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Phosphatidylcholine

Phase 3

Hepatic and Hepatobiliary Disorders | Small molecule | Gastrointestinal |Sanofi|Last Updated: Jul 4, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

Clinical trial landscape

Phosphatidylcholine · 1 trial · 1 indication

Phase 3 1
NCT02517385Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver DiseasesHepatic and Hepatobiliary Disorders
COMPLETED147 Analytics
PHASE3COMPLETED
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Hepatic and Hepatobiliary Disorders
NCT02517385147
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Study Endpoints

Primary Endpoints

Frequency (number) of adverse events (AEs) related to the investigational drug
Week 12

Secondary Endpoints

Change from baseline in patient percentage of global overall symptoms using Likert Scale
Weeks 4, 8, and 12
Change from baseline in gastrointestinal symptom percentage score
Weeks 4, 8, and 12
Percentage of patients with AEs regardless of the Investigator's assessment of relationship to the investigational drug
Weeks 4, 8, and 12
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phosphatidylcholine pasteEXPERIMENTALOne dose of phosphatidylcholine paste 600 mg given orally 3 times a day at Days 0, 28, 56, and 84

Interventions

NameTypeDescription
PhosphatidylcholineDRUGPharmaceutical form:Paste Route of administration: Oral
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Eligibility Criteria

Age Range18 Years to 66 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Males and females ≥18 years of age and less than 66 years old. * Patients with gastrointestinal symptoms (fatigue, abdominal pain/discomfort, early satiety, fullness discomfort after meal, nausea/vomiting, belching/abdominal distension, at least one rated as "Moderate Problem"...

Countries:Russia
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Frequently asked questions about Phosphatidylcholine

What is Phosphatidylcholine used for?

Phosphatidylcholine is an investigational small molecule being developed by Sanofi for the treatment of hepatic and hepatobiliary disorders, which are conditions affecting the liver and bile ducts. It is currently in Phase 3 clinical development, though it remains investigational and has not been approved by regulatory authorities.

Who makes Phosphatidylcholine?

Sanofi (ticker: SNY) is the developer of Phosphatidylcholine. The company is conducting clinical research on this investigational small molecule for hepatic and hepatobiliary disorders, positioning it within the gastrointestinal therapeutic area.

What phase is Phosphatidylcholine in?

Phosphatidylcholine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trial for this asset has been completed, and the drug is being studied for hepatic and hepatobiliary disorders.

What clinical trials is Phosphatidylcholine in?

Phosphatidylcholine has one completed Phase 3 clinical trial, registered as NCT02517385. This study, titled "Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases," enrolled 147 participants in Russia and was an uncontrolled, non-randomized trial.

Is Phosphatidylcholine the same as Essentiale?

Phosphatidylcholine is the active ingredient in the product Essentiale, as indicated by the clinical trial title referencing Essentiale® Paste. The trial NCT02517385 evaluates this formulation in patients with gastrointestinal symptoms associated with acute or chronic liver diseases.