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Freedom251 › Blog › ADHD

What Is a Prescription Digital Therapeutic for ADHD? How EndeavorRx Works

By Freedom251 Team · · 4 min read

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A prescription digital therapeutic is software prescribed to deliver a treatment—not simply a game or general brain-training app. In the United States, the best-documented ADHD example is EndeavorRx, a mobile game prescribed for certain children ages 8–17. It is designed to train a specific, computer-measured attention function and is intended to complement, not replace, a broader ADHD treatment plan.

What is a prescription digital therapeutic for ADHD?

A prescription digital therapeutic (PDT) uses software to deliver a therapeutic intervention. EndeavorRx, also called AKL-T01, is a software-based medical device. A healthcare professional prescribes it, and it is intended for use by the patient named on that prescription. That makes it different from downloading an entertainment game or an unprescribed brain-training app.

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The US indication is for 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—not a general claim to treat every ADHD symptom or outcome. The product is intended as one part of a broader treatment program.

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How does EndeavorRx work?

The child plays a mobile game in which they navigate courses, collect targets, and avoid obstacles. The software combines sensory stimuli with motor challenges: the player must respond to relevant targets while managing competing demands and distractions. An algorithm adjusts the challenge in response to performance.

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The described approach is an attention-training game. The available evidence does not establish that it changes brain structure or works by a specific simplified brain-region mechanism.

The manufacturer describes a typical routine of 10–25 minutes a day, five days a week, for at least four consecutive weeks, or as prescribed. Use the current instructions for use for device compatibility and practical directions; specific compatible device models are not established here.

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Is EndeavorRx FDA approved?

The FDA database lists EndeavorRx under 510(k) K231337, with a substantially equivalent decision dated December 13, 2023. The manufacturer describes the product as FDA-authorized. This regulatory status does not make it a medication, establish that it is a cure, or broaden its indicated use beyond the population and attention-function outcome in its labeling. See the FDA 510(k) record.

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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 prescription ADHD treatment equivalent to EndeavorRx. EndeavorOTC evidence and regulatory information.

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What does the clinical evidence show?

The pivotal randomized trial

The STARS-ADHD study was a randomized, double-blind, parallel-group trial conducted at 20 US research institutions. It evaluated 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 about 25 minutes of play daily, five days a week, for four weeks.

In the 2020 report by Kollins and coauthors, mean TOVA API change was 0.93 points in the AKL-T01 group and 0.03 in the digital-control group. The reported median change estimate was 0.88 points (95% confidence interval 0.24–1.49; p=0.0060). These results concern an objective attention-performance test; they do not show that every core ADHD symptom or day-to-day outcome improves. The authors said further research was needed. Read the trial record.

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Other evidence and its limits

An 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 offer the same controlled comparison as the pivotal randomized trial. Neither study establishes a basis for ranking EndeavorRx against medication or behavioral therapy, or for treating the options as equivalent.

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Safety findings reported in the pivotal study

The pivotal trial reported 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 findings from that trial, not a guarantee that an individual will have no adverse effects. The product FAQ also notes that improvement on an attention test may not translate into improvement in typical behavioral symptoms such as hyperactivity. See the EndeavorRx FAQ.

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Who can use EndeavorRx?

In the United States, the indicated group is children ages 8–17 with primarily inattentive or combined-type ADHD and a demonstrated attention issue. A healthcare professional must prescribe it, and it should be used only by the patient named on the prescription. The pivotal randomized trial itself enrolled children ages 8–12 who were not taking disorder-related medication, so its participant group was narrower than the labeled age range.

The indication should not be generalized to adults, all ADHD presentations, all symptom domains, or jurisdictions outside the United States. A clinician can determine whether it fits a child’s situation and how it should sit alongside other care. The product information describes it as part of a therapeutic program rather than a stand-alone intervention. Manufacturer information about EndeavorRx.

Does EndeavorRx replace ADHD medication or therapy?

No. EndeavorRx is intended as one element of a broader treatment program, not as a substitute for medication, education, or clinician-directed therapy. Its measured target is attention performance, so a change on that test should not be assumed to replace care addressing other symptoms, impairments, or needs. Decisions about combining or changing treatments belong with the child’s healthcare professional.

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How to think about the evidence and treatment fit

  • Check the target: EndeavorRx is indicated for an objective attention-function outcome, not every aspect of ADHD.
  • Check the population: The US indication is pediatric and defined by age, ADHD presentation, and demonstrated attention issue; the pivotal trial studied a narrower group.
  • Keep the evidence design in view: The pivotal evidence was randomized and controlled; the adjunctive study was open-label.
  • Discuss the practical plan: A prescriber can weigh the treatment burden and fit with the child’s existing medication, therapy, education, and other supports.

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.

ADHDdigital therapeuticsEndeavorRxFDAhealth technology

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