Alkermes Reports First Positive Orexin-Agonist Data in ADHD With ALKS 7290 Phase 1b Trial
- Phase 1b study randomized 88 healthy volunteers and 50 adults with ADHD to ALKS 7290 20mg, 50mg, or placebo for 14 days, following a 2-week washout of existing ADHD medications.
- Participants began with a median AISRS score of ~39 (moderate-to-severe); by Day 14, reported median reductions were 14.0 points with 20mg and 19.0 points with 50mg, with the higher dose bringing scores into the mild range.
- Improvement was reported as early as Day 6 and spanned both inattentive and hyperactivity/impulsivity subscales; CGI-S scores fell by a median of 1 point (20mg) and 2 points (50mg).
- The drug was generally well tolerated across doses.
- This marks the first clinical evidence that an orexin 2 receptor agonist -- a drug class previously studied for rare sleep disorders like narcolepsy -- can improve ADHD symptoms.
- Alkermes describes the results as exploratory proof-of-concept rather than a powered efficacy readout, and says they support the dosing already chosen for an ongoing Phase 2 trial.
A genuinely new mechanism in ADHD is rare and commercially precious — this is the first clinical signal that orexin-2 agonism, a pathway built for narcolepsy, can move core ADHD symptoms, in a market still anchored by decades-old stimulant chemistry and underwhelming non-stimulants like atomoxetine and viloxazine. If it replicates, a non-stimulant with this magnitude of effect and no controlled-substance baggage would be a real wedge against stimulant-class incumbents. But read the fine print: only 50 ADHD patients, an unpowered Phase 1b that Alkermes itself calls exploratory proof-of-concept — sizeable AISRS drops here can evaporate once a properly powered, placebo-controlled Phase 2 reads out. For Alkermes, it's a second shot on goal for the orexin-2 franchise beyond narcolepsy (ALKS 2680), spreading platform risk into a much larger indication. Investors should treat this as a call option, not a catalyst, until Phase 2 data land.
Alkermes' orexin agonist shows potential to treat ADHD in early-stage trial ↗