Berberine hydrochloride

ApprovedSmall molecule

Berberine hydrochloride is one of 88 small molecule programs targeting Familial adenomatous polyposis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Familial Adenomatous PolyposisActive, not recruiting

Diabetes MellitusActive, not recruiting

HypertensionActive, not recruiting

Colorectal AdenomaActive, not recruiting

Familial Adenomatous PolyposisPhase 2/Phase 3

Active, not recruiting

Diabetes MellitusPhase 2/Phase 3

Active, not recruiting

HypertensionApproved

Active, not recruiting

Colorectal AdenomaPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

566 competitors in Hypertension

#DrugCompanyPhaseTrials

Berberine hydrochloride

XXijing Hospital of Digestive Diseases

Approved

1 2

Edarbi

Takeda

Preclinical

10 3

Zebeta

Teva

Preclinical

6 4

Edarbi

Takeda

Preclinical

4 5

Aceon

Institut de Recherches Internationales Servier

Preclinical

5 6

Winrevair

Alphagan

Avastin

1 9

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Post-ApprovalNot yet recruiting

Gastric Intestinal Metaplasia

NCT07129460

Clinical

Trials by Indication[1]

Colorectal Adenoma2 trials

A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer

Completed·XXijing Hospital of Digestive Diseases·Phase 2/3·NCT03281096·1,000 enrolled

Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Completed·SShanghai Jiao Tong University School of Medicine·Phase 2/3·NCT02226185·1,108 enrolled

Gastric Intestinal Metaplasia1 trial

Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia

Not yet recruiting·XXijing Hospital of Digestive Diseases·Phase 4·NCT07129460·204 enrolled

PreDiabetes1 trial

Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

Withdrawn·XXijing Hospital·Phase 2/3·NCT02082756

Diabetes Mellitus1 trial

Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment

Withdrawn·XXijing Hospital·Phase 2/3·NCT02084004

Trial1 trial

6-year Follow-up Data After the Berberine Intervention Trial

Recruiting·SShanghai Jiao Tong University School of Medicine··NCT06629051·891 enrolled

2 more indications

Hypertension1 trial

Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension

Unknown status·JJun Tao·Phase 4·NCT04790942·30 enrolled

Familial adenomatous polyposis1 trial

Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

Completed·XXijing Hospital of Digestive Diseases·Phase 2/3·NCT03333265·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Berberine hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Berberine hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Berberine hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Xijing Hospital of Digestive Diseases company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: XXijing Hospital of Digestive Diseases

Berberine hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Colorectal Adenoma2 trials

Gastric Intestinal Metaplasia1 trial

PreDiabetes1 trial

Diabetes Mellitus1 trial

Trial1 trial

Hypertension1 trial

Familial adenomatous polyposis1 trial

References

Drug Info

Quick Facts

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