Centanafadine FDA Approval for ADHD Treatment

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The FDA accepted for priority review the new drug request (NDA) for centanafadine (Otsuka⁤ Pharmaceutical) for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. According to the manufacturer’s news release, the Prescription Drug User Fee Act (PDUFA) target action date ⁤is set for July 24, 2026.¹

Centanafadine is⁣ an investigational first-in-class norepinephrine, dopamine, and serotonin reuptake ⁤inhibitor⁣ (NDSRI). it is only‍ administered orally once per day⁤ and comes as an extended-release capsule. The NDA was supported by findings from 4 pivotal phase⁤ 3 clinical trials that evaluated centanafadine’s safety and efficacy across patient populations.¹

“ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available,” John Kraus,⁣ MD, PhD, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization, Inc, said in a news release. “The FDA’s acceptance and priority review designation of our NDA for ⁤centanafadine marks an vital ⁢milestone in our effort to bring forward a novel treatment option for people living with ADHD.”¹

clinical Data Supporting the FDA’s Action

The 4 multicenter,⁤ randomized, double-blind, placebo-controlled

Adult ⁣Studies

At day 42, statistically significant mean differences in AISRS total score were observed in favor of centanafadine versus placebo in study 1 (200 mg: −3.16, P = .019; 400 mg: −2.74, P = .039) and study 2 (200 mg: −4.01, P = .002; 400 mg: −4.47, P = .001). Additionally, effect⁤ sizes compared with placebo⁤ in study 1 were −0.28 and ‍−0.24 for 200 mg and 400 ‍mg, respectively, and in study ⁣2 were −0.37 and −0.40 ⁣for 200 mg and 400 mg, respectively.

The overall rate ⁢of TEAEs was low, wrote the authors, but there was a small increase in TEAE occurrence with increasing dose. Incidences of serious TEAEs and abuse-potential-related AEs were low.

“If approved, centanafadine would offer a first-in-class NDSRI‍ option designed‍ to support⁢ broad symptom‍ management.We extend ⁣our sincere gratitude⁣ to the patients, caregivers, and investigators whose participation made this milestone possible,” Kraus said in the news release.

REFERENCES

1. Otsuka Pharmaceutical. Otsuka Announces‍ FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children,Adolescents,and Adults. News release. January 27, 2026. Accessed January 29, 2026. https://www.otsuka-us.com/news/otsuka-announces-fda-acceptance-and-priority-review-new-drug-application-centanafadine

Researchers are evaluating the potential of centanafadine,⁢ a⁣ non-stimulant medication, to treat adult ADHD. Two ongoing clinical trials – one assessing immediate-release and another sustained-release formulations – are ⁣currently recruiting participants, according to⁤ data from ClinicalTrials.gov as of january 30, 2026.

Centanafadine ⁤works by selectively targeting the norepinephrine reuptake transporter in the ‍brain. This differs ⁤from traditional stimulants used to treat ADHD, which affect both dopamine and norepinephrine.

Here’s a breakdown of the two key trials:

• NCT05257265: This Phase 3 study is evaluating the efficacy, safety, and tolerability of centanafadine immediate-release⁣ tablets ⁢in adults diagnosed with ADHD. More details ‍is available on ClinicalTrials.gov.
• NCT03605680: This trial focuses on the‍ sustained-release version of centanafadine,⁢ also assessing⁣ its efficacy, safety, and tolerability in adults⁤ with ADHD.⁢ Details can be found on ClinicalTrials.gov.

Both trials are ⁣actively recruiting, suggesting a continued need for new ADHD treatment options. The studies aim ‍to determine if centanafadine can provide effective ⁣symptom management with a perhaps different side effect profile than existing medications.