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Dr. Falk Pharma announces positive results from its pivotal phase 3 trial on norucholic acid in primary sclerosing cholangitis

Dr. Falk Pharma revealed encouraging findings from its key phase 3 NUC-5 study evaluating norucholic acid for the treatment of primary sclerosing cholangitis, with data from the trial conducted in Freiburg shared at the 2025 EASL Congress in Amsterdam.
The trial enrolled 301 patients and tested 1,500 mg norucholic acid or placebo over 192 weeks, analyzing primary data after 96 weeks due to no approved treatments currently available for PSC.
Norucholic acid showed statistically significant superiority in the combined endpoint of partial alkaline phosphatase normalization and no disease progression, with additional benefits in several secondary endpoints and similar safety profiles.
By week 96, 15.1% of patients treated with norucholic acid met the primary study goal, in contrast to 4.2% in the placebo group . Additionally, 25.2% of those receiving norucholic acid showed improvement of at least one Ludwig stage, compared to 10.5% of placebo recipients , supporting both its effectiveness and favorable safety profile.
These results represent a significant advance toward effective pharmacological treatment for PSC, a progressive liver disease lacking approved therapies, with further data expected after the ongoing trial completes 192 weeks of treatment.

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NiagaraFallsReview.ca

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Dr. Falk Pharma announces positive results from its pivotal phase 3 trial on norucholic acid in primary sclerosing cholangitis

Freiburg, May 7th, 2025

2 days ago·Niagara Falls, Canada

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Clinical Trials Arena

Dr. Falk Pharma’s PSC drug achieves endpoints in Phase III trial

There are no therapies approved for the treatment of primary sclerosing cholangitis.The post Dr. Falk Pharma’s PSC drug achieves endpoints in Phase III trial appeared first on Clinical Trials Arena.

14 hours ago

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eastmud.com

Dr. Falk Pharma Announces Positive Topline Results from Phase 3 Pivotal Trial of Norucholic Acid for the Treatment of Primary Sclerosing Cholangitis – EastMud

(SeaPRwire) – Freiburg, May 7, 2025 Study results show that norucholic acid (NCA) is superior to placebo in terms of the co-primary endpoint. There are currently no drugs approved to treat primary sclerosing cholangitis. Results from the 96-week analysis of the NUC-5 trial will be presented at the 2025 EASL Congress in Amsterdam. Dr.

1 day ago

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thailandtribune.com

Dr. Falk Pharma announces positive results from its pivotal phase 3 trial on norucholic acid in primary sclerosing cholangitis – Thailand Tribune

Freiburg, May 7th, 2025 Study results demonstrate superiority of norucholic acid (NCA) over placebo in the combined primary endpoint. There is currently no approved medicine to treat primary sclerosing cholangitis. The results of the 96-week analysis of the NUC-5 trial will be presented at 2025 EASL Congress in Amsterdam. Dr. Falk Pharma, a research-based pharmaceutical ...

2 days ago

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