Drugs / KAI-7535
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07294898 | Dec 2025 → Jan 2026 | obesity disorder | Kailera | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07497880 | Apr 2026 → Jul 2027 expected | obesity disorder | Kailera | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2026-05-28 | 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 ↗
研究达到主要终点及所有降糖相关的关键次要终点 |
| 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) |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-07 | Kailera | 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 ↗ |
| 2026-05-28 | Jiangsu HengRui Medicine Co., Ltd. | 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 | Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates kailera.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KAI-7535 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07294898 ↗ |
| Route | Oral | “Oral tablets.” NCT07294898 ↗ |