New ADHD Stimulant: FDA Decides in 7 Days
Your Doctor Can Now Prescribe an App for ADHD
On December 10, 2025, Lumos Labs received FDA 510(k) clearance for LumosityRx — a prescription-only version of Lumosity with 13 cognitive training games indicated for inattentive or combined ADHD in adults ages 22–55. It’s the kind of headline that scrolls past because “brain training app for ADHD” sounds like something you’d see advertised on a podcast. It isn’t.
This is a different category than the apps you’ve already dismissed. And most adults with ADHD — and most of their prescribers — have never heard of it.
TL;DR for ADHD Brains
LumosityRx EndeavorOTC Requires prescription? Yes No Age range 22–55 18+ FDA status 510(k) cleared Dec 2025 510(k) cleared Jun 2024 Indicated for Inattentive or combined ADHD Inattentive or combined ADHD Insurance path Possible (2026 CMS billing codes) Out of pocket Mechanism 13 cognitive training games Adaptive video game (Project: EVO engine) One-sentence verdict: LumosityRx is the one your doctor can actually prescribe, with a potential insurance path coming; EndeavorOTC is the one you can try today without anyone’s permission.
Best for: Adults who want a non-medication adjunct treatment with real regulatory standing — not just “clinically inspired” marketing copy Skip if: You’re looking for a standalone replacement for medication or therapy — these are adjuncts, not replacements
What Is a Prescription Digital Therapeutic?
This is worth establishing clearly, because the category gets muddied constantly.
A prescription digital therapeutic (PDT) is software that has gone through the FDA’s medical device clearance process and is intended to prevent, manage, or treat a clinical condition. It isn’t a wellness app. It isn’t a “brain training” app in the consumer sense. It’s a medical device that happens to run on a phone or tablet.
The regulatory pathway is either 510(k) clearance (demonstrating substantial equivalence to an already-cleared predicate device) or De Novo authorization (for novel device types without a predicate). LumosityRx took the 510(k) path. Akili’s EndeavorOTC went through 510(k) clearance (using the original EndeavorRx De Novo as its predicate).
What separates these from the apps already on your phone: they’ve submitted clinical evidence to the FDA, the evidence was reviewed, and the clearance is on the record. You can look it up. That’s the bar most apps never bother to reach.
LumosityRx: Brain Training, Upgraded to Medical Device
The LumosityRx product page describes what Lumos Labs built: 13 clinically validated cognitive training games, specifically selected and tested for adults with ADHD, indicated for inattentive or combined presentation in the 22–55 age range.
The clinical data from the clearance application showed that 1 in 3 participants rated “much improved” or better on the CGI-I (Clinical Global Impression of Improvement) scale. Adverse events came in under 1%. Those aren’t earth-shattering numbers — but for a non-pharmacological intervention, they’re real numbers from a real trial, not marketing assertions.
The difference from regular Lumosity matters. Consumer Lumosity makes no clinical claims. It’s a game platform. LumosityRx is a different product that went through FDA review with actual clinical data attached. If your doctor prescribes LumosityRx, they’re prescribing the version with regulatory standing. Don’t confuse the two — a point worth making explicitly because the branding similarity invites that mistake. (We’ve covered this distinction in the working memory tools guide, where LumosityRx comes up in the context of cognitive training evidence.)
The prescription requirement serves a real function: it puts the conversation in a clinical context. Your prescriber looks at your presentation, decides if this is appropriate, and issues a prescription. That means a doctor has reviewed it for you specifically — not a random recommendation from an ad algorithm.
The honest limitation: Cognitive training for ADHD has a complicated evidence history. The research consistently shows that people get better at the trained tasks. Transfer to real-world attention and executive function is where results are more variable. What the FDA clearance means is that the specific evidence for LumosityRx’s 13 games, in this specific population, met the regulatory bar. That’s meaningful. It’s not a guarantee that you’ll notice a difference at work.
EndeavorOTC: No Prescription, No Waiting Room
EndeavorOTC is the over-the-counter version from Akili Interactive — and it’s the first FDA-authorized OTC digital therapeutic for adult ADHD — inattentive or combined type (ages 18+). No prescription. No appointment. You download it and use it.
The mechanism is the Project: EVO engine, the same underlying tech that powers the prescription EndeavorRx platform. The app presents as a video game — you’re guiding a character through environments while managing simultaneous cognitive demands. The dual-task design is intentional: it targets the same frontoparietal attention networks that ADHD affects.
Worth separating from EndeavorRx, which is a different product: prescription-only, originally indicated for children 8–12. EndeavorOTC is the adult, no-prescription product. If you’ve seen coverage of EndeavorRx and assumed it wasn’t for you, that distinction matters.
The OTC framing has real consequences for who can access it. Adults who can’t get an appointment, don’t have a psychiatrist, or are waiting months for an ADHD evaluation can access EndeavorOTC right now. That’s not nothing. For the significant population of adults with late or no diagnosis, an OTC FDA-authorized option is a different kind of access than anything that requires a prescriber in the loop.
