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更新于：2026-02-27
TD-0903
更新于：2026-02-27
概要
基本信息
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C30H37N7O2 |
InChIKeyVQIIUJSNIKEMCK-MHZLTWQESA-N |
CAS号2412496-23-0 |
关联
3
项与 TD-0903 相关的临床试验NCT05091723
Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of Inhaled Nezulcitinib (TD-0903) Administered in the Setting of Supplemental Oxygenation Scenarios in Healthy Participants
NCT04402866
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated With COVID-19
NCT04350736
A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
100 项与 TD-0903 相关的临床结果
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100 项与 TD-0903 相关的转化医学
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100 项与 TD-0903 相关的专利（医药）
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4
项与 TD-0903 相关的文献（医药）2021-11-01Clinical rheumatology3区 · 医学
Janus kinase inhibitors and major COVID-19 outcomes: time to forget the two faces of Janus! A meta-analysis of randomized controlled trials
3区 · 医学
Article
作者: Patoulias, Dimitrios ; Karagiannis, Asterios ; Papadopoulos, Christodoulos ; Doumas, Michael
Coronavirus disease-2019 (COVID-19) represents a global public health nightmare. The "cytokine storm," the most prominent underlying pathophysiologic mechanism of this disease, can theoretically be targeted at several stages. Janus kinase (JAK) inhibitors constitute a drug class that could ameliorate the inflammatory response and enhance antibody production. Herein, we aimed to evaluate the efficacy of JAK inhibitors in patients with COVID-19, performing the most updated relevant meta-analysis. We searched two major databases for randomized controlled trials (RCTs) enrolling adult patients with documented COVID-19 in the in-hospital setting, assigned either to JAK inhibitor treatment plus standard of care or standard of care alone. We set as primary efficacy outcome the endpoint of COVID-19 death on day 28 and as secondary efficacy composite outcome that of mechanical ventilation or initiation of extracorporeal membrane oxygenation (ECMO). We finally pooled data of interest from 4 RCTs in a total of 1338 subjects with documented COVID-19 infection, utilizing the following JAK inhibitors: baricitinib, ruxolitinib, tofacitinib, and nezulcitinib. Treatment with JAK inhibitor compared to control resulted in a significant reduction in the risk for COVID-19 death by 43%, while it also led to a significant decrease in the risk for mechanical ventilation or ECMO initiation by 36%. Herein, we demonstrate a clear benefit with JAK inhibitors added to standard of care in patients with COVID-19 in terms of risk reduction concerning major outcomes. Larger RCTs will elucidate their place in treatment armamentarium against COVID-19.
2021-11-01Clinical and translational science3区 · 医学
Phase I study in healthy participants to evaluate safety, tolerability, and pharmacokinetics of inhaled nezulcitinib, a potential treatment for COVID‐19
3区 · 医学
ArticleOA
作者: Nathan D. Pfeifer ; David L. Bourdet ; Dave Singh ; Kenneth Colley ; Arthur Lo
Abstract:
Nezulcitinib (TD‐0903), a lung‐selective pan–Janus‐associated kinase (JAK) inhibitor designed for inhaled delivery, is under development for treatment of acute lung injury associated with coronavirus disease 2019 (COVID‐19). This two‐part, double‐blind, randomized, placebo‐controlled, single ascending dose (part A) and multiple ascending dose (part B) phase I study evaluated the safety, tolerability, and pharmacokinetics (PK) of nezulcitinib in healthy participants. Part A included three cohorts randomized 6:2 to receive a single inhaled dose of nezulcitinib (1, 3, or 10 mg) or matching placebo. Part B included three cohorts randomized 8:2 to receive inhaled nezulcitinib (1, 3, or 10 mg) or matching placebo for 7 days. The primary outcome was nezulcitinib safety and tolerability assessed from treatment‐emergent adverse events (TEAEs). The secondary outcome was nezulcitinib PK. All participants completed the study. All TEAEs were mild or moderate in severity, and none led to treatment discontinuation. Overall (area under the plasma concentration‐time curve) and peak (maximal plasma concentration) plasma exposures of nezulcitinib were low and increased in a dose‐proportional manner from 1 to 10 mg in both parts, with no suggestion of clinically meaningful drug accumulation. Maximal plasma exposures were below levels expected to result in systemic target engagement, consistent with a lung‐selective profile. No reductions in natural killer cell counts were observed, consistent with the lack of a systemic pharmacological effect and the observed PK. In summary, single and multiple doses of inhaled nezulcitinib at 1, 3, and 10 mg were well‐tolerated in healthy participants, with dose‐proportional PK supporting once‐daily administration.
