Simtriyo (Centanafadine): What the New ADHD Medication Is — and Why You Can’t Get It Yet

A new ADHD medication was approved this summer, and the questions arriving in clinic are already specific: Is it a stimulant? Is it better than Adderall? Can we switch? Here is what the FDA label actually supports — and what it does not.

What to know

• The FDA approved Simtriyo (centanafadine) on July 24, 2026 for ADHD in adults and in children 6 and older who weigh at least 20 kg, about 44 pounds.[1,2,3]
• You cannot get it yet. The DEA has not assigned it a controlled-substance schedule, and until it does, the medication cannot legally be sold. As of August 19, 2026 there is no launch date.[2,4,5]
• Its FDA label calls it a central nervous system stimulant, not a non-stimulant — despite years of coverage describing it the other way.[1]
• It carries a boxed warning with two topics: suicidal thoughts and behavior in children, and abuse, misuse, and addiction.[1]
• No trial has ever compared it head-to-head with another ADHD medication. Anyone claiming it is faster, stronger, or safer than Adderall, Concerta, Strattera, or Qelbree is going beyond the evidence.[6,7,8]

Zoom

Where things actually stand

This is the part most coverage gets muddled, so it is worth separating carefully. Three different milestones are involved, and only the first has happened.

FDA approval — done. On July 24, 2026, the FDA approved Simtriyo under new drug application 218145. It appears as entry 29 on the FDA’s list of novel drug approvals for 2026. Otsuka announced it the same day, and its Japanese parent company announced it the following Monday, July 27; those are two datelines for one approval, not two events.[2,3,9]

DEA scheduling — not done. Centanafadine will be a federally controlled substance, but no one knows which schedule. As of August 19, 2026, there is no DEA notice in the Federal Register, nothing waiting in the publication queue, no listing on the DEA’s own alphabetical roster of controlled substances, and no entry in the federal drug schedules at 21 CFR Part 1308.[4,5]

Availability — not done, and not scheduled. The FDA’s approval letter is explicit: Simtriyo “may be marketed only after DEA has published the notice” and the manufacturer submits updated labeling. It is not in the Orange Book, has no listing in the national drug databases, and Otsuka’s own patient website states plainly that it “is not yet commercially available.”[2,10,11]

There is a further wrinkle that explains the odd state of the paperwork. Under federal law, when a drug still needs scheduling, the legal date of approval becomes the date the DEA publishes its notice. So the approved label itself carries unfilled blanks: where the schedule belongs it reads “[controlled substance schedule pending],” and the initial approval year still reads “YYYY.”[1,2]

What this means for you right now

• As of August 19, 2026, no pharmacy in the United States can fill a prescription for Simtriyo.

• No schedule has been assigned. Any source naming one — Schedule II, Schedule IV, anything — is not drawing on the public federal record.

• Otsuka has said it expects availability “later this year,” but that is a company forecast, not a government deadline. No agency has published a date.

• If you or your child is doing well on current ADHD treatment, there is no reason to change anything while waiting.

• This status is expected to change. It was verified against federal records on August 19, 2026. Once the DEA acts, the picture moves quickly — confirm current availability with your prescriber or pharmacy rather than relying on this page.

What Simtriyo is

Simtriyo is an extended-release capsule taken once each morning. The active drug is centanafadine hydrochloride. It comes in three strengths — 140 mg, 210 mg, and 280 mg — measured as centanafadine base, which corresponds to 164.4, 246.6, and 328.8 mg of the hydrochloride salt. That double numbering matters only if you read the trial papers, which use the salt figures.[1]

Each capsule holds a mix of immediate-release, extended-release, and delayed-release beads. That design is meant to spread the dose across the day. It does not, by itself, prove any particular number of hours of symptom control.[1]

Stimulant or non-stimulant?

