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Actigall (URSODIOL)
Actigall (Ursodiol) is a bile acid medication originally developed by Actavis Labs UT Inc and currently owned by Abbvie. It targets CDGSH iron-sulfur domain-containing protein 1 and is classified as a small molecule bile acid. Actigall is FDA-approved for treating calculus in the biliary tract, preventing cholelithiasis, and primary biliary cirrhosis. The medication is off-patent with 19 generic manufacturers available. Key safety considerations include its potential effects on liver function and interactions with other medications.
At a glance
| Generic name | URSODIOL |
|---|---|
| Also known as | ursodeoxycholic acid |
| Sponsor | AbbVie |
| Drug class | Bile Acid [EPC] |
| Target | CDGSH iron-sulfur domain-containing protein 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1987 |
Approved indications
- Calculus in biliary tract
- Cholelithiasis Prevention
- Primary biliary cirrhosis
Common side effects
- Allergy
- Chest Pain
- Fatigue
- Viral Infection
- Abdominal Pain
- Cholecystitis
- Constipation
- Diarrhea
- Dyspepsia
- Flatulence
- Gastrointestinal Disorder
- Nausea
Key clinical trials
- Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (PHASE4)
- Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation (PHASE2)
- Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
- The Role of Secondary Bile Acids in Intestinal Inflammation (PHASE2,PHASE3)
- Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine. (PHASE2)
- A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. (PHASE3)
- Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (PHASE3)
- Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Actigall CI brief — competitive landscape report
- Actigall updates RSS · CI watch RSS
- AbbVie portfolio CI