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Orlistat (Xenical)
Orlistat inhibits pancreatic and gastric lipases to reduce the absorption of dietary fats in the gastrointestinal tract.
Orlistat inhibits pancreatic and gastric lipases to reduce the absorption of dietary fats in the gastrointestinal tract. Used for Obesity management in adults with BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities.
At a glance
| Generic name | Orlistat (Xenical) |
|---|---|
| Sponsor | St. Louis University |
| Drug class | Lipase inhibitor |
| Target | Pancreatic lipase, gastric lipase |
| Modality | Small molecule |
| Therapeutic area | Obesity/Weight management |
| Phase | FDA-approved |
Mechanism of action
Orlistat is a lipase inhibitor that binds to pancreatic and gastric lipases in the small intestine, preventing the hydrolysis and absorption of approximately 25-30% of dietary triglycerides. By reducing fat absorption, it decreases overall caloric intake and promotes weight loss. The unabsorbed fat is then eliminated in the stool.
Approved indications
- Obesity management in adults with BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities
Common side effects
- Oily spotting/fecal urgency
- Fatty/oily stools
- Abdominal pain/discomfort
- Fecal incontinence
- Headache
Key clinical trials
- RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients. (PHASE4)
- Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity (PHASE2)
- Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women (NA)
- A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America (PHASE4)
- A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
- Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT (NA)
- Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial) (PHASE4)
- Weight Loss Management in Endometrial Cancer Survivors
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:
- Orlistat (Xenical) CI brief — competitive landscape report
- Orlistat (Xenical) updates RSS · CI watch RSS
- St. Louis University portfolio CI