Product Description
Lactulose is used in preventing and treating clinical portal-systemic encephalopathy. Its chief mechanism of action is by decreasing the intestinal production and absorption of ammonia. It has also gained popularity as a potential therapeutic agent for the management of subacute clinical encephalopathy. It is also a laxative for the treatment of chronic constipation. Its osmotic effect and its effect on intestinal motility receive credit for its therapeutic efficacy (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK536930/)
Mechanisms of Action: Osmosis Inducer
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Fresenius
Company Location: BAD HOMBURG 2M 61352
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: India, Russia
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Candidiasis, Vulvovaginal
Phase 1: Acute-On-Chronic Liver Failure|Brain Diseases|End Stage Liver Disease|Hepatic Encephalopathy|Hepatic Insufficiency|Liver Failure, Acute
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| BCAA-HE-ACLF | P1 |
Recruiting |
Hepatic Encephalopathy|Hepatic Insufficiency|Acute-On-Chronic Liver Failure|End Stage Liver Disease|Brain Diseases|Liver Failure, Acute |
2025-04-25 |
|
| 12/21-AVVA RUS | P3 |
Completed |
Candidiasis, Vulvovaginal |
2023-07-26 |
31% |
| 12/21-AVVA RUS | P3 |
Completed |
Candidiasis, Vulvovaginal |
2023-07-26 |
31% |