Therapeutic Areas

IBSA’s commitment to Digital Therapeutics (DTx)

Digital Therapeutics

Digital therapeutics – or digital therapies – are not mere tele-monitoring initiatives, nor simple applications concerning health: they are actual curative interventions, capable of affecting the clinical outcomes, exactly like a pharmacological treatment.

While a drug interacts with the patient’s biology, digital therapies interact with the thoughts and behaviours of the users. The treatment with digital therapies is based on changes in behaviour or lifestyle, as well as on the application of cognitive-behavioral interventions through the implementation of digital guidelines and programs.

As their pharmacological counterparts, digital therapies – which are considered to all intents and purposes like a medical device – also require a basis of scientific evidence, and they should be tested through clinical studies, approved by regulatory authorities, and followed by post-marketing studies.

Furthermore, in the same way as the traditional ones, digital therapies are also composed of an active ingredient and a series of excipients: the active ingredient is the therapeutic algorithm; the excipients – which are also digital – are all the services integrated into the platform, such as reminders and motivational messages.


Patients suffering from chronic diseases are those who can benefit most from digital therapies. These patients, in fact, often report secondary symptoms such as malaise, mood swings, insomnia, migraines, anxiety, weight gain or loss, tiredness: these are all – sometimes underestimated – symptoms which could be signs of therapeutic inadequacy. So, what are the prospects?

In chronic therapies, Digital Therapeutics could be useful to create therapeutic habits, improve the management of chronic therapies and assist patients discreetly, in real time and through personalised treatments.


Faithful to its vision of placing the Person at the centre of its work, IBSA is committed to developing a digital therapy for the treatment of hypothyroidism (a chronic disease).

Patients suffering from thyroid dysfunction, in fact, suffer from both physical and cognitive discomfort – such as depressed mood, reduced cognitive performance and reduced ability to concentrate – which is difficult to treat with drugs alone. Furthermore, they have to manage complex situations by themselves, including adherence to therapy and self-assessment of clinical status – since medical visits are often spread over time – with the risk of feeling abandoned in the management of their condition and/or malaise.

In order to improve the general status of these patients, IBSA is working on a digital therapy that can complement the pharmacological treatment. The objective is to introduce a therapeutic efficacy over the secondary symptoms that negatively impact the quality of life of people who suffer from thyroid disorders, symptoms which unfortunately cannot be managed by hormone therapy only, on which drugs act.

The development of this digital therapy is currently in the stage of a feasibility study (in terms of risks, costs and benefit for the patient), which is the most important phase before starting with clinical research. In this video, Lucia Zaccardi, Sr. R&D Scientific Liaison Manager from IBSA’s R&D Scientific Affairs department, will tell us more about this project.