Dashboard PDUFA PDUFA History Dilution Watch Downside Radar Missed Milestones Earnings Big Movers Blog

🎤 Upcoming Biotech Conferences

Loading conferences...
Free to browse, no account needed Follow the companies behind these drugs with free AI briefings, catalyst countdowns and dilution alerts.
Start 7-day free trial → Log in

Amphetamine · Dyanavel Xr, Dyanavel Xr 20

Small molecule · developed by Tris Pharma

Approved FDA, Nov 2021
1 Registered trials

What is Amphetamine?

The exact mechanism of therapeutic action in ADHD is not known. ADZENYS XR-ODT is an extended-release orally disintegrating tablet formulation.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Dyanavel Xr, Dyanavel Xr 20, ADZENYS XR-ODT
Drug type
Small molecule
Therapy area
Psychiatry
Developer
Tris Pharma Inc
In trials of
AYTU
FDA status
Approved as Dyanavel Xr, Dyanavel Xr 20 (November 4, 2021), NDA210526 · FDA label

✅ FDA-approved uses

From the indications section of the FDA label (version of Feb 24, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07169162 Phase 4 Attention Deficit Hyperactivity Disorder Withdrawn AYTU

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Attention Deficit Hyperactivity Disorder

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.