预约演示
更新于：2026-04-02
Poractant Alfa
猪肺磷脂
更新于：2026-04-02
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 瑞士 (1993-07-07), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
登录后查看时间轴
关联
32
项与 猪肺磷脂 相关的临床试验NCT07350018
Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome
NCT07261787
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age
IRCT20250222064805N1
Investigating the therapeutic and clinical effects of brecsurf compared to curosurf surfactant in premature neonates with respiratory distress syndrome
100 项与 猪肺磷脂 相关的临床结果
登录后查看更多信息
100 项与 猪肺磷脂 相关的转化医学
登录后查看更多信息
100 项与 猪肺磷脂 相关的专利（医药）
登录后查看更多信息
412
项与 猪肺磷脂 相关的文献（医药）2025-10-28JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants
Article
Importance:
Extremely preterm infants are at high risk for bronchopulmonary dysplasia (BPD) and death. Multiple small randomized clinical trials showed that a combination of budesonide with surfactant compared with surfactant alone reduced BPD or death.
Objective:
To determine if early intratracheal administration of a combination of budesonide (0.25 mg/kg) mixed with surfactant, compared with surfactant alone, reduces physiologic BPD or death by 36 weeks’ postmenstrual age in extremely preterm infants.
Design, Setting, and Participants:
This double-masked randomized clinical trial was conducted from April 2021 to June 2024 in the 17 centers of the United States Neonatal Research Network. Infants 22 to 28 weeks’ gestation or 401 to 1000 g birth weight were enrolled after clinical decision to give surfactant, with the first dose of surfactant being study drug (prior surfactant was an exclusion criterion).
Interventions:
Infants were randomly allocated 1:1 to receive 1 to 2 doses of budesonide + surfactant (poractant alfa) or surfactant alone via endotracheal tube within 50 hours of birth.
Main Outcomes and Measures:
The primary outcome was physiologic BPD or death by 36 weeks’ postmenstrual age. There were 5 prespecified secondary outcomes and multiple prespecified exploratory and safety outcomes.
Results:
The trial was stopped with 641 infants enrolled (55.3% of 1160 planned; mean birth weight, 810 g [SD, 256 g]; gestational age, 25.9 weeks [SD, 1.9 weeks]), because interim analysis at 50% enrollment reached the prespecified futility threshold. The incidence of BPD or death was 68.5% in the budesonide + surfactant group and 67.9% in the surfactant-alone group (adjusted relative risk [RR], 1.00 [95% CI, 0.90-1.11]). No differences were noted in mortality (15.3% vs 13.2%; adjusted RR, 1.13 [95% CI, 0.78-1.64]) or BPD among survivors to 36 weeks’ postmenstrual age (62.9% vs 63.0%; adjusted RR, 0.99 [95% CI, 0.87-1.12]). More infants who received budesonide + surfactant compared with surfactant alone had hyperglycemia (66.7% vs 49.8%; adjusted RR, 1.33 [95% CI, 1.17-1.51]).
Conclusions and Relevance:
In this large multicenter trial, the combination of budesonide with surfactant did not reduce the risk of BPD or death at 36 weeks’ postmenstrual age in extremely preterm infants.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT04545866
2025-09-01PEDIATRIC PULMONOLOGY
Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants(28
+0
to 34
+6
Week) With Respiratory Distress Syndrome: A Randomized Controlled Trial
Article
作者: Hazra, Avijit ; Saha, Bijan ; Zamal, Ashadur ; Sk, Md Habibullah
ABSTRACT:
Background:
Respiratory distress syndrome (RDS) is a leading cause of neonatal morbidity and mortality in low‐ and middle‐income countries (LMICs). The feasibility and effectiveness of bovine versus porcine surfactants via less invasive surfactant administration (LISA) remain unstudied in LMICs. We compared clinical outcomes and cost‐effectiveness of BLES versus poractant alfa in preterm infants with RDS managed with LISA.
Methods:
This randomized controlled trial was conducted in a level 3 neonatal intensive care unit in India. Eligible preterm infants born between 28
+0
and 34
+6
weeks of gestation who developed RDS requiring Noninvasive respiratory support and supplemental oxygen (FiO₂ ≥ 30%) within 6 h of birth were enrolled. Infants were randomly assigned (1:1) to receive either BLES 135 mg/kg (5 mL/kg) or poractant alfa 200 mg/kg (2.5 mL/kg) via the LISA technique. The primary outcome was need for intubation within 72 h of life.
