Tauroursodeoxycholic acid

Phase 3Small molecule

Tauroursodeoxycholic acid is one of 249 small molecule programs targeting Insulin resistance. It is currently in Phase 3.

Indications

Total Trials

Active Trials

248

Competitors

Pipeline

Status by Indication[3][1]

Indication

Insulin ResistanceActive, not recruiting

CholestasisActive, not recruiting

Hepatobiliary DiseaseActive, not recruiting

FibrosisActive, not recruiting

Amyotrophic Lateral SclerosisActive, not recruiting

Primary Biliary CirrhosisActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Multiple SclerosisActive, not recruiting

Type 1 DiabetesActive, not recruiting

AsthmaActive, not recruiting

Insulin ResistancePreclinical

Active, not recruiting

CholestasisPreclinical

Active, not recruiting

Hepatobiliary DiseasePreclinical

Active, not recruiting

FibrosisPhase 1

Active, not recruiting

Amyotrophic Lateral SclerosisPhase 2

Active, not recruiting

Primary Biliary CirrhosisPhase 3

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Multiple SclerosisPhase 1/Phase 2

Active, not recruiting

Type 1 DiabetesPhase 2

Active, not recruiting

AsthmaPhase 1

Active, not recruiting

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Tauroursodeoxycholic acid

HHumanitas Mirasole SpA

Phase 3

1 2

Xolair

Roche

Preclinical

25 3

Singulair

AstraZeneca

Preclinical

17 4

Nucala

GGlaxo Dba Glaxosmithkline

Preclinical

35 5

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

30 6

Arcoxia

Formoterol Fumarate

8 8

Symbicort

AstraZeneca

Preclinical

6 9

Aciphex

Akero Therapeutics

Preclinical

2 10

Atrovent

Boehringer Ingelheim

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]

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

Multiple Sclerosis1 trial

A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

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

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

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

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

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

Asthma1 trial

Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma

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

Hepatobiliary Disease1 trial

Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

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

ALS1 trial

Open Label Extension of TUDCA-ALS Study

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

Endoplasmic Reticulum Stress1 trial

Effect of Endoplasmic Reticulum Stress on Metabolic Function

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

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 3[1]
Company: HHumanitas Mirasole SpA

Tauroursodeoxycholic acid

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Acute Lymphoblastic Leukemia1 trial

Multiple Sclerosis1 trial

Insulin resistance1 trial

Fibrosis1 trial

Amyotrophic Lateral Sclerosis1 trial

Hepatocellular Carcinoma1 trial

Type 1 Diabetes1 trial

Primary Biliary Cirrhosis1 trial

Asthma1 trial

Hepatobiliary Disease1 trial

ALS1 trial

Safety and Efficacy1 trial

Endoplasmic Reticulum Stress1 trial

Cholestasis1 trial

References

Drug Info

Quick Facts

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