Drug

Bupropion

Regulatory activity · MHRA

Emerging researchLate-stage developmentCooling momentum

Also known as Amfebutamone, Aplenzin, Auvelity, Buproban+5 more

Amfebutamone, Aplenzin, Auvelity, Buproban, Contrave, Forfivo, Wellbutrin, Zyban, BuPROPion Hydrochloride.

RxNorm42347 ChEMBLCHEMBL894 ATCN06AX12UNII01ZG3TPX31

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

CPT-SMART for Treatment of PTSD and Cigarette Smoking

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis

Clinical trial2026-07-02Withdrawn · ClinicalTrials.gov

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Clinical trial2026-06-24Results expected Q4 2026 · ClinicalTrials.gov

BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder

Clinical trial2026-06-18Results expected Q3 2028 · ClinicalTrials.gov

A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion

Clinical trial2026-06-08Results expected Q1 2027 · ClinicalTrials.gov

The Effect of Multiple Doses of BI 1569912 on the Single-dose Pharmacokinetics of Repaglinide, Midazolam and Bupropion Following Oral Administration in Healthy Male and Female Subjects (an Open-label, 2-period Fixed-sequence Trial)

Clinical trial2026-05-22Results posted · ClinicalTrials.gov

Naltrexone/bupropion for binge-eating disorder: A randomized, double-blind, placebo-controlled trial.

Research2023-09-26Obesity (Silver Spring, Md.)

Drug Safety Update: Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs

Regulatory2020-11-16MHRA

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

Research2018-03-14Bipolar disorders

Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia.

Research2011-04-08Psychopharmacology

Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men.

Research2010-04-01AIDS (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Bupropion

Aliases & brands

AmfebutamoneAplenzinAuvelityBuprobanContraveForfivoWellbutrinZybanBuPROPion Hydrochloride

RxNorm CUI

42347

ChEMBL ID

CHEMBL894

ATC codes

N06AX12

UNII

01ZG3TPX31

Regulatory jurisdictions

mhra

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2020-11-16Safety communicationSafety

Drug Safety Update: Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

153 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

153

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

110

Completed

Discontinued

PHASE DISTRIBUTIONn = 153

Early Phase 14Phase 132Phase 1 / 25Phase 222Phase 2 / 311Phase 321Phase 439Phase N / A19

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center

Unknown statusPH IVNational Institute of Respiratory Diseases, Mexicon=1342026

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

RecruitingPH IVAxsome Therapeutics, Inc.n=3502026

CPT-SMART for Treatment of PTSD and Cigarette Smoking

CompletedPH IVVA Office of Research and Developmentn=1152025

SMART Trial to Predict Anhedonia Response to Antidepressant Treatment

CompletedPH IVMclean Hospitaln=1332025

PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness

CompletedPH IVUniversity of California, San Franciscon=1312025

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase 1, 2-Cohort, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of Repotrectinib on the Pharmacokinetics of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

CompletedPH IBristol-Myers Squibbn=302026

An Open-label, Non-randomised, Fixed-sequence, Two Period, Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 (Survodutide) on the Single Dose Pharmacokinetics of Bupropion, Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity

CompletedPH IBoehringer Ingelheimn=342026

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

CompletedPH IIJoseph Valentino, MDn=1262026

A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants

CompletedPH IInstitut de Recherches Internationales Servier (I.R.I.S.)n=282025

A Randomized Controlled Trial to Determine the Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette

CompletedPH IIIRose Research Center, LLCn=1802025

CPT-SMART for Treatment of PTSD and Cigarette Smoking

CompletedPH IVVA Office of Research and Developmentn=1152025

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20082023

Most influential

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

Bipolar disorders · 2018 · 1,126 cites

Effect of varying levels of disease management on smoking cessation: a randomized trial.

Annals of internal medicine · 2009 · 62 cites

Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia.

Psychopharmacology · 2011 · 59 cites

Bupropion and cognitive behavioral therapy for weight-concerned women smokers.

Archives of internal medicine · 2010 · 55 cites

Naltrexone/bupropion for binge-eating disorder: A randomized, double-blind, placebo-controlled trial.

Obesity (Silver Spring, Md.) · 2023 · 40 cites

Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking.

Journal of substance abuse treatment · 2009 · 40 cites

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Naltrexone

Studied across 4 of the same disease areas as Bupropion in the shared literature.

4 shared diseases1 shared paper

Lamotrigine

Studied across the same disease area as Bupropion in the shared literature.

1 shared disease1 shared paper

Olanzapine

Studied across the same disease area as Bupropion in the shared literature.

1 shared disease1 shared paper

Quetiapine Fumarate

Studied across the same disease area as Bupropion in the shared literature.

1 shared disease1 shared paper

Valproic Acid

Studied across the same disease area as Bupropion in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.