Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ademetionine · 1 trial · 1 indication
Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline
| Arm | Type | Description |
|---|---|---|
| Ademetionine IV | EXPERIMENTAL | - |
| Ademetionine oral | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ademetionine IV+tablet | DRUG | IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks |
| Ademetionine tablet | DRUG | oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks |
Inclusion criteria: * Signed informed consent given by the subject * Age ≥ 18 years to 75 years * Chronic liver disease due to alcoholic liver disease * Compensated alcoholic liver disease, defined as having a Maddrey Score \< 32 and not being treated with pentoxifylline or prednisolone within 6 mo...
Ademetionine is being studied for intrahepatic cholestasis associated with alcoholic liver disease, a gastrointestinal condition in which bile flow within the liver is impaired in patients with alcohol-related liver damage. It is a small molecule developed by Abbott Laboratories.
Ademetionine is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the sponsor behind the clinical program evaluating the drug in liver disease related to alcohol consumption.
Ademetionine is in Phase 3 development. The program includes one completed Phase 3 trial, and no trials are currently active. It is an investigational therapy and is not described as approved.
Ademetionine has been evaluated in the Phase 3 study NCT02200029, titled Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption. The trial enrolled 75 participants in Russia, included adults 18 years and older of both sexes, and has completed.