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Attention Deficit Hyperactivity Disorder

CNS 0 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

CNS indication. Attention Deficit Hyperactivity Disorder has 0 FDA-approved novel treatments across 4 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Phase 3 Readouts Pro

2 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q4 2027

EB-1020 (Centanafadine) 164.4 mg

Otsuka Pharmaceutical Co., Ltd.

Estimated · aging NCT06931080

Q4 2027

EB-1020 (Centanafadine) 164.4 mg

Otsuka Pharmaceutical Co., Ltd.

Estimated · aging NCT06926829

Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Attention Deficit Hyperactivity Disorder Treatments by Mechanism

Top 6 mechanisms across 7 industry trials with a known mechanism of action.

See full pipeline →

GABA receptor

2 trials 1 sponsor

alpha-adrenoreceptors

1 trials 1 sponsor

Central Nervous System Stimulant

1 trials 1 sponsor

Norepinephrine transporter

1 trials 1 sponsor

Dopamine transporter/Norepinephrine transporter

1 trials 1 sponsor

Atypical Antipsychotic

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Attention Deficit Hyperactivity Disorder Clinical Pipeline by Phase

149 industry-sponsored trials across 50 sponsors

Showing 23 of 23 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Takeda	Guanfacine hydrochloride (TAK-503)	—	COMPLETED	2025-09-02	NCT04085172
Tris Pharma, Inc.	Amphetamine Extended Release Suspension [Dyanavel]	—	COMPLETED	2018-05-23	NCT03610464
Rhodes Pharmaceuticals, L.P.	Aptensio XR	—	COMPLETED	2017-11-02	NCT02683265
Eli Lilly	Atomoxetine	—	COMPLETED	2016-07	NCT00716274
Takeda	Lisdexamfetamine dimesylate	—	COMPLETED	2014-09-30	NCT01328756
Arbor Pharmaceuticals, Inc.	AR11	—	COMPLETED	2014-05	NCT01986062
Concordia Pharmaceuticals Inc., Barbados	clonidine hydrochloride	alpha-adrenoreceptors	COMPLETED	2012-10	NCT01439126
Xian-Janssen Pharmaceutical Ltd.	Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)	—	COMPLETED	2010-11	NCT01933880
Eli Lilly	Atomoxetine	—	COMPLETED	2010-11	NCT00607919
Eli Lilly	Atomoxetine	—	COMPLETED	2010-08	NCT00760747
Janssen Korea, Ltd., Korea	OROS Methylphenidate HCl	—	COMPLETED	2010-04	NCT01060150
Ortho-McNeil Janssen Scientific Affairs, LLC	OROS MPH	—	COMPLETED	2010-02	NCT00937040
Janssen Korea, Ltd., Korea	Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride	—	COMPLETED	2009-08	NCT01012622
Ortho-McNeil Janssen Scientific Affairs, LLC	CONCERTA (methylphenidate HCl) or placebo	—	COMPLETED	2009-06-26	NCT00799487
Ortho-McNeil Janssen Scientific Affairs, LLC	Placebo/ CONCERTA (methylphenidate HCl)	—	COMPLETED	2009-06	NCT00799409
Janssen-Cilag Farmaceutica Ltda.	Long-Acting Methylphenidate	—	COMPLETED	2008-10	NCT00783835
Johnson & Johnson Taiwan Ltd	OROS Methylphenidate	—	COMPLETED	2008-06	NCT00758160
Eli Lilly	Atomoxetine	—	TERMINATED	2011-05	NCT01127646
Eli Lilly	Atomoxetine	—	TERMINATED	2009-06	NCT00687609
Aytu BioPharma, Inc.	ADZENYS XR-ODT	Central Nervous System Stimulant [EPC]	WITHDRAWN	2025-09-05	NCT07169162
Pfizer	methylphenidate HCl ERCT	—	WITHDRAWN	2021-10-12	NCT03580005
Pfizer	Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)	—	WITHDRAWN	2021-04-22	NCT03536390
Pfizer	methylphenidate HCl ERCT	—	WITHDRAWN	2020-12-03	NCT03546400

