Which attention-deficit/hyperactivity disorder drugs are in Phase 3?

Phase 3 (or later) programs for attention-deficit/hyperactivity disorder include Centanafadine and Solriamfetol (Sunosi).

How many clinical trials are recruiting for attention-deficit/hyperactivity disorder?

42 drug-interventional attention-deficit/hyperactivity disorder trials are currently recruiting participants, out of 652 registered interventional trials.

Neurodevelopmental Disorders

Attention-deficit/hyperactivity disorder drug pipeline

ICD-11 6A05
MeSH D001289

4 compounds from 4 companies are in active clinical development for attention-deficit/hyperactivity disorder, including 2 at Phase 3 or beyond.

4Compounds

4Companies

2Phase 3+

47Trials recruiting

Phase 31

Solriamfetol (Sunosi)Axsome Therapeutics, Inc.NET Reuptake inhibitor

Approved1

CentanafadineOtsuka Pharmaceutical Co., Ltd.NET Reuptake inhibitor

Discontinued2

Mechanisms: Small molecule (3) · Psychedelic (1)

Pipeline data compiled September 2026 · every fact sourced.

Upcoming readouts & recent results

2026-07-24ReportedCentanafadineRegulatorymet
FDA approved SIMTRIYO (centanafadine) on the 2026-07-24 PDUFA date for ADHD in adults and pediatric patients aged 6+ ↗
2026-06-25ReportedCentanafadineTopline datamet
Phase 3b topline: centanafadine XR 280 mg met primary endpoint in adults with ADHD and comorbid anxiety (AISRS LS mean change -18.5 vs -12.6 placebo at week 8) ↗
2025-03-25ReportedSolriamfetol (Sunosi)Topline datametNCT05972044
FOCUS Phase 3 of solriamfetol in adult ADHD met its primary AISRS endpoint and key secondary endpoints (150 mg). ↗
2025-03-19ReportedLysergide D-tartrate (MM120 / LSD)Full resultsmissedNCT05200936
Phase 2a microdosing trial fails: repeated low-dose MM120 (LSD) no better than placebo for adult ADHD (AISRS p=0.7145) ↗

See the full catalyst calendar →

Compounds in development (4)

Compound	Company	Phase	Status	Mechanism
CentanafadinePriority Review	Otsuka Pharmaceutical Co., Ltd.	Approved	Approved	NET Reuptake inhibitor
Solriamfetol (Sunosi)	Axsome Therapeutics, Inc.	Phase 3	Active	NET Reuptake inhibitor
Lysergide D-tartrate (MM120 / LSD)	Definium Therapeutics, Inc.	Discontinued	Discontinued	5-HT2A Partial agonist
SPN-810 (molindone ER)FDA Fast Track (Impulsive Aggression In ADHD; Granted 2014-08-14)	Supernus Pharmaceuticals, Inc.	Discontinued	Discontinued	D2 Antagonist

Trials recruiting now (42)

42 drug-interventional attention-deficit/hyperactivity disorder trials recruiting now, of 652 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4EEG Biomarkers for ADHD Stimulant Treatment
methylphenidate HCl, Mixed amphetamine salts extended release
Boston Children's Hospitaln=220United States · 1 siteStarted Sep 2026NCT07650643
Phase 4Medication Treatment of ADHD in Pediatric Epilepsy
methylphenidate hydrochloride (Jornay PM)
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.n=25United States · 1 siteStarted May 2026NCT07594652
Phase 4Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
CNS Stimulant, Placebo
Milton S. Hershey Medical Centern=136United States · 1 siteStarted Mar 2026NCT06871488
Phase 4Treating Young Children With Attention Deficit Hyperactivity Disorder
Guanfacine (GUA), Methylphenidate (MPH)
Children's Hospital Medical Center, Cincinnatin=370United States · 5 sitesStarted Feb 2026NCT07300956
Phase 4The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
Adderall XR (mixed salts amphetamine), Placebo
Gagan Joshin=196United States · 1 siteStarted Feb 2026NCT06853665
Phase 4PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder
PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.
University Hospital, Toursn=30France · 1 siteStarted Sep 2025NCT07121621
Phase 4A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Children With ADHD and ODD
Clonidine extended release oral suspension, Placebo
Las Vegas Medical Research, LLC DBA Vector Clinical Trialsn=162Started Jul 2025NCT07044609
Phase 4An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening
Methylphenidate Hydrochloride Extended Release Capsule
NYU Langone Healthn=30United States · 1 siteStarted Jan 2025NCT06577779
Phase 4A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Dyanavel XR, Placebo
Rochester Center for Behavioral Medicinen=50United States · 1 siteStarted Sep 2024NCT06248229
Phase 4Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
100mg SPN-812, Placebo
Supernus Pharmaceuticals, Inc.n=286United States · 47 sitesStarted Mar 2024NCT04781140
Phase 4AWARE: Management of ADHD in Autism Spectrum Disorder
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
Daniel Couryn=500Canada, United States · 12 sitesStarted Oct 2023NCT05916339
Phase 4Evaluating Treatment of ADHD in Children with Down Syndrome
Quillivant XR, Placebo
Children's Hospital Medical Center, Cincinnatin=100United States · 4 sitesStarted Oct 2020NCT04219280

Showing the 12 most advanced of 42 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for attention-deficit/hyperactivity disorder?: 4 compounds from 4 companies are in active clinical development for attention-deficit/hyperactivity disorder, including 2 at Phase 3 or beyond.
Which attention-deficit/hyperactivity disorder drugs are in Phase 3?: Phase 3 (or later) programs for attention-deficit/hyperactivity disorder include Centanafadine and Solriamfetol (Sunosi).
How many clinical trials are recruiting for attention-deficit/hyperactivity disorder?: 42 drug-interventional attention-deficit/hyperactivity disorder trials are currently recruiting participants, out of 652 registered interventional trials.