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Indication
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Research Report
Berberine Ursodeoxycholate (HTD1801): A Comprehensive Pharmacological and Clinical Analysis of a First-in-Class Metabolic Modulator
Executive Summary
Berberine Ursodeoxycholate, identified by the development code HTD1801, is a first-in-class, orally administered, gut-liver anti-inflammatory metabolic modulator under development by HighTide Biopharma.[1] It is a new molecular entity structured as an ionic salt of two well-characterized active moieties: the plant alkaloid Berberine and the secondary bile acid Ursodeoxycholic Acid (UDCA).[3] This novel design aims to leverage the synergistic therapeutic actions of its components to address the complex, interconnected pathophysiology of metabolic diseases.
The compound's therapeutic potential is rooted in a unique dual mechanism of action: the activation of AMP-activated protein kinase (AMPK) and the inhibition of the NLRP3 inflammasome.[2] This allows HTD1801 to simultaneously target fundamental pathways of metabolic dysregulation and chronic inflammation, which are key drivers of conditions such as Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as Non-alcoholic Steatohepatitis (NASH).
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/16 | Phase 3 | Active, not recruiting | |||
2024/05/13 | Phase 2 | Completed | |||
2024/04/09 | Phase 3 | Active, not recruiting | |||
2024/04/08 | Phase 3 | Active, not recruiting | |||
2022/11/21 | Phase 2 | Completed | |||
2018/09/19 | Phase 2 | Withdrawn | |||
2018/09/04 | Phase 2 | Completed | |||
2017/11/07 | Phase 2 | Completed | |||
2017/04/04 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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