Showing 75 of 75 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Otsuka Pharmaceutical Co., Ltd.	EB-1020 (Centanafadine) 164.4 mg	—	RECRUITING	2027-12	NCT06931080
Otsuka Pharmaceutical Co., Ltd.	EB-1020 (Centanafadine) 164.4 mg	—	RECRUITING	2027-12	NCT06926829
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine	—	COMPLETED	2026-04-22	NCT06973577
Axsome Therapeutics, Inc.	Solriamfetol 150 mg	—	COMPLETED	2025-02-07	NCT05972044
Shanghai Ark Biopharmaceutical Co., Ltd.	AK0901 capsule	—	COMPLETED	2025-01-06	NCT06359899
Cingulate Therapeutics	CTx-1301-Dexmethylphenidate 12.5 mg (titration only)	—	COMPLETED	2024-02-29	NCT05286762
Neurocentria, Inc.	NRCT-101-SR	—	COMPLETED	2024-01-17	NCT05683249
Cingulate Therapeutics	CTx-1301 - Dexmethylphenidate 25mg	—	COMPLETED	2023-06-13	NCT05631626
Materia Medica Holding	Prospekta	—	COMPLETED	2022-02-18	NCT04569357
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine SR	—	COMPLETED	2021-09-07	NCT03605849
Pharmasoft	Mexidol	—	COMPLETED	2020-07-13	NCT06854601
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine SR	—	COMPLETED	2020-05-14	NCT03605836
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine SR	—	COMPLETED	2020-04-11	NCT03605680
Takeda	SPD489	—	COMPLETED	2020-01-03	NCT02466386
Supernus Pharmaceuticals, Inc.	SPN-810 (18 mg)	—	COMPLETED	2019-11-15	NCT02618434
Tris Pharma, Inc.	AMPH ER Tab 5, 10, 15 and 20 mg	—	COMPLETED	2019-10-19	NCT03834766
Supernus Pharmaceuticals, Inc.	SPN-810 (18 mg)	—	COMPLETED	2019-09-04	NCT02618408
Orient Pharma Co., Ltd.	ORADUR®-Methylphenidate	—	COMPLETED	2019-08	NCT02704390
Purdue Pharma, Canada	PRC-063 oral capsules	—	COMPLETED	2019-07-05	NCT03618030
Zevra Therapeutics	KP415 oral capsule	—	COMPLETED	2019-06-20	NCT03460652
Arbor Pharmaceuticals, Inc.	Amphetamine Sulfate	—	COMPLETED	2019-04-12	NCT03659929
Supernus Pharmaceuticals, Inc.	400mg SPN-812	—	COMPLETED	2019-02-14	NCT03247556
Takeda	SPD489 (Lisdexamfetamine dimesylate)	—	COMPLETED	2018-10-23	NCT03260205
Supernus Pharmaceuticals, Inc.	200mg SPN-812	—	COMPLETED	2018-10-17	NCT03247543
Supernus Pharmaceuticals, Inc.	200mg SPN-812	—	COMPLETED	2018-10-17	NCT03247517
Supernus Pharmaceuticals, Inc.	100mg SPN-812	—	COMPLETED	2018-09-12	NCT03247530
Takeda	SHP465	—	COMPLETED	2018-06-07	NCT03325881
Zevra Therapeutics	KP415 oral capsule	—	COMPLETED	2018-05-16	NCT03292952
Purdue Pharma, Canada	PRC-063 oral capsules	—	COMPLETED	2017-08-19	NCT03172481
Tris Pharma, Inc.	amphetamine extended-release oral suspension, 2.5 mg/mL	—	COMPLETED	2017-02-25	NCT03088267
Aevi Genomic Medicine, LLC, a Cerecor company	NFC-1	—	COMPLETED	2017-02-10	NCT02777931
Sumitomo Pharma America, Inc.	Dasotraline	—	COMPLETED	2017-02-02	NCT02457819
Orient Pharma Co., Ltd.	Placebo First, then ORADUR®	—	COMPLETED	2017-02	NCT02450890
Rhodes Pharmaceuticals, L.P.	PRC-063	—	COMPLETED	2017-01	NCT02555150
Sumitomo Pharma America, Inc.	Dasotraline	—	COMPLETED	2016-09	NCT02276209
Sumitomo Pharma America, Inc.	Dasotraline	—	COMPLETED	2016-07	NCT02428088
Sumitomo Pharma America, Inc.	Dasotraline	—	COMPLETED	2016-05	NCT02160262
Takeda	SHP465 12.5mg capsules (one capsule daily)	—	COMPLETED	2016-03-24	NCT02604407
Takeda	SHP465	—	COMPLETED	2016-02-16	NCT02466425
Takeda	Extended-release Guanfacine HCl (Intuniv, SPD503)	—	COMPLETED	2015-09-15	NCT01500694
Rhodes Pharmaceuticals, L.P.	Drug: PRC-063	—	COMPLETED	2015-05	NCT02168127
Rhodes Pharmaceuticals, L.P.	PRC-063 25 mg	—	COMPLETED	2015-04	NCT02225639
Rhodes Pharmaceuticals, L.P.	PRC-063 25 mg	—	COMPLETED	2015-03	NCT02139111
Tris Pharma, Inc.	TRI102	—	COMPLETED	2014-10	NCT02083783
Rhodes Pharmaceuticals, L.P.	PRC-063 25 mg	—	COMPLETED	2014-10	NCT02139124
Alcobra Ltd.	MG01CI (1400 mg)	—	COMPLETED	2014-09	NCT02059642
Neos Therapeutics, Inc	NT0102	—	COMPLETED	2014-07	NCT01835548
Takeda	Extended-release Guanfacine Hydrochloride	—	COMPLETED	2013-05-01	NCT01244490
Pfizer	NWP09	—	COMPLETED	2012-10	NCT01654250
Rhodes Pharmaceuticals, L.P.	Methylphenidate Hydrochloride Extended Release Capsules	—	COMPLETED	2012-02	NCT01239030
Eli Lilly	Atomoxetine	—	COMPLETED	2012-01	NCT00969618
Takeda	Lisdexamfetamine dimesylate (LDX)	—	COMPLETED	2011-10-26	NCT00784654
Sumitomo Pharma America, Inc.	eszopiclone	GABA receptor	COMPLETED	2011-10	NCT00857220
Eli Lilly	atomoxetine hydrochloride	Norepinephrine transporter	COMPLETED	2011-08	NCT00700427
Sumitomo Pharma America, Inc.	eszopiclone	GABA receptor	COMPLETED	2011-07	NCT00856973
Rhodes Pharmaceuticals, L.P.	Methylphenidate Hydrochloride Extended Release Capsule	—	COMPLETED	2011-06-18	NCT01269463
Takeda	Lisdexamfetamine Dimesylate (LDX)	—	COMPLETED	2011-03-16	NCT00763971
Eli Lilly	Atomoxetine	—	COMPLETED	2011-02	NCT00962104
Eli Lilly	LY2216684	—	COMPLETED	2010-12	NCT00922636
Takeda	Lisdexamfetamine Dimesylate (LDX)	—	COMPLETED	2010-04-22	NCT00764868
Shionogi	CLONICEL (Clonidine HCl sustained release)	—	COMPLETED	2010-03	NCT00723190
Medice Arzneimittel Pütter GmbH & Co KG	methylphenidate hydrochloride	Dopamine transporter/Norepinephrine transporter	COMPLETED	2010-01	NCT00730249
Takeda	SPD503-AM	—	COMPLETED	2009-12-10	NCT00734578
Pfizer	Quillivant Oral Suspension XR	—	COMPLETED	2009-08	NCT00904670
Takeda	LDX 30 mg	—	COMPLETED	2009-04-06	NCT00735371
Addrenex Pharmaceuticals, Inc.	CLONICEL (clonidine HCl sustained release)	—	COMPLETED	2009-02	NCT00641329
Takeda	LDX	—	COMPLETED	2008-12-20	NCT00697515
Supernus Pharmaceuticals, Inc.	SPN-810	—	TERMINATED	2021-05	NCT02691182
Supernus Pharmaceuticals, Inc.	SPN-810	—	TERMINATED	2020-01-22	NCT03597503
Takeda	SHP465	—	TERMINATED	2019-01-19	NCT03325894
Alcobra Ltd.	MDX	—	TERMINATED	2017-01	NCT02477748
Eli Lilly	Edivoxetine	—	TERMINATED	2015-07	NCT00965419
Cingulate Therapeutics	CTx-1301 - Dexmethylphenidate 6.25mg	—	SUSPENDED	2027-02	NCT05924594
Supernus Pharmaceuticals, Inc.	200 mg SPN-812	—	WITHDRAWN	2020-09	NCT04016792
Takeda	SPD489	—	WITHDRAWN	2011-05-04	NCT01274221

