Drugs / Chiglitazar
Chiglitazar
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | Bilessglu | type 2 diabetes mellitus | 2019-09-19 | “In September 2019, the New Drug Application (NDA) of Chiglitazar Sodium was accepted by Center for Drug Evaluation.” chipscreen.com ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07511010 | Oct 2026 expected | type 2 diabetes mellitus | Chipscreen Biosciences, Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06737523 | Mar → Dec 2025 overdue | acute myeloid leukemia | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 1 | NCT05681273 | Feb → Mar 2023 | type 2 diabetes mellitus | Chipscreen Biosciences, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05515445 | Dec 2022 → Aug 2023 | — | Chipscreen Biosciences, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05515458 | Nov 2022 → Jul 2023 | impaired renal function disease | Chipscreen Biosciences, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05760677 | Oct 2022 → Sep 2023 | polycystic ovary syndrome, type 2 diabetes mellitus | Affiliated Hospital of Nantong University | Unknown | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT07303803 | Jan 2026 → Dec 2030 expected | metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT05193916 | Mar 2022 → Jan 2024 | metabolic dysfunction-associated steatohepatitis | Chipscreen Biosciences, Ltd. | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06125587 | Nov 2023 → Oct 2024 | polycystic ovary syndrome | Shengjing Hospital | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04807348 | Jul 2021 → Feb 2023 | type 2 diabetes mellitus | Chipscreen Biosciences, Ltd. | Completed | Met primary |
| Phase 3 | NCT02173457 | Sep 2014 → Jan 2017 | type 2 diabetes mellitus | Chipscreen Biosciences, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02121717 | Jun 2014 → Nov 2017 | type 2 diabetes mellitus | Chipscreen Biosciences, Ltd. | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07558525 | Apr 2026 → Dec 2028 expected | prediabetes syndrome | Second Xiangya Hospital of Central South University | Not yet recruiting | No outcome recorded |
| — | NCT06773221 | Feb 2025 → Jan 2028 expected | cirrhosis of liver, metabolic dysfunction-associated steatotic liver disease | Beijing Friendship Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06191328 | Jan 2024 → Jun 2025 | diabetes mellitus | Yufan Wang | Unknown | No outcome recorded |
| — | NCT06007014 | Oct 2023 → Oct 2025 | — | Yanbing Li | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-05-14 | Chipscreen Biosciences, Ltd. | Regulatory Two First-in-Class Drugs from Chipscreen Biosciences Enter the Macao Market, Expanding Patient Access chipscreen.com ↗
Shenzhen Chipscreen Biosciences Co., Ltd. (“Chipscreen Biosciences,” stock code: 688321.SH) announced that its independently developed novel drug Bilessglu® (chiglitazar sodium tablets) has received marketing approval from the Pharmaceutical Administration Bureau (ISAF) of the Macao Special Administrative Region of China. |
| 2026-03-16 | Chipscreen Biosciences, Ltd. | Regulatory First-in-Class Combination Therapy: Clinical Trial Application for Chiglitazar Sodium/Metformin Extended-Release Tablets for Type 2 Diabetes Approved chipscreen.com ↗
On March 16, Shenzhen Chipscreen Biosciences Co., Ltd. (stock code: 688321.SH) and its wholly owned subsidiary, Chengdu Chipscreen Pharmaceutical Co., Ltd., announced that the National Medical Products Administration (NMPA) had approved the clinical trial application for their independently developed chiglitazar sodium/metformin extended-release tablets for the treatment of type 2 diabetes. |
| 2025-08-07 | Chipscreen Biosciences, Ltd. | Results International Hepatology Journal Publishes Key Study on Chiglitazar Sodium (Bilessglu®) for MASH Treatment chipscreen.com ↗
After 18 weeks of treatment, patients experienced a 40% reduction in liver fat content, with more than 70% achieving normalization of liver enzyme levels. |
| 2024-11-18 | Chipscreen Biosciences, Ltd. | Regulatory Major NRDL Update｜Chipscreen’s Epidaza® Becomes the Only Oral Novel Drug for First-Line DLBCL, while Bilessglu® Retains Listing at Current Price chipscreen.com ↗
Bilessglu® (Chiglitazar Sodium tablets) has retained its type 2 diabetes indication at the current reimbursement price. |
| 2024-10-15 | Chipscreen Biosciences, Ltd. | Results Chiglitazar for the Treatment of MASH Phase II Clinical Study Selected for Oral Presentation at the 2024 American Liver Disease Annual Meeting chipscreen.com ↗
The study results showed that the liver fat content (LFC) evaluated by MRI-PDFF decreased from baseline by 28.1% and 39.5% respectively after 18 weeks of treatment with Chiglitazar 48mg or 64mg (decrease of 3.2% in the Placebo). |
| 2024-07-19 | Chipscreen Biosciences, Ltd. | Regulatory Chiglitazar Sodium (Bilessglu®) in Combination with Metformin Approved by NMPA for Type 2 Diabetes chipscreen.com ↗
Following its initial approval as a monotherapy for type 2 diabetes in October 2021, this new approval further broadens Chiglitazar Sodium’s clinical applications, offering patients additional combination therapy options. |
| 2024-03-18 | Chipscreen Biosciences, Ltd. | Results Positive results from Phase II clinical trial (CGZ203 study) of Chiglitazar monotherapy for non-alcoholic steatohepatitis chipscreen.com ↗
The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway. |
| 2019-09-20 | Chipscreen Biosciences, Ltd. | Regulatory Chipscreeen Biosciences’s Original New Drug Bilessglu® (for Type 2 Diabetes): Commercialization Application Accepted chipscreen.com ↗
Chiglitazar (Bilessglu®) , an innovative new chemical entity (Category 1 of chemical drug) for type 2 diabetes discovered and developed by Shenzhen Chipscreen Biosciences (Stock Symbol: 688321. SH), has been accepted |
All press releases naming this drug 10 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Chiglitazar | “Chiglitazar Sodium in combination with Venetoclax and Azacitidine” NCT06737523 ↗ |
| Known as | Carfloglitazar | “Chiglitazar (Carfloglitazar) is a novel non-thiazolidinedione (TZD) structured” PMID 36654286 ↗ Mar 2021 |
| Known as | Chiglitazar Sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07558525 ↗ |
| Action | Activate | “peroxisome proliferator-activated receptor (PPAR) pan-agonist” PMID 36654286 ↗ Mar 2021 |
| Route | Oral | “Take orally” NCT02121717 ↗ |