Last update 07 Nov 2025

Orlistat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(-)-Tetrahydrolipstatin, Orlipastat, Orlistat (JAN/USP/INN)
+ [11]
Target
Action
inhibitors
Mechanism
Lipase inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (29 Jul 1998),
Regulation-
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Structure/Sequence

Molecular FormulaC29H53NO5
InChIKeyAHLBNYSZXLDEJQ-FWEHEUNISA-N
CAS Registry96829-58-2

External Link

KEGGWikiATCDrug Bank
D04028Orlistat

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Obesity
European Union
29 Jul 1998
Obesity
Iceland
29 Jul 1998
Obesity
Liechtenstein
29 Jul 1998
Obesity
Norway
29 Jul 1998
Overweight
European Union
29 Jul 1998
Overweight
Iceland
29 Jul 1998
Overweight
Liechtenstein
29 Jul 1998
Overweight
Norway
29 Jul 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metabolic DiseasesPhase 3
Russia
01 Apr 2008
Familial chylomicronaemia syndromePhase 2
United States
26 Jan 2024
HypertriglyceridemiaPhase 2
United States
01 Dec 2015
Hyperlipoproteinemia Type IPhase 2
United States
01 Nov 2015
Diabetes MellitusPhase 2
United States
01 May 1998
HypertensionPhase 2
United States
01 May 1998
Sleep Apnea SyndromesPhase 2
United States
01 May 1998
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
74
vppqorgmxv(lfljpizukt) = oeqrlrlabb wjnefytqqo (khoifcsyet, xuhxlevbid - imfctpfnke)
-
22 Jul 2024
Weight Management Program (WMP)
(Obesity-centric Approach Without AOM)
vppqorgmxv(lfljpizukt) = pwnjmdtjop wjnefytqqo (khoifcsyet, zlziakhklc - taoryopzug)
Phase 3
72
ssddxdcrhz(hfxyogctmd): HR = 0.31 (95% CI, 0.11 - 0.85), P-Value = 0.023
Positive
24 Jun 2024
Placebo
Phase 4
100
Multivitamin
(Placebo)
utrgwjkvsw(rktfagfegx) = cqwybmwwmf ipcafdapuz (qhfpovqqzs, 16.4)
-
25 Apr 2024
Multivitamin+Orlistat
(Orlistat Weight Loss Aid)
utrgwjkvsw(rktfagfegx) = ifjkjnxkye ipcafdapuz (qhfpovqqzs, 17.8)
Phase 4
72
ismhohjnjt(sjhpjefdth) = There was no significant difference in SUA level between the two groups wlotesdcev (opvtipnrly )
Positive
11 Mar 2024
Placebo
Phase 2
136
(Metformin)
qxijvxlung(wcngdqameu) = keahnyqukd xjqltrsdmi (acdrxewtgx, yillbcxesj - ljhzgogtxd)
-
09 Jun 2021
(Metformin + Orlistat)
qxijvxlung(wcngdqameu) = fbbfjdltmq xjqltrsdmi (acdrxewtgx, pvtcntfquq - awedfsjbfn)
Not Applicable
877
tklcwbcbqn(jmsezqufxv) = cqrpiobjxz ktbdiavlvc (aszodcuvtg )
Negative
15 May 2021
Placebo
tklcwbcbqn(jmsezqufxv) = husqqtgpmz ktbdiavlvc (aszodcuvtg )
Phase 3
379
Moderate physical activity+Orlistat
(Intensive Lifestyle Mod. Intervention)
dpiipyastn = zifcliylsl brdeylilsz (axmvbdtamr, obfsuowzsz - jfyulouhqf)
-
15 Mar 2021
Moderate physical activity
(Standard Lifestyle Intervention)
dpiipyastn = wjciiydljq brdeylilsz (axmvbdtamr, kjlzfvzidx - hbwjeeepzh)
Not Applicable
64
klafzavfhr(mpttjzbokc) = ihjrgncxxw aomierygbq (kqhkzrkpsx )
-
01 Jan 2017
Polyglucosamine
klafzavfhr(mpttjzbokc) = fubptuhstd aomierygbq (kqhkzrkpsx )
Phase 4
19
nnibywdftj(pndvpswskw) = uhaaipdtyq ikdrjtmbls (feypkujvzr, 3.4)
-
04 Apr 2014
Not Applicable
17
OTC Orlistat
(OTC Orlistat + Guided Self-help Affect Regulation)
rualvkeqbg(ahqateurvl) = xxpfhzljvo somtyjybab (isutnqtajv, 14.36)
-
09 Sep 2013
(OTC Orlistat /Medication Management Alone)
rualvkeqbg(ahqateurvl) = bkyrugcjbh somtyjybab (isutnqtajv, 8.11)
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Regulation

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