The FDA label calls it a central nervous system stimulant. This is the single most commonly mangled fact about this drug, and it has practical consequences.[1]

For years, centanafadine was described in trade press, conference coverage, and even the manufacturer’s own earlier announcements as a promising non-stimulant. That framing is now obsolete. The words “non-stimulant” appear nowhere in the approved label. What the label says, in the indications, in the description, and in the mechanism section, is that Simtriyo is “a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant.”[1]

It is genuinely first in its class — the first medication approved for ADHD that blocks the reuptake of all three of those messengers. But “new mechanism” and “non-stimulant” are not the same claim, and only one of them is true. A parent who believes this is a non-stimulant may badly misjudge the storage, abuse, and diversion questions that come with it.

How centanafadine works

Nerve cells communicate by releasing chemical messengers into the gap between them. Transporter proteins then pull those messengers back into the cell, which ends the signal. Think of them as return gates.

Centanafadine partially blocks three of those gates — the ones for norepinephrine, dopamine, and serotonin — so those signals may linger. Laboratory and imaging work suggests the effect is strongest at the norepinephrine gate. A small PET study in ten healthy men, using an older tablet form, estimated occupancy at peak concentration of roughly 91% at the norepinephrine transporter and around 47% and 44% at the dopamine and serotonin transporters.[12,13]

Two cautions belong with that. Ten healthy men on a non-marketed regimen cannot tell you when symptoms will improve, and serotonin activity does not imply a benefit for anxiety or depression. The label itself is candid: the mechanism by which centanafadine treats ADHD “is unclear.”[1]

ADHD is not caused by a simple chemical imbalance, and more signal is not automatically better.

Who the approval covers

The indication includes:

• adults;
• children ages 6 to 12 who weigh at least 20 kg; and
• adolescents ages 13 to 17 who weigh at least 20 kg.[1]

It is not recommended below age 6, where weight loss was more common, or below 20 kg, where data are limited. Adults 65 and older were not adequately studied.[1]

The FDA-reviewed indication is ADHD only. It does not cover anxiety, depression, substance use, or emotional dysregulation. A study of ADHD with co-occurring anxiety exists, but only company topline results have been released.[14]

How it is taken

The table below reports what the label says. It is not dosing advice for any individual.

Take it in the morning at about the same time each day, with or without food. Swallow the capsule whole. Alternatively, you may open it and put all the beads on one tablespoon of applesauce or yogurt, or into one tablespoon of orange juice, then take it right away and drink water. Do not save the mixture, and do not chew, crush, or cut the beads or the capsule.[1]

If a dose is missed, the Medication Guide allows taking it only within four hours of the usual time. Never take two doses in one day.[1]

How fast does it work?

This question deserves a careful answer, because the honest one has four parts.

Blood levels. Peak concentration occurs around five hours after a dose, steady state arrives by day two, and the average half-life is 5.2 hours. None of that proves same-day symptom relief.[1]

Earliest group difference. In the trials, the labeled higher-dose groups of children and teens separated from placebo on average by the first scheduled week-one visit. That sounds impressive, and it comes with a real caveat: the lower doses failed the main endpoint in both pediatric trials, and under the pre-planned statistical order, that failure meant the week-one findings could no longer be treated as confirmed. They are supportive, not proven.[1,15,16]

Adults were mixed. One trial first separated from placebo at day 28, the other at day 7 — and both used an older twice-daily tablet, not the capsule being sold.[17]

Main verdict. All four pivotal trials made their primary judgment at week 6.[15,16,17]

Your own response. The trials set no deadline for an individual. Response may come early, late, partially, or not at all.

No reliable study established how many hours one dose covers. Once-daily dosing, a multi-bead capsule, and a five-hour half-life do not add up to a proven claim of eight-, thirteen-, or twenty-four-hour coverage.[1,18]

What the trials found

Children 6 to 12. The trial randomized 480 children. At week 6, the labeled weight-based higher regimen improved ADHD rating-scale scores by 5.6 points more than placebo, with a confidence interval of 2.33 to 8.78 points. The lower regimen failed. About 76.5% completed.[1,15]

Adolescents 13 to 17. The trial randomized 459 teens. At week 6, 280 mg improved scores by 4.4 points more than placebo, confidence interval 1.87 to 6.83, with an effect size of 0.40. The 140 mg dose failed. About 80.8% completed.[1,16]

