NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Sep 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
ADZENYS ER (amphetamine) by Therapeutic Solutions International is non-catecholamine sympathomimetic amines with cns stimulant activity. First approved in 2017.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADZENYS ER is an extended-release oral suspension of amphetamine, a CNS stimulant approved in 2017 for ADHD treatment. It works by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their availability in the extraneuronal space. The suspension formulation enables flexible dosing and is designed for patients who benefit from liquid delivery.
Peak6.0 years to LOE
Product is in peak commercial phase with established market presence; team size and growth trajectory depend on competitive positioning within crowded ADHD stimulant market.
Mechanism of Action
non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Methamphetamine Use Disorder Support in Heart Failure Pilot Study
Started May 2026
50 enrolled
Heart FailureMethamphetamine Use Disorder
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Started Feb 2026
40 enrolled
Methamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse
Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)
Started Feb 2026
35 enrolled
Methamphetamine Abuse
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
Started Sep 2024
20 enrolled
Methamphetamine Use Disorder
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Started Aug 2024
200 enrolled
Methamphetamine UseHeart Failure
Worked on ADZENYS ER at Therapeutic Solutions International? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.