Drugs / Sibutramine
Sibutramine
also known as
Meridia · BTS 54524 · Butramin · Cf-alli · Medaria · NSC-758928 · Racemic sibutramine · Reductil · +6 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | MERIDIA | — | 2001-02-16 – 2005-12-08 | fda.gov ↗ |
| Approved | US (FDA) | MERIDIA | — | 1997-11-22 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01597609 | May 2008 → Mar 2010 | obesity disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT00993421 | Oct 2009 → Jun 2010 | obesity disorder | Eli Lilly and Company | Terminated | Missed primary |
| Phase 2 | NCT00402077 | Nov 2006 → Aug 2007 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00330525 | Jan 2005 → Mar 2006 | obesity disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00134199 | Mar → Nov 2005 | obesity disorder | Pfizer | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT00165685 | Jul 2004 → Mar 2007 | obesity disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00234832 | Jan 2003 → Mar 2009 | obesity disorder | Abbott | Completed | Missed primary |
| Phase 3 | NCT00402584 | Aug 2000 → ? | binge eating disorder, obesity disorder | Abbott | Completed | Met primary |
| Phase 3 | NCT00261911 | Jul 2000 → Feb 2002 | obesity disorder | Abbott | Completed | Met primary |
| Phase 49 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT01170364 | Feb 2009 → Oct 2010 | obesity disorder | New York State Psychiatric Institute | Terminated | Met primary |
| Phase 4 | NCT00537810 | Sep 2007 → Oct 2012 | binge eating disorder, obesity disorder | Yale University | Completed | Missed primary |
| Phase 4 | NCT00433641 | Jul 2006 → Nov 2007 | obesity disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00115063 | Jul 2005 → Dec 2007 | obesity disorder | Pennington Biomedical Research Center | Terminated | Met primary |
| Phase 4 | NCT00234988 | Jun 2004 → Jan 2006 | obesity disorder | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00463112 | Mar 2004 → Sep 2006 | obesity disorder, polycystic ovary syndrome | Hippocration General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01475019 | Jan 2004 → Jan 2010 | obesity disorder, polycystic ovary syndrome | Aristotle University Of Thessaloniki | Unknown | No outcome recorded |
| Phase 4 | NCT00729963 | Jan 2004 → Sep 2007 | hypertensive disorder, obesity disorder, obstructive sleep apnea syndrome | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT00044187 | Apr 2001 → Sep 2003 | bipolar disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00829283 | Nov 2008 → Nov 2013 | binge eating disorder, obesity disorder | Yale University | Completed | No outcome recorded |
| — | NCT00212173 | ? → Aug 2007 | — | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT00914212 Comparator | May → Aug 2009 | obesity disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01421706 Comparator | Jul 2008 → Jul 2009 | — | Inje University | Completed | No outcome recorded |
| Phase 2 | NCT00537420 Comparator | Oct 2007 → Jul 2008 | obesity disorder | Nastech Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05209984 Comparator | Apr 2026 → Mar 2028 | obesity disorder | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT00941382 Comparator | Nov 2008 → Aug 2009 | obesity disorder | Laboratorios Silanes S.A. de C.V. | Unknown | No outcome recorded |
| Phase 3 | NCT00677391 Comparator | Dec 2002 → Nov 2004 | obesity disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00679653 Comparator | Feb 2002 → Dec 2003 | hypertensive disorder, obesity disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00645255 Comparator | Sep 1998 → Jan 2003 | obesity disorder | Abbott | Terminated | No outcome recorded |
| Phase 4 | NCT05821543 Background | Jul 2020 → May 2021 | obesity disorder | Promomed, LLC | Completed | No outcome recorded |
| — | NCT01184560 Background | Feb → Jul 2010 | obesity disorder | Gachon University Gil Medical Center | Completed | No outcome recorded |
| — | NCT00037752 Comparator | Sep 2002 → Aug 2008 | heart disorder, obesity disorder | University of Tennessee | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2010-10-28 | Eisai Inc. | Regulatory EISAI TO WITHDRAW JAPAN MARKETING AUTHORIZATION APPLICATION FOR ANTIOBESITY AGENT KES524 eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) announced today that it has decided to withdraw the Marketing Authorization Application (MAA) and discontinue development of the antiobesity agent KES524 (generic name: sibutramine hydrochloride monohydrate). |
| 2007-11-29 | Eisai Inc. | Regulatory Eisai Submits NDA Application of KES524 for Obesity Management in Japan eisai.com ↗
today announced that the company submitted an application to manufacture and distribute KES524 (generic name: sibutramine hydrochloride monohydrate), which the company had been developing in Japan for obesity management, to the Ministry of Health, Labour, and Welfare (MHLW). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-12-01 | Ache Laboratorios Farmaceuticos S.A. | Posicionamento do Aché sobre sibutramina (Biomag e Cloridrato de Sibutramina Monoidratado) ache.com.br ↗ |
| 2010-10-28 | Eisai Inc. | EISAI TO WITHDRAW JAPAN MARKETING AUTHORIZATION APPLICATION FOR ANTIOBESITY AGENT KES524 eisai.com ↗ |
| 2007-11-29 | Eisai Inc. | Eisai Submits NDA Application of KES524 for Obesity Management in Japan eisai.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sibutramine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01184560 ↗ |
| Known as | BTS 54524 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Butramin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Cf-alli | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Medaria | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Meridia | “Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction.” NCT00829283 ↗2“A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescents” NCT00261911 ↗ “A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder” NCT00402584 ↗ |
| Known as | NSC-758928 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Racemic sibutramine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Reductil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Sibutramina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Sibutramine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Sibutramine Hydrochloride | “A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder” NCT00402584 ↗ |
| Known as | Sibutramine hydrochloride civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Sibutramine hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1419 ↗ |
| Known as | Sibutramine Hydrochloride Monohydrate | “A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescents” NCT00261911 ↗ |
| Action | Inhibit | “serotonin and noradrenaline reuptake inhibitor (SNRI)” NCT00463112 ↗ |
| Modality | Small molecule | — CHEMBL1419 ↗ |
| Route | Oral | “oral tablet” NCT00402077 ↗ |