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Drug

Orlistat

Approved · EMA
ClassGastric lipase inhibitorEmerging researchLate-stage developmentCooling momentum
Also known as Alli, Orlipastatum, Xenical, (-)-Tetrahydrolipstatin+2 more

Alli, Orlipastatum, Xenical, (-)-Tetrahydrolipstatin, Tetrahydrolipstatin, Orlipastat.

5
Research papers
4
Active clinical trials
2
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Clinical Study on the Safety and Efficacy of Orlistat in Third-generation EGFR-TKI Resistance

Clinical trial2025-05-15Primary completion · ClinicalTrials.gov

Approval: Xenical (EMA)

Regulatory1998-07-29EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Orlistat
Aliases & brands
AlliOrlipastatumXenical(-)-TetrahydrolipstatinTetrahydrolipstatinOrlipastat
RxNorm CUI
37925
ChEMBL ID
CHEMBL175247
ATC codes
A08AB01
UNII
95M8R751W8
Primary mechanism
Gastric lipase inhibitor
Regulatory jurisdictions
mhraema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORGastric lipase inhibitor
INHIBITORPancreatic lipase inhibitor

Regulatory timeline

3 events

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.

Earliest approval
1998-07-29
Latest approval
2007-07-22
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2007-07-22Approval
Approval: Alli (previously Orlistat GSK) (EMA)

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 ↗
1998-07-29Approval
Approval: Xenical (EMA)
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 overweightShow full 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 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.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Orlistat: theoretical interaction with antiretroviral HIV medicines
Evidence ↗

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

43 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
43
registered trials across all phases
LATEST COMPLETION 2024
4
Active studies
3
Recruiting
31
Late-stage (III+)
30
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 43
Phase 11Phase 211Phase 33Phase 416Phase N / A12

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

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022024
Most influential
Recent papers
Major research themes8
Anti-Obesity Agents1Black or African American1Diet, Carbohydrate-Restricted1Diet, Fat-Restricted1Glucagon-Like Peptide-1 Receptor Agonists1Pharmacovigilance1Self-Injurious Behavior1Suicidal Ideation1
Journals, researchers & institutions
Top journals
  • Archives of internal medicine1
  • European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology1
  • Journal of pediatric endocrinology & metabolism : JPEM1
  • Obesity research1
  • Pharmacotherapy1
Leading researchers
  • McDuffie JR4
  • Calis KA3
  • Uwaifo GI3
  • Yanovski JA3
  • Fallon EM2
  • Sebring NG2
  • Arillotta D1
  • Bolton J1
Leading institutions
free-text, unnormalised
  • 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

3 matches

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.

1 shared disease1 shared paper

Studied across the same disease area as Orlistat in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Orlistat in the shared literature.

1 shared disease1 shared paper
References & data sources
  • 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.