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atomoxetine

Generic: ATOMOXETINE HYDROCHLORIDE·Brand: ATOMOXETINE HYDROCHLORIDE, ATONCY, STRATTERA, Strattera

atomoxetine: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.

atomoxetine evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect atomoxetine to RDY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could atomoxetine → RDY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence0 indications · 3 study sponsors

Related indications

No linked indication is available.

Development Pipeline (1)
CompanyPhase
DR REDDYS LABORATORIES LTD (RDY)Approved
Clinical Trials (4)

Alzheimer's Disease- Systematic Multi-Arm Adaptive Randomised Trial

NCT07724132·Phase 3
Recruiting

Primary endpoint: Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score

InterventionalRandomizedtriple1,200 targetStarted 2026-07Completion 2031-032 sites · United KingdomUniversity College, London

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans With Posttraumatic Stress Disorder

NCT06573970·Phase 4·GHRS
Recruiting

Primary endpoint: Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

InterventionalRandomizedquadruple160 targetStarted 2026-04Completion 2029-091 site · United StatesVA Office of Research and Development

Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea

NCT05071612·Phase 2·APMD
Completed

Primary endpoint: Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo

InterventionalRandomizedquadruple294 enrolledStarted 2021-11Completion 2022-0825 sites · United StatesApnimed

A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

NCT04085172·Phase 4·SHPGF
Completed

Primary endpoint: Part A: Change From Baseline in the Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI) Task at Week 18

InterventionalRandomizedtriple396 enrolledStarted 2019-09Completion 2025-0950 sites · Austria, Belgium, Germany, Netherlands…Shire
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Atomoxetine hydrochloride 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 capsules are 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 (RDY)FDA ↗
ANDA090609OralCapsule

Frequently asked questions

Who is developing atomoxetine?

atomoxetine is being developed by DR REDDYS LABORATORIES LTD.

How many clinical trials involve atomoxetine?

BioSniper tracks 4 clinical trials involving atomoxetine.

What is atomoxetine's latest FDA decision?

The most recent tracked FDA decision for atomoxetine is Approval for 1 INDICATIONS AND USAGE Atomoxetine hydrochloride 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 capsules are 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 , dated February 23, 2018.