TheraRadar
Data updated: Sep 20, 2026

BUPROPION HYDROCHLORIDE · WATSON LABS

Generic · see WELLBUTRIN XL Trial Activity: Declining 7 active trials
CNS Approved 1985-12-30

BUPROPION HYDROCHLORIDE is FDA-approved to treat 2 conditions (same as WELLBUTRIN XL).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

VA Office of Research and Development conducting 4 trials (5%)
72 indications explored (Broad Platform)
→ smoking cessation (13 trials)
→ major depressive disorder (7 trials)
→ smoking (6 trials)
58
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1985-12-30
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET

Companies

WATSON LABS JUBILANT GENERICS ALEMBIC Sun Pharma ANNORA PHARMA HERITAGE PHARMA PH HEALTH RISING INVAGEN PHARMS SINOTHERAPEUTICS INC Novartis Teva GRANULES Aurobindo Pharma CADILA PHARMS LTD YICHANG HUMANWELL MACLEODS PHARMS EPIC PHARMA LLC CHARTWELL RX WOCKHARDT SCIEGEN PHARMS SENORES PHARMS IPCA LABS LTD GRAVITI PHARMS INVATECH IMPAX LABS TORRENT ACCORD HLTHCARE Lupin MICRO LABS TWI PHARMS ANBISON LAB ZHEJIANG JUTAI PHARM Apotex ZYDUS PHARMS PRINSTON INC
Active Ingredient: BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE Approval History

2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1125 FDA actions from 1999 to 2026
Sep 2026 SUPPL
Label · Labeling
Aug 2026 SUPPL
Label · Labeling
Jul 2026 ORIGINAL
Update
FDA Letter

What BUPROPION HYDROCHLORIDE Treats

2 indications

BUPROPION HYDROCHLORIDE is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as WELLBUTRIN XL (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

82 trials
Trial Sponsor ID Phase Status Title
NCT07584434 VX25-433-001 Ph 1 recruiting A Phase 1, First-in-human Study of VX-433
NCT05646862 INAVO121 WO43919 2022-502322-41-00 Ph 3 recruiting A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
NCT06679413 results posted UP0132 Ph 1 completed A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants
NCT07223671 CA127-1088 Ph 1 completed Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
NCT06564441 1404-0008 2024-512332-29-00, U1111-1307-0132 Ph 1 completed A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity
NCT05732272 (KISV) STUDY00148037 Ph 3 recruiting Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
NCT07235748 S095032-230 Ph 1 completed Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
NCT05205811 BuZonE 2 Ph 3 completed The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette
NCT04634071 TTOP MCC-20-MULTI-34 Ph 2 completed Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
NCT05603104 INTENSIFY 2022-502185-24-00 (EU CT #) Ph 3 recruiting Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT04422652 CONCORD STU-2020-0046 R01DK124379 Ph 2 active not recruiting Combination of Novel Therapies for CKD Comorbid Depression
NCT03978442 CPT-SMART results posted MHBB-008-18F Ph 4 completed CPT-SMART for Treatment of PTSD and Cigarette Smoking
NCT05973786 INTENSIFY BD 2023-506605-19-00 (EU CT#) Ph 3 recruiting The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
NCT06374290 HSC-MS-24-0024 Ph 1 terminated Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
NCT05537584 2022P000896 Ph 4 completed SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
NCT03950427 PARQuit results posted T29IP0235 22637, NCI-2022-02281 Ph 4 completed PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
NCT06973005 CRIOLLO D7930C00007 Ph 1 completed A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
NCT05351606 22639 1U01CA261620-01 Ph 4 completed Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
NCT00943618 results posted 2008-0850 R01DA024709-01A1, NCI-2011-01101 Ph 3 completed Combining Varenicline and Bupropion for Smoking Cessation
NCT03852160 CR108567 2018-001890-26, 54135419TRD3011 Ph 3 withdrawn A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
NCT03342027 results posted HP-00077523 Ph 3 completed Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
NCT02568176 CR108043 ESKETINTRD1010, 2015-002654-13 Ph 1 completed Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants
NCT06223880 AXS-05-MDD-401 Ph 4 recruiting A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
NCT05981365 results posted GBT440-0122 C5341029 Ph 1 completed Voxelotor CYP and Transporter Cocktail Interaction Study
NCT06367153 results posted 1447-0007 2023-510461-10-00, U1111-1303-9187 Ph 1 completed A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood
NCT06254001 C80-23 Ph 4 recruiting Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects
NCT05932277 CN007-1000 Ph 1 completed A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
NCT03226522 ADVANCE results posted AXS-05-AD-301 Ph 2, Ph 3 completed Addressing Dementia Via Agitation-Centered Evaluation
NCT04526210 results posted ALXN1840-HV-103 Ph 1 completed Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
NCT04135937 MESH results posted CDX 19-002 CDA 17-005 Ph 4 completed Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
NCT03326128 1703346 Ph 2 terminated High Dose Bupropion for Smoking Cessation - Pilot Study
NCT03993457 PRECISE-D results posted STU-2019-0623 Ph 4 terminated Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
NCT03897439 results posted Study0000142310 R01DA046576 Ph 3 completed Individualizing Pharmacotherapy for African American Smokers
NCT04457180 HR-APTN-I-008 Ph 1 completed A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Repaglinide or Bupropion in Advanced Solid Tumor Subjects
NCT04388319 BuZonE results posted BuZonE Ph 3 completed Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
NCT04464577 CV018-014 Ph 1 withdrawn A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235
NCT02245308 results posted D1301-R 1828 Ph 4 completed Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
NCT02736474 results posted MZhao-005 Ph 4 completed Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
NCT04643249 KL1333 2020-103 Ph 1 completed Drug-drug Interaction Study of KL1333 in Healthy Subjects
NCT03595579 ASCEND results posted AXS-05-MDD-201 Ph 2 completed Assessing Symptomatic Clinical Episodes in Depression
NCT02188459 BIBS results posted 820364 Ph 2 completed Placebo-controlled Trial of Bupropion for Smoking Cessation in Pregnant Women
NCT02995915 results posted Pro00062101 Ph 4 completed Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
NCT04757532 ESPAMA IMIMFTCL/ESPAMA Ph 1 completed Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.
NCT02741791 STRIDE-1 AXS-05-301 Ph 3 completed A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
NCT04709094 ACH471-017 CA27858 Ph 1 completed A Drug Interaction Study of Danicopan
NCT01769768 CLDE225A2112 Ph 1 completed Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
NCT00749658 ChanBan results posted GCRC 10047 K01DA019446, DPMC Ph 2, Ph 3 completed Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
NCT04388189 LEAP-DB LEAP-DB Ph 4 withdrawn Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion
NCT03169244 results posted 16-1064 1R21AA025186-01 Ph 2 completed Buproprion for Binge Drinking
NCT02191397 results posted 114589 Ph 3 completed Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder

Showing 50 of 82 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BUPROPION HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

BUPROPION HYDROCHLORIDE is FDA-approved to treat 2 conditions — same approved indications as WELLBUTRIN XL.

Looking for the branded version?

WELLBUTRIN XL

Full clinical data, patents, trials, and competitive landscape for bupropion hydrochloride.

See WELLBUTRIN XL

Data Sources

FDA Approval: ANDA077455 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment