sibutramine

Trade name: meridia

Small moleculeapproved

Approved

Nov 22, 1997

Sibutramine, formerly sold under the brand name Meridia among others, is an appetite suppressant which has been discontinued in many countries. It works as a serotonin–norepinephrine reuptake inhibitor (SNRI) similar to certain antidepressants. Until 2010, it was widely marketed and prescribed as an adjunct in the treatment of obesity along with diet and exercise. It has been associated with increased cardiovascular diseases and strokes and has been withdrawn from the market in 2010 in several countries and regions including Australia, Canada, China, the European Union, Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States. It was never approved in Japan. However, the drug remains available in some countries. — Wikipedia

Clinical trial activity

31 trials · 28 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
13
Phase 3
10
Phase 4
9

Earliest trial started Sep 1, 1998 (NCT00645255)

Timeline

1990s

  1. Nov 22, 1997

    Abbott — Earliest FDA Approval

  2. Nov 22, 1997

    Abbott — NDA Organization

  3. Nov 22, 1997

    Abbott — NDA Secondary Org

  4. Jan 1, 1998

    Abbott — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedNov 22, 1997

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)CC(N(C)C)C1(c2ccc(Cl)cc2)CCC1.Cl.O
Mol. weight
334.33 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • bts 54524
  • bts 54524
  • bts 54 524
  • bts-54524
  • bts-54524
  • bts-54524
  • butramin
  • butramin
  • didemethyl sibutramine hcl
  • didemethyl sibutramine hydrochloride
  • didesmethylsibutramine
  • didesmethylsibutramine
  • di-desmethylsibutramine
  • meredia
  • meridia
  • meridia
  • meridia
  • mono-desmethylsibutramine
  • n-1-(1-(4-chlorophenyl)cyclobutyl)-3-methylbutyl-n,n-dimethylamine hcl
  • racemic sibutramine
  • (r)-ddms
  • reductil
  • reductil
  • reductil
  • sibutramina
  • sibutramina
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • sibutramine
  • (+/-)-sibutramine
  • sibutramine hcl
  • sibutramine hcl
  • sibutramine hcl
  • sibutramine hydrochloride
  • sibutramine hydrochloride
  • sibutramine hydrochloride
  • sibutramine hydrochloride
  • sibutramine hydrochloride
  • sibutramine hydrochloride hydrate
  • sibutramine hydrochloride monohydrate
  • sibutraminum
  • sibutraminum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05209984Phase 3Jun 30, 2024Eurofarma Laboratorios S.A.
NCT05821543Phase 4Jul 3, 2020Pirogov Russian National Research Medical University, Promomed, LLC
NCT01184560N/AFeb 1, 2010Gachon University
NCT00993421Phase 2Oct 1, 2009Eli Lilly
NCT00914212Phase 1May 1, 2009Merck
NCT01170364N/AFeb 1, 2009AstraZeneca, Columbia University
NCT00829283N/ANov 1, 2008National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University
NCT00941382Phase 3Nov 1, 2008Laboratorios Silanes S.A. de C.V., University of Guadalajara
NCT01421706Phase 1Jul 1, 2008Inje University
NCT01597609Phase 1May 1, 2008GlaxoSmithKline
NCT00537420Phase 2Oct 1, 2007mdRNA
NCT00537810Phase 4Sep 1, 2007National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Yale University
NCT00402077Phase 2Nov 1, 2006Amylin, AstraZeneca
NCT00433641Phase 4Jul 1, 2006Mayo Clinic, National Institutes of Health (NIH)
NCT00212173N/ASep 13, 2005National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania
NCT00115063Phase 4Jul 1, 2005Louisiana Office of Group Benefits, University of Vermont
NCT00134199Phase 2/Phase 3 (Phase 3)Mar 1, 2005Pfizer
NCT00330525Phase 2Jan 1, 2005Mayo Clinic
NCT00165685Phase 3Jul 1, 2004Eisai
NCT00234988Phase 4Jun 1, 2004Abbott
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (28)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbottFor profit7721998
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3122005
Aristotle University of ThessalonikiAcademic/Hospital2212004
AstraZenecaFor profit2122006
Eli LillyFor profit2222001
Mayo ClinicAcademic/Hospital2222005
National Institutes of Health (NIH)Government2012006
Yale UniversityAcademic/Hospital2222007
AmylinFor profit1012006
Columbia UniversityAcademic/Hospital1112009
EisaiFor profit1112004
Eurofarma Laboratorios S.A.For profit1112024
Gachon UniversityAcademic/Hospital1112010
GlaxoSmithKlineFor profit1112008
Inje UniversityAcademic/Hospital1112008
Laboratorios Silanes S.A. de C.V.For profit1112008
Laval UniversityAcademic/Hospital1112004
Louisiana Office of Group BenefitsAcademic/Hospital1012005
mdRNAFor profit1112007
MerckFor profit1112009
28 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
AbbottFor profitNDANov 22, 1997
AbbottFor profitNDA2Nov 22, 1997