Showing 32 of 32 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Bazelet Nehushtan LtD.	Oral CBD oil enriched with terpenes	—	RECRUITING	2026-08-22	NCT06542445
Definium Therapeutics US, Inc.	MM120	—	COMPLETED	2023-11-06	NCT05200936
Tris Pharma, Inc.	Amphetamine Extended Release (ER) Tablet 20 mg	—	COMPLETED	2021-10-15	NCT04027361
Cingulate Therapeutics	Dexmethylphenidate 5 Mg Oral Capsule, Extended Release	—	COMPLETED	2020-03-06	NCT04138498
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine	—	COMPLETED	2019-12-21	NCT04081363
Aevi Genomic Medicine, LLC, a Cerecor company	AEVI-001	—	COMPLETED	2018-11-23	NCT03609619
Otsuka Pharmaceutical Development & Commercialization, Inc.	OPC-64005	—	COMPLETED	2018-10-31	NCT03324581
Aevi Genomic Medicine, LLC, a Cerecor company	AEVI-001	—	COMPLETED	2018-09-24	NCT03265119
NLS Pharmaceutics	mazindol	—	COMPLETED	2017-03-28	NCT02808104
H. Lundbeck A/S	vortioxetine 10 mg tablet	—	COMPLETED	2016-09	NCT02327013
Takeda	SPD489	—	COMPLETED	2016-06-30	NCT02402166
Otsuka Pharmaceutical Development & Commercialization, Inc.	CTN SR	—	COMPLETED	2016-06-04	NCT02547428
Arbor Pharmaceuticals, Inc.	AR08	—	COMPLETED	2014-10	NCT01876719
Vernalis (R&D) Ltd	V81444	—	COMPLETED	2014-03	NCT02253745
Sumitomo Pharma America, Inc.	SEP-225289	—	COMPLETED	2013-11	NCT01692782
Theravance Biopharma	TD-9855	—	COMPLETED	2013-10	NCT01458340
Noven Pharmaceuticals, Inc.	d-Amphetamine Transdermal Patch	—	COMPLETED	2013-03	NCT01711021
Targacept Inc.	TC-5619-238 5mg	—	COMPLETED	2012-07	NCT01472991
Alcobra Ltd.	Metadoxine (MG01CI)	—	COMPLETED	2011-08	NCT01243242
Otsuka Pharmaceutical Development & Commercialization, Inc.	OPDC-34712	—	COMPLETED	2011-06-20	NCT01074294
Chelsea Therapeutics	Droxidopa+Carbidopa	—	COMPLETED	2011-05	NCT00983814
Targacept Inc.	TC-5619-238	—	COMPLETED	2011-02	NCT01124708
Obslap Research LLC	—	—	COMPLETED	2010-09	NCT00919906
Yaupon Therapeutics	Lobeline sulfate	—	COMPLETED	2010-01	NCT00664703
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Atomoxetine 80 mg/d	—	COMPLETED	2010-01	NCT00880217
Supernus Pharmaceuticals, Inc.	SPN-810	—	COMPLETED	2009-09-23	NCT00626236
Merck	MK-8777	—	COMPLETED	2009-03-02	NCT00610441
Eli Lilly	Atomoxetine	—	COMPLETED	2008-09	NCT00636818
AstraZeneca	AZD3480	—	COMPLETED	—	NCT00683462
Neurocentria, Inc.	NRCT-101SR, NRCT-202XR	—	TERMINATED	2025-07-15	NCT06673368
Brlev Agricultural Crops Ltd	Cannabis oil	—	TERMINATED	2022-12-31	NCT05219370
Supernus Pharmaceuticals, Inc.	SPN-810	—	TERMINATED	2019-11-07	NCT03638466