Result:
From Jan 24, 2024 to Mar 15, 2025, 282 infants were randomized to BLES or poractant alfa (
n
= 141 each). Intubation within 72 h occurred in 19 (13.5%) infants in the BLES group and 16 (11.3%) in the poractant alfa group (
p
= 0.710). There were no statistically significant differences in FiO₂, SpO₂, heart rate, or mean airway pressure at any time point before or after surfactant administration between the two groups. No significant differences were observed in major morbidities or mortality. The average cost of surfactant per infant was significantly lower with BLES (INR 20,539 vs 29,677;
p
< 0.001).
Conclusion:
In LMIC settings, BLES and poractant alfa showed similar effectiveness for RDS management via LISA, with no difference in clinical outcomes. BLES provides a cost‐effective alternative in resource‐constrained neonatal care.
2025-08-01Journal of Aerosol Medicine and Pulmonary Drug Delivery
Preclinical Testing of a New Dry Powder Aerosol Synthetic Lung Surfactant Formulation and Device Combination for the Treatment of Neonatal Respiratory Distress Syndrome
Article
作者: Longest, Worth ; DiBlasi, Robert M. ; Hindle, Michael ; Dalton, Caleb ; Farkas, Dale ; Aladwani, Ghali ; Momin, Mohammad A.M. ; Hall, Felicia ; KenKnight, Hattie
Background: This study advanced the preclinical development of a new dry powder aerosol synthetic lung surfactant (SLS) product for neonatal respiratory distress syndrome (RDS) by integrating a multiple-actuation device and scalable spray-dried formulation, evaluating physicochemical and in vitro aerosol performance, and then comparing biological efficacy with the current clinical standard of high-volume liquid bolus instillation. Methods: A new high-dose air-jet dry powder inhaler was developed that was characterized by a variable-volume aerosolization chamber (D3 device) with the goal of unifying aerosol quality and emitted dose (ED) over multiple actuations. The SLS excipient enhanced growth dry powder formulation was advanced through production on a scalable nozzle-based spray dryer system (Mini Spray Dryer; MSD2 formulation). Physicochemical characterization of the formulation was performed along with in vitro aerosol testing of the new D3-MSD2 device and formulation combination. The optimized D3-MSD2 aerosol therapy was then evaluated in a rabbit model of severe RDS. Results: The new D3-MSD2 combination produced a small-particle aerosol with high fine particle fraction (FPF<5 µm = 87.9%; FPF<2.5 µm = 61.6%) and percent ED (77.4% of loaded). Additional in vitro testing highlighted consistent particle size (Dv50 = 1.6 µm) and ED across multiple actuations. In the animal model experiments, a total device-loaded formulation mass of 60 mg (delivered as 2x30 mg) produced a total phospholipid (PL) dose of 24 mg-PL/kg and a device ED of 18 mg-PL/kg compared with the 200 mg-PL/kg clinical dose of Curosurf liquid. In vivo response rate for the D3-MSD2 aerosol therapy was considerably more rapid with arterial oxygenation recovering 5-12 times faster than for liquid Curosurf. Biological response for the D3-MSD2 aerosol therapy was also superior with 2-fold improvement in final lung compliance compared with liquid Curosurf. Conclusions: The new D3-MSD2 aerosol therapy was found to be superior to clinical-practice liquid bolus instillation in the critical areas of required dose (order-of-magnitude reduction), delivery time, biological response rate, and efficacy.
