A prescription digital therapeutic is software prescribed to deliver a treatment—not simply a health app or a game. In the United States, EndeavorRx is a pediatric ADHD example: a mobile game designed to improve a specific, computer-measured attention function. Its evidence and FDA-listed indication apply to a defined group of children, and it is intended to be used within a broader treatment plan rather than instead of other care.
What is a prescription digital therapeutic for ADHD?
A prescription digital therapeutic (PDT) uses software as the treatment itself. EndeavorRx, also known as AKL-T01, is a software-based medical device accessed through a mobile device. A healthcare professional must prescribe it, and it is intended for use by the patient named on the prescription. That distinguishes it from a general-purpose brain-training app or an entertainment game.
The treatment is designed to train attention through interactive play. The product’s description explains that the game combines sensory stimuli and motor challenges; the player navigates courses, collects targets, and avoids obstacles while managing distractions. The software adjusts the challenge based on performance. This describes the intervention, not proof that it changes brain structure or works through a particular brain region.
How does EndeavorRx work in practice?
The typical routine described by the manufacturer is 10–25 minutes a day, five days a week, for at least four consecutive weeks, or as prescribed. The exact duration and schedule should follow the prescription and current instructions for use. Check those instructions for current device compatibility before starting.
Quick wins for a faster PC:
Scan for outdated or missing drivers - takes under a minuteDriver Scan →Clear out junk files and repair common Windows errorsFree Scan →Fix the driver behind crashes, sound loss and screen glitchesFind Drivers →#1 Best Overall
The intended target is attention function measured by computer-based testing. That is narrower than treating every part of ADHD: product information cautions that improvement on an attention test may not translate into improvement in typical behavioral symptoms such as hyperactivity.
Who can use EndeavorRx, and is it FDA approved?
In the United States, EndeavorRx’s indicated population is children ages 8–17 with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. The indicated benefit is improvement in attention function measured by computer-based testing; it is not an indication for all people with ADHD, all symptom domains, or all countries.
The FDA’s 510(k) database lists EndeavorRx as K231337, with a substantially equivalent decision dated December 13, 2023. This regulatory status supports marketing of the device for its cleared indication; it does not make the software a medication or a cure.
EndeavorOTC is a separate product intended by its manufacturer for adults 18 and older. The manufacturer’s evidence page says it is made available under FDA’s COVID-19 enforcement policy and has not been cleared or authorized by FDA for any indications. It should not be treated as an FDA-authorized adult equivalent of EndeavorRx.
Do these 3 things before closing this tab:
1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minuteWhat did the clinical trial find?
The pivotal STARS-ADHD trial was a randomized, double-blind, parallel-group study at 20 U.S. research institutions. It enrolled children ages 8–12 who were not taking disorder-related medication and had impaired baseline attention on the Test of Variables of Attention (TOVA) Attention Performance Index (API). Of 857 children evaluated, 348 were randomized: 180 to AKL-T01 and 168 to a digital control. Participants were assigned to play about 25 minutes per day, five days a week, for four weeks.
| Trial result | Finding | What it measures |
|---|---|---|
| Median TOVA API change estimate | 0.88 points (95% CI 0.24–1.49; p=0.0060) | Objective attention performance |
| Mean TOVA API change | AKL-T01: 0.93; digital control: 0.03 | Difference in the same attention-test measure |
These results, reported by Kollins and colleagues in The Lancet Digital Health in 2020, show a greater improvement on the trial’s objective attention measure in the treatment group than in the digital-control group. They do not establish that every ADHD symptom, daily functioning, or every child’s experience will improve. The trial authors said further research was needed.
A separate open-label adjunctive study in children ages 8–14 reported improvement in impairment measures among participants taking stimulant medication and among those not taking ADHD medication. Because it was open-label, it does not provide the same controlled comparison as the pivotal randomized trial.
What are the risks and treatment burden?
In the pivotal trial, there were no serious adverse events or discontinuations. Mild treatment-related events included frustration in 5 of 180 participants (3%) and headache in 3 of 180 (2%). These are trial-specific findings, not a guarantee that an individual will have no side effects. Product information also reports no serious adverse events in supporting trials.
Windows Errors? Fix Them Before They Spread
Repair common Windows errors and clear accumulated junk for a smoother, more stable PC - no reinstall needed.Free scan · no reinstallOutdated Drivers Are Slowing You Down
One free scan finds every outdated or missing driver and matches the right update for your exact hardware.Free scan · exact hardware matchThe routine requires regular play over several weeks, so families should consider whether that schedule is manageable and follow the prescribing clinician’s directions. Ask the clinician about side effects, whether the child’s attention issue matches the product’s indication, and how progress will be assessed.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Does EndeavorRx replace ADHD medication or therapy?
No. The product is intended as one part of a broader treatment program, not a stand-alone replacement for medication, education, or clinician-directed therapy. The pivotal trial’s participants were not taking disorder-related medication, while the separate adjunctive study examined use alongside other treatment in an open-label design; neither finding supports stopping or changing an existing treatment without guidance from the prescribing clinician.
Quick Recap
Sources
- EndeavorRx official FAQ: indication, safety, and use within a broader program.
- FDA 510(k) record K231337 and Kollins et al., STARS-ADHD trial abstract, The Lancet Digital Health (2020).
- EndeavorRx official About page: game description and routine.
- STARS-Adjunct study abstract, npj Digital Medicine (2021).
- EndeavorOTC official evidence page: adult product description and stated regulatory status.
Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.
