Attention Deficit Hyperactivity Disorder

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule

150%

Cell Therapy

150%

+ 113 programs with unclassified modality

On Market (6)

Approved therapies currently available

STRATTERAApproved

atomoxetine hydrochloride

Eli Lilly and Company

oral2002

2M Part D

RITALIN LAApproved

methylphenidate

Novartis

oral2002

1M Part D

RITALINApproved

methylphenidate hydrochloride

Novartis

oral1955

756K Part D

DAYTRANAApproved

methylphenidate

Noven Pharmaceuticals

Central Nervous System Stimulant [EPC]transdermal2006

429K Part D

BUPROPION HYDROCHLORIDEApproved

bupropion

Unknown Company

oral2014

ADHANSIA XRApproved

methylphenidate hydrochloride

Purdue Pharma

oral2019

Competitive Landscape

36 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Prevail TherapeuticsNY - New York

46 programs

AtomoxetinePhase 41 trial

+41 more programs

Active Trials

NCT00953862Completed18Est. Apr 2008

NCT00434928Completed60Est. Jan 2007

NCT01177943Completed42Est. Oct 2010

+43 more trials

SandozAustria - Kundl

6 programs

Dex-methylphenidate hydrochloride extended-releasePhase 41 trial

MethylphenidatePhase 41 trial

DexmethylphenidatePhase 31 trial

Methylphenidate 20 mg long-acting capsulesPhase 31 trial

Extended Release MethylphenidatePhase 21 trial

+1 more programs

Active Trials

NCT00772161Completed24Est. Dec 2008

NCT00409708Completed142

NCT00393042Completed77Est. Feb 2009

+3 more trials

Eli Lilly and CompanyINDIANAPOLIS, IN

4 programs

Dietary Intake and Nutrient Status of Children With ADHDN/A

EdivoxetinePHASE_2_3

AtomoxetinePHASE_4

Atomoxetine HydrochloridePHASE_4

PfizerNEW YORK, NY

4 programs

Methylphenidate HydrochloridePhase 41 trial

NWP09Phase 31 trial

Quillivant Oral Suspension XRPhase 31 trial

AtomoxetinePhase 21 trial

Active Trials

NCT00562055Withdrawn0

NCT01654250Completed90Est. Oct 2012

NCT00904670Completed45Est. Aug 2009

+1 more trials

NovartisBASEL, Switzerland

3 programs

MethylphenidatePHASE_1_2

Extended Release MethylphenidatePHASE_2

Methylphenidate 20 mg long-acting capsulesPHASE_3

Noven PharmaceuticalsFL - Miami

3 programs

DaytranaPhase 41 trial

Methylphenidate Transdermal SystemPhase 31 trial

d-Amphetamine Transdermal PatchPhase 21 trial

Active Trials

NCT01711021Completed110Est. Mar 2013

NCT00444574Completed282Est. Jun 2005

NCT00434213Completed309Est. Jul 2008

Purdue PharmaCT - Stamford

3 programs

FoquestPhase 41 trial

Methylphenidate Hydrochloride Controlled-Release CapsulesPhase 41 trial

PRC-063Phase 31 trial

Active Trials

NCT02555150Completed40Est. Jan 2017

NCT04741516Unknown41Est. Dec 2023

NCT03785223Completed60Est. Oct 2022

JPM

3 programs

FoquestPhase 4

Guanfacine extended releasePhase 41 trial

Lisdexamfetamine DimesylatePhase 41 trial

Active Trials

NCT01985581Completed50Est. Mar 2015

NCT03337646Completed48Est. Mar 2023

Human BioSciences

2 programs

MethylphenidatePhase 41 trial

Behavioral Social Skills TrainingN/A1 trial

Active Trials

NCT05102344Completed39Est. Aug 2023

NCT01133847Completed222Est. Jun 2015

Aytu BioPharmaDENVER, CO

2 programs

ADZENYS XR-ODTPhase 41 trial

amphetamine extended-release orally disintegrating tabletPhase 4

Active Trials

NCT07169162Withdrawn0Est. Sep 2025

Acadia PharmaceuticalsSAN DIEGO, CA

2 programs

L. helveticus R0052 and B. longum R0175Phase 41 trial

probioticsPhase 41 trial

Active Trials

NCT02545634Unknown100Est. Jun 2016

NCT02035878Unknown75Est. Apr 2014

Monarch Therapeutics

1 program

AtomoxetinePhase 4

Colorado TherapeuticsCO - Louisville

1 program

BupropionPhase 41 trial

Active Trials

NCT00936299Completed105Est. May 2013

Martin PharmaceuticalsNY - New York

1 program

CariprazinePhase 41 trial

Active Trials

NCT04843423Unknown15Est. Apr 2023

Medice

3 programs

methylphenidate hydrochloridePhase 31 trial

Attentin® in Children and Adolescents With ADHD - A Non-interventional StudyN/A1 trial

