Aplenzin

(bupropion SR)

ApprovedSmall molecule

GGlaxo Dba Glaxosmithkline

Aplenzin is one of 223 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

222

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseCompleted

Methamphetamine DependenceActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

SchizophreniaCompleted

Bipolar DisorderTerminated

Cardiovascular DiseaseApproved

Completed

Methamphetamine DependencePreclinical

Active, not recruiting

Attention Deficit Hyperactivity DisorderPreclinical

Active, not recruiting

Inflammatory Bowel DiseaseApproved

Active, not recruiting

SchizophreniaApproved

Completed

Bipolar DisorderApproved

Terminated

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Aplenzin

GGlaxo Dba Glaxosmithkline

Approved

2 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

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

Clinical

Trials by Indication[1]

Smoking Cessation7 trials

Bupropion for Smoking Cessation During Pregnancy

Completed·TThe University of Texas Medical Branch, Galveston·Phase 4·NCT01390246·65 enrolled

Varenicline and Bupropion for Smoking Cessation

Completed·MMayo Clinic·Phase 2/3·NCT00935818·506 enrolled

Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women

Terminated·MMassachusetts General Hospital·Phase 4·NCT00119210·40 enrolled

Show 4 more trials

Bupropion Treatment for Youth Smoking Cessation

Completed·UUniversity of Arizona·Phase 3·NCT00344695

A Comparison of Bupropion SR and Placebo for Smoking Cessation

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00176449·52 enrolled

Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT01286402·11 enrolled

Bupropion for Smoking Cessation in Pregnancy

Completed·WWatching Over Mothers & Babies Foundation·Phase 2·NCT01875172·135 enrolled

Schizophrenia2 trials

Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

Terminated·MMassachusetts General Hospital·Phase 4·NCT01576640·17 enrolled

Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00307203·51 enrolled

Smokers1 trial

Use of Pharmacotherapy to Reduce Cue-responsiveness in Smokers

Completed·CCentre for Addiction and Mental Health·Phase 1·NCT00133757·50 enrolled

Nicotine Dependence1 trial

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00129272·172 enrolled

Smoking Behavior1 trial

AXS-05 Phase II Trial on Smoking Behavior

Completed·JJames Davis·Phase 2·NCT03471767·58 enrolled

9 more indications

Adolescent1 trial

Combined Pharmaco/Behavior Therapy in Adolescent Smokers

Completed·MMedical University of South Carolina·Phase 2·NCT00330187·134 enrolled

Inflammatory Bowel Disease1 trial

Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

Completed·EEva Szigethy·Phase 4·NCT02162862·99 enrolled

Effectiveness1 trial

Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

Completed·SSouthern Illinois University Carbondale·Phase 4·NCT01048944·197 enrolled

Treatment1 trial

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Unknown status·AAxsome Therapeutics, Inc.·Phase 2·NCT04971291·312 enrolled

Methamphetamine Dependence1 trial

Bupropion in the Treatment of Methamphetamine Dependence

Completed·UUniversity of Nebraska·N/A·NCT00572234·40 enrolled

Cardiovascular Disease1 trial

Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease

Completed·MMassachusetts General Hospital·Phase 4·NCT00181818·248 enrolled

Bipolar Disorder1 trial

Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar Disorder

Terminated·MMassachusetts General Hospital·Phase 4·NCT00181896·1 enrolled

Smokeless Tobacco1 trial

Bupropion SR for Treating Smokeless Tobacco Use

Completed·MMayo Clinic·Phase 3·NCT00414180·225 enrolled

Attention Deficit Hyperactivity Disorder1 trial

Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults

Completed·MMassachusetts General Hospital·N/A·NCT01270555·32 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 30, 1985

WELLBUTRIN

NDA NDA018644

Oct 4, 1996

WELLBUTRIN SR

NDA NDA020358

May 14, 1997

ZYBAN

NDA NDA020711

Aug 28, 2003

WELLBUTRIN XL

NDA NDA021515

Apr 23, 2008

APLENZIN

NDA NDA022108

Nov 10, 2011

FORFIVO XL

NDA NDA022497

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for bupropion SR. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — bupropion SR compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for bupropion SR. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022497). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Aplenzin

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Smoking Cessation7 trials

Schizophrenia2 trials

Smokers1 trial

Nicotine Dependence1 trial

Smoking Behavior1 trial

Adolescent1 trial

Inflammatory Bowel Disease1 trial

Effectiveness1 trial

Treatment1 trial

Methamphetamine Dependence1 trial

Cardiovascular Disease1 trial

Bipolar Disorder1 trial

Smokeless Tobacco1 trial

Attention Deficit Hyperactivity Disorder1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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