ENULOSE

Post-LOE

lactulose

Teva

ANDAORAL, RECTALSOLUTION

Approved

Aug 1988

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

ENULOSE (lactulose) by Teva is clinical pharmacology lactulose causes a decrease in blood ammonia concentration and reduces the degree of portalsystemic encephalopathy. Approved for osmotic laxative [epc]. First approved in 1988.

Drug data last refreshed 3d ago

$0.0BPart D

Mechanism of Action

CLINICAL PHARMACOLOGY Lactulose causes a decrease in blood ammonia concentration and reduces the degree of portalsystemic encephalopathy. These actions are considered to be results of the following: Bacterial degradation of lactulose in the colon acidifies the colonic contents. This acidification…

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (13)

NCT07065942N/ARecruiting

Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients

Started Jul 2023

60 enrolled

Diabetes MellitusConstipation - Functional

NCT04073290Phase 4Recruiting

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Started Jan 2020

238 enrolled

Hepatic EncephalopathyCirrhosis, LiverPortal Hypertension+2 more

NCT03666546Phase 4Completed

Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2

Started Nov 2018

24 enrolled

Diabetes Mellitus, Type 2

NCT03515044Phase 2Completed

Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Started Sep 2018

71 enrolled

Overt Hepatic Encephalopathy

NCT03864978Phase 2Unknown

Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test

Started Jun 2018

236 enrolled

Papulopustular Rosacea

Worked on ENULOSE at Teva? Share your interview experience or compensation data (+7 days Pro)

Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.