DYANAVEL XR

Peak

amphetamine

NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Oct 2015
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
Sep 7, 2036
127 months away
Patent Expiry
Sep 7, 2036

Patent Records (5)

Patent #ExpiryTypeUse Code
8597684
Mar 15, 2027
Product
8883217
Mar 15, 2027
Product
9675703
Mar 15, 2027
Product
10086087
Mar 15, 2027
Product
8747902
Mar 15, 2027
Product