Part of OTSUKA HOLDINGS CO., LTD.
Clinical Trials
469
19 active
Approvals
68
Total approvals
Agencies
5
Regulatory bodies
Founded
1964
Active, not recruiting
8
1.7%
Completed
290
61.8%
Not yet recruiting
11
2.4%
Recruiting
16
3.4%
Suspended
1
0.2%
Terminated
10
2.1%
Withdrawn
1
0.2%
- Otsuka presented Phase 3b results at Psych Congress 2026 showing centanafadine improved ADHD and anxiety symptoms in 315 adults with ADHD and comorbid generalized or social anxiety disorder. - Centanafadine met the primary endpoint with an AISRS treatment difference of -5.87 versus placebo at Week 8, with separation from placebo as early as Week 1. - Pre-specified analyses showed significant gains on self-reported ADHD symptoms, executive function, emotional dyscontrol, and clinician- and patient-rated global severity measures. - The most common treatment-emergent adverse events were nausea, decreased appetite, and diarrhea, consistent with centanafadine's known safety profile in this population.
- The Generic and Biosimilar Medicines Association (GBMA) has been granted leave to intervene as a 'friend of the court' in a High Court case that could reshape Australia's pharmaceutical patent extension regime. - The case, Otsuka Pharmaceutical Co., Ltd & Ors v Sun Pharma ANZ Pty Ltd, examines whether patents covering pharmaceutical formulations—rather than only active pharmaceutical substances—qualify for patent term extensions. - GBMA argues that clear and predictable patent rules are essential for generic and biosimilar medicine suppliers making long-term decisions about product development and market entry. - The outcome will determine how Australia balances protection of genuine pharmaceutical innovation with the public interest in timely generic competition once patent protection expires.
- Otsuka Pharmaceutical has obtained exclusive commercialization rights in Japan for Sky Labs' CART BP pro, a ring-type automated blood pressure monitor that uses photoplethysmography technology to measure blood pressure without a cuff. - The device enables continuous 24-hour monitoring including during sleep, addressing limitations of conventional cuff-based monitors that cause pain and disrupt nocturnal measurements in Japan's 43 million hypertension patients. - CART BP pro has already achieved significant success in South Korea with medical device approval, insurance reimbursement, and adoption by 1,700 hospitals and clinics with over 150,000 prescriptions within one year of launch. - The partnership represents a strategic expansion for Sky Labs following recent CE-MDR certification in Europe, while strengthening Otsuka's comprehensive cardiovascular disease management portfolio in Japan.
- IRLAB Therapeutics received regulatory and ethical approvals for a Phase Ib study of IRL757, targeting apathy in Parkinson's disease patients across 16 European sites. - The 75-patient trial represents a significant advancement for treating apathy, a debilitating condition affecting 20-70% of Parkinson's patients with no current therapeutic options. - Previous Phase I studies demonstrated IRL757's favorable safety profile and systemic exposure, with all participants completing the studies without serious adverse events. - The collaboration with Otsuka's subsidiary MSRD provides full funding for this first-in-class drug candidate that targets central nervous system signaling disruptions underlying apathy.
- The Full Court of the Federal Court of Australia ruled that only patents claiming active pharmaceutical ingredients are eligible for patent term extensions, not pharmaceutical formulations. - The decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd invalidates existing patent term extensions for formulation patents, creating "zombie PTEs" vulnerable to challenge. - Pharmaceutical companies must urgently review their patent portfolios as the ruling affects loss of exclusivity dates and may accelerate generic drug market entry across Australia.
- 4D Molecular Therapeutics announced a strategic partnership with Otsuka Pharmaceutical for exclusive development and commercialization rights of 4D-150 in the Asia-Pacific region, including Japan, China, and Australia. - The agreement includes an $85 million upfront payment and at least $50 million in cost sharing over three years, with potential milestone payments reaching up to $336 million plus tiered double-digit royalties. - 4D-150 is designed as a potentially transformative gene therapy providing multi-year sustained anti-VEGF delivery with a single intravitreal injection for wet AMD and diabetic macular edema. - The partnership aims to address significant unmet medical needs in the APAC region, where wet AMD affects over 4 million patients in major markets and DME represents a large underserved population.
- A matching-adjusted indirect comparison (MAIC) study suggests difamilast 1% cream has comparable efficacy and safety to delgocitinib in treating moderate-to-severe atopic dermatitis (AD). - The MAIC analysis adjusted for differences in baseline characteristics between clinical trials of difamilast and delgocitinib to allow for a more accurate comparison. - Results indicated no statistically significant differences in the proportion of patients achieving EASI-50 or EASI-75, or experiencing adverse events, between the two treatments. - The findings support difamilast as a viable alternative for managing AD, particularly in patients where JAK inhibitors may not be suitable.
