Xenical(orlistat)
Alli, Orlistat, Xenical (orlistat) is a small molecule pharmaceutical. Orlistat was first approved as Xenical on 1998-07-29. It is used to treat obesity in the USA. It has been approved in Europe to treat obesity. The pharmaceutical is active against pancreatic triacylglycerol lipase. In addition, it is known to target lysophosphatidylserine lipase ABHD12, diacylglycerol lipase-alpha, and diacylglycerol lipase-beta.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Alli, Xenical
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Orlistat
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XENICAL | CHEPLAPHARM Arzneimittel | N-020766 RX | 1999-04-23 | 1 products, RLD, RS |
| ALLI | GSK | N-021887 OTC | 2007-02-07 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| all health alliance hand sanitizer with aloe and vitamin e 400ml | OTC monograph not final | 2020-03-26 |
| all health alliance hand sanitizer with aloe and vitamin e 59ml | OTC monograph not final | 2020-03-26 |
| alli | New Drug Application | 2024-03-27 |
| allies of skin sunless tan spf 50 daily self tanner | C200263 | 2024-10-29 |
| allies of skin the one spf-50 invisible sunscreen | C200263 | 2024-06-25 |
| olivia and allison aqua skin sunscreen | C200263 | 2024-02-15 |
| orlistat | NDA authorized generic | 2024-07-08 |
| united sanitizer alliance premium sanitizer | OTC monograph not final | 2020-06-03 |
| xenical | New Drug Application | 2024-07-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| obesity | EFO_0001073 | D009765 | E66.9 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 9 | 4 | 12 | 19 | 44 |
| Overweight | D050177 | — | E66.3 | 3 | 2 | — | 3 | 8 | 15 |
| Weight loss | D015431 | HP_0001824 | — | — | — | 2 | 5 | 5 | 12 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 3 | — | 4 | 1 | 8 |
| Syndrome | D013577 | — | — | 2 | 2 | — | 1 | 2 | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | 4 | — | 6 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 1 | — | 1 | — | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | 3 | — | 3 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | — | 2 | 1 | 3 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Body weight | D001835 | EFO_0004338 | — | 1 | 2 | 2 | — | — | 4 |
| Infertility | D007246 | HP_0000789 | — | — | — | 1 | — | 1 | 2 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | 1 | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | 1 | — | — | 1 |
| Virus diseases | D014777 | — | B34 | — | — | 1 | — | — | 1 |
| Lymphocytosis | D008218 | — | — | — | — | 1 | — | — | 1 |
| Immunity | D007109 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 3 | — | — | 2 | 5 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | 3 | — | — | 1 | 4 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | — | 3 | — | — | 1 | 4 |
| Insulin resistance | D007333 | HP_0000855 | — | — | 1 | — | — | 1 | 2 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | 2 | — | — | — | 2 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | 1 | — | — | — | 1 |
| Microvascular angina | D017566 | — | — | — | 1 | — | — | — | 1 |
| Hyperandrogenism | D017588 | — | — | — | 1 | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | — | — | — | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | 1 | — | — | — | 1 |
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Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 2 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 2 | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Bariatric surgery | D050110 | — | — | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | — | — | 1 | 1 |
| Metabolically benign obesity | D000067329 | — | — | — | — | — | — | 1 | 1 |
| Anovulation | D000858 | — | — | — | — | — | — | 1 | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | — | 1 | 1 |
| Hyperbilirubinemia | D006932 | — | — | — | — | — | — | 1 | 1 |
| Crigler-najjar syndrome | D003414 | Orphanet_205 | E80.5 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Orlistat |
| INN | orlistat |
| Description | Orlistat is a carboxylic ester resulting from the formal condensation of the carboxy group of N-formyl-L-leucine with the hydroxy group of (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one. A pancreatic lipase inhibitor, it is used as an anti-obesity drug. It has a role as an EC 3.1.1.3 (triacylglycerol lipase) inhibitor, a bacterial metabolite, an EC 2.3.1.85 (fatty acid synthase) inhibitor and an anti-obesity agent. It is a beta-lactone, a L-leucine derivative, a member of formamides and a carboxylic ester. |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: gastrointestinal lipase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCCCC[C@@H](C[C@@H]1OC(=O)[C@H]1CCCCCC)OC(=O)[C@H](CC(C)C)NC=O |
Identifiers
| PDB | — |
| CAS-ID | 96829-58-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL175247 |
| ChEBI ID | — |
| PubChem CID | 3034010 |
| DrugBank | DB01083 |
| UNII ID | 95M8R751W8 (ChemIDplus, GSRS) |
Target
Alternate
ABHD12
ABHD12
DAGLA
DAGLA
DAGLB
DAGLB
Organism
Homo sapiens
Gene name
ABHD12
Gene synonyms
C20orf22
NCBI Gene ID
Protein name
lysophosphatidylserine lipase ABHD12
Protein synonyms
2-arachidonoylglycerol hydrolase ABHD12, Abhydrolase domain-containing protein 12, hABHD12, Monoacylglycerol lipase ABHD12, Oxidized phosphatidylserine lipase ABHD12
Uniprot ID
Mouse ortholog
Abhd12 (76192)
lysophosphatidylserine lipase ABHD12 (Q99M06)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Orlistat
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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26,800 adverse events reported
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