NDAORALCAPSULEPriority Review
Approved
Apr 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
XENICAL (orlistat) by GSK is lipase inhibitors [moa]. First approved in 1999.
Drug data last refreshed 2m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XENICAL (orlistat) is an oral intestinal lipase inhibitor approved in 1999 for weight management in obese patients. It works by blocking pancreatic and gastric lipases, reducing dietary fat absorption in the gastrointestinal tract. The drug is indicated for chronic weight management in patients with a BMI ≥30 kg/m² or ≥27 kg/m² with comorbidities.
$0.283MPart D
LOE ApproachingDeclining
Declining Part D utilization signals shrinking market opportunity; commercial teams are likely in maintenance/optimization mode with reduced headcount investment.
Mechanism of Action
Lipase Inhibitors
Pharmacologic Class:
Intestinal Lipase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
Started Sep 2016
638 enrolled
Obesity
Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.
Started Dec 2015
0Weight Loss
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
Started Apr 2011
69 enrolled
Obesity
Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects
Started Apr 2010
486 enrolled
Obesity
Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Started Feb 2010
1 enrolled
Obesity
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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.