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 an investigational small molecule being studied for the treatment of intrahepatic cholestasis associated with alcoholic liver disease. It is a gastrointestinal therapeutic area drug developed by Abbott Laboratories. The drug is currently in Phase 3 clinical development, meaning it is still being tested and is not yet approved for use.
Ademetionine is a small molecule therapeutic. The specific molecular target or target class for Ademetionine has not been disclosed in the available information. The drug is being investigated for its potential effects in treating intrahepatic cholestasis associated with alcoholic liver disease, a condition affecting bile flow in the liver.
Ademetionine is being developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The drug is currently in Phase 3 clinical trials for the treatment of intrahepatic cholestasis associated with alcoholic liver disease. Abbott Laboratories is conducting this research to evaluate the drug's safety and efficacy in patients with this condition.
Ademetionine is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial for Ademetionine has been completed, with a total enrollment of 75 participants. The study was conducted in Russia and involved adult patients with intrahepatic cholestasis associated with alcoholic liver disease.
Ademetionine has one completed Phase 3 clinical trial registered under NCT02200029, titled 'Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption.' This trial enrolled 75 participants with intrahepatic cholestasis associated with alcoholic liver disease. The study was conducted in Russia, included adults aged 18 years and older, and was a controlled trial without randomization or blinding.
Ademetionine is associated with the brand name Heptral, as indicated by the clinical trial title 'Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption.' The trial NCT02200029, which tested Ademetionine, used the name Heptral in its title, suggesting that Heptral is a brand name for Ademetionine. This connection helps identify the drug across different naming conventions.