Wednesday, July 8, 2026

Drug profile · INN

ursodiol

ursodiol (URSODIOL) is a bile acid receptor fxr agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 5
Pipeline programs 8
News articles 0
Drug details — ursodiol
US status
approved
Class
Route
ORAL
Patents
5
Programs
8
Data quality
0.89

Quick answer

ursodiol (URSODIOL) is a bile acid receptor fxr agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ursodiol
Brand URSODIOL
Mechanism Bile acid receptor FXR agonist
Target Bile acid receptor
Route ORAL
Formulation CAPSULE

Mechanism of action

Bile acid receptor FXR agonist

Primary target: Bile acid receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. MYL-1603N-3002 Phase 3 · Mylan Specialty · Major Depression Disorders
  2. PRIN - 20227EA9AN Phase 3 · Talon Biomarkers · Major Depressive Disorder (MDD)
  3. PRIN - 20227EA9AN Phase 3 · Talon Biomarkers · Major Depressive Disorder (MDD)
  4. Sodio ioduro (I131) Curium Netherlands 37-740... Phase 3 · Sana Biotechnology · Graves' disease and Graves' orbitophaty
  5. AECOPD Phase 2 · Telethon Foundation · Chronic Obstructive Pulmonary Disease
  6. AIRC Id. 21939 Phase 2 · Telethon Foundation · Metastatic DTC
  7. BCG-RIS-01 Phase 2 · Telethon Foundation · RIS (Radiologically Isolated Syndrome)
  8. Ursodiol Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. chenodiol Bile acid receptor FXR agonist
  2. obeticholic acid Alimentary tract and metabolism (A05)
  3. chenodeoxycholic acid Alimentary tract and metabolism (A05)
  4. ursodeoxycholic acid Bile acid receptor FXR agonist
  1. US 11583542

    Compositions of bile acids and phenylbutyrate compounds

    Expires Mon Feb 16 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11071742

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Jul 22 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10857162

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Dec 03 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10251896

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Apr 04 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9872865

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Jan 18 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ursodiol?

ursodiol (URSODIOL) is a bile acid receptor fxr agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ursodiol?

URSODIOL is a marketed brand name for ursodiol. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ursodiol?

ursodiol has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.