What Is OnDosis?
OnDosis review introduces a digital drug-delivery system developed to personalize ADHD treatment through flexible, button-activated dosing. Designed by a Swedish health-tech company of the same name, the platform combines a digital dispenser with pre-loaded micropellet cartridges and a mobile app, offering a novel alternative to fixed-dose tablets-particularly in pediatric care.
Unlike traditional pills, OnDosis delivers medication in precisely calibrated micropellets. Each press of the button dispenses a dose unit that can be adjusted based on time of day, symptoms, and clinical feedback. This model allows for more granular control of stimulant medication-a major need in managing attention-deficit/hyperactivity disorder (ADHD), where response can vary significantly between patients and over time.
The company’s goal is to offer ADHD patients-especially adolescents-a personalized and data-enabled experience that improves both therapeutic outcomes and pediatric adherence. Parents and physicians can monitor dosing behavior, while patients benefit from more autonomy and fewer side effects associated with rigid titration schedules.
Early applications are focused on ADHD dosing, but OnDosis has signaled future use cases in neurology and immunology. The system has been presented at several international med-tech forums and is currently advancing through FDA clearance, aiming for U.S. market launch in 2025 under the joint ADHD brand OYSTA®.
How the Micropellet Dosing System Works
At the core of OnDosis is a proprietary micropellet-based delivery mechanism that transforms the way stimulant medications are administered. Instead of receiving a fixed-dose tablet or capsule, the patient uses a handheld digital dispenser that releases medication in individually calibrated granules. These micropellets, typically composed of a compressed active pharmaceutical ingredient (API) and protective excipients, allow for ultra-precise, scalable dosing in small increments.
Each press of the dispenser’s button releases a pre-defined quantity of micropellets-essentially functioning as a customizable titration step. The number of presses per dosing window (morning, midday, afternoon) can be adjusted to match the patient’s clinical profile, daily schedule, or behavioral response. This makes OnDosis especially useful in ADHD dosing, where under- or over-medication can impact attention, appetite, mood, or sleep.
The smart dispenser is digitally connected to a companion mobile app, which tracks dosing history, timestamps, and user behavior.
This data can be shared with physicians, caregivers, or integrated into an electronic health record (EHR) or remote-monitoring platform. Over time, the system creates a longitudinal profile of how the patient responds to therapy-paving the way for adaptive, data-driven medication management.
Unlike liquid titration kits or crushable tablets, OnDosis removes the variability and human error associated with manual dose splitting. It’s also designed to be child-friendly, portable, and intuitive, reducing stigma and improving pediatric adherence in everyday use.
With this approach, OnDosis aims not just to deliver medication, but to enable dynamic, real-world personalization—something rarely seen in stimulant-based ADHD treatment to date.
Clinical Status and Observations
As of mid-2025, OnDosis has not registered or completed any Phase II or III clinical trials in major public registries such as ClinicalTrials.gov or the EU Clinical Trials Register. While the company has actively promoted its technology through patent disclosures, product demonstrations, and healthcare conferences, no peer-reviewed clinical efficacy data have yet been published.
Instead, OnDosis has focused on early usability pilots and pre-clinical dose-delivery simulations, which have received positive informal feedback from pediatric clinicians. These evaluations highlight the system’s potential for personalized titration and improved user engagement. However, any claims regarding treatment outcomes or adherence improvements-such as the reported 22-percentage-point increase—remain unverified and should be considered preliminary pending formal study data.
The company has stated its intent to pursue regulatory clearance via the FDA 510(k) or De Novo pathway, though no active submissions are listed in the public FDA databases as of May 2025. A commercial launch in the U.S. remains a target for 2025, but this timing is subject to change based on regulatory progress and classification outcomes.
Importantly, in 2024 OnDosis entered a verified partnership with AARDEX Group, a Swiss firm specializing in digital adherence analytics. This collaboration supports future real-world evidence collection and integration with adherence-tracking platforms across clinical and home-use settings.
UX Aspects for Parents and Children
User experience is a central design pillar for OnDosis, particularly given its focus on pediatric ADHD. Unlike conventional tablets or capsules, which require strict supervision and offer little flexibility, the OnDosis system is engineered for daily usability, child safety, and family control.
The dispenser itself is compact and intuitive, requiring only a simple button press to deliver a dose. It avoids the need for pill counting, splitting, or liquid measuring—common sources of friction for parents. The device’s feedback system (audible click and LED light) provides immediate confirmation that a dose has been dispensed.
To enhance pediatric adherence, OnDosis is paired with a mobile app that tracks dosing patterns and provides customizable reminders. Parents can view logs in real time, set limits on daily usage, and adjust dosage intervals in coordination with healthcare providers. The interface is designed to be friendly and non-clinical, helping reduce stigma for children managing ADHD at school or at home.
Safety features include a dose-lockout system, preventing unintentional double-dosing or unsupervised use. In some models, two-step activation (e.g., unlock + press) ensures secure delivery, particularly in younger age groups. The dispenser is also tamper-resistant and designed to withstand drops or misuse.
A unique benefit for parents is the dynamic dosing schedule: they can collaborate with clinicians to fine-tune the timing and quantity of medication across the day (e.g., more in the morning, tapering by evening), based on the child’s behavior and needs. This eliminates the rigidity of standard pill packs and gives families more day-to-day control over treatment.
Overall, the UX model aims to shift ADHD care from a “compliance burden” to a personalized, tech-enabled experience-empowering both parents and children with tools that fit real life, not just prescriptions.
Risks and Regulatory Considerations
As with any connected drug-delivery system-particularly those used in pediatric care-OnDosis must balance innovation with stringent regulatory and safety requirements. Its core value proposition lies in flexible, personalized dosing, but this comes with unique risks and oversight responsibilities.
Device-specific risks
- Incorrect dosing due to user error (e.g., accidental double-pressing or missed inputs)
- Hardware malfunction, such as battery depletion or dispenser failure during active use
- Connectivity loss between the dispenser and mobile app, impairing dose tracking
- Data security and privacy, especially in school-age populations or multi-user households
To mitigate these, the OnDosis device incorporates several safeguards: dose-lockout systems, two-step activation for child protection, encrypted cloud communication, and offline logging. The app complies with GDPR and HIPAA requirements for health-data transmission and consent.
Regulatory status
OnDosis is expected to be regulated as a combination product in both the U.S. and EU, involving drug, device, and software components. In the United States, the company has stated its intent to submit a 510(k) application, but as of May 2025, no official filing is listed in FDA’s public databases. The regulatory route—510(k), De Novo, or full NDA/IND-will depend on how FDA classifies the novelty and intended use of the product.
In the EU, the digital dispenser must comply with MDR (EU 2017/745) rules governing programmable medical devices, while the micropellet formulation is subject to traditional EMA drug review.
Real-world evidence and compliance
With the FDA placing increasing emphasis on real-world evidence (RWE), OnDosis’s connected system is well-positioned to generate post-market adherence and safety data. The company’s partnership with AARDEX Group adds credibility here, offering integration with validated behavioral-tracking tools and supporting SaMD-level audit trails.
As combination products gain traction in digital therapeutics, OnDosis represents a high-impact case where flexible dosing and smart analytics must meet established medical-device and drug-safety thresholds.
Explore More / Download Resources
OnDosis represents a new generation of digital dosing platforms that blend precision, personalization, and patient empowerment-especially in pediatric ADHD care. If you’re a clinician, researcher, or digital-therapeutics innovator, there are several ways to go deeper:
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