Meridia

(Sibutramine)

ApprovedSmall molecule

Sibutramine is a weight-loss medication that works by reducing appetite and helping people feel fuller, making it easier to eat less and lose weight.[2] Meridia is currently approved and in use across 8 indications[4].[1]

Meridia is one of 259 small molecule programs targeting Binge Eating. It is currently in Approved.

Indications

Total Trials

Active Trials

258

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Binge EatingActive, not recruiting

Eating DisorderActive, not recruiting

Schizoaffective DisorderActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

Weight LossActive, not recruiting

Polycystic Ovary SyndromeActive, not recruiting

ObesityActive, not recruiting

Smoking CessationActive, not recruiting

Binge EatingApproved

Active, not recruiting

Eating DisorderPhase 3

Active, not recruiting

Schizoaffective DisorderApproved

Active, not recruiting

Obstructive Sleep ApneaApproved

Active, not recruiting

Weight LossPhase 3

Active, not recruiting

Polycystic Ovary SyndromeApproved

Active, not recruiting

ObesityPhase 2

Active, not recruiting

Smoking CessationPreclinical

Active, not recruiting

Competition

Competitive Landscape

392 competitors in Obesity

#DrugCompanyPhaseTrials

Meridia

AAbbott

Approved

1 2

Avapro

Sanofi

Preclinical

1 3

Amidate

Pfizer

Preclinical

—4

Calciferol

Alnylam Pharmaceuticals

Adenocard

Activella

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Cetrotide

EMD Serono

Preclinical

2 9

Oxycontin

PProtega

Preclinical

1 10

Spiriva

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Weight loss7 trials

A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects

Completed·NNastech Pharmaceutical Company, Inc.·Phase 2·NCT00537420·551 enrolled

A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT00134199·282 enrolled

A Weight Loss Study in Overweight Men and Women

Terminated· Eli Lilly logo

Eli Lilly·Phase 2·NCT00993421·343 enrolled

Show 4 more trials

A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.

Completed·AAbbott·Phase 3·NCT00261911·498 enrolled

Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

Completed·GGachon University Gil Medical Center·N/A·NCT01184560·174 enrolled

Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes

Completed·MMayo Clinic·Phase 4·NCT00433641·181 enrolled

A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects

Completed· GSK logo

GSK·Phase 1·NCT01597609·60 enrolled

Overweight3 trials

Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population

Completed·AAbbott·Phase 3·NCT00677391·103 enrolled

Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS

Completed·HHippocration General Hospital·Phase 4·NCT00463112·80 enrolled

A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00402077·258 enrolled

Schizoaffective Disorder1 trial

The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00044187·130 enrolled

Eating Disorder1 trial

A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

Completed·AAbbott·Phase 3·NCT00402584·304 enrolled

Obstructive Sleep Apnea1 trial

Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

Completed·LLaval University·Phase 4·NCT00729963·45 enrolled

8 more indications

Blood Pressure1 trial

Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

Completed·AAbbott·Phase 3·NCT00679653·171 enrolled

Obese Patients1 trial

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

Unknown status·LLaboratorios Silanes S.A. de C.V.·Phase 3·NCT00941382·60 enrolled

Polycystic Ovary Syndrome1 trial

The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)

Unknown status·—·Phase 4·NCT01475019·200 enrolled

Binge Eating1 trial

Treatment of Binge Eating in Obese Patients in Primary Care

Completed·YYale University·Phase 4·NCT00537810·104 enrolled

Obesity1 trial

Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity

Completed·MMayo Clinic·Phase 2·NCT00330525·72 enrolled

Weight Management1 trial

Adolescent Weight Management Study

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·N/A·NCT00212173·120 enrolled

Smoking Cessation1 trial

Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates

Completed·UUniversity of Tennessee·N/A·NCT00037752·436 enrolled

Unspecified1 trial

Studying the Effects of Sibutramine on Eating Behavior

Terminated·NNew York State Psychiatric Institute·Phase 4·NCT01170364·14 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 22, 1997

MERIDIA

NDA NDA020632

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Sibutramine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Meridia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sibutramine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sibutramine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020632). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Abbott company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Monoamine Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAbbott

Meridia

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Weight loss7 trials

Overweight3 trials

Schizoaffective Disorder1 trial

Eating Disorder1 trial

Obstructive Sleep Apnea1 trial

Blood Pressure1 trial

Obese Patients1 trial

Polycystic Ovary Syndrome1 trial

Binge Eating1 trial

Obesity1 trial

Weight Management1 trial

Smoking Cessation1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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