NDAORALCAPSULEPriority Review
Approved
Apr 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
5/8 — Partial
Priority Review
XENICAL (orlistat) by GSK is lipase inhibitors [moa]. Approved for obesity, overweight. First approved in 1999.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XENICAL (orlistat) is an oral lipase inhibitor capsule approved in 1999 that reduces intestinal fat absorption by inhibiting pancreatic and gastric lipases. It is indicated for obesity, overweight, and weight-related metabolic conditions including fatty liver disease, diabetes, hypertension, and sleep apnea. The drug works locally in the GI tract without systemic absorption, making it a peripheral mechanism distinct from newer GLP-1 and dual-mechanism approaches.
$0.283MPart D
LOE ApproachingDeclining
LOE approaching with minimal Part D spending ($283K, 225 claims in 2023) indicates a declining franchise with limited team expansion opportunity; GSK is likely in legacy management mode.
Mechanism of Action
Lipase Inhibitors
Pharmacologic Class:
Intestinal Lipase Inhibitor
Indications (2)
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.