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Research Report
Enavogliflozin: A Comprehensive Pharmacological and Clinical Review
1. Introduction to Enavogliflozin
1.1. Overview of Enavogliflozin
Enavogliflozin is an orally administered, selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2).[1] It has been developed primarily for the management of type 2 diabetes mellitus (T2DM) and is also under investigation for its potential therapeutic applications in obesity, heart failure, diabetic retinopathy, and for cardioprotection.[1] The development of Enavogliflozin, particularly its efficacy at a notably low dosage of 0.3 mg, reflects a strategic approach by its developers to potentially offer advantages over existing therapies in the SGLT2 inhibitor class.[2] This low-dose efficacy, coupled with claims of being a "best-in-class" agent, suggests an aim to achieve a differentiated profile, possibly in terms of improved tolerability or cost-effectiveness, within a competitive therapeutic landscape. Pooled analyses demonstrating superior glucose-lowering effects compared to dapagliflozin in specific patient populations, such as those with mild renal impairment, at this low dose, lend support to this distinct positioning.[14]
The SGLT2 inhibitor class, to which Enavogliflozin belongs, constitutes a significant advancement in antidiabetic therapy. These agents operate via a mechanism independent of insulin, providing glycemic control alongside a range of other metabolic benefits, including potential cardiovascular and renal protection.[5] Enavogliflozin's emergence as a new entity within this class, particularly with its specific dosing and efficacy claims, necessitates a thorough evaluation of its comparative clinical performance.
1.2. Chemical Identity and Synonyms
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/25 | Phase 4 | Recruiting | |||
2024/10/15 | Phase 4 | Recruiting | |||
2024/07/30 | Phase 4 | Not yet recruiting | |||
2024/05/06 | Phase 4 | Recruiting | |||
2023/09/07 | Phase 3 | Recruiting | |||
2023/07/03 | N/A | Active, not recruiting | Daewoong Pharmaceutical Co. LTD. | ||
2023/04/04 | Phase 1 | Recruiting | Daewoong Pharmaceutical Co. LTD. | ||
2023/02/28 | Phase 1 | Recruiting | Daewoong Pharmaceutical Co. LTD. | ||
2023/02/21 | Phase 1 | Recruiting | Daewoong Pharmaceutical Co. LTD. | ||
2023/01/05 | Phase 4 | Recruiting | Duk-Woo Park, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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