Overview
Atomoxetine is a selective norepinephrine (NE) reuptake inhibitor used for the treatment of attention deficit hyperactivity disorder (ADHD). Also known as the marketed product Strattera, atomoxetine is used with other treatment modalities (psychological, educational, cognitive behaviour therapy, etc) to improve developmentally inappropriate symptoms associated with ADHD including distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. Although the underlying pathophysiology that causes ADHD remains unclear, evidence suggests that dysregulation in noradrenergic and dopaminergic pathways plays a critical role in suboptimal executive functioning within prefrontal regions of the brain, which are involved in attention and memory. Atomoxetine has been shown to specifically increase NA and DA within the prefrontal cortex, but not in the nucleus accumbens (NA) or striatum. This is beneficial in the treatment of ADHD as DA activation in the subcortical NA and striatum is associated with many stimulant-associated side effects and an increase in abuse potential, which is a limiting factor associated with the use of stimulant medications such as Methylphenidate, Dextroamphetamine, and Lisdexamfetamine. Use of non-stimulant medications such as atomoxetine is therefore thought to offer a clinical advantage over the use of traditional medications for the management of ADHD. More recently, positron emission tomography (PET) imaging studies in rhesus monkeys have shown that atomoxetine also binds to the serotonin transporter (SERT), and blocks the N-methyl-d-aspartate (NMDA) receptor, indicating a role for the glutamatergic system in the pathophysiology of ADHD. Long-acting formulations of psychostimulants (such as Methylphenidate, Dextroamphetamine, and Lisdexamfetamine) are typically considered the most effective and first-line treatment for ADHD in adults and children as recommended by CADDRA (Canadian ADHD Resource Alliance). However, these stimulant medications are limited by dose-related side effects and concerns of abuse. Many contain a blackbox warning stating that CNS stimulants, including methylphenidate-containing products and amphetamines, have a high potential for abuse and dependence. In particular, increased dopamine in key areas caused by these stimulant medications is associated with their reinforcing and addictive properties, and even amplifies the potency and reinforcing effects of other drugs of abuse such as amphetamines, making ADHD sufferers more susceptible to their addictive effects. Concerns about abuse potential have spurred research into medications with fewer effects on DA and the use of non-stimulant ADHD medications including atomoxetine, Modafinil and Guanfacine. The non-stimulant norepinephrine/dopamine reuptake inhibitor Bupropion (commonly used for the treatment of depression and for smoking cessation) has also been shown to be effective in the treatment of ADHD.
Indication
Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Research Report
Atomoxetine (DB00289): A Comprehensive Pharmacological and Clinical Review
1. Introduction and Drug Identification
1.1. Overview
Atomoxetine is a small molecule drug that occupies a unique and significant position in the therapeutic armamentarium for Attention-Deficit/Hyperactivity Disorder (ADHD).[1] It was the first non-stimulant medication to receive approval from the U.S. Food and Drug Administration (FDA) for this indication, representing a paradigm shift in treatment options for a condition historically managed with psychostimulants.[1] Classified pharmacologically as a selective norepinephrine reuptake inhibitor (SNRI), its mechanism is distinct from that of methylphenidate and amphetamine-based medications.[2]
Atomoxetine, identified by DrugBank Accession Number DB00289 and CAS Number 83015-26-3, is indicated for the management of ADHD in children aged six years and older, adolescents, and adults.[1] Its use is intended as a component of a comprehensive treatment program that integrates psychological, educational, and social interventions to address the multifaceted nature of the disorder.[1] The development of atomoxetine was driven by the clinical need for an effective ADHD therapy devoid of the abuse potential and diversion risks associated with traditional stimulant medications. Consequently, its primary clinical utility is often realized in patients for whom stimulants are contraindicated, ineffective, or poorly tolerated, or in cases where there is a significant concern for substance misuse.[4]
1.2. Chemical and Physical Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/27 | Phase 2 | Not yet recruiting | |||
2025/02/24 | Early Phase 1 | Not yet recruiting | |||
2024/08/27 | Phase 4 | Not yet recruiting | |||
2024/08/22 | Phase 3 | ENROLLING_BY_INVITATION | Apnimed | ||
2024/08/07 | Phase 2 | Not yet recruiting | |||
2024/03/06 | Phase 4 | Recruiting | |||
2023/07/14 | Phase 1 | Not yet recruiting | |||
2023/07/06 | Phase 2 | Recruiting | |||
2022/09/22 | Phase 1 | Recruiting | |||
2022/04/28 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Glenmark Pharmaceuticals Inc., USA | 68462-265 | ORAL | 10 mg in 1 1 | 3/9/2023 | |
Glenmark Pharmaceuticals Inc., USA | 68462-267 | ORAL | 25 mg in 1 1 | 3/9/2023 | |
Dr. Reddy's Laboratories Limited | 55111-520 | ORAL | 18 mg in 1 1 | 1/24/2022 | |
Dr. Reddy's Laboratories Limited | 55111-519 | ORAL | 10 mg in 1 1 | 1/24/2022 | |
Dr. Reddy's Laboratories Limited | 55111-521 | ORAL | 40 mg in 1 1 | 1/24/2022 | |
TYA Pharmaceuticals | 64725-3228 | ORAL | 25 mg in 1 1 | 8/5/2013 | |
STAT RX USA LLC | 16590-337 | ORAL | 10 mg in 1 1 | 3/22/2010 | |
N/A | 50090-6703 | ORAL | 25 mg in 1 1 | 5/10/2023 | |
American Health Packaging | 60687-326 | ORAL | 40 mg in 1 1 | 12/14/2023 | |
REMEDYREPACK INC. | 70518-4337 | ORAL | 100 mg in 1 1 | 5/19/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
STRATTERA 18 mg HARD CAPSULE | SIN13071P | CAPSULE | 18 mg | 4/4/2005 | |
STRATTERA 25 mg HARD CAPSULE | SIN13073P | CAPSULE | 25 mg | 4/4/2005 | |
STRATTERA 60 mg HARD CAPSULE | SIN13075P | CAPSULE | 60 mg | 4/4/2005 | |
STRATTERA 40mg HARD CAPSULE | SIN13074P | CAPSULE | 40 mg | 4/4/2005 | |
STRATTERA 10 mg HARD CAPSULE | SIN13072P | CAPSULE | 10 mg | 4/4/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.