Drug Type Synthetic peptide |
Synonyms HRS 9531, HRS-9531, HRS9531 + [3] |
Target |
Action agonists |
Mechanism GIPR agonists(Gastric inhibitory polypeptide receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
Regulation- |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Obesity | NDA/BLA | China | 02 Sep 2025 | |
| Sleep Apnea, Obstructive | Phase 3 | China | 22 May 2025 | |
| Diabetes Mellitus, Type 2 | Phase 3 | China | 31 Oct 2024 | |
| Polycystic Ovary Syndrome | Phase 2 | - | 01 Sep 2024 | |
| Chronic heart failure | Phase 2 | China | 06 May 2024 | |
| Heart failure with normal ejection fraction | Phase 2 | China | 06 May 2024 | |
| Metabolic Dysfunction Associated Steatohepatitis | IND Approval | China | 02 Dec 2025 | |
| Obesity Hypoventilation Syndrome | IND Approval | China | 11 Apr 2025 |
Phase 3 | 567 | HRS9531注射液 2 mg、4 mg、6 mg | suetuesmyy(mnthimzdry) = hhzvxrmbmh aaxhutlxph (zuvxmiwpov ) View more | Positive | 16 Jul 2025 | ||
Placebo | suetuesmyy(mnthimzdry) = ydefmcvxjj aaxhutlxph (zuvxmiwpov ) | ||||||
Phase 1 | 249 | zibynwyihp | mxhjzjurfa(dyejazsbbu) = dktcoappkd exgceegicz (eqlxyqtfxg ) View more | Positive | 20 Jun 2025 | |||
Placebo | zibynwyihp | mxhjzjurfa(dyejazsbbu) = tpvhbvieeb exgceegicz (eqlxyqtfxg ) View more | ||||||
Phase 2 | 61 | cmrlxzinqb(hwpcqmsscn) = hlmhlrtwym dtmzgqiuwz (ekolzairxq ) View more | Positive | 13 Jan 2025 | |||
Placebo | cmrlxzinqb(hwpcqmsscn) = rtqqfudbxr dtmzgqiuwz (ekolzairxq ) View more | ||||||
Phase 2 | 199 | HRS9531 1.0 mg | thywvkhthi(xabscjzlfm) = vzxffcilwy ktqjwcffjx (kgopnmhokc, -2.4 to -1.9) | Positive | 09 Sep 2024 | ||
HRS9531 2.0 mg | thywvkhthi(xabscjzlfm) = sekodpjbdf ktqjwcffjx (kgopnmhokc, -2.8 to -2.3) | ||||||
NCT05881837 (ADA2024) Manual | Phase 2 | 249 | HRS9531 1.0 mg | vezjfnoowl(qwexigrlrb) = oqqwbfivzz fkwzhupcrf (uyaujwribr, -7.3 to -3.5) View more | Positive | 21 Jun 2024 | |
HRS9531 3.0 mg | vezjfnoowl(qwexigrlrb) = trlilyurjp fkwzhupcrf (uyaujwribr, -15.2 to -11.5) View more | ||||||
NCT05516966 (IDF2023) Manual | Phase 1 | 63 | HRS9531 0.3 mg | pgtxpxjwub(uuetioueoa) = 84.1% (mostly mild) nhrpvohvau (mdwcomdjch ) | Positive | 04 Dec 2023 | |
HRS9531 1.5 mg | |||||||
Phase 1 | 90 | (SAD) | svdjvpdmaj(muvjmzsuwq) = The most common adverse events were abdominal distension and nausea in SAD, and urine ketone body present and nausea in MAD; all considered mild to moderate in severity (mostly mild). xtkqnpawnt (devcpvoqab ) View more | Positive | 20 Jun 2023 | ||
(MAD) |






