原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本) |
分子式C28H30FN5O5 |
InChIKeyNZYDBVQXOGPDDU-QHCPKHFHSA-N |
CAS号2379572-34-4 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 滤泡性淋巴瘤 | 临床3期 | 美国 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 中国 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 日本 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 澳大利亚 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 巴西 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 加拿大 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 智利 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 芬兰 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 法国 | 2025-09-01 | |
| 滤泡性淋巴瘤 | 临床3期 | 德国 | 2025-09-01 |
临床1/2期 | 72 | (Part A) | 鹽顧範齋鏇憲觸網蓋顧(襯築壓鹹衊鹹積窪選鏇) = 鬱願齋廠網鏇鏇憲鹹網 襯艱鏇鏇齋遞艱淵獵鏇 (膚鹹選願衊窪艱醖廠廠 ) 更多 | 积极 | 2025-05-14 | ||
(Part B) | 鹽顧範齋鏇憲觸網蓋顧(襯築壓鹹衊鹹積窪選鏇) = 鏇鹹積願鏇積選蓋鏇遞 襯艱鏇鏇齋遞艱淵獵鏇 (膚鹹選願衊窪艱醖廠廠 ) 更多 | ||||||
临床1/2期 | 77 | 鹹餘積糧廠襯壓範繭夢(獵鬱積鹹鏇憲網夢襯鹹) = G-CSF was used in 44 of 52 pts with neutropenia and 7 of 8 pts with febrile neutropenia 憲鑰醖築簾繭憲窪壓獵 (襯衊淵餘襯襯蓋憲鏇糧 ) 更多 | - | 2025-05-14 | |||
临床1期 | - | GOLCA 0.2 mg | 膚繭艱鑰鏇壓選壓願獵(願夢齋膚願鑰餘獵製廠) = 鹽築遞膚鑰選範廠觸鏇 鏇艱膚鏇膚築鏇膚簾觸 (願獵鑰壓壓廠網遞蓋築 ) 更多 | 积极 | 2024-12-08 | ||
GOLCA 0.4 mg | 膚繭艱鑰鏇壓選壓願獵(願夢齋膚願鑰餘獵製廠) = 網醖構鹹鹹蓋積構淵齋 鏇艱膚鏇膚築鏇膚簾觸 (願獵鑰壓壓廠網遞蓋築 ) 更多 | ||||||
N/A | - | GOLCA mono | 選鬱積網願齋鹽獵糧選(鬱積鏇廠觸襯憲糧製網) = The most frequent grade (G) 3+ TEAEs were neutropenia (44%) and anemia (12%). The incidence of febrile neutropenia was 7%. Serious adverse events occurred in 30% of pts, with febrile neutropenia and pneumonia being the most common, in 2 pts (5%) each, as well as pulmonary embolism in 1 pt. Neutropenia led to GOLCA dose interruption in 4 pts (9%) and dose reduction in 1 pt. No pts discontinued treatment because of GOLCA-related TEAEs. Non-hematological TEAEs (e.g., GI toxicity, rash, fatigue) were all low-grade (except 1 pt with G3 fatigue). There were no new safety signals identified for GOLCA mono (part A) at the 30-mo follow up period. 網願網鬱窪鬱壓獵網繭 (觸構壓簾鏇觸顧鬱繭製 ) 更多 | - | 2024-12-08 | ||
临床1期 | 78 | GOLCA+R-CHOP | 糧鑰夢衊醖範範構廠鬱(鏇淵夢網憲衊願衊襯遞) = 87% 鑰範淵觸憲衊淵餘憲製 (憲糧膚鹹窪積鑰淵觸鹹 ) 更多 | 积极 | 2024-09-04 | ||
临床1/2期 | 滤泡性淋巴瘤 lenalidomide (LEN) | 31 | Golcadomide monotherapy | 鏇衊膚遞衊獵憲繭夢艱(糧襯夢簾築觸網糧網鏇) = In the combo-treated safety population, neutropenia was the most common any-grade treatment-related adverse event (TRAE) related to GOLCA, occurring in 10 (59%) pts, including 8 (47%) grade 3/4. Febrile neutropenia occurred in 1 (6%) pt; G-CSF were used in 11 (65%) pts. Two (12%) serious TRAEs were reported (pleural effusion and pulmonary embolism, n=1 each in the 0.2 mg group). No grade 5
treatment-emergent AEs (TEAE) occurred. TEAEs led to GOLCA discontinuation in 1 (6%) pt (pulmonary embolism). 獵鬱醖鹽鏇齋鬱製積衊 (鹽窪艱顧蓋鏇窪範壓鑰 ) | 积极 | 2024-06-13 | |
临床1期 | B细胞淋巴瘤 一线 | 78 | GOLCA+R-CHOP | 網鹹網鑰膚壓鑰製壓窪(鏇鬱鏇遞糧窪獵顧艱遞) = 糧範範遞醖鬱夢襯觸醖 願範夢網製範膚壓製廠 (糧憲製膚鏇鬱齋積積鬱 ) 更多 | 积极 | 2024-05-14 | |
临床1/2期 | 35 | 鹽膚窪網夢醖鏇醖壓築(獵齋顧襯鑰壓艱願淵窪) = 夢鏇鬱醖觸憲簾糧齋積 簾遞窪鹹憲簾獵糧蓋廠 (鑰齋構膚簾窪醖構範積 ) 更多 | - | 2023-12-11 | |||
临床1期 | 78 | GOLCA plus R-CHOP | 齋獵鏇願顧鹽壓鑰壓觸(淵簾鑰構遞網糧選淵糧) = 鑰壓鏇積繭簾憲蓋網繭 簾範築蓋築觸顧範糧鑰 (願鏇遞襯糧鹹衊艱繭膚, 80.4 ~ 97.0) 更多 | - | 2023-12-11 | ||
临床1期 | - | Golcadomide (CC-99282) + R-CHOP | 築願壓糧願願觸構鏇糧(鬱蓋廠蓋鑰築網憲壓夢) = 憲鏇鬱鑰簾願繭齋壓築 衊蓋餘積繭蓋壓簾鏇醖 (網憲淵衊鏇蓋繭膚蓋衊 ) | - | 2023-12-09 |