2021-10-01The European respiratory journal
A phase 2 multiple ascending dose study of the inhaled pan-JAK inhibitor nezulcitinib (TD-0903) in severe COVID-19
Letter
作者: Saggar, Rajeev ; Kaufman, Elad ; Crater, Glenn D ; Moskalenko, Valentyn ; Bogus, Maxim ; Singh, Dave ; Pfeifer, Nathan D ; Woodcock, Ashley ; Nguyen, Tuan ; Woo, Jacky ; Haumann, Brett ; Moran, Edmund J ; Bourdet, David L ; Lord, Robert ; Weng, Emily Y ; Lombardi, David A
The novel inhaled pan-JAK inhibitor nezulcitinib (TD-0903) was designed to target all JAK isoforms ( JAK1, JAK2, JAK3, TYK2; -log inhibition constant 9.2) and optimize delivery to the lungs while limiting systemic exposure.We report results from the completed part 1 of a 2-part phase 2 trial (NCT04402866) in hospitalised patients with severe COVID-19.The study was designed with sep. data reporting for parts 1 and 2.Part 1 was a randomised, double-blind, placebo-controlled, multiple-ascending-dose trial conducted in the UK, Moldova and Ukraine.Patients were sequentially enrolled in three ascending-dose cohorts (n=6 active and 2 placebo per cohort) and received once-daily nezulcitinib 1 mg (day 1 loading dose 2 mg), 3 mg (day 1 loading dose 6 mg), or 10 mg (no loading dose) or matched placebo via inhalation (Aerogen Solo+Ultra nebuliser system, Galway, Ireland) for up to 7 days, with follow-up through day 28.Based on all evidence, inhaled nezulcitinib 3 mg was advanced for further evaluation in part 2, a larger (n≈200) double-blind, placebo-controlled parallel-group phase 2 study in hospitalised COVID-19 patients requiring supplemental oxygen (OS 5-6) (NCT04402866).
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项与 TD-0903 相关的新闻（医药）
100 项与 TD-0903 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 纤维化 | 临床2期 | 美国 | 2022-09-05 | |
| 下呼吸道感染 | 临床2期 | 芬兰 | 2020-08-11 | |
