原始来源记录
决策级顶线结果
United Therapeutics：ralinepag 在 3 期试验中将 PAH 恶化风险降低 55%
ADVANCE OUTCOMES 3 期试验达到主要终点，显示临床恶化事件较安慰剂减少 55%。United Therapeutics 计划在 2026 年下半年提交 ralinepag 的 NDA，将这款每日一次的口服前列环素定位为 PAH 潜在的新标准治疗。
关键事实
- 申报时间
- 2026年3月2日 11:32
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- p值
- <0.0001
- WHO FC II级比例
- 70%
- 风险比
- 0.45
- 风险降低
- 55%
- 接受双重治疗患者
- 80%
- 临床改善几率
- 47%
来源摘录
EX-99.1 2 tm267696d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 United Therapeutics Corporation Announces Ralinepag Achieved 55% Reduction in Risk of Clinical Worsening in Pivotal Pulmonary Arterial Hypertension Study, Delivering Exceptional, Highly Statistically Significant Efficacy The phase 3 ADVANCE OUTCOMES study of ralinepag met its primary endpoint and several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension ( PAH ) Ralinepag has the potential to redefine the PAH treatment landscape as the first and only once-daily oral prostacyclin, combining potent receptor affinity with continuous exposure to deliver long-term, durable efficacy and disease-mitigating outcomes United T