A note on where those numbers live: the placebo-adjusted differences and their confidence intervals come from the FDA label’s tables. The journal articles report the raw group changes instead, so a reader who opens the papers looking for “5.6 points” will not find that figure.[1,15,16]

Adults. Two trials randomized 906 adults after a placebo run-in week. Both doses beat placebo at week 6, by 2.7 to 4.4 points on the adult rating scale, with standardized effects of 0.24 to 0.40 — small to moderate. One trial numerically favored the lower dose, the other the higher, so there is no clean dose-response story.[1,17]

Those adult trials used centanafadine sustained-release tablets dosed twice daily, not the once-daily capsule now approved. The FDA accepted a pharmacokinetic bridge between the two. That is a reasonable regulatory judgment, not a demonstration that the marketed product performs identically.[1,17]

One design detail limits how far the adult results generalize: anyone whose self-rated symptoms improved by 30% or more during the single-blind placebo week was not randomized. Overall, 24.1% of people entering the run-in never made it into the trial, for all reasons combined — placebo response, side effects, protocol problems, and people lost to follow-up.[17]

Long-term. The 52-week adult study had no placebo group and used the older tablet; 345 of 662 adults finished, about 52%. The pediatric long-term study completed in April 2026, and full results were not public at this review.[1,19,20]

Otsuka funded all four pivotal trials and the long-term studies, and company employees were involved in the research. The trials were short, used no active comparator, and excluded many of the co-occurring conditions that make real ADHD care complicated.

How it compares with other ADHD medicines

There is no randomized head-to-head trial comparing centanafadine’s effectiveness against any other ADHD medication. Not against amphetamines, not against methylphenidate, not against atomoxetine or viloxazine or guanfacine.[6,7,8]

What exists instead are four sponsor-funded matching-adjusted indirect comparisons. These take one trial’s data and statistically reweight it to resemble another trial’s published averages. They adjust only for characteristics that were measured and reported in both, and they cannot remove the effects of different populations, different sites, different eras, or anything nobody thought to record.[6,21,22,23]

Two of those analyses compared centanafadine with lisdexamfetamine (Vyvanse), and both favored lisdexamfetamine — by 6.58 rating-scale points at week 4, and by 6.15 points in the longer-term analysis.[6,23] The comparison against extended-release methylphenidate initially favored methylphenidate, but that difference disappeared when the researchers capped a handful of extreme statistical weights in a sensitivity analysis — meaning the result was not robust to how the matching was done.[21] Comparisons against atomoxetine and viloxazine at week 6 were inconclusive, which is not the same as showing the drugs are equal.[6]

The practical translation: nothing in the current evidence supports telling a patient that Simtriyo works better, faster, or more safely than an established option. The one direction the indirect data lean is toward lisdexamfetamine, and even that should be held loosely.

Side effects by age

These are label rates from separate six-week placebo-controlled programs. They cannot be used to rank Simtriyo against another drug’s label, because those drugs were never studied in the same trial.[1]

Context helps here. Adult headache at 8% sits against 7% on placebo — barely a signal — while decreased appetite at 7% sits against 2%, and dry mouth at 6% against essentially none.[1]

Side effects led to stopping treatment in 10 of 157 children, 12 of 151 adolescents, and 18 of 292 adults, versus 2, 0, and 4 in the matching placebo groups. Rash was a notable reason for stopping, which is unusual enough among ADHD medications to be worth flagging.[1]

Weight moved in the expected direction. Over six weeks, children lost an average of 0.6 kg while the placebo group gained 0.8 kg. Teens lost 1.2 kg against a 0.6 kg gain. Longer uncontrolled data showed decreases in weight, body mass index, and height percentiles in some patients.[1]

The boxed warning

The label carries one boxed warning covering two topics. The heading reads: “SUICIDAL IDEATION AND BEHAVIORS IN PEDIATRIC PATIENTS AGED 6 YEARS AND OLDER; and ABUSE, MISUSE AND ADDICTION.”[1]

