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 | HALEON US HOLDINGS | 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 |
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
No data
Clinical
Clinical Trials
72 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 | — | 8 | 3 | 11 | 17 | 39 |
| Overweight | D050177 | — | E66.3 | 2 | 1 | — | 1 | 8 | 11 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | 3 | — | 4 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | 1 | — | 1 | — | 2 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | 1 | 1 | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | 2 | — | 2 |
| Bulimia | D002032 | — | F50.2 | — | — | — | 1 | 1 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | — | 1 | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Weight loss | D015431 | HP_0001824 | — | — | — | 2 | — | 1 | 3 |
| 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 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | 1 | 2 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | 1 | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | 1 | — | — | — | 1 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | 1 | — | — | — | 1 |
| Hyperlipoproteinemia type i | D008072 | Orphanet_411 | E78.3 | — | 1 | — | — | — | 1 |
| Hyperlipoproteinemia type v | D006954 | Orphanet_70470 | E78.3 | — | 1 | — | — | — | 1 |
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 |
| Body weight changes | D001836 | — | — | — | — | — | — | 1 | 1 |
| Metabolically benign obesity | D000067329 | — | — | — | — | — | — | 1 | 1 |
| Anovulation | D000858 | — | — | — | — | — | — | 1 | 1 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | — | 1 | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | — | 1 | 1 |
| Crigler-najjar syndrome | D003414 | Orphanet_205 | E80.5 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 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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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,093 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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25,826 adverse events reported
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