Orion’s phase 2 study of ODM-105 in insomnia did not meet primary goal
ORION CORPORATION
PRESS RELEASE
30 SEPTEMBER 2025 at 13.00 EEST
Orion’s phase 2 study of ODM-105 in insomnia did not meet primary goal
- Orion to discontinue development of ODM-105 for insomnia.
- ODM-105 (tasipimidine) was well tolerated. Detailed results, including safety data, and their assessment are to be finalized.
Orion Corporation today announced that its candidate ODM-105 (tasipimidine) did not meet the primary goal in the clinical Phase 2 UNITAS study for the treatment of patients with insomnia. According to the study results, ODM-105 did not significantly improve insomnia-related symptoms such as time to fall asleep or sleep duration compared with placebo. ODM-105 was generally safe and well tolerated. Detailed results, including safety data, and their assesment are not yet finalized.
“We are disappointed that our study did not meet its primary goal. Our biggest regret is that we’re not able to provide a new and more efficient treatment option for people suffering from insomnia”, said Professor Outi Vaarala, Executive Vice President, Innovative Medicines and Research & Development at Orion. “Recruitment for the UNITAS study was faster than expected, which enabled an earlier read-out of efficacy signals. On the other hand, it also reflects the huge unmet need for new insomnia treatments that still remains. We will focus our efforts and resources on advancing our other assets both in research and clinical phases.”
About the UNITAS study
UNITAS is a Phase 2b randomized, triple-blind, and placebo-controlled trial evaluating the safety and efficacy of ODM-105 (tasipimidine) compared with placebo in 153 adult patients diagnosed with insomnia disorder. The endpoints of the study are wake after sleep onset (WASO) and latency to persistent sleep (LPS), measured via polysomnography.
Orion Corporation
Contact person:
Tuukka Hirvonen, Head of Investor Relations, Orion Corporation
Tel. +358 10 426 2721
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com
Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion’s net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion’s A and B shares are listed on Nasdaq Helsinki.