Suicidal thoughts and behavior in children. In the six-week trial of children 6 to 12, suicide attempts occurred in 2 of 304 children on centanafadine, 0.7%, and in 0 of 153 on placebo. The investigator judged those events unrelated to the drug, and the FDA required the boxed warning anyway. In the long-term open-label pediatric study, suicidal ideation was reported in 5 of 620 patients, 0.8%, leading 4 of 620 to stop. That study had no placebo group.[1,15]

Families should report new suicidal thoughts, worsening symptoms, or unusual behavior to the prescriber immediately.

Abuse, misuse, and addiction. The warning states that abuse and misuse can lead to addiction, overdose, and death, and directs clinicians to assess risk before and during treatment.[1]

Other serious risks

Trials reported angioedema and suspected anaphylaxis. Several further label warnings are inherited from the CNS-stimulant class rather than measured in centanafadine trials: sudden death in people with serious cardiac disease, roughly a 0.1% estimate for new psychosis or mania, Raynaud phenomenon and other circulation problems, tics, and a serious neurological syndrome in overdose.[1]

Two specifics worth knowing: the 210 mg capsule contains FD&C Yellow No. 5 (tartrazine), which can trigger allergic reactions, particularly in people sensitive to aspirin. And one severe liver-test abnormality occurred in the teen 140 mg group — a dose that failed and is not recommended for that age — with no group-level liver pattern.[1,16]

Get urgent help

• Call 911 or go to the nearest emergency department for trouble breathing; swelling of the face, lips, mouth, tongue, or throat; collapse; seizure; or if someone cannot be woken. Severe chest pain and fainting also need emergency care.

• Possible serotonin syndrome needs urgent medical care. Signs can include agitation or confusion, high temperature, heavy sweating, shaking, stiff or twitching muscles, overactive reflexes, large blood-pressure swings, fast heart rate, vomiting, or diarrhea. Risk rises when another serotonin-acting medicine is added.

• New suicidal thinking or behavior in a child or teen needs immediate contact with the prescriber. In a suicidal crisis, call or text 988, or chat at 988lifeline.org. If danger is immediate, call 911. The 988 Lifeline is not a substitute for emergency medical care for anaphylaxis, cardiac symptoms, overdose, or serotonin syndrome.

• New hallucinations, delusions, mania, or dangerous agitation need prompt care. Use emergency services when there is immediate danger.

What a prescriber checks

Before starting, the label directs clinicians to assess risk of abuse and addiction; personal and family cardiac history, including sudden death and serious rhythm problems; blood pressure and pulse; risk factors for mania, including depression, bipolar disorder, and family history of suicide; and any personal or family history of tics or Tourette syndrome.[1]

During treatment, blood pressure and pulse are rechecked after dose increases and periodically. Children and teens need height, weight, and body mass index tracked. Clinicians also watch for suicidality, mental status changes, tics, circulation changes, allergic reactions, serotonin syndrome, and misuse.[1]

The label does not require an ECG or lab panel for everyone. An individual’s history may justify testing.

Interactions, alcohol, and caffeine

Simtriyo is contraindicated after an allergic reaction to centanafadine or any ingredient, in people with pheochromocytoma or a history of it, and with an MAOI or within 14 days of stopping one. MAOIs include linezolid and intravenous methylene blue. That combination can cause hypertensive crisis or serotonin syndrome.[1]

Other serotonin-acting medicines raise the risk too — many antidepressants, triptans, certain opioids, tryptophan, and St. John’s wort. This does not mean an antidepressant is forbidden. It means the combination needs to be reviewed deliberately.[1]

Alcohol should be avoided at the time of the dose and for at least two hours after. In a laboratory dissolution test, higher alcohol concentrations caused much faster drug release from the capsule. That was a benchtop test, not a study of people drinking.[1]

