Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2023-04-26 | “application for marketing approval for Class 1 new chemical drug Prusogliptin Tablets (DBPR108) for the treatment of type 2 diabetes was accepted.” irasia.com ↗ “the application for marketing approval of Prusogliptin Tablets (DBPR108) for the treatment of type 2 diabetes was officially accepted.” irasia.com ↗ “In April 2023, application for marketing approval of prusogliptin tablets (DBPR108) for the treatment of type 2 diabetes was accepted.” irasia.com ↗ “Application for marketing approval of Prusogliptin Tablets (DBPR108) for the treatment of type 2 diabetes was accepted in April 2023.” irasia.com ↗ “NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF PRUSOGLIPTIN TABLETS” irasia.com ↗ |
Trials 13
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-01-12 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR PRUSOGLIPTIN AND METFORMIN EXTENDED-RELEASE TABLETS irasia.com ↗ |
| 2025-12-29 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN, DAPAGLIFLOZIN AND METFORMIN EXTENDED-RELEASE TABLETS OBTAIN CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗ |
| 2025-04-22 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN AND METFORMIN EXTENDED-RELEASE TABLETS OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗
The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that Prusogliptin and Metformin Extended-Release Tablets (the ‘‘Product ’’) developed by the Group has obtained approval from the National Medical Products Administration of the People ’s Republic of China to conduct clinical trials in China. |
| 2025-01-13 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN TABLETS OBTAINS MARKETING APPROVAL GRANTED BY NMPA irasia.com ↗ |
| 2023-04-26 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF PRUSOGLIPTIN TABLETS irasia.com ↗
NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF PRUSOGLIPTIN TABLETS |
| 2022-08-22 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - CLASS 1 NEW DRUG "PRUSOGLIPTIN TABLETS" MEETS PREDEFINED ENDPOINTS IN THE PIVOTAL CLINICAL TRIALS FOR THE TREATMENT OF TYPE 2 DIABETES irasia.com ↗ |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DBPR108 | “DBPR108” NCT05045313 ↗ |
| Known as | prusogliptin | “DBPR108 (prusogliptin) is a novel, orally bioavailable dipeptidyl peptidase-4 (DPP-4) inhibitor.” PMID 40252162 ↗ Apr 2025 |
| Action | Inhibit | “dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108” NCT01650324 ↗ |
| Modality | Small molecule | — CHEMBL1082462 ↗ |
| Route | Oral | “single oral doses of DBPR108 in healthy male subjects” NCT01650324 ↗ |
| Target | DPP4 | “DPP4 inhibitor DBPR108” NCT02163278 ↗ |