TrialSignal
Clinical trial intelligence report
A Phase 1 Open-label Study of the Safety, Tolerability, and Pharmacokinetics of d- and l-Amphetamine After Multiple Daily Doses of SHP465 6.25 mg Administered in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 25, 2026
Report code
NCT03327402-Jun 25, 2026
NCT ID
NCT03327402
Status
COMPLETED
Phase
Phase 1
Sponsor
Shire
Executive brief
Investment-Ready Snapshot
SHP465, a formulation of amphetamine salts, is being evaluated for safety and pharmacokinetics in a pediatric population (ages 4-5) with ADHD. The market for ADHD treatments is substantial, with increasing demand for effective therapies in younger populations. The completion of this Phase 1 trial positions Shire (now part of Takeda) to further explore the therapeutic potential of SHP465, particularly in a demographic that has limited treatment options. Competitive implications include the need to monitor existing ADHD medications and emerging therapies targeting similar patient populations. Diligence should focus on the safety profile and potential market entry strategies, given the stringent regulatory environment for pediatric medications.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT03327402
Indication
Attention Deficit Hyperactivity Disorder (ADHD)
Modality
small molecule
Target
Dopamine and norepinephrine reuptake inhibition via d- and l-amphetamine enantiomers.
Intervention
SHP465
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.