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Actigall

(ursodiol)

ApprovedSmall molecule

Ursodiol is used to dissolve gallstones and to protect the liver in people with certain liver diseases. It works by reducing the amount of cholesterol your body produces and absorbs.[2] Actigall is currently approved and in use across 32 indications[4].[1]

Actigall is one of 628 small molecule programs targeting Colitis. It is currently in Approved.

32

Indications

23

Total Trials

1

Active Trials

627

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

ColitisActive, not recruiting

Familial Adenomatous PolyposisApproved

Gestational DiabetesApproved

Glucose IntoleranceApproved

Cholestatic Liver DiseaseActive, not recruiting

Non-Alcoholic Fatty Liver DiseaseApproved

CholestasisActive, not recruiting

Hepatobiliary DiseaseActive, not recruiting

AgeApproved

Drug-Induced Liver InjuryApproved

ColitisPhase 1

Active, not recruiting

Familial Adenomatous PolyposisApproved

Approved

Gestational DiabetesApproved

Approved

Glucose IntoleranceApproved

Approved

Cholestatic Liver DiseasePhase 2

Active, not recruiting

Non-Alcoholic Fatty Liver DiseaseApproved

Approved

CholestasisPhase 2

Active, not recruiting

Hepatobiliary DiseasePreclinical

Active, not recruiting

AgeApproved

Approved

Drug-Induced Liver InjuryApproved

Approved

Showing 10 of 32 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Actigall

Spikevax

Bnt162b2

COVID-19 Vaccine

Biaxin

Stivarga

Aimovig

Aldactone

Nexavar

Singulair

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

Timeline

Expected Milestones

Q2 2028

Phase 1Not yet recruiting

Colitis

NCT06884748

Clinical

Trials by Indication[1]

Primary Biliary Cirrhosis2 trials

Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004784·315 enrolled

Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004748·90 enrolled

Fed2 trials

Ursodiol 500 mg Tablets Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT00909753·92 enrolled

A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT03512821·77 enrolled

Fasting Conditions2 trials

Ursodiol Tablets 500 mg Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00909610·80 enrolled

A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT03512808·77 enrolled

Colorectal Cancer2 trials

Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

Completed·—·Phase 1·NCT00873275·11 enrolled

Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00062023·12 enrolled

Huntington's Disease1 trial

Ursodiol in Huntington's Disease

Unknown status·OOregon Health and Science University·Phase 1·NCT00514774·21 enrolled

14 more indications

Treatment1 trial

Lithotripsy for the Treatment of Gallstones

Terminated·MMedstone International·Phase 4·NCT00042549·184 enrolled

Barrett Esophagus1 trial

Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01097304·36 enrolled

CNS Tumors1 trial

Auto Transplant for High Risk or Relapsed Solid or CNS Tumors

Completed·MMasonic Cancer Center, University of Minnesota·N/A·NCT01505569·44 enrolled

Homeostasis1 trial

Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00706381·31 enrolled

Cholestatic liver disease1 trial

Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

Unknown status·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004315·20 enrolled

Hepatobiliary Disease1 trial

Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

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

MPA1 trial

Comparative Bioavailability Study of UDCA

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT02385032·50 enrolled

Peroxisomal Disorders1 trial

Study of Bile Acids in Patients With Peroxisomal Disorders

Terminated·UUniversity of Cincinnati·N/A·NCT00004442·25 enrolled

Bariatric Surgery1 trial

Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery

Unknown status·HHaEmek Medical Center, Israel·N/A·NCT02319629·266 enrolled

Type 2 Diabetes1 trial

Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin

Completed·MMayo Clinic·Phase 2·NCT02033876·24 enrolled

Cholestasis1 trial

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Completed·IIbrahim Mohamed·Phase 2/3·NCT00846963·26 enrolled

Colitis1 trial

Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy

Not yet recruiting·MMedical College of Wisconsin·Phase 1·NCT06884748·30 enrolled

Inflammation1 trial

The Role of Secondary Bile Acids in Intestinal Inflammation

Terminated·SStanford University·Phase 2/3·NCT03724175·2 enrolled

Unspecified1 trial

C. Difficile and Ursodiol

Completed·NNYU Langone Health·Phase 4·NCT02748616·9 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 31, 1987

ACTIGALL

NDA NDA019594

Dec 10, 1997

URSO 250

NDA NDA020675

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for ursodiol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Actigall drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — ursodiol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for ursodiol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020675). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bile Acid Receptor FXR Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

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