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orlistat [Xenical]

Phase 3
Roche Holding AG (RHHBY)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Drug Information

Target Indication

Obesity

Clinical Trial

NCT00940628

Last updated: 1/28/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA7/22/2007

Alli (previously Orlistat GSK)

Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.

View on EMA
EMA7/29/1998

Xenical

Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI > 28 kg/m2) with associated risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.

View on EMA
Drug Science
Mechanism of action & safety profile
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