Caffeine is affected. Centanafadine moderately blocks CYP1A2, the enzyme that clears caffeine and several medications. In one study, total exposure to 200 mg of caffeine roughly doubled, though the peak changed little. That does not translate into a single coffee limit for everyone — it means caffeine intake is worth mentioning honestly.[1]

Combining Simtriyo with other stimulants may add to blood-pressure and pulse effects. A healthy-volunteer interaction study is not evidence that two ADHD medicines work better together.[1]

Pregnancy, breastfeeding, age, and organ function

Human pregnancy data are insufficient. Animal studies found effects on maternal, fetal, or offspring weight and development at several exposure levels; what that means for people is uncertain. A pregnancy registry for ADHD medications accepts enrollment at 1-866-961-2388.[1,24]

There are no data on centanafadine in human or animal milk, and effects on a breastfed infant or on milk supply are unknown.[1]

Use is not recommended under age 6 or under 20 kg. Adults 65 and older were not adequately studied.[1]

On organ function, the label is narrower than it first appears. Only moderate liver impairment was studied — mild impairment was not studied either, though the label keeps the same dose for both. Moderate impairment produced about 25% lower total exposure and 30% lower peak exposure. Severe liver impairment was not studied, and use is not recommended there.[1]

For kidneys, severe impairment in people not on dialysis produced about 20% lower total exposure and 25% lower peak. The label contains no renal-impairment section and gives no kidney dosing guidance at all — silence, not an instruction that the dose should stay the same. People on dialysis were not studied.[1]

Abuse, dependence, and scheduling

Two human abuse-potential studies were run in people who use stimulants recreationally, using an immediate-release form at doses roughly two to four times the recommended adult starting dose.[1]

In the first, drug liking scores were higher than placebo and were not statistically lower than amphetamine 40 mg at either 400 mg or 800 mg; the 800 mg dose was also not statistically lower than lisdexamfetamine 150 mg. In the second, liking was above placebo but below amphetamine 15 mg and 30 mg.[1,25]

“Not statistically lower” is a failure to demonstrate a difference. It is not proof of equivalence. The FDA’s own conclusion was that these data demonstrate centanafadine has abuse potential.[1]

Controlled withdrawal assessments, using the older adult formulation, found very low withdrawal scores, which the label reads as no signal of physical dependence under study conditions. Physical dependence is a different thing from addiction or misuse.[1,19]

Because no schedule exists yet, no one can tell you what the refill rules will look like — whether it will require a new prescription each month like Schedule II stimulants, or allow refills like Schedule IV medications. That answer arrives with the DEA notice.

What we still do not know

• How Simtriyo compares directly with amphetamine, methylphenidate, atomoxetine, viloxazine, guanfacine, clonidine, or off-label bupropion.
• How many hours of the day one dose actually covers.
• Real-world effectiveness, adherence, misuse, and safety once it is in wide use.
• Rare harms that six-week trials are too small and too short to detect.
• Long-term effects on school, work, driving, relationships, and quality of life.
• Use in pregnancy and breastfeeding, in severe liver disease, on dialysis, and in adults 65 and older.
• The best sequence to try it in, after another ADHD medicine has failed or caused problems.
• How it performs in people who also have anxiety, depression, bipolar disorder, autism, tics, heart disease, or substance use — the conditions pivotal trials excluded.
• Whether benefits hold up long term in a controlled comparison.

What you can do next

If you were hoping to start this medication soon, the useful move today is not to wait for it. Bring the underlying problem to your prescriber instead: what is not working about the current plan, what side effect is driving the question, what goal is not being met. Those answers usually point to something available now.

If Simtriyo still looks like a reasonable fit once it reaches pharmacies, it will be a better conversation for having had the first one.

For a broader comparison of what is available today, see ADHD Medications Compared: Stimulants vs. Non-Stimulants for Kids and Adults. If a medication that used to help has stopped helping, Why ADHD Medications May Seem to Stop Working covers the usual reasons.

FAQs

Is Simtriyo a stimulant or a non-stimulant?

