Tauroursodeoxycholic acid

Phase 2Small molecule

Tauroursodeoxycholic acid is one of 83 small molecule programs targeting Insulin resistance. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Insulin ResistanceActive, not recruiting

CholestasisActive, not recruiting

Hepatobiliary DiseaseActive, not recruiting

Hepatocellular CarcinomaRecruiting

Endoplasmic Reticulum StressCompleted

Insulin ResistancePreclinical

Active, not recruiting

CholestasisPreclinical

Active, not recruiting

Hepatobiliary DiseasePreclinical

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Recruiting

Endoplasmic Reticulum StressPreclinical

Completed

Competition

Competitive Landscape

251 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Tauroursodeoxycholic acid

HHumanitas Mirasole SpA

Phase 2

1 2

Cysteine Hydrochloride

Novartis

Preclinical

1 3

Ibrance

Pfizer

Preclinical

1 4

Viread

Gilead

Preclinical

1 5

Sovaldi

Gilead

Preclinical

1 6

Hepsera

Coreg

2 8

Doptelet

AAkarx

Preclinical

1 9

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 10

Vermox

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q3 2028

Phase 2Recruiting

Hepatocellular Carcinoma

NCT07100392

Clinical

Trials by Indication[1]

Insulin resistance1 trial

Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

Completed·WWashington University School of Medicine·N/A·NCT01877551·27 enrolled

Fibrosis1 trial

The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 1·NCT04727320·60 enrolled

Hepatobiliary Disease1 trial

Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

Completed·—·N/A·NCT00004441·39 enrolled

Endoplasmic Reticulum Stress1 trial

Effect of Endoplasmic Reticulum Stress on Metabolic Function

Completed·WWashington University School of Medicine·N/A·NCT00771901·101 enrolled

Amyotrophic Lateral Sclerosis1 trial

Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis

Completed·FFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta·Phase 2·NCT00877604·34 enrolled

9 more indications

Type 1 Diabetes1 trial

Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes

Completed·—·Phase 2·NCT02218619·20 enrolled

Primary Biliary Cirrhosis1 trial

Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

Completed·—·Phase 3·NCT01857284·216 enrolled

Hepatocellular Carcinoma1 trial

Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Recruiting·FFudan University·Phase 2·NCT07100392·141 enrolled

Asthma1 trial

Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma

Terminated·UUniversity of Vermont·Phase 1·NCT03878654·11 enrolled

Cholestasis1 trial

Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

Completed·—·N/A·NCT00004410·50 enrolled

ALS1 trial

Open Label Extension of TUDCA-ALS Study

Unknown status·HHumanitas Mirasole SpA·Phase 3·NCT05753852·184 enrolled

Multiple Sclerosis1 trial

A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

Completed·JJohns Hopkins University·Phase 1/2·NCT03423121·59 enrolled

Acute Lymphoblastic Leukemia1 trial

The Discovery of the Double Sphincter in Gallbladder

Unknown status·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT01998451·150 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS

Unknown status·HHumanitas Mirasole SpA·Phase 3·NCT03800524·337 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Tauroursodeoxycholic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tauroursodeoxycholic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tauroursodeoxycholic acid. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Humanitas Mirasole SpA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: HHumanitas Mirasole SpA

Tauroursodeoxycholic acid

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Insulin resistance1 trial

Fibrosis1 trial

Hepatobiliary Disease1 trial

Endoplasmic Reticulum Stress1 trial

Amyotrophic Lateral Sclerosis1 trial

Type 1 Diabetes1 trial

Primary Biliary Cirrhosis1 trial

Hepatocellular Carcinoma1 trial

Asthma1 trial

Cholestasis1 trial

ALS1 trial

Multiple Sclerosis1 trial

Acute Lymphoblastic Leukemia1 trial

Safety and Efficacy1 trial

References

Drug Info

Quick Facts

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