312 Participants NeededMy employer runs this trial

ALKS 7290 for ADHD

Recruiting at 24 trial locations
GC
Overseen ByGlobal Clinical Services
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alkermes, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether a new treatment, ALKS 7290, is safe and can improve symptoms for people with ADHD compared to a placebo. Participants are divided into groups, with some receiving different doses of ALKS 7290 and others receiving a placebo. The trial seeks individuals diagnosed with ADHD who have had stable symptoms without major medication changes for at least two months. Participants should not have other serious mental health conditions or substance use issues that could interfere with the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ALKS 7290 is generally safe for people. In studies with adults who have ADHD, researchers found no serious side effects. While some individuals might experience mild side effects, nothing severe has emerged. Additionally, the treatment did not cause any serious problems in these trials, suggesting that the medication is safe for most people, though individual experiences can vary.12345

Why do researchers think this study treatment might be promising for ADHD?

Unlike the standard ADHD treatments, which typically include stimulants like methylphenidate or amphetamines, ALKS 7290 offers a potentially new approach. Researchers are excited about ALKS 7290 because it may have a unique mechanism of action that sets it apart from current options. While many ADHD medications work by increasing neurotransmitter activity, particularly dopamine, ALKS 7290 might target different pathways, potentially offering benefits to patients who do not respond well to traditional therapies. Additionally, the varying dose levels being tested could provide flexibility in treatment, allowing for personalized adjustments based on individual needs.

What evidence suggests that ALKS 7290 might be an effective treatment for ADHD?

Research has shown that ALKS 7290, a new drug tested in this trial, offers promising results for treating ADHD. In a study with 50 adults, taking the drug for 14 days led to noticeable improvements. Higher doses provided greater benefits, with larger amounts of the drug offering more symptom relief. Specifically, participants experienced fewer ADHD symptoms, with scores on a symptom scale dropping by 14 points for a 20 mg dose and 19 points for a 50 mg dose. These results suggest that ALKS 7290 could effectively manage ADHD symptoms.678910

Who Is on the Research Team?

MD

Medical Director, MD

Principal Investigator

Alkermes, Inc.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with ADHD who are otherwise healthy, have moderate or worse symptoms, and a BMI between 18 and 35. Participants must be stable on allowed medications. People with certain mental health disorders, significant cognitive problems, or substance use issues cannot join.

Inclusion Criteria

Meets the DSM-5 criteria for ADHD, confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2
Is otherwise healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
AISRS total score of ≥26
See 3 more

Exclusion Criteria

I have a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or unstable depression or anxiety.
Clinically significant cognitive difficulties including dementia, delirium, amnestic syndromes, or other cognitive disorders within past 2 years interfering with study participation
Moderate to severe substance use disorder per DSM-5 including alcohol, nicotine, cannabis, narcotics, or illicit substances
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALKS 7290 or placebo tablets daily to evaluate safety and efficacy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALKS 7290

Trial Overview

The study compares ALKS 7290 tablets to placebo tablets in adults with ADHD to see if ALKS 7290 is safe and helps improve symptoms. Participants are randomly assigned to receive either the medication or placebo.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose Level 3Experimental Treatment1 Intervention
Group II: Dose Level 2Experimental Treatment1 Intervention
Group III: Dose Level 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials
118
Recruited
27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

Citations

Form 8-K for Alkermes PLC filed 09/21/2026

ALKS 7290 is a novel, investigational, oral orexin 2 receptor (OX2R) agonist in development for the treatment of attention-deficit hyperactivity ...

ALKS 7290 Shows Dose-Dependent ADHD Symptom ...

In 50 adults with ADHD, 14 days of treatment produced dose-dependent, clinically meaningful improvements in ADHD symptoms and overall disease ...

Alkermes Reports Positive Phase 1b Results for ALKS ...

Alkermes reported positive Phase 1b results for ALKS 7290, an orexin-2 receptor agonist in adults with ADHD. The study provides what appears ...

Alkermes makes argument for orexin expansion into ADHD

The drugmaker said Monday that ALKS 7290 is the first in its class to meaningfully improve symptoms of attention-deficit hyperactivity disorder ...

Alkermes posts positive phase 1b ADHD results | ALKS 8-K ...

At day 14, ALKS 7290 showed median AISRS total score reductions of 14.0 points (20 mg) and 19.0 points (50 mg), and CGI-S reductions of 1.0 and ...

ALKS 7290 Shows Dose-Dependent ADHD Symptom ...

In 50 adults with ADHD, 14 days of treatment produced dose-dependent, clinically meaningful improvements in ADHD symptoms and overall disease ...

R&D Pipeline

ALKS 7290 is an investigational orexin 2 receptor agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD) and as an ...

Well, That Was Fast - Michael Halassa - Substack

ALKS 7290 appears reasonably well tolerated so far. There were no serious treatment-emergent adverse events in the ADHD group, and no ...

A multi-part, randomized, double-blind, placebo-controlled ...

This is a clinical study to assess how safe and well tolerated an investigational drug (ALKS 7290) is in healthy adults and adults with attention deficit.

ALKS-7290 Drug Profile

ALKS 7290 is an investigational orexin 2 receptor agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD).