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Crystalline Lactulose
Crystalline Lactulose is a Osmotic laxative Small molecule drug developed by Benaroya Research Institute. It is currently FDA-approved for Constipation, Hepatic encephalopathy.
Lactulose is a non-absorbable disaccharide that acts as an osmotic laxative to increase stool frequency and soften stool consistency.
Lactulose is a non-absorbable disaccharide that acts as an osmotic laxative to increase stool frequency and soften stool consistency. Used for Constipation, Hepatic encephalopathy.
At a glance
| Generic name | Crystalline Lactulose |
|---|---|
| Sponsor | Benaroya Research Institute |
| Drug class | Osmotic laxative |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Lactulose passes through the small intestine largely unabsorbed and reaches the colon, where colonic bacteria ferment it into short-chain fatty acids and gases. This increases osmotic pressure in the colon, drawing water into the intestinal lumen and promoting bowel movements. Additionally, the fermentation products lower colonic pH, which may reduce ammonia absorption and support hepatic encephalopathy management.
Approved indications
- Constipation
- Hepatic encephalopathy
Common side effects
- Abdominal bloating
- Flatulence
- Abdominal cramping
- Diarrhea
Key clinical trials
- Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2 (PHASE4)
- Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers (NA)
- Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy (PHASE2)
- Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults (PHASE2)
- A Preference Study Comparing Kristalose® and Liquid Lactulose (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Crystalline Lactulose CI brief — competitive landscape report
- Crystalline Lactulose updates RSS · CI watch RSS
- Benaroya Research Institute portfolio CI
Frequently asked questions about Crystalline Lactulose
What is Crystalline Lactulose?
How does Crystalline Lactulose work?
What is Crystalline Lactulose used for?
Who makes Crystalline Lactulose?
What drug class is Crystalline Lactulose in?
What development phase is Crystalline Lactulose in?
What are the side effects of Crystalline Lactulose?
Related
- Drug class: All Osmotic laxative drugs
- Manufacturer: Benaroya Research Institute — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Constipation
- Indication: Drugs for Hepatic encephalopathy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing