ADHD treatments have long relied on stimulants like methylphenidate and amphetamines, plus a handful of nonstimulant options. Centanafadine is a different kind of medicine that’s drawing attention because recent clinical trials show promising results and the U.S. Food and Drug Administration has given its application an accelerated review. If approved, centanafadine would be the first in a new class of once‑daily oral drugs that target three brain chemical transporters at once – norepinephrine, dopamine, and serotonin – which may help with attention, impulsivity, and mood symptoms.
What centanafadine is and how it works
What it does. Centanafadine is an investigational extended‑release capsule designed to block the reuptake of norepinephrine, dopamine, and serotonin. Blocking reuptake means these neurotransmitters stay active in the spaces between brain cells a bit longer, which can improve focus and reduce impulsive behavior. Because it affects three systems, researchers call it a norepinephrine‑dopamine‑serotonin reuptake inhibitor, or NDSRI.
Why that matters. Most current ADHD stimulants primarily boost dopamine and norepinephrine. Adding serotonin modulation could help with emotional regulation and anxiety symptoms that often come with ADHD, though that idea still needs confirmation in broader real‑world use.
The clinical trial evidence so far
Otsuka, the company developing centanafadine, submitted a New Drug Application (NDA) to the FDA supported by four pivotal Phase 3 trials that enrolled children, adolescents, and adults. These were randomized, double‑blind, placebo‑controlled studies – the gold standard for testing a drug’s effect. Across the trials, centanafadine showed statistically significant improvements in standard ADHD symptom scales compared with placebo, and the most common side effects were generally mild to moderate (decreased appetite, nausea, rash, fatigue, abdominal pain, somnolence, and headache).
Key trial highlights in plain language
- Multiple age groups tested. Trials included children, teens, and adults so the company could show the drug works across ages.
- Dose ranges. Studies tested different doses to find the balance between benefit and side effects. Higher doses tended to show stronger symptom improvement in the short trials.
- Safety profile. Side effects were mostly what you’d expect for a medication that affects appetite and the nervous system; serious adverse events were uncommon in the trial reports.
A Phase 3b study is also listed for adults with ADHD and comorbid anxiety, reflecting interest in how centanafadine might help people who have both conditions. That trial is ongoing and will add useful information about benefits and tolerability in people with anxiety plus ADHD.
Why the FDA is fast‑tracking the review
The FDA accepted Otsuka’s NDA and granted priority review, which shortens the agency’s review timeline and signals that the drug could offer a meaningful improvement over existing therapies. The Prescription Drug User Fee Act (PDUFA) target action date for centanafadine is set for July 24, 2026, meaning the FDA aims to make a decision by that date. Priority review doesn’t guarantee approval, but it does mean the agency considers the drug potentially important for public health.
What “promising” actually means for patients
Not a miracle cure, but another option: Promising trial results mean centanafadine reduced ADHD symptoms more than placebo in controlled settings. That’s an important first step, but real‑world effectiveness, long‑term safety, and how it compares directly with existing medications will matter a lot to patients and prescribers.
Who might benefit: People who don’t respond well to current stimulants, who experience intolerable side effects, or who have coexisting mood or anxiety symptoms might find a triple‑action drug useful – if later studies and clinical experience confirm those advantages.
What to watch for: Appetite suppression and sleepiness were among the more common side effects in trials. Anyone considering a new ADHD medication should discuss potential benefits and risks with their clinician, including how the drug might interact with other medications or medical conditions.
How the approval process works and what priority review means for timing
Steps to approval: After an NDA is submitted, the FDA reviews the full package of clinical data, manufacturing information, and labeling proposals. The agency may ask for more data, request inspections, or convene advisory committees for complex cases. Priority review shortens the review goal from the standard 10 months to about 6 months, but the FDA still evaluates safety and efficacy thoroughly.
If approved: The FDA will issue labeling that explains who the drug is for, recommended dosing, and safety warnings. Insurance coverage and real‑world prescribing patterns usually follow after approval, and additional post‑marketing studies may be required to monitor long‑term safety.
Practical questions people ask
Will centanafadine be a stimulant? No. It’s not classified as a stimulant like amphetamines or methylphenidate. It works by blocking reuptake of three neurotransmitters rather than directly increasing release. That difference could influence side effects and abuse potential, but those aspects will be carefully evaluated by regulators.
How soon would it be available? If the FDA approves centanafadine by the PDUFA date, it could become available shortly afterward, depending on manufacturing and distribution plans. Priority review only speeds the FDA’s decision timeline; it doesn’t change the time needed to scale up production.
Will it replace current medications? Unlikely. New drugs typically add options rather than replace existing ones. Different people respond differently to ADHD treatments, so having more choices helps clinicians tailor therapy.
Stop Overpaying for Meds.
Coupons aren’t your only option – see if safer, more effective, and lower-cost alternatives are available. It’s fast, personalized, and 100% free. Learn More →
What to look for next
- FDA decision and labeling details: The PDUFA date will be a key milestone; the FDA’s approval letter and final label will clarify approved uses and safety warnings.
- Post‑approval studies: Watch for longer‑term safety data and head‑to‑head trials comparing centanafadine with established treatments.
- Real‑world reports: After approval, clinicians’ and patients’ experiences will reveal how the drug performs outside tightly controlled trials.
Quick comparison table
| Attribute | Centanafadine | Typical stimulant |
| Mechanism | Norepinephrine, dopamine, serotonin reuptake inhibitor | Dopamine and norepinephrine release/reuptake modulation |
| Dosing | Once daily extended release | Once or multiple times daily depending on formulation |
| Controlled substance status | Under regulatory review; not a classic stimulant class | Often Schedule II (for amphetamines, methylphenidate) |
| Common side effects in trials | Decreased appetite; nausea; somnolence; rash | Decreased appetite; insomnia; increased heart rate |
| Trial evidence | Positive Phase 3 results across ages | Long history of efficacy and safety data |
(Trial and regulatory details are based on company and trial reports.)
Centanafadine represents a potentially meaningful addition to ADHD treatment options because it targets three neurotransmitter systems and has shown benefit in large Phase 3 trials. The FDA’s priority review reflects the agency’s view that the drug could offer an important new option. That said, approval is not guaranteed, and patients should wait for the FDA’s final decision and the full prescribing information before making any treatment changes. When new medicines arrive, the best approach is to talk with a clinician about how the option fits individual needs, medical history, and treatment goals.
Better Treatment, Lower Cost – No Catch.
Find safer, more effective medications with fewer side effects – often for less money. It’s fast, free, and personalized. Learn More →
Sources (3)
- Otsuka Pharmaceutical Co., Ltd. – Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults
https://www.otsuka-us.com/news/otsuka-announces-fda-acceptance-and-priority-review-new-drug-application-centanafadine - Pharmacy Times – Centanafadine for Treatment of ADHD in Children, Adolescents, and Adults Accepted By FDA for Priority Review
https://www.pharmacytimes.com/view/centanafadine-for-treatment-of-adhd-in-children-adolescents-and-adults-accepted-by-fda-for-priority-review - ClinicalTrials.gov. – P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety.
https://clinicaltrials.gov/study/NCT06973577