Drugs / HRS9531
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 | — | “Hengrui submitted a marketing authorization application to the National Medical Products Administration (NMPA) in China for long-term weight management of HRS9531.” kailera.com ↗ “其中用于成人长期体重管理的上市申请2025年9月已在中国获受理，目前正在审评中。” hengrui.com ↗ |
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2026-09-10 | “瑞普泊肽注射液（HRS9531注射液）的药品上市许可申请获国家药监局受理，拟定适应症为：适用于成人2型糖尿病患者的血糖控制。” hengrui.com ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT06506175 | Jul → Sep 2026 overdue | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07559136 | Jun 2026 → Feb 2027 expected | — | Fujian Shengdi Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07540754 | May 2026 → Jan 2027 expected | diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07150962 | Oct 2025 → Feb 2026 overdue | obesity disorder | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06855147 | Apr → Jun 2025 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06762600 | Jan 2025 → Mar 2026 | obesity disorder | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06723691 | Dec 2024 → Jun 2025 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06654960 | Nov → Dec 2024 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06435676 | Jun → Oct 2024 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06246175 | Feb 2024 → Sep 2025 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05893576 | May → Sep 2023 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05516966 | Oct 2022 → May 2023 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05152277 | Dec 2021 → Aug 2022 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07599410 | Jul 2026 → May 2027 expected | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07660848 | Jul 2026 → Mar 2028 expected | metabolic dysfunction-associated steatohepatitis | Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06841445 | Apr 2025 → Jan 2026 | — | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT06595797 | Sep 2024 → Dec 2025 overdue | polycystic ovary syndrome | Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06565871 | Aug 2024 → Dec 2025 overdue | — | Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06391710 | May 2024 → Jan 2026 overdue | diastolic heart failure | Fujian Shengdi Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06287437 | Jan 2024 → Jun 2025 | obesity disorder | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06054698 | Oct 2023 → Sep 2024 | obesity disorder | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05966272 | Aug 2023 → Sep 2024 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05881837 | Jun 2023 → Oct 2024 | obesity disorder | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 39 trials · 2 met primary | ||||||
| Phase 3 | NCT07670884 | Jul 2026 → Jul 2027 expected | — | Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07551492 | May 2026 → May 2031 expected | atherosclerotic cardiovascular disease | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07285902 | Dec 2025 → Mar 2027 expected | obesity disorder | Fujian Shengdi Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06994650 | Aug 2025 → Dec 2026 expected | obstructive sleep apnea syndrome | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07060456 | Jul 2025 → Feb 2027 expected | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06974851 | Jul 2025 → Dec 2026 expected | obstructive sleep apnea syndrome | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06650007 | Nov 2024 → Jan 2026 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT06649344 | Oct 2024 → Sep 2026 overdue | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT06396429 | May 2024 → Jul 2025 | obesity disorder | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Kailera | Results Kailera Therapeutics Presents New Clinical Data at EASD 2026 Annual Meeting kailera.com ↗
Plasma drug exposure following subcutaneous ribupatide injection to the upper arm or thigh was similar to that observed following abdominal injection, supporting these sites as alternative injection locati |
| 2026-09-10 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药GLP-1/GIP双重受体激动剂瑞普泊肽注射液用于成人2型糖尿病上市申请获受理 hengrui.com ↗
近日，恒瑞医药子公司福建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类创新药GLP-1/GIP双重受体激动剂瑞普泊肽注射液（HRS9531注射液）的药品上市许可申请获国家药监局受理，拟定适应症为：适用于成人2型糖尿病患者的血糖控制。 |
| 2026-08-05 | Jiangsu HengRui Medicine Co., Ltd. | Results HbA1c降幅最高达2.78%！恒瑞医药 GLP-1/GIP双重受体激动剂瑞普泊肽注射液中国T2DM口服药控制不佳人群Ⅲ期研究取得积极顶线结果 hengrui.com ↗
瑞普泊肽注射液4 mg和2 mg两个剂量组均达到预设的主要终点，即HbA1c相对基线的变化均非劣于司美格鲁肽注射液1 mg组。 |
| 2026-07-21 | Jiangsu HengRui Medicine Co., Ltd. | Results HbA1c降幅最高达2.67%！恒瑞医药 GLP-1/GIP双重受体激动剂瑞普泊肽注射液中国T2DM初治人群Ⅲ期研究取得积极顶线结果 hengrui.com ↗
基于有效性估计目标分析结果显示，瑞普泊肽注射液治疗36周后，2 mg和4 mg剂量组HbA1c平均降幅分别达2.37%、2.67%（安慰剂平均降幅0.36%）。 |
| 2026-06-05 | Kailera | Results Hengrui Pharma and Kailera Therapeutics Present Ribupatide Clinical Data at ADA 2026 kailera.com ↗
Phase 1 single ascending dose trial, the first ribupatide injection clinical data generated outside of China, demonstrated similar exposure, tolerability, and weight reduction in participants of Asian and non-Asian descent |
| 2026-02-10 | Kailera | Results Kailera Therapeutics and Hengrui Pharma Report Positive Topline Data from Phase 2 Obesity Trial of Oral Ribupatide kailera.com ↗ |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Kailera | Kailera Therapeutics Presents New Clinical Data at EASD 2026 Annual Meeting kailera.com ↗ |
| 2026-09-10 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞创新药GLP-1/GIP双重受体激动剂瑞普泊肽注射液用于成人2型糖尿病上市申请获受理 hengrui.com ↗ |
| 2026-08-05 | Jiangsu HengRui Medicine Co., Ltd. | HbA1c降幅最高达2.78%！恒瑞医药 GLP-1/GIP双重受体激动剂瑞普泊肽注射液中国T2DM口服药控制不佳人群Ⅲ期研究取得积极顶线结果 hengrui.com ↗ |
| 2026-07-21 | Jiangsu HengRui Medicine Co., Ltd. | HbA1c降幅最高达2.67%！恒瑞医药 GLP-1/GIP双重受体激动剂瑞普泊肽注射液中国T2DM初治人群Ⅲ期研究取得积极顶线结果 hengrui.com ↗ |
| 2026-06-05 | Kailera | Hengrui Pharma and Kailera Therapeutics Present Ribupatide Clinical Data at ADA 2026 kailera.com ↗ |
| 2026-02-10 | Kailera | Kailera Therapeutics and Hengrui Pharma Report Positive Topline Data from Phase 2 Obesity Trial of Oral Ribupatide kailera.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HRS9531 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05516966 ↗ |
| Route | Subcutaneous | “Administered SC once” NCT05152277 ↗ |