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  1. pharmadog
  2. ›drugs
  3. ›DYANAVEL XR 20
drug · small molecule
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DYANAVEL XR 20

Marketedupdated 3mo ago
by $TRAW Traws Pharma, Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 8
  • drugDYANAVEL XR252 co-mentions · 84 sources
  • drugamfetamine ER-ODT206 co-mentions · 84 sources
  • tagApproval186 co-mentions · 70 sources
  • drugdextroamphetamine98 co-mentions · 14 sources
  • drugdextroamphetamine ER98 co-mentions · 14 sources
  • tagSmall Molecule93 co-mentions · 70 sources
  • drugamfetamine72 co-mentions · 37 sources
  • drugAMPHETAMINE SULFATE72 co-mentions · 37 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for attention deficit hyperactivity disorder and 3 investigational indications.

targets

Sodium-dependent dopamine transporterSodium-dependent noradrenaline transporter

all catalysts(6)

approval · 6
Nov 4, 2021
approval
$TRAW
5y ago
DYANAVEL XR 20 (AMPHETAMINE) — FDA approval
DYANAVEL XR 20
→
Feb 25, 2022
approval
$TRAW
4y ago
DYANAVEL XR 20 (AMPHETAMINE) — FDA approval
DYANAVEL XR 20
→
Jun 1, 2022
approval
$TRAW
4y ago
DYANAVEL XR 20 (AMPHETAMINE) — FDA approval
DYANAVEL XR 20
→
Oct 14, 2022
approval
$TRAW
4y ago
DYANAVEL XR 20 (AMPHETAMINE) — FDA approval
DYANAVEL XR 20
→
Oct 13, 2023
approval
$TRAW
3y ago
DYANAVEL XR 20 (AMPHETAMINE) — FDA approval
DYANAVEL XR 20
→
Sep 23, 2025
approval
$TRAW
11mo ago
DYANAVEL XR 20 (AMPHETAMINE) — FDA approval
DYANAVEL XR 20
→

Trials studying DYANAVEL XR 20

  • phase4EEG Biomarkers for ADHD Stimulant Treatmentnot yet recruitingn=220
  • phase3MDMA-assisted Massed Prolonged Exposure for PTSDrecruitingn=20
  • phase1A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Userscompletedn=80
  • phase2A Phase 2A Trial of DT402 for Autism Spectrum Disorderrecruitingn=20
  • phase2A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetaminerecruitingn=40
  • phase3MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSDcompletedn=16
  • —A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetaminecompletedn=430,000
  • phase1A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Participantscompletedn=76
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 15, 2027
216 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (5)

  • Feb 11, 2040method-of-use (U-3538)US 12458592
  • Sep 24, 2038formulationUS 11590081
  • Mar 15, 2027formulationUS 8337890216d
  • Mar 15, 2027formulationUS 8747902216d
  • Mar 15, 2027formulationUS 9675704216d

News(0)

no news has mentioned this drug yet

brand
DYANAVEL XR 20
trade names
Adzenys er, Adzenys xr-odt, Dyanavel xr, Mydayis (mixed salts of a single entity)
generic
AMPHETAMINE
MOA
Dopamine transporter releasing agent; Norepinephrine transporter releasing agent
indication
attention deficit hyperactivity disorder
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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