A stimulant, according to the FDA label. It is also a norepinephrine-dopamine-serotonin reuptake inhibitor, which is a genuinely new mechanism for ADHD. “Non-stimulant” is leftover language from its development years and no longer matches the approved label.[1]

Can I get it now?

No. As of August 19, 2026, no U.S. pharmacy can dispense it. The DEA has not assigned a controlled-substance schedule, and the FDA’s approval letter states the medication may be marketed only after that notice publishes.[2,4]

When will it be available?

Nobody has published a date. Otsuka has said it expects availability later in 2026, which is a company statement rather than a government commitment. No agency has announced a deadline.[9,10]

What controlled-substance schedule will it be?

Unknown. The label leaves the space blank. Treat any specific schedule you see quoted as unverified.[1]

Is it better than Adderall, Vyvanse, Ritalin, Strattera, or Qelbree?

Unknown, because nobody has run that trial. The indirect analyses that exist were funded by the manufacturer, and the two that compared it with lisdexamfetamine favored lisdexamfetamine.[6,23]

How fast does it work?

Higher-dose pediatric groups separated from placebo on average by week one, but those timing results were descriptive rather than confirmed. Adults separated at day 7 in one trial and day 28 in the other. Main endpoints were at week 6. None of that predicts one person’s response.[1,15,16,17]

Does it treat anxiety or depression too?

ADHD is the only approved indication. Serotonin activity does not establish a benefit for mood or anxiety, and the one study of ADHD with anxiety has released only company topline results.[1,14]

Can it be taken with an antidepressant?

Sometimes, with attention. MAOIs are contraindicated outright. Other serotonin-acting antidepressants raise the risk of serotonin syndrome and require monitoring. The specific drug and dose matter.[1]

Can the capsule be opened?

Yes. Put all the contents on one tablespoon of applesauce or yogurt, or into one tablespoon of orange juice, take it without chewing, then drink water.[1]

What if a dose is missed?

Take it only within four hours of the usual time. Otherwise skip it and resume the next day. Never take two doses in one day.[1]

What if too much is taken?

Call the prescriber or Poison Help at 1-800-222-1222, or go to the nearest emergency room right away. Call 911 for collapse, seizure, trouble breathing, or if someone cannot be woken.[1,26]

Educational disclaimer

This article is for education. It does not diagnose ADHD, select a medication for anyone, or replace the judgment of the clinician who knows your history. Do not start, stop, or change any medication without your prescriber. If there is imminent danger or you cannot keep yourself or someone else safe, call 911 or go to the nearest emergency department. In the United States, call or text 988, or chat at 988lifeline.org, for any mental-health crisis. Regulatory status, availability, and scheduling for this medication were verified against primary federal sources on August 19, 2026 and are expected to change; confirm current status before acting on anything in this article. Evidence reviewed through August 19, 2026.

