Centanafadine (Simtriyo): approval and availability

Centanafadine, brand name Simtriyo, is a new molecular entity, meaning an active ingredient the FDA had not approved before, and its label covers adults with ADHD. It is sometimes described as a non-stimulant, which does not match its label. This page explains what the FDA label actually says, where its approval and DEA schedule stand, and what Schedule III means for prescriptions. Status details were checked against the Federal Register on November 4, 2026. It is not advice about whether you should take it.

Status as of November 4, 2026

Why an approved drug had to wait for the DEA

When the FDA tells a company it intends to recommend that a new drug be controlled under the Controlled Substances Act, a special rule applies. Under 21 U.S.C. 355(x), the approval "shall not take effect until the interim final rule controlling the drug is issued" by the DEA. The Simtriyo approval letter says exactly this: the scheduling "is not yet complete," so the date of approval "shall be the date on which the Drug Enforcement Administration (DEA) publishes a notice in the Federal Register announcing the interim final scheduling of centanafadine." The company must then update the label to show the schedule before selling the drug.

A separate law sets the DEA's clock. Under 21 U.S.C. 811(j), once the Department of Health and Human Services recommends a schedule for a newly approved drug, the DEA must issue an interim final rule within 90 days of the later of two dates: when it receives that recommendation, or when it is notified of the FDA approval. The public record does not show when the DEA received the recommendation, so a firm deadline cannot be calculated from public documents.

Otsuka's July 2026 announcement said Simtriyo "will be commercially available later this year following scheduling" by the DEA. The scheduling has now happened. The launch date is the company's to announce, so a pharmacy or the manufacturer is the place to check.

It is labeled a stimulant

The indications section describes Simtriyo as "a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant." Section 12.1 explains that it blocks the reuptake transporters for norepinephrine, dopamine and serotonin, and that its mechanism in ADHD "is unclear" but could work through that triple action. That serotonin activity is what sets it apart from amphetamine and methylphenidate products.

What the label covers

• Indication: ADHD in adults and in pediatric patients 6 years and older who meet a minimum body weight.
• Form: extended-release capsules, taken once daily in the morning. The capsules may be swallowed whole or opened and sprinkled on applesauce or yogurt, or in orange juice.
• Adult evidence: two six-week, randomized, double-blind, placebo-controlled trials in adults aged 18 to 55 (906 randomized in total) used another formulation of centanafadine. In both, ADHD symptom scores fell significantly more than with placebo. The label states that no differences in effectiveness are expected between that formulation and Simtriyo.
• Older adults: the trials did not include patients 65 and older.

Two boxed warnings

1. Suicidal ideation and behaviors in pediatric patients aged 6 and older. Higher rates occurred in children aged 6 to 12 on the drug than on placebo.
2. Abuse, misuse and addiction. The same class warning carried by other CNS stimulants since the FDA's 2023 labeling update: the drug "has a potential for abuse and misuse," abuse can lead to a substance use disorder, and misuse can result in overdose and death. Prescribers are told to assess each patient's risk before prescribing and to reassess during treatment.

Section 9.3 adds that, in two adult phase 3 studies, abruptly stopping the drug produced withdrawal symptoms indistinguishable from placebo, but the label still says it "may produce tolerance." How misuse risk is weighed for adults is covered in ADHD medication misuse and addiction risk.

Contraindications and key warnings

The label lists three contraindications: known allergy to centanafadine or its ingredients; taking an MAOI or having stopped one within 14 days; and pheochromocytoma, now or in the past. Other warnings include:

• Serious heart disease: avoid in people with known structural heart abnormalities, cardiomyopathy, serious arrhythmia or coronary artery disease. See ADHD medication, heart health and blood pressure.
• Blood pressure and heart rate increases, with checks before starting and periodically.
• Psychosis or mania in people with pre-existing psychotic or bipolar disorders.
• Serotonin syndrome when combined with other serotonergic drugs.
• Raynaud's phenomenon and other circulation changes in fingers and toes.
• Tics and Tourette's syndrome may start or worsen.
• Tartrazine (FD&C Yellow No. 5) in one capsule strength, which can cause allergic-type reactions in susceptible people, especially those with aspirin sensitivity.

Side effects and interactions

In adults, the most common adverse reactions (at least 5% and more than placebo) were headache, decreased appetite, insomnia, nausea, dry mouth and diarrhea.

• Alcohol: the label says to avoid alcohol at the same time as, and for at least two hours after, a dose. Alcohol can make the capsule release the drug faster, which may raise side effects and weaken the effect later in the day.
• CYP1A2 substrates: centanafadine is a moderate CYP1A2 inhibitor, so levels of drugs cleared by that enzyme may rise.
• Other CNS stimulants: combined use raises cardiovascular risk.
• Serotonergic drugs and MAOIs: as above.

Pregnancy and breastfeeding

The label says human data are insufficient to evaluate risk in pregnancy and describes some effects in animal studies; it enrolls patients in the National Pregnancy Registry for ADHD Medications. There are no data on centanafadine in human or animal milk. The NIH LactMed database has an entry on centanafadine that a prescriber or lactation specialist can review with you. See ADHD medication, pregnancy and the postpartum period.

What Schedule III means in New York and New Jersey

Schedule III puts centanafadine under different rules from amphetamine and methylphenidate, which are Schedule II:

• Refills: federal law allows up to five refills within six months of the date written (21 CFR 1306.22). Schedule II prescriptions cannot be refilled (21 CFR 1306.12).
• New Jersey telehealth: the visit requirements in P.L.2026, c.40 are written for Schedule II stimulants, so by their terms they do not apply to it. See New Jersey's 2026 telehealth rules.
• New York: state refill and prescribing rules for controlled substances still apply. See New York's rules.

The general differences are explained in ADHD medication schedules.

Questions to ask your prescriber

• What would centanafadine offer me compared with the medicines already approved for adults?
• Do I take anything serotonergic, and how would that be handled?
• How would insurance treat a newly launched brand-only drug?

For the current list of medications adults can be prescribed today, see ADHD medications approved for adults in 2026. Dr. Shershow evaluates adults for ADHD and discusses medication options that are available and appropriate; see adult ADHD treatment.