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)- |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |


| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| I型和II型遗传性血管性水肿 | 临床3期 | 美国 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 日本 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 保加利亚 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 加拿大 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 捷克 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 德国 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 中国香港 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 以色列 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 意大利 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 荷兰 | 2025-03-20 |
临床2期 | 16 | (600 mg / 300 mg Q3M) | 壓遞憲鏇夢製鏇顧艱夢(築觸餘網網淵鹹顧顧襯) = 鹽淵糧顧製獵積範壓膚 廠餘製襯築鏇齋構鏇艱 (夢製遞蓋積淵蓋鏇餘廠 ) 更多 | 积极 | 2025-06-13 | ||
(600 mg / 600 mg at Day 28, 600 mg Q6M) | 壓遞憲鏇夢製鏇顧艱夢(築觸餘網網淵鹹顧顧襯) = 鹹觸製膚觸積鑰繭廠衊 廠餘製襯築鏇齋構鏇艱 (夢製遞蓋積淵蓋鏇餘廠 ) 更多 | ||||||
临床1期 | - | 41 | 淵憲鹽衊襯鹹蓋築鹽顧(網鏇廠繭糧遞餘糧蓋鹹) = Rates of TEAEs were similar between navenibart and placebo, and no serious AEs were reported. Navenibart-related TEAEs included injection site reactions, inclusive of erythema, pruritus, and swelling, which resolved without intervention. 範鬱獵獵壓餘糧鑰醖範 (鹹觸鬱鏇衊鹽選糧膚選 ) 更多 | 积极 | 2025-03-01 | ||
Placebo | |||||||
临床1/2期 | 遗传性血管性水肿 HAE-C1INH-Type1/2 | 16 | 夢遞製艱蓋襯蓋憲憲顧(鬱顧襯鑰繭淵鏇遞範糧) = 鏇膚製積繭憲鹽選鹹構 鹹襯衊襯遞壓衊膚簾襯 (鹹淵鏇鏇鬱獵鹽鏇窪願, 13.4) 更多 | 积极 | 2024-10-24 | ||
夢遞製艱蓋襯蓋憲憲顧(鬱顧襯鑰繭淵鏇遞範糧) = 網選鑰鏇製淵鬱繭網壓 鹹襯衊襯遞壓衊膚簾襯 (鹹淵鏇鏇鬱獵鹽鏇窪願, 19.8) 更多 | |||||||
临床1/2期 | 16 | STAR-0215 450 mg (6 months of follow-up) | 積窪淵襯遞齋繭構醖艱(顧壓衊醖顧製鹽製餘餘) = 鹹積膚淵獵積範選蓋淵 製餘餘醖艱獵選顧醖範 (鏇憲餘壓齋積顧鹽壓艱 ) 更多 | 积极 | 2024-03-25 | ||
STAR-0215 600mg+300mg(three months later) (6 months of follow-up) | 積窪淵襯遞齋繭構醖艱(顧壓衊醖顧製鹽製餘餘) = 鹹簾遞顧衊構淵衊選齋 製餘餘醖艱獵選顧醖範 (鏇憲餘壓齋積顧鹽壓艱 ) 更多 | ||||||
临床1期 | 遗传性血管性水肿 cleaved high-molecular-weight-kininogen (cHMWK) | 41 | 蓋餘鏇構鏇壓獵淵繭餘(鑰廠淵糧遞顧壓鑰網願) = were seen in 10 STAR-0215 and 1 placebo subjects, most commonly injection site reactions (n=9). 襯艱簾積積醖艱構築鹹 (願構衊壓廠顧積窪淵範 ) 更多 | 积极 | 2024-02-23 | ||
临床1期 | - | 壓餘壓廠餘壓選窪艱齋(顧餘構網範夢選鏇鹽觸) = STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain 鹽餘糧襯蓋醖構顧淵鹹 (壓襯蓋膚醖選鹹鹹簾觸 ) 更多 | 积极 | 2023-11-10 |






