Bupropion clinical trials
Bupropion is named as an intervention in 10 current clinical trials in our USA, Canada, China, Germany, Spain, Italy, Turkey, Mexico, UK, France, Belgium, Poland, Brazil, South Korea, Taiwan, Australia, Austria and Sweden registers. 7 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Axsome Therapeutics, Inc (2). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Bupropion is approved
All regulators →Of the three regulators tracked here, the first to approve Bupropion was the US, on 30 Dec 1985. It is approved in 2 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: adverse event for Mysimba, 29 May 2025
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Bupropion patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Bupropion, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 23 Aug 2028 (US 7674479).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Bupropion
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Bupropion works
All drug targets →- Dopamine transporter inhibitor InhibitorTarget: SLC6A3 solute carrier family 6 member 3✓ In ChEMBL and the Guide to Pharmacology
- Norepinephrine transporter inhibitor InhibitorTarget: SLC6A2 solute carrier family 6 member 2✓ In ChEMBL and the Guide to Pharmacology
- AgitationPhase 3
- Alzheimer diseasePhase 3
- ApathyPhase 3
- Acute coronary syndromePhase 3
- Bipolar disorderPhase 3
- Depressive disorderPhase 3
- Methamphetamine dependencePhase 3
- Nicotine dependencePhase 3
- SchizophreniaPhase 3
- Smoking behaviorPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL894, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7135, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Bupropion
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Bupropion. 2 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Naltrexone–bupropion for managing overweight and obesity NICE TA494 | Not recommended | 12 Dec 2017 | Current |
| The clinical effectiveness and cost effectiveness of bupropion (Zyban) and Nicotine Replacement Therapy for smoking cessation NICE TA39 | Recommended | 27 Mar 2002 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Bupropion
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Bupropion
- ATC code
- N06AX12
- ChEMBL
- CHEMBL894
- DrugBank
- DB01156
- PubChem CID
- 444
- CAS number
- 34911-55-2
- FDA UNII
- 01ZG3TPX31
- Wikidata
- Q834280
- Wikipedia
- Bupropion
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Bupropion
10 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Bupropion in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Bupropion. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A 52-week multicenter, randomized, parallel-group trial in overweight people investigating lifestyle changes, mushroom supplementation and bupropion to reduce adiposity and cardiometabolic risk
2026-527136-13-00 · Nutritional and Metabolic Diseases
|
Phase 3 | Authorised | Uppsala University | Sweden |
Bupropion across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
5 single-substance products containing Bupropion on the HPRA medicines list.
- Zyban 150 mg prolonged release tabletsGlaxoSmithKline (Ireland) Limited · PA1077/017/001 · Marketed
- Zyban 150 mg prolonged release tabletsOriginalis B.V. · PPA2306/005/001
- Zyban 150 mg prolonged release tabletsPCO Manufacturing Ltd. · PPA0465/496/001
- Zyban 150 mg prolonged release tabletsMerit Pharmaceuticals Limited · PPA23080/035/001
- Zyban 150 mg prolonged-release tabletsIMED Healthcare Ltd., · PPA1463/229/001
Supply shortages
No entry for Bupropion in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Bupropion
16 conditionsAll 16 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 1 |
| Narcolepsy Type 1 (NT1) | 1 |
| Smoking Cessation | 1 |
| Major Depressive Disorder | 1 |
| ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 1 |
| Bipolar Depression | 1 |
| Cardiometabolic Syndrome | 1 |
| Obesity and Cardiovascular Risk | 1 |
| Overweight , Obesity | 1 |
| Healthy | 1 |
| Major Depressive Disorder (MDD) | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Late Life Treatment Resistant Depression | 1 |
| Depression - Major Depressive Disorder | 1 |
| Treatment Resistant Depression | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Axsome Therapeutics, Inc | 2 |
| Hoffmann-La Roche | 1 |
| Vertex Pharmaceuticals Incorporated | 1 |
| Jiangsu Simcere Pharmaceutical Co., Ltd | 1 |
| Dr. Inge Winter | 1 |
| Uppsala University | 1 |
| Mehmet Kemal Arikan | 1 |
| Duke University | 1 |
| Washington University School of Medicine | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Bupropion trials
How many clinical trials are testing Bupropion?
10 current trials in our USA, Canada, China, Germany, Spain, Italy, Turkey, Mexico, UK, France, Belgium, Poland, Brazil, South Korea, Taiwan, Australia, Austria and Sweden registers name Bupropion (also registered as ATC cose: N06AX12) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Bupropion trials recruiting patients?
Yes. 7 of the 10 trials are recruiting: 4 with sites in USA, 2 with sites in Canada, 1 with sites in China, 2 with sites in Germany, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Turkey, 2 with sites in Mexico, 1 with sites in UK, 1 with sites in France, 1 with sites in Belgium, 1 with sites in Poland, 1 with sites in Brazil, 1 with sites in South Korea, 1 with sites in Taiwan, 1 with sites in Australia and 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Bupropion clinical trials?
Axsome Therapeutics, Inc (2), Hoffmann-La Roche (1), Vertex Pharmaceuticals Incorporated (1) and Jiangsu Simcere Pharmaceutical Co., Ltd (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Bupropion licensed in Ireland?
Yes. The HPRA medicines list includes 5 single-substance products containing Bupropion, for example Zyban 150 mg prolonged release tablets (GlaxoSmithKline (Ireland) Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Bupropion shortage?
Not in the lists we track: Bupropion has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Bupropion works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Bupropion works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Bupropion (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.