The drug works differently from stimulants, but the two-week study was designed to test safety, and its symptom results were not compared with placebo.
An experimental pill that targets orexin, a brain chemical best known for keeping people awake, was followed by improvements in ADHD symptoms among adults in a small, early-stage study, drugmaker Alkermes announced on September 21. The company's phase 1b results announcement describes the findings as the first clinical evidence of the effects of an orexin-activating drug in ADHD.
The limits matter as much as the results. The ADHD portion of the trial enrolled 50 adults, 40 of whom received the drug, called ALKS 7290, for 14 days. Its main goal was safety. The symptom measures were exploratory, and the company says the study was not designed or powered to detect statistically significant differences between groups.
For adults with ADHD who have faced stimulant shortages, side effects, or concerns about misuse, a new mechanism could eventually widen the options, but that is a long way off. The drug is not approved, is not available outside clinical trials, and still has to succeed in larger studies.
Early Numbers and Their Limits
Participants stopped their usual ADHD medicines for two weeks before the study began. They were then randomly assigned, in a 4-to-1 ratio, to receive ALKS 7290 at a total daily dose of 20 milligrams or 50 milligrams, split into two doses, or a placebo. Treatment took place in an inpatient setting.
At the start, participants had a median score of about 39 on the Adult ADHD Investigator Symptom Rating Scale, a 54-point clinician-rated measure on which higher scores mean more severe symptoms. After 14 days, the median score fell by 14 points in the 20 mg group and 19 points in the 50 mg group, according to Alkermes. A separate severity scale showed a median shift from moderately or markedly ill to mildly ill.
Those reductions were measured against each person's own starting point, not against the placebo group. Alkermes states that the findings it disclosed are not in reference to any other study group. With only 10 people on placebo and a short treatment period, the study cannot show how much of the change came from the drug itself.
In short, this was an early-phase, randomized, double-blind study released as a company announcement rather than a peer-reviewed paper. It included 88 healthy volunteers and 50 adults with ADHD. It found dose-related symptom improvement from baseline and no serious side effects over 14 days. It did not show that the drug works better than placebo or that benefits last, and current treatment guidance has not changed.
A Different Target from Current ADHD Drugs
Orexin is produced in a small region of the brain called the lateral hypothalamus. It helps regulate wakefulness and connects to brain circuits involved in attention, thinking, and mood. Drugs that activate one of its receptors, known as orexin-2 receptor agonists, have drawn attention mainly for narcolepsy, a sleep disorder in which the brain loses orexin-producing cells.
That mechanism differs from those of current ADHD medicines. Approved options include stimulants that act on dopamine and norepinephrine, nonstimulants that target norepinephrine, and alpha-2 agonists, according to a summary by AllSci. In July 2026, the FDA also approved centanafadine, sold as Simtriyo, which blocks the reuptake of norepinephrine, dopamine, and serotonin.
"This exploratory, first-in-patient study was designed to provide early insights," Alkermes chief medical officer Craig Hopkinson, MD, said in the announcement. The company also cited EEG readings and cognitive tests suggesting effects on processing speed, working memory, and attention, which it used to choose doses for the next trial.
Independent analysis has been limited so far. STAT reported that the drug showed a signal of efficacy, placing it within a new class of treatments drawing broad interest from drugmakers. A psychiatrist quoted in the company's announcement, Greg Mattingly, MD, an associate clinical professor of psychiatry at Washington University School of Medicine, described the data as early evidence supporting the approach. The announcement did not disclose whether he has financial ties to the company, and outside experts have not yet reviewed full study data.
Side Effects and Who Might Benefit Most
Alkermes reported no serious treatment-related adverse events among participants with ADHD. Most side effects were mild. The most common, each reported by at least 10% of people taking the drug, were insomnia, frequent urination, urgent urination, dizziness, constipation, and a change in sustained attention. No one taking ALKS 7290 dropped out, while two people in the placebo group did.
Insomnia is a notable signal for a drug that boosts a wakefulness system. Two weeks in a supervised inpatient setting cannot reveal problems that may appear over months of everyday use, including effects on blood pressure, sleep quality, or mood.
If later studies are positive, adults who cannot tolerate stimulants, have not responded to them, or have concerns about misuse could be among those most interested. No conclusions can be drawn for children or teens.
Next Steps for Patients and the Phase 2 Trial
A phase 2 study is now enrolling about 312 adults with ADHD, with the first participant dosed in September 2026. According to its ClinicalTrials.gov listing, it will compare three dosing regimens of ALKS 7290 with placebo, using change on the same symptom scale at week four as its main measure. Alkermes expects results in 2027.
Patients should not stop or change current ADHD medication based on this news. Anyone struggling with side effects, supply problems, or poor symptom control should talk with their prescriber about approved options. Adults interested in the new study can review eligibility on the trial listing and discuss it with their clinician, because participation requires stopping current ADHD medicine for two weeks.
Cost and coverage questions are years away. MedicalDaily will report the phase 2 results when they are released.
Key Questions Answered
What is ALKS 7290? An experimental oral drug from Alkermes that activates orexin 2 receptors in the brain. It is being tested as a treatment for adult ADHD and is not approved.
What did the study find? Among adults with ADHD, median symptom scores fell from baseline by 14 points at 20 mg and 19 points at 50 mg after 14 days, with no serious side effects reported.
Was the drug compared with placebo? A placebo group was included, but the reported symptom results measured change from each person's starting point, and the study was not designed to show a statistically significant difference.
How is it different from Adderall or Ritalin? Stimulants act on dopamine and norepinephrine. ALKS 7290 targets the orexin system, which regulates wakefulness and connects to attention circuits.
What side effects were reported? The most common were insomnia, frequent or urgent urination, dizziness, constipation, and a change in sustained attention. Most were mild.
When could it be available? Not soon. A phase 2 trial of about 312 adults is underway, with results expected in 2027, and further studies would likely follow.
Should I change my ADHD treatment? No. Talk with your prescriber before making any change to current medication.
Published by Medicaldaily.com
