DYANAVEL XR 15

Peak

amphetamine

NDAORALTABLET, EXTENDED RELEASE
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9

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

Clinical Trials (5)

NCT06721494Phase 2Recruiting

A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine

Started Feb 2026
NCT04132557N/ACompleted

A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine

Started Oct 2019
430,000 enrolled
Attention Deficit Disorder With Hyperactivity
NCT05611385N/ACompleted

Amphetamine Induced Adult Respiratory Distress Syndrome

Started Jan 2019
49 enrolled
BurnsAcute Lung InjuryAcute Respiratory Distress Syndrome+1 more
NCT02959892Phase 1Completed

A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS)

Started Dec 2016
12 enrolled
Healthy Volunteers
NCT01449565Phase 2Completed

Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)

Started Sep 2012
100 enrolled
Amphetamine-Related Disorders

Loss of Exclusivity

LOE Date
Feb 11, 2040
169 months away
Patent Expiry
Feb 11, 2040

Patent Records (5)

Patent #ExpiryTypeUse Code
8337890
Mar 15, 2027
Product
8747902
Mar 15, 2027
Product
9675704
Mar 15, 2027
Product
11590081
Sep 24, 2038
Product
U-3538
12458592
Feb 11, 2040
U-3538