Showing 19 of 19 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Boehringer Ingelheim	BI 3031185	—	RECRUITING	2026-10-27	NCT07001475
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine	—	COMPLETED	2026-03-30	NCT07314333
Otsuka Pharmaceutical Development & Commercialization, Inc.	CTN XR (TBM)	—	COMPLETED	2024-12-30	NCT07253441
Vallon Pharmaceuticals, Inc.	ADAIR 10 mg IR tablets	—	COMPLETED	2021-12-17	NCT04647903
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine	—	COMPLETED	2021-04-01	NCT04398225
Vallon Pharmaceuticals, Inc.	ADAIR 10mg IR capsules	—	COMPLETED	2019-07-17	NCT04232644
Takeda	SHP465	—	COMPLETED	2018-10-05	NCT03327402
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2018-05-21	NCT03292848
Aevi Genomic Medicine, LLC, a Cerecor company	NFC-1 100 mg	—	COMPLETED	2017-02-26	NCT03006367
Sumitomo Pharma America, Inc.	dasotraline	—	COMPLETED	2016-11	NCT02795637
Takeda	SHP465 12.5mg	—	COMPLETED	2015-11-10	NCT02578030
Sumitomo Pharma America, Inc.	Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily	—	COMPLETED	2015-03	NCT02195167
Theravance Biopharma	TD-9855	—	COMPLETED	2013-11	NCT01924143
Takeda	SPD544	—	COMPLETED	2010-10-22	NCT01183234
Alcobra Ltd.	Extended Release Metadoxine	—	COMPLETED	2010-10	NCT00995085
Eli Lilly	Atomoxetine	—	COMPLETED	2010-10	NCT01177943
P2D, Inc.	Betahistine Hydrochloride	—	COMPLETED	2009-12	NCT00829881
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	JNJ-31001074	—	COMPLETED	2009-12	NCT00890292
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	JNJ-31001074	—	COMPLETED	2009-11	NCT00890240

Novel Attention Deficit Hyperactivity Disorder Drugs by Company (New molecular entities)

No novel drugs found for this indication.

Reformulations (35 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.