Discovered by KalVista, sebetralstat is an investigational novel, orally-administered therapy for the on-demand treatment of HAE. Sebetralstat works by targeting the kallikrein-kinin system (KKS) cascade, selectively inhibiting plasma kallikrein and its …

Sebetralstat is an investigational new drug that is being evaluated for the treatment of hereditary angioedema. [1] It is a plasma kallikrein inhibitor. [2]

May 31, 2024 · Oral sebetralstat provided faster times to the beginning of symptom relief, reduction in attack severity, and complete attack resolution than placebo.

Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025.

Sebetralstat是一种正在研究的新型口服血浆激肽释放酶抑制剂，旨在针对激肽释放酶-激肽系统级联，选择性抑制血浆激肽释放酶及其驱动遗传性血管性水肿发作的不受控制的活性。

KalVista announced positive phase 3 data from the KONFIDENT trial for its oral, on-demand therapy, sebetralstat for HAE in February 2024. The Company’s NDA for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. In addition, KalVista received validation of its MAA from the EMA in August 2024.

Feb 11, 2023 · Sebetralstat (KalVista Pharmaceuticals) is a novel oral plasma kallikrein inhibitor that is in development for the on-demand treatment of hereditary angioedema attacks.

Jul 4, 2024 · Oral sebetralstat provided faster times to the beginning of symptom relief, reduction in attack severity, and complete attack resolution than placebo. (Funded by KalVista Pharmaceuticals; KONFIDENT ClinicalTrials.gov number, NCT05259917; EudraCT number, 2021-001226-21.).

Sebetralstat, an oral plasma kallikrein (PKa) inhibitor, was evaluated in KONFIDENT,6 a randomized, double-blind, placebo-controlled, phase 3 crossover trial for on-demand treatment of HAE-C1INH. Compared with placebo, sebetralstat provided significantly faster symptom relief, reduction in attack severity, and complete attack resolution. Figure 1.

Feb 11, 2023 · 该研究旨在评估正在开发的新型口服血浆激肽素抑制剂sebetralstat，用于按需治疗遗传性血管性水肿发作的疗效。 在这项分为两部分的二期试验中，研究组从欧洲和美国9个国家的25个地点（包括专科门诊中心）招募年龄在18岁及以上的1或2型遗传性血管性水肿患者。 如果患者在过去93天内经历了至少三次遗传性血管性水肿发作，没有预防性治疗，并且有机会、有能力自我管理常规发作治疗，则符合条件。 在试验的第一部分，参与者被给予单次600 mg开放标签 …