5
项与 猪肺磷脂 相关的新闻（医药）2026-03-28
高管变更上市批准
2026-03-28
2026-01-30
100 项与 猪肺磷脂 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 成人呼吸窘迫综合征 | 美国 | 1999-11-18 | |
| 新生儿呼吸窘迫综合征 | 瑞士 | 1993-07-07 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 早产 | 临床3期 | 美国 | 2021-05-18 | |
| 呼吸窘迫综合征 | 临床3期 | 美国 | 2021-05-18 | |
| 新型冠状病毒感染 | 临床2期 | 美国 | 2021-01-06 | |
| 新型冠状病毒感染 | 临床2期 | 意大利 | 2021-01-06 | |
| 新型冠状病毒感染 | 临床2期 | 英国 | 2021-01-06 | |
| 急性呼吸窘迫综合征 | 临床2期 | 美国 | 2021-01-06 | |
| 急性呼吸窘迫综合征 | 临床2期 | 意大利 | 2021-01-06 | |
| 急性呼吸窘迫综合征 | 临床2期 | 英国 | 2021-01-06 | |
| 左心发育不全综合征 | 临床1期 | 美国 | 2020-02-25 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 33 | (Curosurf LISA) | 廠顧壓鏇積遞鬱構齋鑰 = 鹽壓顧窪鏇願鏇鑰觸鏇 築繭窪構廠糧顧蓋遞衊 (餘夢齋壓蓋選衊衊選餘, 襯淵壓觸夢範積築鹹膚 ~ 範鬱網構淵遞積顧窪顧) 更多 | - | 2023-11-03 | ||
(Curosurf Endotracheal Tube) | 廠顧壓鏇積遞鬱構齋鑰 = 顧獵製遞簾膚構願蓋鹹 築繭窪構廠糧顧蓋遞衊 (餘夢齋壓蓋選衊衊選餘, 顧憲顧願鑰繭簾淵觸憲 ~ 鏇糧製顧膚網觸齋淵獵) 更多 | ||||||
临床3期 | 88 | (Curosurf (Group 1)) | 顧壓餘鬱糧壓壓簾衊鬱 = 遞鹽願襯憲觸觸鹹壓築 簾網鏇製積鑰壓鬱築範 (廠餘衊構鏇觸憲獵願壓, 願膚範壓夢網顧顧衊鹽 ~ 餘網選鏇簾醖醖簾鏇繭) 更多 | - | 2017-10-25 | ||
(BLES (Group 2)) | 顧壓餘鬱糧壓壓簾衊鬱 = 衊範獵鑰糧糧簾願襯觸 簾網鏇製積鑰壓鬱築範 (廠餘衊構鏇觸憲獵願壓, 築蓋觸蓋夢憲顧獵齋艱 ~ 鏇顧蓋憲顧鏇夢鏇網襯) 更多 | ||||||
临床3期 | - | 87 | 鏇鑰願衊觸壓觸積廠鏇(觸襯願積齋鏇蓋構構窪) = 構積廠製繭構廠鹹壓製 餘襯選積憲鹽鬱鏇遞蓋 (廠顧醖醖淵襯鬱憲積廠 ) | - | 2017-01-01 | ||
Bovine lipid extract surfactant | 鏇鑰願衊觸壓觸積廠鏇(觸襯願積齋鏇蓋構構窪) = 醖鏇範簾積願艱選齋憲 餘襯選積憲鹽鬱鏇遞蓋 (廠顧醖醖淵襯鬱憲積廠 ) | ||||||
临床4期 | 52 | beractant+Survanta (Beractant Arm) | 鹹膚襯網遞獵鏇夢膚範(廠構遞壓選窪窪鏇鹽顧) = 鑰選壓製選製選淵齋顧 簾鑰襯鬱壓憲構選醖齋 (鹽窪夢憲簾鹹壓觸蓋壓, 0.8) 更多 | - | 2011-09-20 | ||
Poractant Alfa (Poractant Alfa Arm) | 鹹膚襯網遞獵鏇夢膚範(廠構遞壓選窪窪鏇鹽顧) = 窪製齋顧網網遞選齋糧 簾鑰襯鬱壓憲構選醖齋 (鹽窪夢憲簾鹹壓觸蓋壓, 0.4) 更多 | ||||||
临床4期 | 50 | 鹽糧簾襯積鹹醖廠觸鬱(積衊夢製淵鑰築鬱觸遞) = 選繭顧淵壓網積鹽窪蓋 艱顧廠顧鬱鑰鹹鬱壓顧 (醖選蓋蓋鹽夢遞製網艱 ) | - | 2010-10-01 | |||
鹽糧簾襯積鹹醖廠觸鬱(積衊夢製淵鑰築鬱觸遞) = 淵顧廠襯壓遞網網廠餘 艱顧廠顧鬱鑰鹹鬱壓顧 (醖選蓋蓋鹽夢遞製網艱 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用