Berberine

Phase 3Small molecule

XXijing Hospital of Digestive Diseases

Berberine is one of 215 small molecule programs targeting Cardiovascular Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

214

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseNot yet recruiting

Cognitive ImpairmentActive, not recruiting

Polycystic Ovary SyndromeActive, not recruiting

SchizophreniaUnknown status

Percutaneous Coronary InterventionRecruiting

DiabetesNot yet recruiting

LipEnrolling by invitation

Cardiovascular DiseasePhase 3

Not yet recruiting

Cognitive ImpairmentPreclinical

Active, not recruiting

Polycystic Ovary SyndromePreclinical

Active, not recruiting

SchizophreniaPhase 3

Unknown status

Percutaneous Coronary InterventionPhase 3

Recruiting

DiabetesPhase 3

Not yet recruiting

LipPhase 3

Enrolling by invitation

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Berberine

XXijing Hospital of Digestive Diseases

Phase 3

5 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Diabetes

NCT04698330

Q4 2028

Post-ApprovalNot yet recruiting

Cardiovascular Disease

NCT05105321

Clinical

Trials by Indication[1]

Schizophrenia5 trials

Berberine as Adjuvant Treatment for Schizophrenia Patients

Completed·TThe University of Hong Kong·Phase 2/3·NCT02983188·113 enrolled

Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients

Unknown status·TTianjin Anding Hospital·Phase 4·NCT03708549·100 enrolled

Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients

Completed·TTianjin Anding Hospital·N/A·NCT02936414·100 enrolled

Show 2 more trials

Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

Completed·TTianjin Anding Hospital·N/A·NCT03548155·65 enrolled

Berberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms

Enrolling by invitation·TTianjin Anding Hospital·Preclinical·NCT07356765·120 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia

Completed·SShanghai Jiao Tong University School of Medicine·Phase 3·NCT00462046·120 enrolled

Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT06514274·558 enrolled

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05014334·300 enrolled

Helicobacter Pylori Eradication3 trials

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02633930·566 enrolled

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02296021·612 enrolled

Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT04697186·524 enrolled

Polycystic Ovary Syndrome2 trials

Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

Unknown status·HHeilongjiang University of Chinese Medicine·N/A·NCT01138930·120 enrolled

Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Unknown status·HHeilongjiang University of Chinese Medicine·N/A·NCT01116167·660 enrolled

Metabolic Syndrome2 trials

Berberine Treat Metabolic Syndrome in Schizophrenia

Completed·TTianjin Anding Hospital·N/A·NCT03251716·36 enrolled

Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.

Unknown status·HHospital Civil de Guadalajara·Phase 3·NCT04860063·40 enrolled

19 more indications

Randomized Controlled Trial1 trial

A Mechanistic Randomized Controlled Trial on the Cardiovascular Effect of Berberine

Completed·TThe University of Hong Kong·Phase 2/3·NCT03770325·84 enrolled

Type 2 Diabetes1 trial

Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Completed·SShanghai Jiao Tong University School of Medicine·Phase 1/2·NCT00425009·70 enrolled

Nephropathy1 trial

Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Completed·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT02808351·800 enrolled

Cirrhosis1 trial

Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on GOV in Cirrhosis

Unknown status·UUnknown Sponsor·Phase 3·NCT04543643·288 enrolled

Lip1 trial

Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine

Enrolling by invitation·TThe University of Hong Kong·Phase 2/3·NCT06782646·100 enrolled

Ulcerative Colitis1 trial

Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

Withdrawn·XXijing Hospital of Digestive Diseases·Phase 4·NCT02962245

Non-Alcoholic Fatty Liver Disease1 trial

Role of Pioglitazone and Berberine in Treatment of Non-Alcoholic Fatty Liver Disease

Completed·XXin Gao·Phase 2·NCT00633282·184 enrolled

Bismuth Quadruple Therapy1 trial

Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

Unknown status·XXijing Hospital of Digestive Diseases·Phase 4·NCT06603688·548 enrolled

Helicobacter1 trial

Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT03609892·658 enrolled

Mixed Dyslipidemia1 trial

Bezafibrate Plus Berberine in Mixed Dyslipidemia

Completed·UUniversity of Guadalajara·Phase 3·NCT02548832·36 enrolled

COVID-191 trial

The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19

Completed·CChinese Medical Association·Phase 4·NCT04479202·76 enrolled

Lung Adenocarcinoma1 trial

Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

Unknown status·FFujian Cancer Hospital·Phase 2·NCT03486496·50 enrolled

Cardiovascular Disease1 trial

Cardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP)

Not yet recruiting·TTang Yida·Phase 4·NCT05105321·5,200 enrolled

Percutaneous Coronary Intervention1 trial

Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention

Recruiting·PPeking Union Medical College Hospital·Phase 4·NCT03378934·64 enrolled

Coronary Artery Disease1 trial

Effect of Berberine for Endothelial Function and Intestinal Microflora in Patients With Coronary Artery Disease

Unknown status·PPeking Union Medical College Hospital·Phase 1/2·NCT04434365·24 enrolled

Diabetes1 trial

Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA

Not yet recruiting·SSecond Xiangya Hospital of Central South University·Phase 4·NCT04698330·240 enrolled

Akkermansia Muciniphila1 trial

A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.

Completed·YYu Chen·N/A·NCT05720299·110 enrolled

Non-Alcoholic Steatohepatitis1 trial

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial

Terminated·FFudan University·Phase 2·NCT03198572·89 enrolled

Schizophrenia Therapeutics1 trial

Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on Gut-brain Axis

Completed·TTianjin Anding Hospital·Preclinical·NCT07359209·124 enrolled

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Berberine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Berberine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Berberine. 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: Phase 3[1]
Company: XXijing Hospital of Digestive Diseases

Berberine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2028

Trials by Indication[1]

Schizophrenia5 trials

Efficacy and Safety3 trials

Helicobacter Pylori Eradication3 trials

Polycystic Ovary Syndrome2 trials

Metabolic Syndrome2 trials

Randomized Controlled Trial1 trial

Type 2 Diabetes1 trial

Nephropathy1 trial

Cirrhosis1 trial

Lip1 trial

Ulcerative Colitis1 trial

Non-Alcoholic Fatty Liver Disease1 trial

Bismuth Quadruple Therapy1 trial

Helicobacter1 trial

Mixed Dyslipidemia1 trial

COVID-191 trial

Lung Adenocarcinoma1 trial

Cardiovascular Disease1 trial

Percutaneous Coronary Intervention1 trial

Coronary Artery Disease1 trial

Diabetes1 trial

Akkermansia Muciniphila1 trial

Non-Alcoholic Steatohepatitis1 trial

Schizophrenia Therapeutics1 trial

References

Drug Info

Quick Facts

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