Attention Deficit Hyperactivity Disorder

22
Pipeline Programs
14
Companies
7
Clinical Trials
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
4
1
3
12
Early DiscoveryClinical DevelopmentMarket

On Market (5)

Approved therapies currently available

U
GUANFACINE HYDROCHLORIDEApproved
guanfacine hydrochloride
Unknown Company
oral2024
Teva
MODAFINILApproved
modafinil
Teva
oral2012
U
PROVIGILApproved
modafinil
Unknown Company
Sympathomimetic-like Agent [EPC]oral1998
Eli Lilly and Company
STRATTERAApproved
atomoxetine hydrochloride
Eli Lilly and Company
oral2002
U
TENEXApproved
guanfacine hydrochloride
Unknown Company
oral1986

Competitive Landscape

13 companies ranked by most advanced pipeline stage

Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
4 programs
1
2
AtomoxetinePhase 41 trial
Atomoxetine HydrochloridePhase 41 trial
EdivoxetinePhase 2/31 trial
Dietary Intake and Nutrient Status of Children With ADHDN/A1 trial
Active Trials
NCT00434928Completed60Est. Jan 2007
NCT00965419Terminated267Est. Jul 2015
NCT00406354Completed181Est. Jan 2009
+1 more trials
Teva
TevaIsrael - Petach Tikva
2 programs
1
1
1
ModafinilPhase 31 trial
ModafinilPhase 21 trial
Active Trials
NCT00315276Completed370Est. Jan 2007
NCT00343811Completed120Est. Sep 2006
Aytu BioPharma
Aytu BioPharmaDENVER, CO
1 program
1
ADZENYS XR-ODTPhase 41 trial
Active Trials
NCT07169162WithdrawnEst. Sep 2025
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
1
AtomoxetinePhase 41 trial
Active Trials
NCT00938743Completed50Est. Dec 2009
Takeda
TakedaTOKYO, Japan
1 program
1
Guanfacine hydrochloridePhase 42 trials
Active Trials
NCT04085172Completed396Est. Sep 2025
NCT00151996Completed75Est. Dec 2004
Acadia Pharmaceuticals
1 program
1
L. helveticus R0052 and B. longum R0175Phase 41 trial
Active Trials
NCT02545634Unknown100Est. Jun 2016
UP
UCB PharmaBelgium - Brussels
1 program
1
Methylphenidate Extended Release CapsulesPhase 41 trial
Active Trials
NCT00381758Completed184Est. Aug 2002
Novartis
NovartisBASEL, Switzerland
3 programs
1
1
1
Methylphenidate 20 mg long-acting capsulesPhase 31 trial
Extended Release MethylphenidatePhase 21 trial
MethylphenidatePhase 1/21 trial
Active Trials
NCT00772161Completed24Est. Dec 2008
NCT00409708Completed142
NCT00428792Completed150Est. Dec 2007
Pfizer
PfizerNEW YORK, NY
1 program
1
Quillivant Oral Suspension XRPhase 31 trial
Active Trials
NCT00904670Completed45Est. Aug 2009
Avalo Therapeutics
3 programs
2
AEVI-001Phase 21 trial
AEVI-001Phase 21 trial
A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR N/A1 trial
Active Trials
NCT03233867CompletedEst. Aug 2018
NCT03265119CompletedEst. Oct 2018
NCT03609619CompletedEst. Nov 2018
BrainsWay
BrainsWayJerusalem, Israel
1 program
1
treatment by HLPFC coilPhase 11 trial
Active Trials
NCT01196910UnknownEst. Sep 2020
Boehringer Ingelheim
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
Jerusalem Pharmaceuticals
Jerusalem PharmaceuticalsIsrael - Ramallah
1 program
Coenzyme Q10N/A1 trial
Active Trials
NCT02315651Unknown60Est. Nov 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TakedaGuanfacine hydrochloride
Aytu BioPharmaADZENYS XR-ODT
Acadia PharmaceuticalsL. helveticus R0052 and B. longum R0175
Heidelberg PharmaAtomoxetine
Eli Lilly and CompanyAtomoxetine
Eli Lilly and CompanyAtomoxetine Hydrochloride
UCB PharmaMethylphenidate Extended Release Capsules

Clinical Trials (7)

Total enrollment: 1,413 patients across 7 trials

NCT04085172TakedaGuanfacine 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
NCT07169162Aytu BioPharmaADZENYS XR-ODT

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

Start: May 2019Est. completion: Sep 2025
Phase 4Withdrawn
NCT02545634Acadia 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
NCT00938743Heidelberg 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
NCT00406354Eli Lilly and CompanyAtomoxetine

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
NCT00190775Eli Lilly and CompanyAtomoxetine 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
NCT00381758UCB 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

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

3 late-stage (Phase 3) programs — potential near-term approvals
14 companies competing in this space