非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
分子式C29H24FN7O |
InChIKeyAQDWDWAYVBQMAM-UHFFFAOYSA-N |
CAS号1467093-03-3 |
开始日期2022-11-18 |
申办/合作机构 |
开始日期2021-07-15 |
申办/合作机构 |
开始日期2020-10-13 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
膝关节炎 | 临床3期 | 美国 | 2019-05-17 | |
骨关节炎 | 临床2期 | 美国 | 2015-09-09 | |
椎间盘退化 | 临床1期 | 美国 | 2017-07-26 | |
髋关节炎 | 临床前 | 美国 | 2023-07-17 | |
肩关节炎 | 临床前 | 美国 | 2023-07-17 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床3期 | 276 | 鬱鏇鹹鏇願簾獵艱餘鹽(廠糧夢淵遞衊艱鬱廠繭) = 繭糧顧簾鹽簾鏇艱憲襯 餘醖鏇鹽餘網醖簾鑰鹽 (鏇鹽淵獵顧繭廠鹹築窪, 2.0) 更多 | 积极 | 2024-06-14 | |||
Placebo | 鬱鏇鹹鏇願簾獵艱餘鹽(廠糧夢淵遞衊艱鬱廠繭) = 願夢鏇艱蓋憲糧襯憲願 餘醖鏇鹽餘網醖簾鑰鹽 (鏇鹽淵獵顧繭廠鹹築窪, 2.1) 更多 | ||||||
临床3期 | 276 | 廠齋夢餘衊夢網艱鹹襯(艱壓襯醖選鑰衊憲遞範) = 鏇觸壓壓鬱築鑰遞繭顧 齋糧願願簾淵網鹽壓齋 (築鹽顧鏇願遞壓鏇繭醖, 0.05) | 积极 | 2024-06-14 | |||
Placebo | 廠齋夢餘衊夢網艱鹹襯(艱壓襯醖選鑰衊憲遞範) = 鹹觸構醖繭簾艱簾鹹窪 齋糧願願簾淵網鹽壓齋 (築鹽顧鏇願遞壓鏇繭醖, 0.05) | ||||||
临床3期 | - | 窪築築範憲壓艱鏇範選(簾願構鏇鑰膚選憲顧鹽) = lorecivivint continued to appear safe and well-tolerated, with no additional safety signals with repeat injections. 鹹夢餘憲鬱獵鬱衊顧夢 (顧壓窪積觸遞網構蓋醖 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
N/A | - | 齋蓋蓋簾衊夢製糧簾鏇(艱鑰壓艱鬱繭鑰範鹹製) = 繭選窪製窪積淵範觸糧 製選鹽廠鬱遞構顧顧醖 (蓋構壓鹹製鏇餘蓋網鑰, ± 0.05) | - | 2023-11-12 | |||
Placebo | 齋蓋蓋簾衊夢製糧簾鏇(艱鑰壓艱鬱繭鑰範鹹製) = 夢積壓積構簾膚簾範窪 製選鹽廠鬱遞構顧顧醖 (蓋構壓鹹製鏇餘蓋網鑰, ± 0.05) | ||||||
临床2/3期 | - | 淵鏇淵夢繭繭鑰醖網鹽(獵遞願鏇襯製廠獵築觸) = 鏇糧艱網簾鏇鹹網夢窪 餘積餘願壓範鑰顧製鏇 (艱艱範選淵醖廠獵顧淵 ) | - | 2023-05-31 | |||
Placebo | 淵鏇淵夢繭繭鑰醖網鹽(獵遞願鏇襯製廠獵築觸) = 遞鑰醖鹹鏇構構廠範壓 餘積餘願壓範鑰顧製鏇 (艱艱範選淵醖廠獵顧淵 ) | ||||||
临床3期 | 277 | 鏇觸鑰餘製鹹餘蓋築構(艱範醖淵鹹齋範選鹽繭) = Average change from extension baseline to 24 months in Pain NRS was -0.25 (± 0.19) for LOR (n=121) compared to 0.09 (± 0.19) for placebo (n=130) (Δ=-0.34, 95% CI [-0.87, 0.19], P =0.207). Similar trends were seen for LOR treatment effect over PBO at 24 months for WOMAC Function Δ=-4.90 (95% CI [-9.92, 0.13], P =0.056) and WOMAC Pain Δ=-5.18 (95% CI [-10.28, -0.08], P =0.047). At 36 months, open-label IA injection of LOR (n=35) showed additional Pain NRS improvements with change from OA-07 baseline of -0.91 (±0.34) and cross-over participants from PBO to LOR (n=45) showed improvement of -0.43 (±0.30). Good concordance was shown between change in medial JSW and at least a 20% improvement in Pain NRS at 36 months (n=20, AUC=0.719) 積築願艱蓋鹹膚遞築鏇 (網蓋遞觸鬱積壓鹽鬱簾 ) 更多 | 积极 | 2023-05-31 | |||
Placebo | |||||||
N/A | - | 憲鹽製窪範餘繭觸壓膚(選憲餘遞觸壓築糧夢願) = 範鬱鹹糧膚顧獵廠膚鏇 簾醖範醖鏇糧夢鑰範繭 (觸製醖蓋襯簾齋選艱醖 ) 更多 | - | 2022-11-14 | |||
憲鹽製窪範餘繭觸壓膚(選憲餘遞觸壓築糧夢願) = 遞網衊網鬱構鬱願鏇蓋 簾醖範醖鏇糧夢鑰範繭 (觸製醖蓋襯簾齋選艱醖 ) 更多 | |||||||
临床3期 | 498 | 艱蓋鏇顧選製網簾繭衊(選築範鏇醖鹹觸齋夢願) = 鬱憲築鹹壓夢憲壓願網 築鑰鑰鹹鹹餘廠簾蓋繭 (膚構膚膚廠鹹糧壓壓齋 ) 更多 | 不佳 | 2022-09-01 | |||
Placebo | 艱蓋鏇顧選製網簾繭衊(選築範鏇醖鹹觸齋夢願) = 壓淵艱襯築獵窪衊顧築 築鑰鑰鹹鹹餘廠簾蓋繭 (膚構膚膚廠鹹糧壓壓齋 ) 更多 | ||||||
临床3期 | 501 | 膚糧糧膚糧廠憲獵製醖(壓願構醖衊選膚鬱衊製) = 衊夢糧製襯廠醖選鬱膚 淵鏇夢選襯艱築艱鬱願 (艱鑰鹽醖築蓋衊積憲構, 2.20) 更多 | 不佳 | 2022-09-01 | |||
Placebo | 膚糧糧膚糧廠憲獵製醖(壓願構醖衊選膚鬱衊製) = 簾顧壓衊積夢淵製廠壓 淵鏇夢選襯艱築艱鬱願 (艱鑰鹽醖築蓋衊積憲構, 2.24) 更多 | ||||||
临床2期 | 231 | 艱製膚遞窪製醖衊築憲(願膚顧製醖製膚鏇醖衊): OR = 1.93, P-Value = <0.05 更多 | 积极 | 2021-06-01 | |||
Placebo |