Drugs / Bexagliflozin
Bexagliflozin
also known as
Brenzavvy · EGT0001442 · THR-1442 · bexagliflozin (Brenzavvy) · Bexagliflozina · Bexagliflozine · EGT-1442
Small molecule targets SLC5A2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BRENZAVVY | — | 2023-01-20 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 missed | ||||||
| Phase 1 | NCT06600178 | Jul 2025 → Oct 2027 expected | coronary microvascular disorder, nonobstructive coronary artery disease | University of Virginia | Recruiting | No outcome recorded |
| Phase 1 | NCT05369078 | Dec 2021 → May 2022 | type 2 diabetes mellitus | Newsoara Biopharma Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03417076 | Aug → Sep 2018 | type 2 diabetes mellitus | Theracos | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03557658 | Jul → Dec 2018 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 1 | NCT03296800 | Sep → Dec 2017 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 1 | NCT03167411 | May → Jun 2017 | type 2 diabetes mellitus | Theracos | Completed | Missed primary |
| Phase 1 | NCT02820298 | Jun → Aug 2016 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT01377844 | Dec 2011 → Nov 2013 | type 2 diabetes mellitus | Theracos | Completed | Met primary |
| Phase 2 | NCT01029704 | Dec 2009 → Jul 2010 | type 2 diabetes mellitus | Theracos | Completed | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03514641 | Oct 2017 → Nov 2018 | essential hypertension | Theracos | Completed | Met primary |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT05159882 | Apr 2021 → Sep 2022 | type 2 diabetes mellitus | Newsoara Biopharma Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03259789 | Nov 2017 → Jan 2019 | type 2 diabetes mellitus | Theracos | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05612594 | Mar 2024 → Sep 2027 expected | obstructive sleep apnea syndrome | Yale University | Recruiting | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT03197324 Comparator | Jul → Sep 2017 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 1 | NCT02956044 Comparator | Nov 2016 → Mar 2017 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 2 | NCT02390050 Comparator | May 2015 → Jun 2016 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 3 | NCT03115112 Comparator | Oct 2017 → Oct 2018 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 3 | NCT02836873 Comparator | Sep 2016 → Jan 2018 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 3 | NCT02769481 Comparator | Aug 2016 → Jun 2019 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 3 | NCT02715258 Comparator | Mar 2016 → Apr 2017 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 3 | NCT02558296 Comparator | Oct 2015 → Aug 2018 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07325435 Comparator | Dec 2024 → Dec 2027 expected | type 2 diabetes mellitus | MaryAnn Banerji | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-04-15 | Theracos | Results Head-to-Head Study Finds BRENZAVVY® (bexagliflozin) Non-Inferior to Dapagliflozin in Chinese Patients With Type 2 Diabetes theracosbio.com ↗
The study results demonstrated the noninferiority of BRENZAVVY® (bexagliflozin) to dapagliflozin, marketed as Farxiga in the United States, in patients with type 2 diabetes mellitus. |
| 2024-01-08 | Theracos | Results CV Safety Profile of TheracosBio’s BRENZAVVY® (bexagliflozin) Confirmed in Research Published in Diabetes, Obesity and Metabolism theracosbio.com ↗
The research, published in Diabetes, Obesity and Metabolism, detailed the results of a pre-specified analysis of nine Phase 2 and 3 studies used to gain FDA approval for BRENZAVVY. |
| 2023-08-04 | Theracos | Results TheracosBio Announces Publication of Data on the Safety and Effectiveness of Brenzavvy™ (bexagliflozin) as an Adjunct to Metformin theracosbio.com ↗
The study results showed that BRENZAVVY treatment improved glycemic control and decreased systolic blood pressure levels and fasting plasma glucose levels in patients with type 2 diabetes. |
| 2023-01-23 | Theracos | Regulatory TheracosBio Announces FDA Approval of Brenzavvy™ (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes theracosbio.com ↗
TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. |
All press releases naming this drug 10 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bexagliflozin | “bexagliflozin (Brenzavvy®)” NCT07325435 ↗ |
| Known as | bexagliflozin (Brenzavvy) | “bexagliflozin (Brenzavvy®)” NCT07325435 ↗ |
| Known as | Bexagliflozina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1808388 ↗ |
| Known as | Bexagliflozine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1808388 ↗ |
| Known as | Brenzavvy | “Brenzavvy (bexagliflozin), 20 mg Oral Tablet” NCT06600178 ↗ |
| Known as | EGT-1442 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1808388 ↗ |
| Known as | EGT0001442 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01377844 ↗ |
| Known as | THR-1442 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05369078 ↗ |
| Action | Inhibit | “Sodium/glucose cotransporter 2 inhibitor” CHEMBL1808388 ↗1“Human SGLT2 inhibitor” NCT01029704 ↗ |
| Modality | Small molecule | — CHEMBL1808388 ↗ |
| Route | Oral | “EGT0001442 capsules orally once daily for 28 days” NCT01029704 ↗ |
| Target | SLC5A2 | “Sodium/glucose cotransporter 2 inhibitor” CHEMBL1808388 ↗ |