Wednesday, July 8, 2026

Drug profile · INN

orlistat

orlistat (XENICAL) is a pancreatic lipase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Alimentary tract and metabolism (A08) A08AB01
US status approved
Patents linked 20
Pipeline programs 30
News articles 0
Drug details — orlistat
US status
approved
Class
Alimentary tract and metabolism (A08)
Route
ORAL
Patents
20
Programs
30
Data quality
0.84

Quick answer

orlistat (XENICAL) is a pancreatic lipase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN orlistat
Brand XENICAL
Mechanism Pancreatic lipase inhibitor
Target Gastric triacylglycerol lipase
Therapeutic class Alimentary tract and metabolism (A08)
Route ORAL
Formulation CAPSULE
ATC code A08AB01

Mechanism of action

Pancreatic lipase inhibitor

Primary target: Gastric triacylglycerol lipase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. 116130 Phase 3 · Disc Medicine · Parkinson's disease
  2. Crystalline cellulose simple occlusive dressing Phase 3 · First People's Hospital · Split-thickness Skin Graft Donor Sites
  3. GSK 2132231A Phase 3 · GSK Glaxo Smith · Melanoma
  4. GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) Phase 3 · GSK Glaxo Smith · Influenza
  5. LBS-008-CT05 Phase 3 · ELITE PHARMACEUTICALS INC · Geographic Atrophy
  6. NICOTINAMIDE, cellulose microcristalline Phase 3 · Ishita Pharma - · Acute kidney injury
  7. NOE-TGN-201 Phase 3 · Anaxis Pharma · Trigeminal neuralgia, Trigeminal neuralgia
  8. Nano-crystalline Megestrol Acetate Oral Suspension Phase 3 · Chinese Academy of · Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Related & competitor drugs

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  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. WO 2026047020

    FORMES CRISTALLINES D'INHIBITEURS DE HER2/MUTEGFR ET LEUR PROCÉDÉ DE PRÉPARATION

    Expires Wed Feb 28 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. WO 2026047022

    FORME POSOLOGIQUE PHARMACEUTIQUE SOLIDE ET STABLE COMPRENANT UNE FORME CRISTALLINE D'UN INHIBITEUR DE HER2/MUTEGFR ET SA MÉTHODE DE PRÉPARATION

    Expires Wed Feb 28 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2025242585

    FORMES CRISTALLINES DE SELS D'ÉLINZANÉTANT ET COMPOSITIONS CONTENANT DES SELS D'ÉLINZANÉTANT

    Expires Wed Nov 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12410184

    Crystalline forms of a menin inhibitor

    Expires Mon Sep 04 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12384854

    Plasma kallikrein binding proteins and uses thereof in treating hereditary angioedema

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 12378245

    Crystalline forms of an RSK inhibitor

    Expires Mon Jul 31 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 12344585

    Crystalline salts of a plasma kallikrein inhibitor

    Expires Mon Jun 26 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 12338249

    Crystalline forms of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea

    Expires Mon Jun 19 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 12329805

    Dosage forms of tissue kallikrein 1

    Expires Mon Jun 12 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 12319693

    Crystalline forms of CFTR modulators

    Expires Mon May 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 12319657

    Solid state crystalline forms of a selective potassium channel modulator

    Expires Mon May 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 12319651

    Crystalline forms and methods of producing crystalline forms of a compound

    Expires Mon May 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 12286431

    Crystalline forms of a KRas G12C inhibitor

    Expires Mon Apr 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 12281136

    Crystalline forms of a CD73 inhibitor and uses thereof

    Expires Mon Apr 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 12281113

    Crystalline forms of a KRas G12C inhibitor

    Expires Mon Apr 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 12239638

    Crystalline form of a 4-[2-(2-fluorophenoxymethyl)phenyl]piperidine compound

    Expires Mon Feb 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 12240918

    Bispecific antibodies against plasma kallikrein and factor XII

    Expires Mon Feb 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 12221441

    Plasma kallikrein inhibitors and uses thereof

    Expires Mon Feb 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 12187698

    Crystalline forms of C21H22Cl2N4O2

    Expires Mon Jan 02 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 12162838

    Human plasma kallikrein inhibitors

    Expires Mon Dec 05 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is orlistat?

orlistat (XENICAL) is a pancreatic lipase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for orlistat?

XENICAL is a marketed brand name for orlistat. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of orlistat?

orlistat has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.