Takeda today presented additional results from two pivotal Phase 3 studies at SLEEP 2026, demonstrating that oveporexton (TAK-861) improved daily functioning, cognitive symptoms, and nighttime sleep in patients with narcolepsy type 1 (NT1). The data, derived from the FirstLight and RadiantLight studies, support the potential of oveporexton to address the broad disease spectrum driven by orexin deficiency. Regulatory submissions for the drug are currently under review in multiple jurisdictions, including the United States, China, and Japan.

The presentations focused on secondary and exploratory endpoints from the global, multicenter, placebo-controlled studies. FirstLight (TAK-861-3001) evaluated twice-daily doses of 2mg and 1mg against placebo, while RadiantLight (TAK-861-3002) assessed a twice-daily 2mg dose against placebo. The studies enrolled 168 and 105 participants respectively across 19 countries.

Key Findings from Phase 3 Studies

Results indicated statistically significant improvements across multiple domains of patient health at week 12 compared to placebo.

Functional Improvement

Oveporexton significantly improved daily functioning across all six domains of the Functional Impacts of Narcolepsy Instrument (FINI) at all tested doses (p<0.001). Most patients reached or exceeded published normative domain thresholds, indicating an ability to better manage everyday lives. The FINI domains include tiredness, cognitive functioning, cataplexy, social activities, everyday activities, and everyday responsibilities.

Cognitive Symptoms

The drug improved cognitive symptoms associated with NT1, as measured by objective neuropsychological tests and patient-reported measures. Approximately 70% of patients across all doses reported no significant cognitive difficulties on the FINI Cognitive Function domain, compared to approximately 15% in the placebo arm.

Nighttime Sleep Quality

Exploratory endpoints showed improvements in sleep quality. Most patients reported no hallucinations or sleep paralysis. Those on the 2/2mg dose reported meaningful reductions in disturbed nighttime sleep from baseline. Additionally, the timing and pattern of rapid eye movement (REM) sleep shifted toward patterns observed in healthy controls.

Regulatory Status and Next Steps

The United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for oveporexton and granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. Submissions are also under review in China and Japan, with additional filings planned throughout the year. Oveporexton is an investigational compound and has not yet been approved for use by any regulatory authority.

Takeda Pharmaceutical Company Limited announced that its investigational drug zasocitinib (TAK-279) demonstrated statistical superiority over Bristol-Myers Squibb Co.'s Sotyktu (deucravacitinib) in the Phase 3 LATITUDE Atlas head-to-head study involving adults with moderate-to-severe plaque psoriasis. The primary endpoint of Psoriasis Area and Severity Index (PASI) 100 response rate at week 16 was met, along with all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16. The drug was generally well tolerated with no new safety signals identified.

The LATITUDE Atlas (TAK-279-PsO-3004) study was a randomized, multicenter, double-blind trial comparing zasocitinib, a next-generation oral tyrosine kinase 2 (TYK2) inhibitor, to deucravacitinib. Results indicated that more than 35% of patients treated with zasocitinib achieved complete skin clearance (PASI 100) at week 16, which was more than 2.5 times the response rate observed for deucravacitinib. Separation from the deucravacitinib curve was evident as early as week 8.

Key Study Findings

Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and principal investigator for the study, noted that the results highlight clinically meaningful differences within the oral treatment class. Chinwe Ukomadu, MD, PhD, senior vice president and head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda, emphasized that the findings reinforce the potential of zasocitinib to deliver rapid and durable skin clearance.

AI-Developed Drug Targets Multi-Billion-Dollar Opportunity

Zasocitinib was developed using artificial intelligence, highlighting the pharmaceutical industry's increasing use of AI to accelerate drug development, streamline clinical trials, and reduce reliance on animal testing. Takeda stated that, if approved, zasocitinib could achieve peak annual sales of $3 billion to $6 billion.

Takeda intends to present detailed data from the head-to-head study at upcoming medical congresses. These results build on previously presented Phase 3 LATITUDE PsO data from studies 3001 and 3002. The company remains on track to submit a New Drug Application for plaque psoriasis with the United States Food and Drug Administration and other regulatory authorities starting this fiscal year.