The Insurance Question (This Is Where Things Get Interesting)
Here’s the part that most coverage of these products misses entirely.
The 2026 CMS Physician Fee Schedule final rule includes a new billing category for prescription digital therapeutics. This is the first time Medicare has created a reimbursement pathway specifically for this product class. The new HCPCS billing codes (G0552–G0554) cover prescription digital mental health treatment devices.
What this means practically: LumosityRx — as a prescription digital therapeutic with FDA clearance — now has a plausible path to insurance reimbursement that simply didn’t exist before. “Plausible path” is doing real work in that sentence. Billing code existence doesn’t guarantee that your specific plan will cover it, that your doctor knows to bill it, or that the reimbursement rates will make it economically viable for prescribers. But the infrastructure is being built. That’s new.
For adults who’ve historically paid out of pocket for every non-medication ADHD support (coaching, therapy, tools), this represents a structural shift. Not an immediate fix. A structural shift.
EndeavorOTC, being OTC, doesn’t fit into this prescription billing framework. You pay for it directly. Pricing varies.
How Do These Fit Into an ADHD Treatment Stack?
These are adjunct treatments. Not replacements for medication if medication is working. Not substitutes for therapy.
The appropriate frame is something like: you already have your medication, or you’ve decided to manage without it. You’re already using productivity tools, maybe a body doubling app or AI task manager. The PDT category is trying to address a layer those tools don’t touch — the cognitive training layer. Directly targeting the attention networks, not just accommodating for what they can’t do.
A few things to think through before deciding whether to pursue either product:
If you’re already in treatment with a psychiatrist: Ask about LumosityRx directly. Most psychiatrists haven’t prescribed one yet — this category is genuinely new to most prescribers. Bring the name, bring the FDA clearance date. You may need to educate them slightly, which is annoying but not impossible.
If you want to try something without a prescription first: EndeavorOTC exists for exactly that reason. Try it. See whether you notice anything. The absence of a prescription requirement means you can evaluate it empirically without a clinical commitment.
If your primary issue is working memory specifically: The working memory tools guide covers both LumosityRx and the full picture of training approaches, including free options. That’s the more complete picture for that symptom profile.
If you’re currently unmedicated and looking for non-pharma clinical-grade options: The BMJ umbrella review of ADHD treatments gives context for where cognitive training sits in the evidence hierarchy relative to medication, CBT, and other interventions.
What’s Actually Happening in This Category
Prescription digital therapeutics have been a regulatory category for a few years now. The rollout has been slower than proponents hoped. Pear Therapeutics, one of the first PDT companies, went bankrupt in 2023 before its products reached scale. Akili Interactive went through significant restructuring. The category’s commercial viability has been a live question.
LumosityRx’s December 2025 clearance, combined with the 2026 CMS billing framework, represents something like a second attempt at getting this right. Different companies, different products, a regulatory infrastructure now starting to match the clinical ambition.
Whether it reaches patients at scale depends on things that are genuinely uncertain: whether prescribers adopt new prescribing habits, whether payers honor the billing codes, whether adults with ADHD find the user experience compelling enough to stick with it. The clearance is step one of a multi-step process that has stalled before.
The honest answer to “should I try this?” is: if you can access it, the evidence supports trying it as an add-on to whatever you’re already doing. The FDA clearance means something. The CGI-I data is real. The adverse event rate is essentially zero — there’s no meaningful downside risk here in the way there is with medication.
If your prescriber hasn’t heard of it, that’s not a red flag about the product. It’s a reflection of how slow clinical adoption of new treatment categories tends to be, especially ones that require a mindset shift about what “prescribing” means.
The Bottom Line
LumosityRx is what you ask your doctor about. FDA-cleared, prescription-required, 13 cognitive training games indicated for your specific presentation (inattentive or combined, ages 22–55). The insurance reimbursement infrastructure is being built right now via 2026 CMS billing codes. If you’re already seeing a prescriber, this is worth a conversation.
EndeavorOTC is what you try today. Download it. No prescription, no appointment. FDA-authorized for adult ADHD — inattentive or combined type. The same video game engine that the prescriber products use, without the gatekeeping.
Neither of these is going to feel like taking a stimulant. The mechanism is different, the timeline is different, the magnitude is different. What they offer is a non-medication option with genuine regulatory standing — not “clinically inspired,” not “research-backed” (meaningless marketing language) — actually cleared by the FDA based on actual clinical data.
For adults with ADHD who are mostly choosing between medication and nothing, that’s a real addition.
LumosityRx received FDA 510(k) clearance on December 10, 2025. It is indicated for adults aged 22–55 with inattentive or combined ADHD as an adjunct to their current treatment. EndeavorOTC received FDA 510(k) clearance in June 2024 for adults 18+ with inattentive or combined ADHD. Neither product is approved as a standalone replacement for medication or behavioral therapy.
