ATOMOXETINE HYDROCHLORIDE
Atomoxetine hydrochloride is used for children six years and older, adolescents, and adults who have Attention-Deficit/Hyperactivity Disorder (ADHD). It helps patients with persistent symptoms of inattention or hyperactivity-impulsivity that cause significant impairment in settings like school, work, or home. This medication is prescribed when these symptoms are more severe than typical for a person's developmental level and interfere with their social or academic functioning.
How ATOMOXETINE HYDROCHLORIDE Works
This drug works by selectively inhibiting the pre-synaptic norepinephrine transporter. While the exact process is not fully understood, this specific action on norepinephrine uptake is thought to be responsible for the medication's therapeutic effects.
Details
- Status
- Prescription
- First Approved
- 2010-09-16
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
ATOMOXETINE HYDROCHLORIDE Approval History
What ATOMOXETINE HYDROCHLORIDE Treats
1 indicationsATOMOXETINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention-Deficit/Hyperactivity Disorder (ADHD)
ATOMOXETINE HYDROCHLORIDE Boxed Warning
SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely f...
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions ( 5.1 )] . WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS See full prescribing information for complete boxed warning. Increased risk of suicidal ideation in children or adolescents (5.1) No suicides occurred in clinical trials (5.1) Patients started on therapy should be monitored closely (5.1)
ATOMOXETINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04085172 results posted | SPD503-401 2018-000821-29, TAK-503-401 | Ph 4 | completed | A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) |
| NCT05159687 POST7 | POST 7 | Ph 3 | recruiting | Study of Atomoxetine in the Prevention of Vasovagal Syncope |
| NCT05071612 MARIPOSA | MARIPOSA | Ph 2 | completed | Parallel Arm Trial of AD109 and AD504 In Patients With OSA |
| NCT01244490 results posted | SPD503-316 2010-018579-12 | Ph 3 | completed | Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) |
| NCT01106430 results posted | SPD489-317 2009-011745-94 | Ph 3 | completed | Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate |
| NCT00700427 results posted | 9655 B4Z-MC-LYDO | Ph 3 | completed | A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ATOMOXETINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)ATOMOXETINE HYDROCHLORIDE is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk ...
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ATONCY
Full clinical data, patents, trials, and competitive landscape for atomoxetine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.