Otsuka Pharmaceutical Europe Ltd., Otsuka Pharmaceuticals (U.K.) Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) today announce the launch of Rejoyn^® in Great Britain, a prescription smartphone app developed as a treatment for depressive disorder. Rejoyn is the first prescription-only app in Great Britain for depressive disorder with this mode of action and is currently available within select NHS Trusts.

Designed to be used alongside a patient's existing care plan, Rejoyn offers patients a new approach to treat their symptoms. Unlike many cognitive behavioural therapy-based technologies available, Rejoyn is designed to increase cognitive control over emotions using an interactive cognitive-emotional and behavioural therapeutic approach.^2,3 The app has been shown to reduce the symptoms of depressive disorder within a six-week treatment programme, with patients continuing to have reduced symptoms at week 10 in the MIRAI clinical study.³

For patients in the pivotal MIRAI clinical study, on average, individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline.³ Symptom improvement was also consistently observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), the Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression - Severity scale (CGI-S).³

In addition, there were no treatment-emergent adverse events (TEAEs) assessed as being related to Rejoyn, no serious TEAEs, discontinuations due to a TEAE, or deaths in the patients receiving Rejoyn during the trial.³

Rejoyn is currently available within select NHS Trusts, with additional Trusts expected to arrange for provision of the treatment within the next 12 months.

Rejoyn holds a NHS Digital Technology Assessment Criteria (DTAC) certification and was granted a UK Conformity Assessment (UKCA) mark on the 26^th March 2025.

Rejoyn was developed in a collaboration between Otsuka and Click Therapeutics. In the U.S., Rejoyn was the first app to be granted clearance for the treatment of major depressive disorder by the U.S. Food and Drug Administration last year. ⁴ The launch in Great Britain marks the first in Europe and is part of Otsuka and Click's expansion of access to Rejoyn.

About Rejoyn
Rejoyn is a digital therapeutic for patients experiencing depressive disorder episodes.

Rejoyn requires a prescription or referral from a healthcare professional and is designed to be used alongside a patient's existing care plan.

Rejoyn combines three key components designed to reduce depressive symptoms over a six-week course:
　• Evidence-based Emotional Faces Memory Task (EFMT) 'brain exercises' which target an imbalance between brain regions that are implicated in depression
　• Cognitive behavioural therapy-based psychotherapy lessons which help patients to learn and apply key cognitive and emotional skills
　• Text messages and in-app notifications to help patients stay on track with their treatment

Rejoyn holds an NHS Digital Technology Assessment Criteria (DTAC) certification and is a UKCA marked medical device.

About the MIRAI Clinical Study
The indications for use of Rejoyn are supported by the results from the MIRAI clinical study, a pivotal, 13-week, multi-centre, remote, double-blinded, randomised controlled trial in adult participants diagnosed with Major Depressive Disorder (MDD), commonly known as depressive disorder in Great Britain, who were on antidepressant medication for the treatment of depression. The primary efficacy endpoint was the change from baseline to week six in the MADRS total score. Effectiveness was also evaluated using the PHQ-9 and the CGI-S.³

In the trial, a total of 386 participants were randomised to receive Rejoyn (194) or a sham control app (192) that resided on the patients' personal smartphones. The study enrolled patients from 22 to 64 years of age with a current primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and who reported an inadequate response to their current antidepressant medication, defined as <50% reduction in depression symptom severity in the current major depressive episode. The study included a 3-week screening period, a 6-week treatment period, and a 4-week extension period.³

Participants in both groups received personalised reminders and text messages throughout the study duration to maintain engagement, and trial visits were conducted remotely by video or telephone. Furthermore, all participants were expected to adhere to their app exercises during the treatment period, and adherence was monitored. During the trial, no serious treatment-emergent adverse events (TEAEs), discontinuations due to a TEAE, or deaths occurred in patients receiving Rejoyn that were related to the use of Rejoyn.³

About Otsuka
Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

References

• ¹Office for National Statistics. Cost of living and depression in adults, Great Britain: 29 September to 23 October 2022.Published 6 December 2022. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/mentalhealth/articles/costoflivinganddepressioninadultsgreatbritain/29septemberto23october2022.
• ²Rejoyn for Depressive Disorder Episodes Digital Therapeutic Software. Published 18 March 2025.
• ³Rothman B et al. Presented at Psych Congress 2024. October 29-November 02, 2024; Boston, MA, USA. Poster 185.
• ⁴ Otsuka. Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms. Published 1 April 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2305635