Active Trials

NCT02801604Completed150Est. Dec 2019

NCT00619840Completed363

NCT00730249Completed150

ShionogiJapan - Osaka

1 program

CLONICELPhase 3Cell Therapy1 trial

Active Trials

NCT00723190Completed303Est. Jun 2010

Medica CorpMA - Bedford

1 program

ProspektaPhase 31 trial

Active Trials

NCT04569357Completed363Est. Feb 2022

Supernus PharmaceuticalsMD - Rockville

1 program

SPN-810Phase 31 trial

Active Trials

NCT03597503Terminated41Est. Jan 2020

Avalo TherapeuticsWAYNE, PA

3 programs

NFC-1Phase 2/34 trials

AEVI-001Phase 22 trials

A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR N/A1 trial

Active Trials

NCT03233867Completed2,503Est. Aug 2018

NCT03609619Completed109Est. Nov 2018

NCT03265119Completed69Est. Oct 2018

+4 more trials

OtsukaJapan - Tokushima

4 programs

CentanafadinePhase 21 trial

OPDC-34712Phase 21 trial

aripiprazolePhase 2Small Molecule1 trial

CentanafadinePhase 11 trial

Active Trials

NCT04398225Completed32Est. Apr 2021

NCT04081363Completed13Est. Dec 2019

NCT01074294Completed740Est. Jun 2011

+1 more trials

AbbottABBOTT PARK, IL

1 program

ABT-089Phase 21 trial

Active Trials

NCT00443391Completed141Est. Oct 2008

AbbVieNORTH CHICAGO, IL

1 program

ABT-089Phase 2

RespireRx Pharmaceuticals

1 program

CX717 200 mgPhase 21 trial

Active Trials

NCT03375021Completed68Est. Jan 2006

MSDIreland - Ballydine

1 program

MK-8777Phase 21 trial

Active Trials

NCT00610441Completed67Est. Mar 2009

Sharp TherapeuticsPA - Pittsburgh

1 program

MK-8777Phase 2

LundbeckDenmark - Copenhagen

1 program

vortioxetine 10 mg tabletPhase 21 trial

Active Trials

NCT02327013Completed227Est. Sep 2016

Oregon Therapeutics

3 programs

EmpowerPlus Lightning SticksN/A1 trial

Mental health care implemented by telepsychiatryN/A1 trial

NAT electroencephalographyN/A

Active Trials

NCT05234593Completed20Est. Apr 2023

NCT01096953Withdrawn0Est. Sep 2011

Angeles Therapeutics

2 programs

NAT electroencephalographyN/A1 trial

UC-AN/A1 trial

Active Trials

NCT02756286Completed258Est. Jul 2018

NCT06256003Completed140Est. Nov 2024

Boehringer IngelheimINGELHEIM, Germany

2 programs

Performance and FMRI BOLD Signal Changes in Impulsive PatientsN/A1 trial

Zentiva®N/A1 trial

Active Trials

NCT06491160Completed20Est. Oct 2024

NCT05278104Completed63Est. Oct 2024

TevaIsrael - Petach Tikva

2 programs

ModafinilPHASE_21 trial

ModafinilPHASE_31 trial

Active Trials

NCT00315276Completed370Est. Jan 2007

NCT00343811Completed120Est. Sep 2006

+6 more companies

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Martin PharmaceuticalsCariprazine

Purdue PharmaFoquest

TakedaGuanfacine hydrochloride

Aytu BioPharmaADZENYS XR-ODT

Purdue PharmaMethylphenidate Hydrochloride Controlled-Release Capsules

JPMLisdexamfetamine Dimesylate

PfizerMethylphenidate Hydrochloride

Acadia PharmaceuticalsL. helveticus R0052 and B. longum R0175

JPMGuanfacine extended release

Human BioSciencesMethylphenidate

Prevail TherapeuticsAtomoxetine

Colorado TherapeuticsBupropion

Prevail TherapeuticsAtomoxetine

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 9,376 patients across 50 trials

