Alkermes reported positive phase 1b results for ALKS 7290 in adults with ADHD.
Why it matters: The ADHD market is large, so even early signals can move biotech sentiment. But this is still a small phase 1b study, and the results need confirmation in later-stage testing.
- Alkermes said Sept. 21, 2026 that ALKS 7290 met a phase 1b proof-of-concept goal in adults with ADHD.
- The study enrolled 50 adults with ADHD and 88 healthy volunteers; the ADHD group was randomized 4:1 to drug or placebo for 14 days.
- The company said ALKS 7290 was generally well tolerated and improved exploratory measures including AISRS and CGI-S by day 14.
- Alkermes said its phase 2 ADHD study is enrolling and is expected to read out in 2027.
Alkermes said its investigational oral orexin 2 receptor agonist ALKS 7290 produced positive phase 1b proof-of-concept results in adults with ADHD.
The company said the study enrolled 50 adults with ADHD and 88 healthy volunteers. In the ADHD cohort, participants were randomized 4:1 to ALKS 7290 or placebo for 14 days. Alkermes said the drug was generally well tolerated at the doses tested and showed dose-dependent improvements on exploratory symptom scales, including AISRS and CGI-S, by day 14.
Alkermes did not present the data in the release as a definitive efficacy readout. The company said the findings support further study in a larger phase 2 trial, which it said is enrolling now and expected to read out in 2027. The company’s pipeline page describes ALKS 7290 as an investigational oral orexin 2 receptor agonist for ADHD. Pipeline page
STAT reported the same update and noted that Greg Mattingly, a psychiatrist and clinical professor at Washington University School of Medicine, said the data provide early evidence supporting the orexin pathway in ADHD. STAT also quoted him saying ALKS 7290 could represent a meaningful new therapeutic approach for patients. STAT's report
The result matters because ADHD remains a large treatment market, and new mechanisms can draw outsized attention from investors and drugmakers. But the signal is still preliminary until the company reports larger, controlled data from phase 2.
By the numbers
- 50 - adults with ADHD enrolled in the phase 1b study
- 88 - healthy volunteers included alongside the ADHD cohort
- 2027 - expected readout for the ongoing phase 2 study
Yes, but: The company described the efficacy findings as exploratory, so the phase 1b data are not enough to establish clinical benefit.
What's next: Alkermes' phase 2 ADHD study is enrolling, with results expected in 2027.