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Orlistat

Generic Name
Orlistat
Brand Names
Alli, Xenical, Alli (previously Orlistat GSK)
Drug Type
Small Molecule
Chemical Formula
C29H53NO5
CAS Number
96829-58-2
Unique Ingredient Identifier
95M8R751W8

Overview

The global prevalence of obesity is increasing rapidly. Obesity-related complications lead to significant personal and economic burden by reducing quality of life and increasing the cost of healthcare. In some individuals, diet and exercise are insufficient to maintain weight loss, and pharmacological or surgical intervention is required. Orlistat is a lipase inhibitor used in the treatment of obesity that works by inhibiting fat-metabolizing enzymes. It was approved by the FDA for use in combination with a reduced-calorie diet in 1999. This drug is a generally well-tolerated and effective weight-loss aid and is now available in both over-the-counter and prescription preparations, depending on the dosage quantity.

Indication

Orlistat is indicated for obesity management including weight loss and weight maintenance when used in combination with calorie reduction in overweight and obese adults; this indication applies to both the prescription formulation of 120 mg and the over-the-counter formulation of 60 mg. Orlistat in the 120 mg prescription formulation is also indicated to reduce the risk of weight regain following weight loss.

Associated Conditions

  • Weight Gain

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2011/07/04
N/A
Completed
2011/05/11
Phase 2
Terminated
2011/04/11
N/A
Completed
2010/08/19
Not Applicable
Completed
2010/07/27
Not Applicable
Completed
University of Campinas, Brazil
2010/05/20
Phase 2
Completed
2009/12/18
Phase 4
Completed
2009/10/28
Phase 2
Completed
Yazd Research & Clinical Center for Infertility
2009/10/08
N/A
Completed
Federico II University
2009/07/16
Phase 3
Completed

FDA Drug Approvals

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EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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Health Canada Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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