Last reviewed · How we verify
norUrsodeoxycholic acid
norUrsodeoxycholic acid is a FXR agonist Small molecule drug developed by Dr. Falk Pharma GmbH. It is currently in Phase 3 development for Primary biliary cholangitis. Also known as: norucholic acid, norUDCA, NCA, NUC.
NorUrsodeoxycholic acid is a bile acid that acts as an FXR agonist.
NorUrsodeoxycholic acid is a bile acid that acts as an FXR agonist. Used for Primary biliary cholangitis.
-
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 | norUrsodeoxycholic acid |
|---|---|
| Also known as | norucholic acid, norUDCA, NCA, NUC |
| Sponsor | Dr. Falk Pharma GmbH |
| Drug class | FXR agonist |
| Target | FXR |
| Modality | Small molecule |
| Therapeutic area | Liver disease |
| Phase | Phase 3 |
Mechanism of action
FXR agonists like norUrsodeoxycholic acid work by activating the farnesoid X receptor, which plays a key role in regulating bile acid synthesis and transport. This can lead to reduced bile acid levels in the liver and improved liver function.
Approved indications
- Primary biliary cholangitis
Common side effects
- Abdominal pain
- Nausea
- Diarrhea
Key clinical trials
- Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC) (PHASE3)
- norUrsodeoxycholic Acid vs Placebo in PSC (PHASE3)
- Norursodeoxycholic Acid vs. Placebo in NASH (PHASE2)
- Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (PHASE2)
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:
- norUrsodeoxycholic acid CI brief — competitive landscape report
- norUrsodeoxycholic acid updates RSS · CI watch RSS
- Dr. Falk Pharma GmbH portfolio CI
Frequently asked questions about norUrsodeoxycholic acid
What is norUrsodeoxycholic acid?
How does norUrsodeoxycholic acid work?
What is norUrsodeoxycholic acid used for?
Who makes norUrsodeoxycholic acid?
Is norUrsodeoxycholic acid also known as anything else?
What drug class is norUrsodeoxycholic acid in?
What development phase is norUrsodeoxycholic acid in?
What are the side effects of norUrsodeoxycholic acid?
What does norUrsodeoxycholic acid target?
Related
- Drug class: All FXR agonist drugs
- Target: All drugs targeting FXR
- Manufacturer: Dr. Falk Pharma GmbH — full pipeline
- Therapeutic area: All drugs in Liver disease
- Indication: Drugs for Primary biliary cholangitis
- Also known as: norucholic acid, norUDCA, NCA, NUC