Drugs / norUrsodeoxycholic Acid
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05083390 | Jul 2019 → Jan 2025 | metabolic dysfunction-associated steatohepatitis | Dr. Falk Pharma GmbH | Unknown | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06886360 | Mar 2025 → Sep 2027 expected | primary sclerosing cholangitis | Dr. Falk Pharma GmbH | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03872921 | Feb 2018 → Jan 2025 overdue | primary sclerosing cholangitis | Dr. Falk Pharma GmbH | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-05-07 | Dr. Falk Pharma GmbH | Results Positive results from pivotal phase 3 trial on norucholic acid in PSC drfalkpharma.com ↗
Study results demonstrate superiority of norucholic acid (NCA) over placebo in the combined primary endpoint. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-05-07 | Dr. Falk Pharma GmbH | Positive results from pivotal phase 3 trial on norucholic acid in PSC drfalkpharma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | norUrsodeoxycholic acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05083390 ↗ |
| Known as | norucholic acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06886360 ↗ |
| Route | Oral | “oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules” NCT03872921 ↗ |