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Atomoxetine

Phase 3

Alzheimer's Disease (AD) | Small molecule | Neurology |United Therapeutics Corporation|Last Updated: Jul 23, 2026

Target and mechanism

Molecular targetSLC6A2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL641

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,200

FDA Designations

No designations recorded

Clinical trial landscape

Atomoxetine · 1 trial · 3 indications

Phase 3 1
NCT07724132An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's DiseaseAlzheimer's Disease (AD)
RECRUITING1,200 Analytics
PHASE3RECRUITING
An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease
Alzheimer's Disease (AD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score
Baseline to 18 months

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) measures the severity of cognitive impairment in dementia. Scores range from 0 to 70, with higher scores indicating worse cognitive performance (Unit of Measure: ADAS-Cog score (0-70). ADAS-Cog will be administered at baseline, month 6, month 12, and month 18 (end of study), and change over time will be assessed.

Change in Amsterdam Instrumental Activities of Daily Living Questionnaire - Short Version (A-IADL-Q-SV) score
Baseline to 18 months

The Amsterdam Instrumental Activities of Daily Living Questionnaire - Short Version (A-IADL-Q-SV) assesses functional impairment in instrumental activities of daily living. Scores range from 0 to 100, with higher scores indicating better functional performance (Unit of Measure: A-IADL-Q-SV score (0-100). The A-IADL-Q-SV will be administered at baseline, month 6, month 12, and month 18 (end of study), and change over time will be evaluated.

Secondary Endpoints

Change in Neuropsychiatric Inventory (NPI) total score
Baseline to 18 months
Change in EQ-5D-5L health-related quality-of-life score (participant-reported)
Baseline to 18 months
Change in EQ-5D-5L health-related quality-of-life score (study partner-reported)
Baseline to 18 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard of Care + PlaceboPLACEBO_COMPARATORPlacebo arm (Oral capsule matching active treatments)
Standard of Care + AtomoxetineACTIVE_COMPARATORAtomoxetine (Oral, up to 100 mg/day)
Standard of Care + MetforminACTIVE_COMPARATORMetformin (immediate release) Oral, up to 2000 mg/day

Interventions

NameTypeDescription
PlaceboDRUGOral capsule matching active treatments
AtomoxetineDRUGAtomoxetine (Oral, up to 100 mg/day)
Metformin 1000 mg Oral TabletDRUGMetformin IR Oral, up to 2000 mg/day
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria * Patient meets all inclusion criteria: 1\. Adults aged ≥55 years on the day of screening, no upper age limit 2. Either: 1. Confirmed clinical diagnosis of Alzheimer's Disease (AD) 2. Confirmed clinical diagnosis of Mixed Dementia consisting of Alzheimer's Disease and Vasc...

Countries:United Kingdom
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Frequently asked questions about Atomoxetine

What is Atomoxetine used for in Alzheimer's Disease?

Atomoxetine is a small molecule being studied for the treatment of symptomatic Alzheimer's Disease, including mild cognitive impairment due to Alzheimer's Disease and Alzheimer Disease Dementia. It is currently in Phase 3 clinical development as an investigational therapy for these conditions.

What does Atomoxetine target?

Atomoxetine is a small molecule therapeutic being evaluated for its effects in Alzheimer's Disease. The specific molecular target of Atomoxetine in this context has not been disclosed in the available clinical trial information.

Who is developing Atomoxetine?

Atomoxetine is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 3 clinical trial to evaluate the drug for Alzheimer's Disease.

What phase is Atomoxetine in?

Atomoxetine is in Phase 3 clinical development for Alzheimer's Disease. It is currently being evaluated in a randomized, double-blind, placebo-controlled trial with an enrollment of 1,200 participants, and the trial is actively recruiting patients.

What clinical trials is Atomoxetine in?

Atomoxetine is being studied in a Phase 3 clinical trial with the identifier NCT07724132. This trial is titled 'An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease' and is recruiting participants in the United Kingdom.

Is Atomoxetine the same as other drugs for Alzheimer's?

Atomoxetine is a distinct investigational drug being developed by United Therapeutics Corporation for Alzheimer's Disease. It is not identified as being the same as any other marketed or investigational Alzheimer's treatment in the available clinical trial information.