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Drug ReportsOrlistat
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
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
XENICALCHEPLAPHARM ArzneimittelN-020766 RX1999-04-23
1 products, RLD, RS
ALLIGSKN-021887 OTC2007-02-07
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
all health alliance hand sanitizer with aloe and vitamin e 400mlOTC monograph not final2020-03-26
all health alliance hand sanitizer with aloe and vitamin e 59mlOTC monograph not final2020-03-26
alliNew Drug Application2024-03-27
allies of skin sunless tan spf 50 daily self tannerC2002632025-01-07
allies of skin the one spf-50 invisible sunscreenC2002632025-06-09
manna dd tea (detox and diet tea)unapproved drug other2025-05-28
olivia and allison aqua skin sunscreenC2002632024-02-15
orlistatNDA authorized generic2024-07-08
united sanitizer alliance premium sanitizerOTC monograph not final2020-06-03
xenicalNew Drug Application2024-07-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
obesityEFO_0001073D009765E66.9
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A08: Antiobesity preparations, excl. diet products
— A08A: Antiobesity preparations, excl. diet products
— A08AB: Peripherally acting antiobesity products
— A08AB01: Orlistat
HCPCS
No data
Clinical
Clinical Trials
80 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9———134
OverweightD050177—E66.31——113
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Weight lossD015431——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOrlistat
INNorlistat
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 classenzyme inhibitors: gastrointestinal lipase inhibitors
Image (chem structure or protein)Loading
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-ID96829-58-2
RxCUI—
ChEMBL IDCHEMBL175247
ChEBI ID—
PubChem CID3034010
DrugBankDB01083
UNII ID95M8R751W8 (ChemIDplus, GSRS)
Target
Agency Approved
PNLIP
PNLIP
Organism
Homo sapiens
Gene name
PNLIP
Gene synonyms
NCBI Gene ID
5406
Protein name
pancreatic triacylglycerol lipase
Protein synonyms
triacylglycerol acylhydrolase, triacylglycerol lipase
Uniprot ID
Q5VSQ2
Mouse ortholog
Pnlip (69060)
pancreatic triacylglycerol lipase (Q6P8U6)
Alternate
ABHD12
ABHD12
DAGLA
DAGLA
DAGLB
DAGLB
Organism
Homo sapiens
Gene name
ABHD12
Gene synonyms
C20orf22
NCBI Gene ID
26090
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
Q9UFV6
Mouse ortholog
Abhd12 (76192)
lysophosphatidylserine lipase ABHD12 (Q99M06)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
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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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 37,894 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,297 adverse events reported
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