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FDA approves ABILIFY (aripiprazole)
FDA approves SAMSCA (tolvaptan)
FDA approves ABILIFY MAINTENA (aripiprazole)
FDA approves REXULTI (brexpiprazole)
FDA approves ABILIFY MYCITE (aripiprazole tablets with sensor) Not commercially available
FDA approves JYNARQUE (tolvaptan)
FDA approves ABILIFY ASIMTUFII (aripiprazole) for extended release injectable suspension
FDA approves VOYXACT (sibeprenlimab-szsi)
FDA approved SIMTRIYO (centanafadine) Under U.S. Drug Enforcement Administration (DEA) scheduling review
Otsuka has launched an early access program for ulefnersen for people with FUS-ALS. The program aims to facilitate early access to the investigational drug outside clinical trials and support patients with limited treatment options.
Otsuka's Ulefnersen showed significant improvement in FUS-ALS patients, supporting its potential to modify disease progression. The drug was well tolerated with mostly mild adverse events. Results will be discussed with regulatory authorities for potential expedited approval.
New Phase 3b results demonstrate consistent improvements in ADHD and anxiety symptoms, executive function, and emotional dysregulation, as assessed by both clinicians and patients. The findings build on SIMTRIYO’s established ADHD clinical program and expand its profile in adults with comorbid anxiety disorders. The data are part of 26 Otsuka-sponsored abstracts presented at Psych Congress 2026, reflecting the company’s continued investment in CNS and psychiatric neuroscience research.
The REIGNITE Study is a multi‑year, longitudinal registry that will enroll more than 6,000 patients with IgA nephropathy to evaluate treatment patterns and health outcomes. The data generated will provide real‑world evidence to help shape future disease management and patient care.
The Phase 3 VISIONARY study met its key secondary endpoint, showing an annualized eGFR slope of +0.3 mL/min/1.73 m²/year with VOYXACT versus –4.2 with placebo. VOYXACT is the first FDA‑approved IgAN treatment to demonstrate stabilization of kidney function over two years, with a safety profile comparable to placebo. The results support VOYXACT’s selective APRIL inhibition as a disease‑modifying approach that targets a key driver of IgA nephropathy.
Otsuka will present Phase 3 VISIONARY data at GlomCon Hawaii 2026, showing that VOYXACT is the only APRIL inhibitor to achieve statistically significant eGFR stabilization over two years versus placebo. The results support kidney function preservation and halt disease progression in IgA nephropathy. These findings strengthen the evidence for selective APRIL inhibition as a safe, disease‑modifying therapy targeting underlying IgAN drivers.
VOYXACT® (sibeprenlimab-szsi), the first APRIL inhibitor to demonstrate statistically significant eGFR stabilization over two years, showed robust reductions in the risk of progression to kidney failure and improved kidney function in IgA nephropathy. The drug also received U.S. FDA accelerated approval in November 2025 for reducing proteinuria in adults with IgAN. These Phase 3 VISIONARY results complete the dataset and represent a milestone in Otsuka’s rolling submission of a supplemental Biologics License Application.