermes reports positive Phase 1b data for ADHD drug ALKS 7290

Alkermes plc announced on September 21, 2026 positive topline results from a phase 1 proof-of-concept study evaluating ALKS 7290, its investigational orexin 2 receptor (OX2R) agonist for attention-deficit hyperactivity disorder.¹ The study evaluated safety, tolerability, pharmacokinetics and pharmacodynamics in 88 healthy volunteers and 50 adults with ADHD.¹

In the ADHD cohort, participants were randomized in a double-blind, placebo-controlled trial to receive total daily doses of 20 mg or 50 mg of ALKS 7290 in split doses, or placebo, for 14 days of inpatient treatment, following a two-week washout of existing ADHD medications.¹

On the AISRS scale, median reductions from baseline at day 14 were 14.0 points for the 20 mg dose and 19.0 points for the 50 mg dose.¹ On CGI-S, median reductions were 1.0 for the 20 mg dose and 2.0 for the 50 mg dose, representing a shift in disease severity from markedly or moderately ill to mildly ill.¹ The company noted the study was not designed or powered to detect statistically significant differences between treatment groups.¹

On safety, the drug was generally well tolerated across all doses tested in ADHD participants, with no serious treatment-emergent adverse events reported.¹ The most common adverse events included insomnia, pollakiuria, dizziness, change in sustained attention, micturition urgency, and constipation.¹ In healthy volunteers, single- and multiple-ascending doses were tested for up to 10 days, and the compound was tolerated at every dose level without reaching a maximum tolerated dose.¹

A Phase 2 study, registered as NCT07755410, is currently enrolling and is expected to include approximately 312 participants with ADHD, with the first participant dosed in September 2026.¹ The trial's primary endpoint is change from baseline in AISRS total score at week four compared to placebo.¹ Data from that study are expected in 2027, according to the release headline.