References

1. U.S. Food and Drug Administration. SIMTRIYO (centanafadine) extended-release capsules — full prescribing information and Medication Guide. NDA 218145, revised 7/2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218145s000lbl.pdf. Accessed 2026-08-19.
2. U.S. Food and Drug Administration. NDA 218145 approval letter. July 24, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218145Orig1s000ltr.pdf. Accessed 2026-08-19.
3. U.S. Food and Drug Administration. Novel Drug Approvals for 2026 (entry 29: Simtriyo, centanafadine, 7/24/2026). https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026. Accessed 2026-08-19.
4. U.S. Drug Enforcement Administration, Diversion Control Division. Controlled Substances — Alphabetical Order, revision 12-Aug-26: https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf. And Lists of Scheduling Actions, Controlled Substances, and Regulated Chemicals: https://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf. Both checked 2026-08-19; centanafadine absent from each.
5. Federal Register. Search results for centanafadine. https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=centanafadine. Checked 2026-08-19; no DEA scheduling document. The only results are U.S. Patent and Trademark Office patent-term-extension notices published 2026-07-23.
6. Schein J, Cloutier M, Gauthier-Loiselle M, et al. Matching-adjusted indirect comparison of centanafadine versus lisdexamfetamine, atomoxetine, and viloxazine extended-release in adults with ADHD. J Manag Care Spec Pharm. 2024;30(6):528-540. PMID 38824626. doi:10.18553/jmcp.2024.30.6.528. https://pubmed.ncbi.nlm.nih.gov/38824626/
7. PubMed and ClinicalTrials.gov. Centanafadine searches for randomized head-to-head ADHD treatment trials. https://pubmed.ncbi.nlm.nih.gov/?term=centanafadine and https://clinicaltrials.gov/search?intr=Centanafadine. Searched 2026-08-19; none identified.
8. U.S. Food and Drug Administration. Current prescribing information for established ADHD medications (Concerta, Strattera, Vyvanse, Adderall XR, Qelbree, Intuniv, clonidine ER). Checked 2026-08-19.
9. Otsuka Pharmaceutical. Otsuka Receives FDA Approval for First-in-Class SIMTRIYO (centanafadine) for the Treatment of ADHD in Adults and Pediatric Patients Aged 6 Years and Older. Company source, July 24, 2026 (Otsuka Japan release dated July 27, 2026). https://www.otsuka-us.com/otsuka-shares-fda-review-update-for-centanafadine. Accessed 2026-08-19. Note: the URL slug does not match the page title; the page serves the approval announcement.
10. Otsuka America Pharmaceutical. Simtriyo product website. https://www.simtriyo.com. Accessed 2026-08-19: “currently under review by the US Drug Enforcement Administration for scheduling … and is not yet commercially available.”
11. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, and the National Drug Code Directory. Checked 2026-08-19; NDA 218145 returns no product listing.
12. Bymaster FP, Golembiowska K, Kowalska M, et al. Pharmacological characterization of the norepinephrine and dopamine reuptake inhibitor EB-1020. Synapse. 2012;66(6):522-532. PMID 22213195. doi:10.1002/syn.21538. https://pubmed.ncbi.nlm.nih.gov/22213195/
13. Matuskey D, Gallezot J-D, Nabulsi N, et al. Neurotransmitter transporter occupancy following administration of centanafadine sustained-release tablets: a phase 1 study in healthy male adults. J Psychopharmacol. 2023;37(2):164-171. PMID 36515395. PMCID PMC9912308. doi:10.1177/02698811221140008. https://pmc.ncbi.nlm.nih.gov/articles/PMC9912308/
14. ClinicalTrials.gov NCT06973577, and Otsuka. Phase 3b topline results, centanafadine in adults with ADHD and comorbid anxiety. Company source, June 25, 2026. https://clinicaltrials.gov/study/NCT06973577. Accessed 2026-08-19; no peer-reviewed publication at this review.
15. Ward CL, Nasser A, Adeojo LW, et al. Efficacy and safety of centanafadine for the treatment of ADHD in children: a randomized clinical trial. Pediatrics Open Science. 2025;1(3). doi:10.1542/pedsos.2024-000349. ClinicalTrials.gov NCT05428033.
16. Ward CL, Nasser A, Adeojo LW, et al. Centanafadine for the treatment of ADHD in adolescents: a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2026;65(6):805-817. doi:10.1016/j.jaac.2025.06.023. ClinicalTrials.gov NCT05257265.
17. Adler LA, Adams J, Madera-McDonough J, et al. Efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD: results of two phase 3 randomized clinical trials. J Clin Psychopharmacol. 2022;42(5):429-439. PMID 35652746. PMCID PMC9426730. doi:10.1097/JCP.0000000000001575. ClinicalTrials.gov NCT03605680 and NCT03605836.
18. Wigal SB, Nasser A, Kabbani S, et al. Centanafadine sustained-release tablets in adults with ADHD: results of phase 2 studies. Neuropsychiatr Dis Treat. 2020;16:1411-1426. PMID 32606696. doi:10.2147/NDT.S242084. https://pubmed.ncbi.nlm.nih.gov/32606696/
19. Mattingly GW, Nasser A, Adeojo LW, et al. Fifty-two-week open-label safety and tolerability study of centanafadine sustained release in adults with ADHD. J Clin Psychopharmacol. 2025;45(5):454-462. doi:10.1097/JCP.0000000000002020. ClinicalTrials.gov NCT03605849.
20. ClinicalTrials.gov. NCT05279313: long-term safety of centanafadine in children and adolescents. https://clinicaltrials.gov/study/NCT05279313. Completed April 24, 2026; no posted results at this review.
21. Schein J, Cloutier M, Gauthier-Loiselle M, et al. Assessment of centanafadine in adults with ADHD: a matching-adjusted indirect comparison versus methylphenidate hydrochloride extended release. Curr Med Res Opin. 2024;40(8):1397-1406. doi:10.1080/03007995.2024.2373883. https://pubmed.ncbi.nlm.nih.gov/38961630/
22. Schein J, Cloutier M, Gauthier-Loiselle M, et al. Matching-adjusted indirect comparison of centanafadine versus long-acting methylphenidate in adults with ADHD. Can J Psychiatry. 2025;70(8):629-638. doi:10.1177/07067437251342279.
23. Schein J, Cloutier M, Gauthier-Loiselle M, et al. Long-term matching-adjusted indirect comparison of centanafadine versus established ADHD medications. J Comp Eff Res. 2024;13(9):e240089. PMID 39132746. PMCID PMC11363209. doi:10.57264/cer-2024-0089. https://pmc.ncbi.nlm.nih.gov/articles/PMC11363209/ Funded by Otsuka; first author is an Otsuka employee.
24. Massachusetts General Hospital Center for Women’s Mental Health. National Pregnancy Registry for ADHD Medications. 1-866-961-2388. https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. Accessed 2026-08-19.
25. ClinicalTrials.gov. NCT02144415: abuse potential of centanafadine (EB-1020) immediate-release in healthy recreational stimulant users. https://clinicaltrials.gov/study/NCT02144415. This registration covers the first of the two abuse-potential studies described in label section 9.2; the second study is not separately identified in the registry.
26. Poison Help / Health Resources and Services Administration. Poison emergency guidance. National number 1-800-222-1222. https://www.poisonhelp.org/. Accessed 2026-08-19.