NCT04843423 Martin PharmaceuticalsCariprazine

Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder

Start: Dec 2021Est. completion: Apr 202315 patients

Phase 4Unknown

NCT04741516 Purdue PharmaFoquest

Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD

Start: Dec 2020Est. completion: Dec 202341 patients

Phase 4Unknown

NCT04085172 TakedaGuanfacine hydrochloride

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

Start: Sep 2019Est. completion: Sep 2025396 patients

Phase 4Completed

NCT07169162 Aytu BioPharmaADZENYS XR-ODT

ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disorder

Start: May 2019Est. completion: Sep 20250

Phase 4Withdrawn

NCT03785223 Purdue PharmaMethylphenidate Hydrochloride Controlled-Release Capsules

A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity

Start: Apr 2019Est. completion: Oct 202260 patients

Phase 4Completed

NCT03337646 JPMLisdexamfetamine Dimesylate

Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism

Start: Sep 2018Est. completion: Mar 202348 patients

Phase 4Completed

NCT03536390 PfizerMethylphenidate Hydrochloride

A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD

Start: Sep 2018Est. completion: Apr 20210

Phase 4Withdrawn

NCT02545634 Acadia PharmaceuticalsL. helveticus R0052 and B. longum R0175

Effects of a Probiotic Supplement on Symptoms of Attention Deficit Hyperactivity Disorder and Anxiety in Children

Start: Jun 2015Est. completion: Jun 2016100 patients

Phase 4Unknown

NCT01985581 JPMGuanfacine extended release

Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD

Start: Oct 2013Est. completion: Mar 201550 patients

Phase 4Completed

NCT01133847 Human BioSciencesMethylphenidate

Interventions for Children With Attention and Reading Disorders

Start: Nov 2010Est. completion: Jun 2015222 patients

Phase 4Completed

NCT01127646 Prevail TherapeuticsAtomoxetine

A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents

Start: Jun 2010Est. completion: May 201123 patients

Phase 4Terminated

NCT00936299 Colorado TherapeuticsBupropion

Bupropion for ADHD in Adolescents With Substance Use Disorder

Start: Jan 2009Est. completion: May 2013105 patients

Phase 4Completed

NCT00716274 Prevail TherapeuticsAtomoxetine

Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia

Start: Sep 2008Est. completion: Jul 2016110 patients

Phase 4Completed

NCT00687609 Prevail TherapeuticsAtomoxetine

Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE

Start: Sep 2008Est. completion: Jun 20097 patients

Phase 4Terminated

NCT00760747 Prevail TherapeuticsAtomoxetine

Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)

Start: Sep 2008Est. completion: Sep 2010112 patients

Phase 4Completed

NCT00607919 Prevail TherapeuticsAtomoxetine

Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

Start: Mar 2008Est. completion: Feb 2011209 patients

Phase 4Completed

NCT00938743 Heidelberg PharmaAtomoxetine

Driving in Adults With Attention-deficit/Hyperactivity Disorder (ADHD) Before and During Treatment With Atomoxetine

Start: Jan 2008Est. completion: Dec 200950 patients

Phase 4Completed

NCT00564954 SandozDex-methylphenidate hydrochloride extended-release

A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start: Oct 2007Est. completion: Nov 200786 patients

Phase 4Completed

NCT00546910 Prevail TherapeuticsAtomoxetine

Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start: Oct 2007Est. completion: May 2009125 patients

Phase 4Completed

NCT00536419 SandozMethylphenidate

Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents

Start: Sep 2007Est. completion: Sep 200853 patients

Phase 4Unknown

NCT00510276 Prevail TherapeuticsAtomoxetine hydrochloride

Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes

Start: Aug 2007Est. completion: Feb 2009445 patients

Phase 4Completed

NCT00471354 Prevail TherapeuticsAtomoxetine

A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

Start: Apr 2007Est. completion: Nov 2008228 patients

Phase 4Completed

NCT00434213 Noven PharmaceuticalsDaytrana

Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

Start: Jan 2007Est. completion: Jul 2008309 patients

Phase 4Completed

NCT00918567 Prevail Therapeuticsatomoxetine

Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD

Start: Jan 2007Est. completion: Sep 200856 patients

Phase 4Completed

NCT00406354 Prevail TherapeuticsAtomoxetine

Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

Start: Nov 2006Est. completion: Jan 2009181 patients

Phase 4Completed

NCT00299234 Prevail TherapeuticsAtomoxetine

Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL

Start: Jun 2006Est. completion: Dec 20071 patients

Phase 4Terminated

NCT00216918 Prevail TherapeuticsAtomoxetine Hydrochloride

Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.

