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更新于：2026-04-19
Otsuka Holdings Co., Ltd.
更新于：2026-04-19
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NCT07229339
Phase 2 Trial of Zipalertinib in Patients With Resectable Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion or Uncommon/Compound Mutations
NCT07525960
A Phase 1b, Open-label Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of NDI-5001 in a Capsule Following Daily Oral Doses to Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus
NCT07530250
A Randomized, Double-blind, Crossover Study to Assess the Relative Bioavailability of Two Coenzyme Q10 Products in Men and Women
100 项与 Otsuka Holdings Co., Ltd. 相关的临床结果
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2026-06-01PSYCHIATRY RESEARCH
Efficacy and safety of brexpiprazole in early-episode schizophrenia: post hoc analysis of Phase 3 clinical trials in adults and adolescents
Article
作者: Palma, Anton M ; Pham, Tim ; Correll, Christoph U ; Pflug, Brian ; Zhang, Zhen ; Yildirim, Murat
OBJECTIVE:
To evaluate the efficacy and safety of brexpiprazole in patients with early-episode schizophrenia.
METHODS:
Data were pooled from four 6-week, randomized, double-blind, placebo-controlled trials in schizophrenia. Three trials (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380) enrolled adults aged 18-65 years; one trial (NCT03198078) enrolled adolescents aged 13-17 years. Data from participants meeting early-episode criteria (age 13-35 years, ≤5 years illness duration) were pooled for participants randomized to brexpiprazole 2-4 mg or placebo. Efficacy on schizophrenia symptoms was primarily evaluated using the Positive and Negative Syndrome Scale (PANSS; primary endpoint in all trials). Change in functioning was measured using the Personal and Social Performance (PSP) scale in adults and Children's Global Assessment Scale (CGAS) in adolescents. Safety was also assessed.
RESULTS:
Across 476 participants (brexpiprazole 2-4 mg/day, n = 289; placebo, n = 187), change from baseline to Week 6 was greater with brexpiprazole versus placebo on PANSS total score (least squares [LS] mean difference -3.6; 95% confidence interval [CI] -7.0, -0.1; p = 0.04; Cohen's d 0.19), and a combined PSP/CGAS functioning score (LS mean difference 2.3; 95% CI: 0.1, 4.5; p = 0.04; Cohen's d 0.19). The incidence of treatment-emergent adverse events (TEAEs) was 50.7% with brexpiprazole and 46.3% with placebo. The most common TEAEs with brexpiprazole were insomnia (brexpiprazole, 9.2%; placebo, 9.5%) and akathisia (brexpiprazole, 6.5%; placebo, 2.1%).
CONCLUSION:
This analysis expands the evidence base for brexpiprazole in schizophrenia by demonstrating efficacy in patients who are early in their disease course. The safety profile of brexpiprazole was consistent with previous clinical trials.
2026-03-03ACS Omega
Site-Specific Glycan Conjugation Improves Stability and Efficacy of an Antibody–Drug Conjugates Bearing DXd as a Cytotoxic Payload
Article
作者: Senga, Shogo ; Kinoshita, Takashi ; Takahashi, Ryo ; Hiranyakorn, Methanee ; Mitani, Ai ; Sumiyoshi, Wataru ; Manabe, Shino ; Yarita, Hikaru ; Hoshinoo, Asako ; Iwamoto, Shogo ; Yoshimura, Chihoko
This study developed a homogeneous ADC via site-specific conjugation of a potent antitumor agent, a camptothecin derivative, to the N-glycan in the Fc domain of an antibody, achieving a drug-to-antibody ratio (DAR) of 4. The resulting glycan-conjugated ADC exhibited improved thermal stability, reduced aggregation, and reduced premature payload release in human plasma. Despite utilizing the same antibody and payload, this glycan-linked ADC outperformed a clinically approved cysteine-conjugated homogeneous ADC (DAR 8) in vivo.
2026-03-01Respiratory Investigation
All-case post-marketing surveillance of delamanid for treating multidrug-resistant pulmonary tuberculosis in Japan
Article
作者: Saito, Takefumi ; Mori, Toru ; Nagai, Hideaki ; Shigeto, Eriko ; Komaniwa, Satoshi ; Yoshiyama, Takashi ; Hashizume, Hiroyuki ; Tsuyuguchi, Kazunari ; Suzue, Kyoko ; Yamashige, Yuko ; Sasaki, Yuka
BACKGROUND:
Delamanid is a nitro-dihydro-imidazooxazole derivative that possesses highly potent activity against Mycobacterium tuberculosis, including strains linked to multidrug-resistant tuberculosis (MDR-TB). We conducted an all-case post-marketing surveillance to assess the real-world safety and effectiveness of delamanid in treating MDR-TB in Japan.
METHODS:
All patients diagnosed with MDR-TB were included if they started delamanid between September 2014 and February 2023. Case report forms were collected every 6 months during the treatment period and every 12 months during the follow-up period. Safety assessment included any adverse events that occurred during the treatment period. Effectiveness assessment included the proportion of patients with sputum-culture conversion and treatment success.
RESULTS:
In the safety analysis set, 61.6 % of patients (114/185) were males, and the median (interquartile range) age was 48.0 (32.0, 64.0) years. During the treatment period, 54.05 % of patients (100/185) experienced adverse drug reactions (ADRs), and 8.65 % (16/185) experienced serious ADRs. Electrocardiogram QT prolongation was reported in 8.65 % of patients (16/185) but was not associated with an increased risk of cardiovascular events. In the sputum-culture conversion analysis set, sputum-culture conversion was achieved in 86.0 % of patients (80/93). In the effectiveness analysis set, treatment success was achieved in 54.1 % of patients (99/183) by the end of the treatment period.
CONCLUSIONS:
This surveillance showed the effectiveness of ≥6 months of delamanid treatment among patients with MDR-TB in real-world settings in Japan, with no new safety issues identified.
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