If you or someone you know is in crisis

• Call 911 or go to your nearest emergency room for any life-threatening emergency.
• 988 Suicide & Crisis Lifeline — call or text 988, available 24/7. En español: marque 988 y oprima 2. Veterans: 988 and press 1, or text 838255.
• Crisis Text Line — text HOME to 741741.
• The Trevor Project (crisis support for LGBTQ+ young people) — call 1-866-488-7386, or text START to 678-678.
• National Sexual Assault Hotline (RAINN) — call 1-800-656-HOPE (4673) or text HOPE to 64673; free, confidential, 24/7. Online chat at RAINN.org/hotline.
• National Domestic Violence Hotline — call 1-800-799-SAFE (7233) or text START to 88788; 24/7, help in 200+ languages. Online chat at TheHotline.org. If your phone or computer may be monitored, calling from a safer device is an option.
• Riverside County — Inland SoCal Crisis Helpline 951-686-HELP (4357), 24/7 (Inland SoCal United Way / 211+, in partnership with RUHS-BH); Community Access, Referral, Evaluation and Support (CARES) Line 800-499-3008, 24/7.
• San Bernardino County — Access Unit (Behavioral Health Helpline) 888-743-1478, 24/7; Mobile Crisis/CCRT 800-398-0018 (24/7, all ages) or text 909-420-0560. Arrowhead Regional Medical Center (ARMC) has a dedicated walk-in adolescent psychiatric ER (ages 13–17).
• Children under 13 — call 911 for immediate danger, contact your county's mobile crisis team (they respond to all ages), or go to the nearest pediatric emergency room.
• California Peer-Run Warm Line (non-crisis — someone to talk to) — call or text 1-855-600-WARM (9276); daytime and evening hours, not a 24/7 line.
• NP Fady (non-emergency) — for routine scheduling or questions, call (909) 707-6261. This line is not monitored for emergencies.