Drugs / HRS-7535
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed obesity disorder 1 milestone | |||||
| Filed | China (NMPA) | — | obesity disorder | 2026-09-04 | “恒瑞医药子公司山东盛迪医药有限公司收到国家药监局下发的《受理通知书》，公司1类创新药、口服小分子胰高血糖素样肽-1（GLP-1）受体激动剂HRS-7535片的药品上市申请获受理” hengrui.com ↗ |
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2026-10-01 | “HRS-7535片用于成人2型糖尿病的上市申请已于近日获国家药监局受理” hengrui.com ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07269756 | Dec 2025 → Mar 2026 | obesity disorder | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06961643 | Jun 2025 → Jan 2026 | diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06819488 | Feb → Apr 2025 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06727838 | Dec 2024 → Jan 2025 | diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06495931 | Jul → Aug 2024 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06422039 | May → Aug 2024 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06132204 | Dec 2023 → Mar 2024 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05347758 | May → Sep 2022 | — | Shandong Suncadia Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06621316 | Oct 2024 → May 2025 overdue | obesity disorder | Shandong Suncadia Medicine Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 26 trials · 3 met primary | ||||||
| Phase 2 | NCT06820099 | Apr 2025 → Dec 2026 expected | mild heart failure | Shandong Suncadia Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06671821 | Nov 2024 → Aug 2025 | — | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT06415214 | Jun 2024 → Jul 2025 | diabetic kidney disease | Shandong Suncadia Medicine Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT06393348 | May → Nov 2024 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT06250946 | Feb 2024 → Jan 2025 | morbid obesity | Shandong Suncadia Medicine Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT05759897 | Feb → Dec 2023 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Unknown | Met primary |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT07625774 | Jul 2026 → May 2031 expected | chronic kidney disease | Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07528027 | May 2026 → Dec 2027 expected | — | Shandong Suncadia Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06904105 | Apr 2025 → May 2026 overdue | obesity disorder | Shandong Suncadia Medicine Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT06589765 | Sep 2024 → May 2026 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT06672172 | Sep 2024 → Nov 2025 | type 2 diabetes mellitus | Shandong Suncadia Medicine Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Jiangsu HengRui Medicine Co., Ltd. | Results 同步亮相EASD大会与《Nature Medicine》：恒瑞口服小分子GLP-1受体激动剂HRS-7535中国关键Ⅲ期2型糖尿病研究（OUTSTAND-1）结果公布 hengrui.com ↗
治疗第32周时，HRS-7535 30/60/90 mg组HbA1c较基线分别下降1.40%、1.38%和1.63%，安慰剂组下降0.18%。 |
| 2026-09-04 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药口服小分子GLP-1受体激动剂HRS-7535片用于成人长期体重管理上市申请获受理 hengrui.com ↗
近日，恒瑞医药子公司山东盛迪医药有限公司收到国家药监局下发的《受理通知书》，公司1类创新药、口服小分子胰高血糖素样肽-1（GLP-1）受体激动剂HRS-7535片的药品上市申请获受理，拟定适应症为：适用于在控制饮食和增加运动基础上，初始体重指数（BMI）符合以下要求的成人的长期体重管理：①≥ 28 kg/m 2 （肥胖），或②≥ 24 kg/m 2 （超重）并伴有至少一种体重相关合并症（例如高血糖、高血压、血脂异常、阻塞性睡眠呼吸暂停、脂肪肝等）。 |
| 2026-08-31 | Jiangsu HengRui Medicine Co., Ltd. | Results 再获国际权威学术认可！恒瑞创新药HRS-7535糖尿病肾病Ⅱ期临床研究发表于《柳叶刀》子刊 hengrui.com ↗
治疗16周时，HRS-7535 30 mg组和90 mg组UACR较基线分别下降30%和46%，安慰剂组下降14%，总体呈现剂量依赖性的白蛋白尿降低作用。 |
| 2026-07-17 | Jiangsu HengRui Medicine Co., Ltd. | Results 再获国际权威学术认可！恒瑞创新药HRS-7535中国Ⅱ期肥胖研究发表于Nature子刊 hengrui.com ↗ |
| 2026-07-07 | Kailera | Results Kailera Therapeutics Announces Positive Topline Data from Two Hengrui Pharma Phase 3 Clinical Trials of Oral Small Molecule GLP-1 Receptor Agonist HRS-7535/KAI-7535 kailera.com ↗
OUTSTAND-2 met its primary endpoint, non-inferiority to dapagliflozin across all HRS-7535 dose levels (30 mg, 60 mg, and 90 mg) at Week 32, with the HRS-7535 90 mg group demonstrating significant HbA1c reduction compared to dapagliflozin. |
| 2026-06-08 | Jiangsu HengRui Medicine Co., Ltd. | Results 重磅！恒瑞口服小分子GLP-1受体激动剂HRS-7535用于成人2型糖尿病Ⅱ期研究发表于JAMA子刊 hengrui.com ↗
结果显示，HRS-7535可显著改善血糖水平，16周时糖化血红蛋白（HbA1c）降幅最高达到1.82%ⁱ（安慰剂组降幅0.25%），并具有良好的安全性及耐受性 [1] 。 |
| 2026-05-28 | Jiangsu HengRui Medicine Co., Ltd. | Results 恒瑞医药披露口服小分子GLP-1受体激动剂HRS-7535中国Ⅲ期2型糖尿病研究（OUTSTAND-1）积极顶线结果 hengrui.com ↗ |
| 2026-05-26 | Kailera | Results Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates kailera.com ↗
We are also pleased to announce new topline data for HRS-7535 (KAI-7535) and HRS-4729 (KAI-4729) that reflect the shared commitment with our partner to advance a diverse portfolio with multiple mechanism |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HRS-7535 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06672172 ↗ |
| Action | Activate | “To evaluate the efficacy and safety of HRS-7535, an oral nonpeptide GLP-1 RA, as add-on therapy among adults with type 2 diabetes inadequately controlled with metformin.” PMID 42234428 ↗ Jun 2026 |
| Modality | Small molecule | “HRS-7535 is an orally active small-molecule glucagon-like peptide-1 receptor agonist” PMID 42331800 ↗ Jun 2026 |
| Route | Oral | “Participants were randomized (1:1:1:1:1) to once-daily oral HRS-7535 (15, 30, 60, or 90 mg) or matching placebo.” PMID 42234428 ↗ Jun 2026 |