Start: Sep 2005Est. completion: Jun 200640 patients

Phase 4Completed

NCT00190879 Prevail TherapeuticsAtomoxetine hydrochloride

Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

Start: Jun 2005Est. completion: May 2007440 patients

Phase 4Completed

NCT00191906 Prevail TherapeuticsAtomoxetine Hydrochloride

Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

Start: Apr 2005Est. completion: Dec 2007121 patients

Phase 4Completed

NCT00190775 Prevail TherapeuticsAtomoxetine Hydrochloride

A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start: Sep 2004Est. completion: Oct 2009502 patients

Phase 4Completed

NCT00485875 Prevail TherapeuticsAtomoxetine Hydrochloride

Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD

Start: Jun 2004Est. completion: Jan 200562 patients

Phase 4Completed

NCT00485849 Prevail TherapeuticsAtomoxetine Hydrochloride

A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD

Start: Feb 2004Est. completion: Oct 200412 patients

Phase 4Completed

NCT00486122 Prevail TherapeuticsAtomoxetine Hydrochloride

Evaluation of Continuous Symptom Treatment of ADHD

Start: Sep 2003Est. completion: Jun 2004282 patients

Phase 4Completed

NCT00381758 UCB PharmaMethylphenidate Extended Release Capsules

The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting

Start: May 2002Est. completion: Aug 2002184 patients

Phase 4Completed

NCT04569357 Medica CorpProspekta

Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children

Start: Nov 2020Est. completion: Feb 2022363 patients

Phase 3Completed

NCT03597503 Supernus PharmaceuticalsSPN-810

Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

Start: Jul 2018Est. completion: Jan 202041 patients

Phase 3Terminated

NCT02555150 Purdue PharmaPRC-063

A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD

Start: Sep 2015Est. completion: Jan 201740 patients

Phase 3Completed

NCT01654250 PfizerNWP09

NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Start: Jul 2012Est. completion: Oct 201290 patients

Phase 3Completed

NCT00969618 Prevail TherapeuticsAtomoxetine

A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder

Start: Nov 2009Est. completion: Jan 2012211 patients

Phase 3Completed

NCT00962104 Prevail TherapeuticsAtomoxetine

Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder

Start: Aug 2009Est. completion: Feb 2011391 patients

Phase 3Completed

NCT00904670 PfizerQuillivant Oral Suspension XR

Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Start: Apr 2009Est. completion: Aug 200945 patients

Phase 3Completed

NCT00730249 Medicemethylphenidate hydrochloride

Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

Start: Sep 2008150 patients

Phase 3Completed

NCT00700427 Prevail Therapeuticsatomoxetine hydrochloride

A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start: Jun 2008Est. completion: Oct 20132,017 patients

Phase 3Completed

NCT00723190 ShionogiCLONICEL

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Start: Jan 2008Est. completion: Jun 2010303 patients

Phase 3Completed

NCT00568685 Prevail TherapeuticsAtomoxetine Hydrochloride

Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start: Nov 2007Est. completion: Nov 2008153 patients

Phase 3Completed

NCT00428792 SandozMethylphenidate 20 mg long-acting capsules

Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

Start: Apr 2007Est. completion: Dec 2007150 patients

Phase 3Completed

NCT00447278 Prevail TherapeuticsAtomoxetine

A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents

Start: Mar 2007Est. completion: Jul 2009399 patients

Phase 3Completed

NCT00343811 TevaModafinil

Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

Start: Jun 2006Est. completion: Sep 2006120 patients

Phase 3Completed

NCT00393042 SandozDexmethylphenidate

Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR

Start: Jan 2006Est. completion: Feb 200977 patients

Phase 3Completed

NCT00191945 Prevail TherapeuticsAtomoxetine Hydrochloride

Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Start: May 2005Est. completion: Feb 2008151 patients

Phase 3Completed

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

30 late-stage (Phase 3) programs, potential near-term approvals

30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.