NCT05257265 is a Phase 3 clinical trial of Centanafadine Hydrochloride in Attention-Deficit/Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT05257265?

NCT05257265 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT05257265?

Interventions in NCT05257265: Centanafadine Hydrochloride, Placebo.

What condition does NCT05257265 study?

NCT05257265 studies Attention-Deficit/Hyperactivity Disorder.

Is NCT05257265 still recruiting?

NCT05257265 is currently completed. Last updated 27 September 2024.

Last reviewed 2024-09-27 · How we verify

NCT05257265

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Completed Phase 3 Last updated 27 September 2024

What this trial tests

Phase 3 trial testing Centanafadine Hydrochloride in Attention-Deficit/Hyperactivity Disorder in 459 participants. Completed in 5 October 2023.

Timeline

2 February 2022

Primary endpoint
29 September 2023

5 October 2023

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	459
Start date	2 February 2022
Primary completion	29 September 2023
Estimated completion	5 October 2023
Sites	1 location across United States

Drugs / interventions tested

Centanafadine Hydrochloride — full drug profile →
Placebo

Conditions studied

Attention-Deficit/Hyperactivity Disorder — all drugs for Attention-Deficit/Hyperactivity Disorder →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 13 to 17, any sex, with Attention-Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
Treatment of ADHD: Drugs, psychological therapies, devices, complementary and alternative methods as well as the trends in clinical trials.
Nazarova VA, Sokolov AV, Chubarev VN, Tarasov VV, et al · · 2022 · cited 44× · PMID 36467081 · DOI 10.3389/fphar.2022.1066988
Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial.
Ward CL, Childress AC, Jin N, Turkoglu O, et al · · 2026 · cited 4× · PMID 40619095 · DOI 10.1016/j.jaac.2025.06.023
Efficacy of Centanafadine for Executive Functioning and Learning Problems in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.
Wilens TE, Oberdhan D, Jin N, Skubiak T, et al · · 2026 · PMID 41958186 · DOI 10.1177/10445463261441745
New frontiers in pharmacological treatment of attention-deficit hyperactivity disorder.
Noah AA, Sedky HE. · · 2025 · PMID 40478337 · DOI 10.1007/s00210-025-04328-z
Poster Abstracts - Academy of Managed Care Pharmacy 2024
· 2024

Verify or expand the search:

Other trials of Centanafadine Hydrochloride

Trials testing the same drug.

NCT05279313 — A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder. · Phase 3 · active not recruiting

Other recruiting trials for Attention-Deficit/Hyperactivity Disorder

Currently open trials in the same condition.

NCT07327775 — Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder · recruiting

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Trials by the same sponsor.

NCT07525960 — A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for · Phase 1 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults · Phase 1 · not yet recruiting
NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05257265 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 27 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05257265.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing