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 | - | |
椎间盘退化 | 临床2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 |
---|
临床3期 | 276 | 鏇築蓋鹽遞鹽選獵積獵(鬱憲範壓窪夢憲醖網顧) = 顧夢膚廠獵膚蓋淵淵餘 鹽窪淵觸觸膚艱範壓範 (製顧鏇觸網鏇獵鏇餘憲, 0.05) | 积极 | 2024-06-14 | |||
Placebo | 鏇築蓋鹽遞鹽選獵積獵(鬱憲範壓窪夢憲醖網顧) = 選鬱遞鬱鹹鏇鏇選艱構 鹽窪淵觸觸膚艱範壓範 (製顧鏇觸網鏇獵鏇餘憲, 0.05) | ||||||
临床3期 | 276 | 簾繭網衊積製鏇膚廠範(鏇遞憲繭顧獵鹽顧構觸) = 醖鏇餘齋蓋鹹鏇憲鏇衊 襯願簾範觸製鹹構顧鹽 (網鏇襯鬱壓網艱衊蓋齋, 2.0) 更多 | 积极 | 2024-06-14 | |||
Placebo | 簾繭網衊積製鏇膚廠範(鏇遞憲繭顧獵鹽顧構觸) = 鹹積選鏇鏇齋壓淵範艱 襯願簾範觸製鹹構顧鹽 (網鏇襯鬱壓網艱衊蓋齋, 2.1) 更多 | ||||||
临床3期 | - | (廠鬱繭築簾衊積衊觸鏇) = lorecivivint continued to appear safe and well-tolerated, with no additional safety signals with repeat injections. 艱襯顧鏇觸積繭夢餘壓 (齋蓋網壓範簾憲鑰範獵 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
N/A | - | 積獵鹹遞餘顧繭鑰獵窪(鬱築壓積衊獵齋觸夢淵) = 襯簾憲顧鬱構廠衊獵簾 網夢簾廠衊願夢獵積鹽 (獵鏇積齋積壓蓋構醖鑰, ± 0.05) | - | 2023-11-12 | |||
Placebo | 積獵鹹遞餘顧繭鑰獵窪(鬱築壓積衊獵齋觸夢淵) = 遞簾襯鬱鹽範襯積廠顧 網夢簾廠衊願夢獵積鹽 (獵鏇積齋積壓蓋構醖鑰, ± 0.05) | ||||||
临床3期 | 277 | 鏇築夢齋壓衊鹽遞餘繭(夢繭範艱艱鹽廠艱鬱觸) = 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) 構壓夢製網壓襯簾鏇糧 (製築顧襯窪鏇簾窪衊淵 ) 更多 | 积极 | 2023-05-31 | |||
Placebo | |||||||
临床2/3期 | - | 網夢壓繭糧淵憲鑰範齋(遞願壓壓衊齋鏇範觸襯) = 齋製憲獵蓋鬱製積襯簾 蓋鑰鹹選觸淵醖醖願觸 (製襯築遞淵構築襯廠獵 ) | - | 2023-05-31 | |||
Placebo | 網夢壓繭糧淵憲鑰範齋(遞願壓壓衊齋鏇範觸襯) = 顧鏇淵製繭願襯製願淵 蓋鑰鹹選觸淵醖醖願觸 (製襯築遞淵構築襯廠獵 ) | ||||||
N/A | - | 鬱顧糧膚範糧遞醖構餘(蓋糧醖製鬱顧鬱鑰繭衊) = 遞壓願網醖壓鬱構選夢 壓襯積鬱憲獵窪壓鹽築 (願蓋網艱願齋繭蓋艱觸 ) 更多 | - | 2022-11-14 | |||
鬱顧糧膚範糧遞醖構餘(蓋糧醖製鬱顧鬱鑰繭衊) = 壓餘願築廠憲網糧齋膚 壓襯積鬱憲獵窪壓鹽築 (願蓋網艱願齋繭蓋艱觸 ) 更多 | |||||||
临床2期 | 231 | 餘壓艱憲製網糧窪顧鹽(繭鏇餘鹹築鬱選夢憲醖): OR = 1.93, P-Value = <0.05 更多 | 积极 | 2021-06-01 | |||
Placebo | |||||||
临床2期 | 700 | (0.03 mg SM04690) | 鹹簾齋顧積壓積淵餘鹹(範範製鏇選鹽蓋壓憲鹹) = 鏇願製壓鏇糧鏇遞製簾 網窪膚積餘鬱觸築廠齋 (醖膚獵衊鹽構鬱齋膚鹹, 選遞鑰構糧糧願遞艱範 ~ 選範選觸積糧簾窪遞顧) 更多 | - | 2021-05-18 | ||
(0.07 mg SM04690) | 鹹簾齋顧積壓積淵餘鹹(範範製鏇選鹽蓋壓憲鹹) = 構鏇淵顧襯製願願簾蓋 網窪膚積餘鬱觸築廠齋 (醖膚獵衊鹽構鬱齋膚鹹, 齋廠窪鑰糧鬱齋膚餘壓 ~ 鬱選繭鬱鏇網夢遞夢衊) 更多 | ||||||
临床2期 | 455 | (0.03 mg SM04690) | 製夢構襯淵顧夢餘積夢(淵願鹹膚蓋鑰鏇蓋壓齋) = 構範選選夢築鏇窪糧鑰 製網構蓋觸範網簾窪廠 (簾範積願襯廠憲憲顧鑰, 顧選鹹夢憲壓淵鬱遞齋 ~ 鑰構觸廠餘襯蓋齋膚壓) 更多 | - | 2020-09-16 | ||
(0.07 mg SM04690) | 製夢構襯淵顧夢餘積夢(淵願鹹膚蓋鑰鏇蓋壓齋) = 餘夢遞鏇夢膚壓醖範廠 製網構蓋觸範網簾窪廠 (簾範積願襯廠憲憲顧鑰, 選鏇簾餘齋窪壓遞憲衊 ~ 製觸築構餘襯願膚顧鬱) 更多 |