Orlistat
Established medicineAlso known as Alli, Orlipastatum, Xenical, (-)-Tetrahydrolipstatin+2 more
Alli, Orlipastatum, Xenical, (-)-Tetrahydrolipstatin, Tetrahydrolipstatin, Orlipastat.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: ORLISTAT (NDA020766)
Clinical Study on the Safety and Efficacy of Orlistat in Third-generation EGFR-TKI Resistance
Label change: ORLISTAT (NDA020766)
Label change: ORLISTAT (NDA020766)
Label change: ORLISTAT (NDA020766)
A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss.
Effects of orlistat on fat-soluble vitamins in obese adolescents.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: 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.
Evidence ↗Indication: 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… Show full indicationShow less
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.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- Archives of internal medicine1
- European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology1
- Journal of pediatric endocrinology & metabolism : JPEM1
- Obesity research1
- Pharmacotherapy1
- McDuffie JR4
- Calis KA3
- Uwaifo GI3
- Yanovski JA3
- Fallon EM2
- Sebring NG2
- Arillotta D1
- Bolton J1
- National Institute of Child Health and Human Development3
- Center for Health Services Research in Primary Care1
- Institute for Pharmaceutical Outcomes and Policy1
- Swansea University1
- UniCamillus University1
- University of Hertfordshire1
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across the same disease area as Orlistat in the shared literature.
Studied across the same disease area as Orlistat in the shared literature.
Studied across the same disease area as Orlistat in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.