drugset
Drugs / HRS-5965
last change Jun 2026 re-read 9 days ago

HRS-5965

Small molecule

Developed for
paroxysmal nocturnal hemoglobinuria · IgA glomerulonephritis
Investigated by
Chengdu Suncadia Medicine Co., Ltd.

Trials 14

today NCT07582133 · Ph 2 NCT07040787 · Ph 1 NCT07035665 · Ph 1 NCT07014826 · Ph 3 NCT06715943 · Ph 3 NCT06674915 · Ph 1 NCT06684041 · Ph 1 NCT06593938 · Ph 3 NCT06567392 · Ph 1 NCT06490991 · Ph 1 NCT06238544 · Ph 2 NCT06137768 · Ph 2 NCT06051357 · Ph 2 NCT05505955 · Ph 1
2023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07040787 Jul → Aug 2025 glomerulonephritis, hemolytic anemia Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT07035665 Jun → Jul 2025 IgA glomerulonephritis, paroxysmal nocturnal hemoglobinuria Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT06674915 Nov 2024 → Jan 2026 glomerular disorder Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT06684041 Nov 2024 → Apr 2025 hemolytic anemia Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT06567392 Sep → Oct 2024 glomerular disorder Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT06490991 Jul → Aug 2024 IgA glomerulonephritis, paroxysmal nocturnal hemoglobinuria Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT05505955 Oct 2022 → Nov 2023 glomerulonephritis Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 24 trials
Phase 2 NCT07582133 May 2026 → Jul 2029 expected IgA glomerulonephritis Chengdu Suncadia Medicine Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT06238544 Feb 2024 → Dec 2027 expected paroxysmal nocturnal hemoglobinuria Chengdu Suncadia Medicine Co., Ltd. Active not recruiting No outcome recorded
Phase 2 NCT06137768 Dec 2023 → Dec 2024 overdue IgA glomerulonephritis Chengdu Suncadia Medicine Co., Ltd. Active not recruiting No outcome recorded
Phase 2 NCT06051357 Nov 2023 → Mar 2024 paroxysmal nocturnal hemoglobinuria Chengdu Suncadia Medicine Co., Ltd. Completed No outcome recorded
Phase 33 trials · 2 met primary
Phase 3 NCT07014826 Jun 2025 → Oct 2027 expected IgA glomerulonephritis Chengdu Suncadia Medicine Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06715943 Jan 2025 → Jan 2026 paroxysmal nocturnal hemoglobinuria Chengdu Suncadia Medicine Co., Ltd. Completed Met primary
Phase 3 NCT06593938 Oct 2024 → Jul 2025 paroxysmal nocturnal hemoglobinuria Chengdu Suncadia Medicine Co., Ltd. Completed Met primary

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-06-15 Jiangsu HengRui Medicine Co., Ltd. Results 2026 EHA｜恒瑞创新药海曲泊帕、立康可泮、泽美妥司他等10余项血液学最新研究成果亮相 hengrui.com ↗
治疗24周后，主要终点（第18至24周期间至少4次测量中有3次达到Hb≥12 g/dL，且第2周后无红细胞输注）的达标率为69.2%（95% CI：52.4-83.0%）。
2026-03-18 Jiangsu HengRui Medicine Co., Ltd. Regulatory 恒瑞创新药富马酸立康可泮胶囊用于经治阵发性睡眠性血红蛋白尿症上市申请获受理 hengrui.com ↗
近日，恒瑞医药子公司成都盛迪医药有限公司收到国家药品监督管理局下发的《受理通知书》，公司自主研发的1类新药富马酸立康可泮胶囊的药品上市申请获受理，适应症为： 治疗既往使用C5补体抑制剂治疗后仍贫血的阵发性睡眠性血红蛋白尿症（PNH）成人患者 ，有望为这一罕见病治疗带来新选择。
2026-01-14 Jiangsu HengRui Medicine Co., Ltd. Regulatory 恒瑞创新药富马酸立康可泮胶囊用于血红蛋白尿症适应症上市申请获受理 hengrui.com ↗
近日，恒瑞医药子公司成都盛迪医药有限公司收到国家药品监督管理局下发的《受理通知书》，公司自主研发的1类新药富马酸立康可泮胶囊 的药品上市许可申请获受理，适应症为： 治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者 。
2025-11-04 Jiangsu HengRui Medicine Co., Ltd. Regulatory 恒瑞创新药、补体B因子抑制剂HRS-5965拟纳入优先审评程序 hengrui.com ↗

All press releases naming this drug 4 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as HRS-5965 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06593938 ↗
13

NCT06674915 ↗

NCT07014826 ↗

NCT07040787 ↗

NCT06490991 ↗

NCT06137768 ↗

NCT05505955 ↗

NCT06715943 ↗

NCT07582133 ↗

NCT06567392 ↗

NCT06051357 ↗

Show 3 more sources
Action Inhibit “HRS-5965 is an oral selective small-molecule inhibitor of complement factor B, a key component of the alternative pathway.” PMID 40378845 ↗ May 2025
Modality Small molecule “HRS-5965 is an oral selective small-molecule inhibitor of complement factor B, a key component of the alternative pathway.” PMID 40378845 ↗ May 2025
Route Oral “HRS-5965 is an oral selective small-molecule inhibitor of complement factor B, a key component of the alternative pathway.” PMID 40378845 ↗ May 2025