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Ursodeoxycholic Acid Capsules
Ursodeoxycholic Acid Capsules is a Bile acid Small molecule drug developed by Beijing Friendship Hospital. It is currently in Phase 3 development for Primary biliary cholangitis (PBC), Primary sclerosing cholangitis (PSC), Cholestasis of pregnancy. Also known as: Ursofalk.
Ursodeoxycholic acid is a bile acid that reduces cholesterol saturation in bile and increases bile flow to improve hepatic function and reduce cholestasis.
Ursodeoxycholic acid capsules are used to treat conditions such as ulcerative colitis, pouchitis, chronic cholecystitis, and acute pancreatitis due to gallstones, based on studies listed on ClinicalTrials.gov. The mechanism of action of ursodeoxycholic acid is related to secondary bile acids in intestinal inflammation, as per the study "The Role of Secondary Bile Acids in Intestinal Inflammation" on ClinicalTrials.gov.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ursodeoxycholic Acid Capsules |
|---|---|
| Also known as | Ursofalk |
| Sponsor | Beijing Friendship Hospital |
| Drug class | Bile acid |
| Target | Farnesoid X receptor (FXR), TGR5 receptor |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Ursodeoxycholic acid (UDCA) is a naturally occurring hydrophilic bile acid that decreases the cholesterol content of bile and promotes its flow through the biliary system. It protects hepatocytes from cytotoxic bile acids and has immunomodulatory properties that reduce inflammation in the liver. These mechanisms make it effective in treating cholestatic liver diseases by improving bile flow and reducing hepatic injury.
Approved indications
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis (PSC)
- Cholestasis of pregnancy
- Gallstone dissolution
Common side effects
- Diarrhea
- Abdominal pain
- Nausea
- Pruritus
- Headache
Key clinical trials
- Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation (PHASE2)
- 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)
- Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study (PHASE3)
- Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin (PHASE3)
- Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes (PHASE3)
- Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia (NA)
- Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia (PHASE4)
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 |
|---|---|
| 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:
- Ursodeoxycholic Acid Capsules CI brief — competitive landscape report
- Ursodeoxycholic Acid Capsules updates RSS · CI watch RSS
- Beijing Friendship Hospital portfolio CI
Frequently asked questions about Ursodeoxycholic Acid Capsules
What is Ursodeoxycholic Acid Capsules?
How does Ursodeoxycholic Acid Capsules work?
What is Ursodeoxycholic Acid Capsules used for?
Who makes Ursodeoxycholic Acid Capsules?
Is Ursodeoxycholic Acid Capsules also known as anything else?
What drug class is Ursodeoxycholic Acid Capsules in?
What development phase is Ursodeoxycholic Acid Capsules in?
What are the side effects of Ursodeoxycholic Acid Capsules?
What does Ursodeoxycholic Acid Capsules target?
Related
- Drug class: All Bile acid drugs
- Target: All drugs targeting Farnesoid X receptor (FXR), TGR5 receptor
- Manufacturer: Beijing Friendship Hospital — full pipeline
- Therapeutic area: All drugs in Hepatology / Gastroenterology
- Indication: Drugs for Primary biliary cholangitis (PBC)
- Indication: Drugs for Primary sclerosing cholangitis (PSC)
- Indication: Drugs for Cholestasis of pregnancy
- Also known as: Ursofalk
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing