Not recruiting
Registered drug
Comparing liquid versus capsule forms of phosphatidylcholine in patients with alcoholic liver disease, chronic hepatitis B, and metabolic liver disease
Registered drug
- Participants:Adults
Phosphatidyl choline
- 0 / 1
- trials open to patients / all trials
- 3+
- Countries
About the substance
Table of contents
- What is phosphatidyl choline?
- How does phosphatidyl choline work?
- Which conditions is phosphatidyl choline used or studied for?
- How is phosphatidyl choline given?
- What do the clinical trials show?
- Who can take part in the trials?
What is phosphatidyl choline?
Phosphatidyl choline is a structurally diverse substance of natural origin, classified under the ATC code A05BA10, which places it among liver therapies.[1] It is the active substance in the authorised medicine Essentiale Forte, marketed in Poland as 300 mg hard capsules by Opella Healthcare Poland Sp. z o.o.[1] In the trial records, it appears under the development code NC0304.
How does phosphatidyl choline work?
The trial data do not describe the mechanism of action of phosphatidyl choline. It is registered as a substance for digestive system diseases, specifically liver conditions.[1] The Phase 3 study focuses on demonstrating that a new liquid formulation is clinically non-inferior to the existing capsule form when added to standard of care.[1]
Which conditions is phosphatidyl choline used or studied for?
- Chronic viral hepatitis B — a long-term liver infection caused by the hepatitis B virus.
- Alcoholic liver disease — liver damage resulting from long-term alcohol consumption.
- MASLD / MASH — metabolic dysfunction-associated steatotic liver disease, including its more severe form, metabolic dysfunction-associated steatohepatitis.
How is phosphatidyl choline given?
Phosphatidyl choline is given by mouth. The authorised product is a hard capsule containing 300 mg of the substance.[1] The trial also tests a new liquid formulation in stick packs, given at a dose of 1800 mg once daily.[1]
What do the clinical trials show?
One Phase 3 trial is registered, with 486 participants planned.[1] The study compares Essentiale liquid 1800 mg once daily against Essentiale 300 mg capsules, both added to standard of care, in people with chronic viral hepatitis B, alcoholic liver disease, or MASLD/MASH.[1] The main outcome is the change in overall symptoms measured with the GOS score.[1] The trial is currently authorised to proceed.[1]
Who can take part in the trials?
Participants are adults with one of the three studied chronic liver conditions: chronic viral hepatitis B, alcoholic liver disease, or MASLD/MASH.[1] The trial compares the new liquid formulation against the existing capsule form, with placebo arms also included to allow blinding.[1]
Conditions where Phosphatidyl choline is being studied
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Trials with Phosphatidyl choline
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