ATONCY (atomoxetine hydrochloride)
ATONCY is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients 6 years of age and older.
Details
- Status
- Prescription
- First Approved
- 2026-03-20
- Routes
- ORAL
- Dosage Forms
- SOLUTION
ATONCY Approval History
What ATONCY Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
ATONCY Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All pediatric patients 6 years of age or older treated with ATONCY should be monitored and observed closely for suicidal thoughts and behaviors, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping AT...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All pediatric patients 6 years of age or older treated with ATONCY should be monitored and observed closely for suicidal thoughts and behaviors, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping ATONCY in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions (5.1) ] . Atomoxetine increased the risk of suicidal ideation in pediatric patients 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER See full prescribing information for complete boxed warning. All pediatric patients 6 years of age and older treated with ATONCY should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. ( 5.1 ) Consider stopping ATONCY in patients who experience emergent suicidal thoughts and behavior. ( 5.1 ) ATONCY (atomoxetine) increased the risk of suicidal ideation in pediatric patients 6 years of age and older with attentiondeficit/ hyperactivity disorder (ADHD) in short-term studies. ( 5.1 )
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.
ATONCY FDA Label Details
Indications & Usage
FDA Label (PDF)ATONCY is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients 6 years of age and older. ATONCY is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. ATONCY is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All pediatric patients 6 years of age or older treated with ATONCY should be monitored and observed closely for suicidal thoughts and behaviors, clinical worsening, or unusual changes in behavior, especially duri...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.