What OnDosis does

OnDosis AB (publ) is a Swedish life-science company founded in 2017 in Gothenburg as a spin-out from AstraZeneca, headquartered at the BioVenture hub in Mölndal. The company has developed the OnDosis Dosage Manager, a connected handheld electromechanical drug-delivery device that dispenses oral solid prescription medicines formulated as multiparticulates (granules, pellets, powders, or mini-tablets) with the press of a single button, alongside a Connected Services digital ecosystem comprising a patient mobile app, a domain-driven cloud platform with FHIR integration, and a physician web dashboard for remote therapeutic monitoring and closed-loop disease management.

The core product architecture is a reusable, rechargeable Control Unit paired with disposable pre-filled Cartridges available in three variants (OnDosis01 for pellets/granules, OnDosis02 for powders and smaller granules, and OnDosis03 for mini-tablets) and a dose Cup, with optional PIN, child-proofing, and tamper-resistant features. The platform is regulated as a drug-led drug/device combination, prescribed by physicians and intended for reimbursement as a medicine (e.g., via US Pharmacy benefits), and is built on ISO 13485, GDPR, and HIPAA standards.

OnDosis operates as a B2B out-licensor, collaborating with pharmaceutical partners on co-development programs across new drug applications, life-cycle management, value-added generics, clinical trials, and feasibility studies. The active pipeline includes ADHD programs with Tiefenbacher (under the OYSTA joint brand, targeting a 2025 US launch) and an undisclosed EU partner, peanut allergy with Camallergy, generalized anxiety disorder using low-dose psilocybin with Diamond Therapeutics, and specialty chronic-use categories (narrow-therapeutic-index medicines and immunosuppressants) with Revio Therapeutics, with clinical-trial adherence integration through AARDEX Group. Ownership spans AstraZeneca, Aeternum Capital, DIG Investment, Albonja, Ryd Gruppen, BCG, GU Ventures, and Nordic family offices, and the company raised SEK 92 million (approximately USD 11.1 million) in May 2021 to fund drug-device development, digital platform scaling, and supply chain expansion.

Name

OnDosis

Legal name

OnDosis AB (publ)

Website

https://ondosis.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

OnDosis is a Swedish life-science company that out-licenses a connected handheld drug-device platform (Dosage Manager) and digital adherence/physician ecosystem to pharmaceutical partners for individualized oral-solid dosing in ADHD, allergy, mental health, and specialty indications.

Ownership category

akta.pro rank

Headquarters

HQ city

Mölndal

HQ country

Sweden

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Marketing or Sales, Operations

Revenue model

1. Out-licensing of device technology and digital solutions: Business model built on out-licensing the proprietary Dosage Manager device technology and digital solutions to pharmaceutical partners. Revenue tied to co-development programs across new drug applications, life cycle management initiatives, value-added generics, clinical trials, and feasibility/prototype development. Partners typically lead formulation, clinical trials, registration and commercialization while OnDosis contributes the device and digital platform.
2. Drug/device combination product commercialization (planned): First planned commercial launch is the OYSTA stimulant drug/device combination for ADHD with Tiefenbacher in the US (targeted 2025), reimbursed as a medicine / through Pharmacy benefits, which implies per-unit hardware-plus-drug revenue at commercialization.

Go-to-market motion2 records

Core offering

OnDosis develops and out-licenses the Dosage Manager, a connected handheld electromechanical device that delivers precise individualised doses of oral solid prescription medicines formulated as multiparticulates (granules, pellets, powders, or mini-tablets) with one button click. The device is paired with OnDosis Connected Services, a digital ecosystem comprising a mobile patient app, a cloud platform, and a web-based Digital Physician Dashboard with FHIR integration, enabling closed-loop disease management and remote therapeutic monitoring. The technology is white-labelled to pharmaceutical partners as part of drug/device combination products across ADHD, rare diseases, transplantation, and specialty CNS indications.

Product overview

OnDosis offers a platform-plus-modules architecture for individualized dosing of oral solid medicines. The core offering is the OnDosis Dosage Manager, a connected handheld device (with reusable Control Unit and disposable pre-filled Cartridge plus Cup) that delivers precise, customizable doses of granules, pellets, powders, or mini-tablets with the click of a button. The Dosage Manager is available in three hardware variants tailored to formulation type: OnDosis01 for pellets/granules, OnDosis02 for powders and smaller granules, and OnDosis03 for mini-tablets. Complementing the hardware, OnDosis Connected Services is a digital ecosystem comprising the Patient App (mobile), a Domain-Driven cloud platform, and the Digital Physician Dashboard (web with Smart FHIR integration), which together enable remote therapeutic monitoring, adherence tracking, and closed-loop disease management. Under the joint brand OYSTA, OnDosis partners with Tiefenbacher Pharmaceuticals to develop an ADHD-specific drug/device combination planned for US launch in 2025. The technology is out-licensed to pharmaceutical companies for new drug applications, life cycle management, value-added generics, and clinical trials.

