STRATTERA (atomoxetine hydrochloride) · Eli Lilly
STRATTERA is FDA-approved to treat 1 condition (same as ATOMOXETINE HYDROCHLORIDE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2002-11-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
STRATTERA Approval History
What STRATTERA Treats
1 indicationsSTRATTERA is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention-Deficit/Hyperactivity Disorder (ADHD)
Same approved indications as ATOMOXETINE HYDROCHLORIDE (same active ingredient).
Eli Lilly's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
7 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 |
| NCT01340885 results posted | PANUC - Lou 5P50NS062684-02 | Ph 4 | completed | Cognitive Decline in Non-demented PD |
| 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.
STRATTERA FDA Label Details
Indications & Usage
FDA Label (PDF)STRATTERA is FDA-approved to treat 1 condition — same approved indications as ATOMOXETINE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment