Drugs / GZR101
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06556641 | Dec 2022 → Feb 2023 | — | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT06548932 | Jun 2022 → Feb 2023 | — | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06558708 | Jun → Dec 2024 overdue | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Recruiting | No outcome recorded |
| Phase 2 | NCT06199505 | Nov 2023 → Jun 2024 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies ganlee.com ↗
After 16 weeks of treatment in patients with Type 2 diabetes, the premixed dual insulin analog GZR101 injection showed superior efficacy in reducing HbA1c and postprandial glucose compared to insulin degludec/insulin aspart (Ryzodeg ® ). |
| 2024-07-11 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Successfully Shines at the American Diabetes Association's 84th Scientific Sessions ganlee.com ↗
both GZR4 and GZR101 showed excellent pharmacokinetic and pharmacodynamic characteristics in preclinical studies. |
| 2024-06-22 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Announces Significant Progress on New Diabetes and Obesity Treatments at the American Diabetes Association's 84th Scientific Sessions ganlee.com ↗
In diabetic animal models, GZR101 is significantly superior than insulin degludec/insulin aspart (IDegAsp) in blood glucose reduction and safety. |
| 2022-05-12 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces IND Clearance by NMPA for Premixed Insulin GZR101 ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that China’s National Medical Products Administration (NMPA) has cleared its investigational new drug (IND) application for GZR101, an investigational compound which is independently developed by Gan & Lee Pharmaceuticals, for the treatment of patients with diabetes. |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GZR101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06558708 ↗ |
| Route | Subcutaneous | “GZR101 injection s.c., once daily, treat-to-target dose” NCT06199505 ↗ |