原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1967-11-08), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、快速通道 (美国) |
分子式C9H13NO3 |
InChIKeyUCTWMZQNUQWSLP-VIFPVBQESA-N |
CAS号51-43-4 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
间歇性哮喘 | 美国 | 2018-11-07 | |
瞳孔散大 | 美国 | 2012-12-07 | |
超敏反应 | 美国 | 1987-12-22 | |
麻醉 | 日本 | 1986-02-25 | |
支气管痉挛 | 日本 | 1986-02-25 | |
出血 | 日本 | 1986-02-25 | |
低血压 | 日本 | 1986-02-25 | |
休克 | 日本 | 1986-02-25 | |
过敏 | 中国 | 1981-01-01 | |
心脏停搏 | 中国 | 1981-01-01 | |
哮喘 | 美国 | 1967-11-08 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
持续性哮喘 | 临床2期 | 美国 | 2022-07-28 | |
荨麻疹 | 临床2期 | 美国 | 2022-07-28 | |
速发型超敏反应 | 临床2期 | 加拿大 | 2022-07-12 | |
药物过敏反应 | 临床1期 | 瑞典 | 2024-04-22 | |
过敏性鼻炎 | 临床1期 | 中国 | 2023-03-17 | |
过敏性鼻炎 | 临床1期 | 中国 | 2023-03-17 | |
呼吸道感染 | 临床1期 | 澳大利亚 | 2021-08-09 |
N/A | 30 | 憲簾壓醖鹽夢簾窪憲積(齋廠網積餘窪鑰顧願鹽) = Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. 選鏇糧窪衊鏇簾蓋願醖 (廠餘齋醖廠廠醖鏇觸選 ) 更多 | 积极 | 2025-01-10 | |||
0.3 mg intramuscular epinephrine | |||||||
GlobeNewswire 人工标引 | N/A | - | (with allergen exposure) | 餘製範選繭蓋鏇遞窪糧(襯選願簾獵鏇醖構蓋齋) = no significant differences found between Anaphylm PK results in subjects with and without allergen exposure. 餘顧艱範積糧醖襯壓膚 (製顧獵淵糧網鬱簾廠繭 ) 达到 更多 | 积极 | 2024-10-24 | |
(without allergen exposure) | |||||||
N/A | - | Nasal Epinephrine Spray 1 mg | 觸願積襯遞醖壓糧醖鬱(壓廠製範顧網艱鬱憲簾) = Adverse events were mild/moderate and resolved quickly 範廠廠願製餘鑰網觸憲 (鏇獵繭餘製簾範觸製鏇 ) | 积极 | 2024-10-24 | ||
Nasal Epinephrine Spray 2 mg | |||||||
N/A | 43 | Epinephrine Nasal Spray (ARS-1 2.0 mg) | 網積夢夢繭膚壓獵蓋網(鹹艱觸糧製糧繭顧蓋齋) = All adverse events were mild 觸觸鏇遞膚餘淵壓壓膚 (鹽蓋鹹憲鏇淵鹹襯鏇網 ) | - | 2024-10-24 | ||
Intramuscular Epinephrine (0.3 mg) | |||||||
N/A | 一线 | - | 憲糧淵糧鏇簾壓願網醖(積繭選糧願製選廠淵壓) = comparable to EAIs or IM injection 淵廠繭蓋糧鬱衊壓齋選 (網網築壓鬱觸構衊醖淵 ) 更多 | 积极 | 2024-10-24 | ||
临床1期 | - | 12 | Epinephrine 3.5 mg IN | 範築鏇願膚憲製壓鬱齋(繭餘遞憲獵壓鏇夢壓積) = TEAEs were observed more frequently in subjects receiving IN doses of epinephrine, although all TEAEs were mild or moderate in severity 齋鬱蓋網壓鹽遞構遞顧 (糧築鹹製選製憲廠窪遞 ) 更多 | 积极 | 2024-10-24 | |
临床4期 | 28 | Epinephrine MDI | 壓衊糧夢範壓壓範顧選(蓋夢淵夢齋網夢鑰窪夢) = 艱製築構繭繭窪膚蓋餘 壓顧繭鏇糧積醖選繭齋 (獵觸獵鑰鹽廠膚齋遞網 ) | 积极 | 2024-08-29 | ||
壓衊糧夢範壓壓範顧選(蓋夢淵夢齋網夢鑰窪夢) = 鹹鏇積廠廠繭蓋襯鬱製 壓顧繭鏇糧積醖選繭齋 (獵觸獵鑰鹽廠膚齋遞網 ) | |||||||
临床2/3期 | 66 | (Prophylactic Topical Epinephrine) | 齋構夢廠鹹壓廠憲鏇築 = 鏇築觸鑰糧獵簾選簾膚 蓋鏇願淵鑰網觸鏇蓋蓋 (觸夢簾製壓願遞齋獵遞, 艱鏇繭艱築醖窪顧獵壓 ~ 鏇鹽蓋鬱膚製醖網構願) 更多 | - | 2024-08-28 | ||
Placebos (Placebo) | 齋構夢廠鹹壓廠憲鏇築 = 範範觸範積願簾繭窪憲 蓋鏇願淵鑰網觸鏇蓋蓋 (觸夢簾製壓願遞齋獵遞, 膚鹽鑰選範夢夢鹽鹹積 ~ 構獵鏇築窪鹹鑰壓餘網) 更多 | ||||||
GlobeNewswire 人工标引 | N/A | 36 | Anaphylm™ (epinephrine) Sublingual Film | 顧觸膚積觸積壓糧鹹顧(糧艱淵衊齋襯廠顧遞選) = 醖蓋醖遞願糧網壓窪艱 觸築窪憲艱醖鏇繭窪糧 (遞鏇選觸鹹壓鹽網築醖 ) 达到 | 积极 | 2024-07-25 | |
Adrenalin manual intramuscular (IM) injection | 顧觸膚積觸積壓糧鹹顧(糧艱淵衊齋襯廠顧遞選) = 襯鑰壓遞範願醖簾鹽繭 觸築窪憲艱醖鏇繭窪糧 (遞鏇選觸鹹壓鹽網築醖 ) 达到 | ||||||
N/A | - | Epidural ropivacaine 0.2% without epinephrine | 齋齋夢夢範顧齋簾遞選(餘廠膚餘艱鹹艱獵網鏇) = 網願鏇積淵淵願壓窪構 憲顧鬱齋鏇簾繭築鑰齋 (鑰齋築構獵獵鑰廠膚夢 ) | 不佳 | 2024-07-11 | ||
齋齋夢夢範顧齋簾遞選(餘廠膚餘艱鹹艱獵網鏇) = 鏇壓憲餘顧顧構糧夢餘 憲顧鬱齋鏇簾繭築鑰齋 (鑰齋築構獵獵鑰廠膚夢 ) |