| 急性肺损伤 | 临床2期 | 美国 | 2020-06-24 | |
| 急性肺损伤 | 临床2期 | 巴西 | 2020-06-24 | |
| 急性肺损伤 | 临床2期 | 芬兰 | 2020-06-24 | |
| 急性肺损伤 | 临床2期 | 摩尔多瓦 | 2020-06-24 | |
| 急性肺损伤 | 临床2期 | 罗马尼亚 | 2020-06-24 | |
| 急性肺损伤 | 临床2期 | 乌克兰 | 2020-06-24 | |
| 急性肺损伤 | 临床2期 | 英国 | 2020-06-24 | |
| 新型冠状病毒感染 | 临床2期 | 美国 | 2020-06-24 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 205 | Nebulised nezulcitinib 3mg | 窪網願鏇願築觸選願膚(衊簾淵鑰範窪齋夢顧選) = 糧築憲鏇範襯構壓醖醖 獵襯蓋鏇鏇積觸網憲夢 (鬱蓋膚築選製選窪鑰廠 ) | - | 2023-07-01 | ||
Placebo | 窪網願鏇願築觸選願膚(衊簾淵鑰範窪齋夢顧選) = 壓範鏇夢糧壓廠積壓願 獵襯蓋鏇鏇積觸網憲夢 (鬱蓋膚築選製選窪鑰廠 ) | ||||||
临床2期 | 210 | 獵膚淵積憲鹽鏇獵鬱積(壓糧鬱廠夢齋顧築齋鬱) = 鏇蓋選積願壓觸鬱獵艱 鏇窪範構簾艱蓋醖衊廠 (鏇簾鹹淵窪餘簾窪鏇網 ) | 积极 | 2022-09-04 | |||
Placebo | 獵膚淵積憲鹽鏇獵鬱積(壓糧鬱廠夢齋顧築齋鬱) = 窪築壓壓遞壓網衊糧獵 鏇窪範構簾艱蓋醖衊廠 (鏇簾鹹淵窪餘簾窪鏇網 ) | ||||||
N/A | - | Inhaled nezulcitinib 1 mg | 餘積醖膚齋繭願鹹鬱觸(鏇餘網膚簾範顧衊構築) = the majority of treatment-emergent AEs (TEAEs) were mild and not considered related to nezulcitinib. All serious TEAEs were considered related to underlying disease; the most frequent were acute respiratory distress syndrome (Part 1) and respiratory failure (Part 2) 構製憲淵簾蓋齋餘齋鏇 (衊簾簾憲網壓鑰廠衊夢 ) | - | 2022-05-15 | ||
Inhaled nezulcitinib 3 mg | |||||||
临床2期 | 235 | placebo (Part 2: Matching Placebo) | 遞選齋構夢鏇鹹蓋願鹽(遞鏇積廠襯夢積遞鬱簾) = 鬱鬱齋遞鬱夢鏇獵鬱窪 膚醖簾齋夢襯簾齋憲鏇 (齋窪鬱蓋積鹽築壓衊願, 鏇構鏇窪齋積顧簾選窪 ~ 選夢壓獵構築鑰糧構廠) 更多 | - | 2022-03-17 | ||
(Part 2: TD-0903 - 3 mg) | 遞選齋構夢鏇鹹蓋願鹽(遞鏇積廠襯夢積遞鬱簾) = 選築鹹衊鹹鹽蓋鹹憲願 膚醖簾齋夢襯簾齋憲鏇 (齋窪鬱蓋積鹽築壓衊願, 艱構鏇壓範鹹餘築壓繭 ~ 壓鹽鹽蓋壓願築夢網壓) 更多 | ||||||
临床1期 | 24 | 鹽鹹鏇齋願襯願鑰製觸(鏇壓鏇構築鏇網積蓋網) = 廠觸鬱願醖壓鹹鏇範齋 願艱夢鬱餘鏇遞構醖顧 (範齋積膚醖積構網簾憲 ) | 积极 | 2021-11-01 | |||
Placebo | 鹽鹹鏇齋願襯願鑰製觸(鏇壓鏇構築鏇網積蓋網) = 憲繭襯獵築築窪製顧選 願艱夢鬱餘鏇遞構醖顧 (範齋積膚醖積構網簾憲 ) | ||||||
临床2期 | 200 | 齋艱選願獵顧簾築襯築(顧製衊襯齋鬱艱遞蓋憲) = 醖鬱繭壓鬱衊艱鹹獵築 壓獵觸糧網製夢範鬱膚 (網鑰憲鑰範淵淵製觸淵 ) 更多 | 不佳 | 2021-06-21 | |||
Placebo | 齋艱選願獵顧簾築襯築(顧製衊襯齋鬱艱遞蓋憲) = 鹹鹹顧鹽獵網艱網積壓 壓獵觸糧網製夢範鬱膚 (網鑰憲鑰範淵淵製觸淵 ) 更多 |
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