Differentiator

Problem solved

Functional benefit

Brands

• OYSTA: Joint brand with Tiefenbacher for the Dosage Manager plus stimulant drug/device combination product for ADHD treatment.

Products and services

• OnDosis Dosage Manager A first-in-class reusable, rechargeable, electromechanical, connected handheld device that delivers oral solid prescription medicines formulated as granules, pellets, powders or mini-tablets with the click of a button. The device is disease-agnostic, customized per drug/device combination, prescribed by physicians, and dispensed ready-to-use from the pharmacy as a drug/device combination product. It replaces conventional capsules and pills for medicines requiring dose titration, up-titration, tapering, or individualisation.
• OnDosis Connected Services A suite of connected digital services that closes the loop between physicians and patients, enabling remote therapeutic monitoring, closed-loop disease management, manufacturing support, operational tools, integration of third-party sensors and electronic medical records, advanced analytics, AI/ML capabilities, and biomarker tracking. Comprises a patient mobile app with end-to-end encrypted communication and a web-based Digital Physician Dashboard with Smart FHIR integration for adherence data and patient communication.
• OYSTA ADHD Drug-Device Combination Joint brand co-developed with Tiefenbacher Pharmaceuticals, an ADHD-specific Dosage Manager and stimulant drug/device combination addressing dose titration, adherence support, mitigation of non-medical use, and pediatric-friendly easy-to-swallow formulation.

Named customers6 records

Segments6 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• BioCorpx: French medical device company building connected drug delivery products (e.g., Inspair connected inhaler sensor, Injay prefilled syringe system) that pharma partners integrate into their therapies. Highly comparable to OnDosis in business model and connected-device positioning.
• Adherium: Digital health company commercializing connected inhaler sensors (Hailie) that capture adherence and provide patient feedback for respiratory therapies. Comparable to OnDosis as a small-cap connected medication adherence and digital health company partnering with pharma.
• etectRx: US digital health company with the ID-Cap system - an ingestible sensor embedded in a gelatin capsule for tracking oral medication adherence via a wearable patch. Directly comparable to OnDosis as a digital oral medication adherence/digital drug-device combination solution.
• Propeller Health (ResMed): Connected inhaler platform acquired by ResMed in 2019, providing sensors and a digital health platform for respiratory medication management. Comparable to OnDosis in building a connected medication + digital health ecosystem that pharma partners integrate with.
• Otsuka Pharmaceutical (Abilify MyCite): Commercialized Abilify MyCite in partnership with Proteus Digital Health - the first FDA-approved digital medicine system pairing an oral drug with an ingestible sensor and wearable patch. Closest comparable for a digital drug/device combination product, though Otsuka is far larger.

Broad incumbents

• Ypsomed: Swiss medical technology company with a broad connected self-medication portfolio (YpsoMate, SmartPilot connected add-on for autoinjectors) serving pharma partners in injectable therapy. Comparable as a connected drug delivery device supplier, though focused on injectables and operating at a much larger scale than OnDosis.
• Becton Dickinson (BD): Global medical technology incumbent with a broad drug delivery portfolio spanning auto-injectors, prefilled syringes, safety systems and drug-device combinations. Comparable as a drug delivery device partner to pharma, though operating at a much larger scale and across multiple delivery modalities.
• West Pharmaceutical Services: Global manufacturer of drug containment and delivery components, including elastomer seals, syringes, and self-injection platforms. Comparable as a pharma-facing drug delivery and containment partner, though at significantly larger scale and with a different therapeutic focus.
• Stevanato Group: Italian manufacturer of drug containment, drug delivery and diagnostic solutions, including syringes, vials and auto-injector platforms. Comparable as a drug delivery device supplier to pharma, though broader in scope and significantly larger than OnDosis.
• Aptar Pharma: Global drug delivery and active material solutions provider, including dispensing systems and digital therapeutics (post-Voluntis acquisition). Comparable as a partner to pharma offering both device hardware and digital/connected health layers, though at significantly larger scale and across multiple delivery modalities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/ondosis

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds4 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about OnDosis