Atomoxetine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Atomoxetine appears in the FDA drug-label database. Marketed as Atomoxetine.
- Boxed warning
- The FDA label for Atomoxetine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies ( 14 )]. 1.2 Diagnostic Considerations A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of A…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-29 |
| Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. — Safecor Health, LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-04-30 |
| CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-29 |
| CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-29 |
| CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-29 |
Phase breakdown
Conditions being studied
Recruiting trials involving Atomoxetine
- An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease
- Atomoxetine and Executive Function in PTSD
- Atomoxetine in Melanocortin Obesity Syndrome
- Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
- Role of Coenzyme Q in ADHD in Children
- Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Common questions
Is Atomoxetine FDA-approved?
Yes, marketed as Atomoxetine. Its FDA label carries a boxed warning.
How many recruiting trials involve Atomoxetine?
6 recruiting trials across 14 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.