NDAORALTABLET, EXTENDED RELEASE
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
DYANAVEL XR 20 (amphetamine) by Teva is non-catecholamine sympathomimetic amines with cns stimulant activity. Approved for attention-deficit/hyperactivity disorder. First approved in 2021.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYANAVEL XR 20 is an extended-release oral amphetamine tablet approved for Attention-Deficit/Hyperactivity Disorder (ADHD). It is a CNS stimulant that works through non-catecholamine sympathomimetic mechanisms, though the exact therapeutic mode of action in ADHD remains unknown. The drug is formulated as an extended-release tablet to provide sustained symptom control throughout the day.
Peak13.8 years to LOE
DYANAVEL XR 20 is in peak commercial phase with modest spending ($483K for the base XR formulation) and faces intense competition in a crowded ADHD market; team size and investment likely focused on defending share against higher-spending competitors.
Mechanism of Action
non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
Pharmacologic Class:
Central Nervous System Stimulant
Indications (1)
Clinical Trials (20)
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
Methamphetamine Use Disorder Support in Heart Failure Pilot Study
Started Nov 2025
50 enrolled
Heart FailureMethamphetamine Use Disorder
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
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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.