In short
De-oiled enriched phospholipids from soya-beans is an investigational substance studied for several chronic liver conditions, including chronic viral hepatitis B, alcoholic liver disease, and metabolic dysfunction-associated steatotic liver disease (MASLD/MASH). One Phase 3 trial with 486 participants is currently authorised to test a once-daily liquid form against the established capsule formulation.
Key points
- One Phase 3 trial is authorised to investigate de-oiled enriched phospholipids from soya-beans in chronic liver diseases.
- The trial plans to enrol 486 participants with chronic viral hepatitis B, alcoholic liver disease, or MASLD/MASH.
- The study compares a 1800 mg once-daily oral liquid with Essentiale Forte 300 mg capsules.
- The main goal is to show non-inferiority of the liquid form compared to the capsule form.
- The primary outcome measures changes in overall symptoms using the GOS score.
- The substance is not yet authorised as a medicine in these product records.
What is de-oiled enriched phospholipids from soya-beans?
De-oiled enriched phospholipids from soya-beans is the full registry name for a substance derived from soya-beans. In the trial record, the product name appears as NC0304 Phosphatidylcholine, and the intervention is also described as Essentiale Forte 300 mg capsules and an oily liquid in stick packs. The substance is classified as a structurally diverse substance of natural origin, meaning it is not a single chemically synthesised molecule but a mixture of related components. It is an investigational substance with no marketing authorisation in the product records, supplied by Opella Healthcare Group S.A.S.
How does de-oiled enriched phospholipids from soya-beans work?
The trial record does not describe a molecular mechanism of action for this substance. Phospholipids are natural components of cell membranes, and products containing them are used in some countries as supportive treatments for liver conditions. However, the registry data provided here does not state how this particular preparation is thought to act in the body, so no mechanism is described on this page.
Which conditions is it used or studied for?
The authorised Phase 3 trial includes participants with the following chronic liver conditions:
- Chronic viral hepatitis B — a long-term infection of the liver caused by the hepatitis B virus.
- Alcoholic liver disease — liver damage that develops from long-term heavy alcohol use.
- MASLD (metabolic dysfunction-associated steatotic liver disease) — fat build-up in the liver linked to metabolic factors such as obesity and insulin resistance.
- MASH (metabolic dysfunction-associated steatohepatitis) — a more advanced form of fatty liver disease with inflammation and liver cell injury.
How is de-oiled enriched phospholipids from soya-beans given?
In the trial, the substance is given by mouth as an oral liquid in stick packs. The tested dose is 1800 mg once daily, and the liquid formulation is called Essentiale Advance oily liquid. The comparator product, Essentiale Forte 300 mg capsules, is also taken orally at a total daily dose of 1800 mg. The pharmaceutical form in the product record is oral liquid, and the route of administration is oral.
What do the clinical trials show?
One Phase 3 interventional trial is authorised but not yet reporting results. The study plans to enrol 486 participants. Its purpose is to demonstrate clinical non-inferiority of Essentiale EPL liquid 1800 mg on top of standard of care compared to Essentiale EPL oral capsules on top of standard of care. The primary outcome is the change in overall symptoms evaluated using the GOS score, a measure of how patients rate their symptoms. The trial uses placebo arms for both the test liquid and the comparator capsules, designed to match the appearance, taste, smell and mouthfeel of the active products so that participants and investigators cannot tell them apart.
What side effects are known?
No side effect information is provided in the registry data or supplementary sources available for this page, so this section is left out.