Bupropion: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Bupropion appears in the FDA drug-label database. Marketed as buPropion Hydrochloride XL.
- Boxed warning
- The FDA label for Bupropion carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) (1.1) prevention of seasonal affective disorder (SAD) ( 1.2) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ]. 1.2 Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Tablet/Capsule Specifications — Graviti Pharmaceuticals Private Limited | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-15 |
| Failed Dissolution Specifications; the product is dissolving faster than the specified limits. — Amerisource Health Services LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-06-24 |
| Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. — Actavis Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2013-11-15 |
| Failed Dissolution Specifications — Sun Pharmaceutical Industries, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2016-06-27 |
| Failed Dissolution Specifications; 18 month stability time point — Sun Pharmaceutical Industries, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2016-12-20 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Depression · Bupropion for Depression | 3 |
| Bipolar Depression | 2 |
| Bipolar disorder | 2 |
| Major Depressive Disorder | 2 |
| Breast Cancer | 1 |
| Schizophrenia | 1 |
| Schizophrenia and Related Disorders | 1 |
Recruiting trials involving Bupropion
- 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
- A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
- 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.
Common questions
Is Bupropion FDA-approved?
Yes, marketed as buPropion Hydrochloride XL. Its FDA label carries a boxed warning.
How many recruiting trials involve Bupropion?
4 recruiting trials across 7 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.