Overview
Ursodeoxycholic acid (UDCA), also known as ursodiol, is a naturally-occurring bile acid that constitutes a minor fraction of the human bile acid pool. UDCA has been used to treat liver disease for decades: its first use in traditional medicine dates back more than a hundred years. UDCA was first characterized in the bile of the Chinese black bear and is formed by 7b-epimerization of chenodeoxycholic acid, which is a primary bile acid. Due to its hydrophilicity, UDCA is less toxic than cholic acid or chenodeoxycholic acid. UDCA was first approved by the FDA in 1987 for dissolution of gallstones and for primary biliary cirrhosis in 1996. UDCA works by replacing the hydrophobic or more toxic bile acids from the bile acid pool.
Indication
Ursodeoxycholic acid is indicated for the treatment of patients with primary biliary cholangitis. It is used for the short-term treatment of radiolucent, noncalcified gallbladder stones in patients selected for elective cholecystectomy. It is also used to prevent gallstone formation in obese patients experiencing rapid weight loss.
Associated Conditions
- Gallstones
- Primary Biliary Cholangitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/16 | Not Applicable | Recruiting | Phenomen Pharma | ||
2025/04/10 | Not Applicable | Recruiting | General Hospital of Shenyang Military Region | ||
2025/03/19 | Early Phase 1 | Not yet recruiting | |||
2024/12/04 | Phase 3 | Completed | |||
2024/09/24 | Phase 4 | Recruiting | Yongquan Shi | ||
2024/09/19 | Early Phase 1 | Active, not recruiting | Han Ying | ||
2024/09/19 | Phase 2 | ENROLLING_BY_INVITATION | Han Ying | ||
2024/07/24 | Phase 4 | Not yet recruiting | Amira Adel Fouly | ||
2024/04/15 | Phase 2 | Recruiting | Xijing Hospital of Digestive Diseases | ||
2024/02/22 | Phase 4 | Completed | Daewoong Pharmaceutical Co. LTD. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Golden State Medical Supply, Inc. | 51407-754 | ORAL | 300 mg in 1 1 | 9/25/2023 | |
| Major Pharmaceuticals | 0904-6890 | ORAL | 250 mg in 1 1 | 8/8/2019 | |
| Bryant Ranch Prepack | 63629-2287 | ORAL | 500 mg in 1 1 | 4/11/2018 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-205 | ORAL | 300 mg in 1 1 | 2/16/2024 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1127 | ORAL | 250 mg in 1 1 | 3/22/2024 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1128 | ORAL | 500 mg in 1 1 | 3/22/2024 | |
| BluePoint Laboratories | 68001-377 | ORAL | 250 mg in 1 1 | 5/8/2023 | |
| Chartwell RX, LLC | 62135-430 | ORAL | 300 mg in 1 1 | 10/5/2023 | |
| Bryant Ranch Prepack | 72162-1501 | ORAL | 500 mg in 1 1 | 8/25/2023 | |
| Aurobindo Pharma Limited | 59651-421 | ORAL | 300 mg in 1 1 | 9/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| URSOFALK FILM-COATED TABLETS 500MG | SIN14545P | TABLET, FILM COATED | 500.00 mg | 5/2/2014 | |
| URSOSAN HARD CAPSULES 250 MG | SIN16926P | CAPSULE | 250.00 mg | 1/5/2024 | |
| GRINTEROL HARD CAPSULE 250MG | SIN15883P | CAPSULE | 250MG | 2/12/2020 | |
| URSOSAN FORTE FILM-COATED TABLETS 500MG | SIN16918P | TABLET, FILM COATED | 500.00 mg | 12/19/2023 | |
| URSOFALK CAPSULE 250 mg | SIN05742P | CAPSULE | 250 mg | 4/8/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ursodeoxycholic Acid Tablets | 国药准字H32023786 | 化学药品 | 片剂 | 9/9/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H42022793 | 化学药品 | 片剂 | 9/18/2021 | |
| Ursodeoxycholic Acid Tablets | 国药准字H51021463 | 化学药品 | 片剂 | 5/15/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H33020469 | 化学药品 | 片剂 | 5/22/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H32022028 | 化学药品 | 片剂 | 6/15/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H31021313 | 化学药品 | 片剂 | 4/9/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H44021575 | 化学药品 | 片剂 | 5/14/2024 | |
| Ursodeoxycholic Acid Tablets | 国药准字H31021876 | 化学药品 | 片剂 | 2/24/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H21024374 | 化学药品 | 片剂 | 5/29/2020 | |
| Ursodeoxycholic Acid Tablets | 国药准字H42021791 | 化学药品 | 片剂 | 2/28/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HIYA KIOGAN SILVER PILLS | N/A | N/A | N/A | 8/23/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| URSO Ursodeoxycholic acid 250mg/5mL oral liquid bottle | 116751 | Medicine | A | 11/15/2006 | |
| URSODOX GH ursodeoxycholic acid 250 mg capsules blister pack | 232480 | Medicine | A | 2/15/2016 | |
| URSO ursodeoxycholic acid 500 mg tablet blister pack | 262733 | Medicine | A | 10/6/2016 | |
| URSOFALK ursodeoxycholic acid 250mg/5mL oral liquid bottle | 75484 | Medicine | A | 8/1/2000 | |
| URSO Ursodeoxycholic acid 250mg capsule blister pack | 116741 | Medicine | A | 11/15/2006 | |
| URSODEOXYCHOLIC ACID-WGR ursodeoxycholic acid 250 mg capsule blister pack | 276338 | Medicine | A | 4/20/2017 | |
| URSODOX LAPL ursodeoxycholic acid 500 mg capsule blister pack | 400953 | Medicine | A | 5/30/2024 | |
| URSOFALK ursodeoxycholic acid 250mg capsule blister pack | 66042 | Medicine | A | 5/24/1999 | |
| APO-URSODEOXYCHOLIC ACID ursodeoxycholic acid 250 mg capsule blister pack | 276339 | Medicine | A | 4/20/2017 | |
| URSODOX GH ursodeoxycholic acid 500 mg capsule blister pack | 400951 | Medicine | A | 5/30/2024 |
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