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  1. pharmadog
  2. ›drugs
  3. ›Vivitrol
drug · small molecule
save

naltrexone ER

Marketedupdated 5mo ago
by $AARD Aardvark Therapeutics, Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • drugVIVITROL113 co-mentions · 29 sources
  • tagApproval112 co-mentions · 28 sources
  • drugnaltrexone LA57 co-mentions · 29 sources
  • drugnaltrexone57 co-mentions · 29 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 47 investigational indications.

targets

Opioid receptors; mu/kappa/delta

all catalysts(28)

approval · 28
Apr 13, 2006
approval
$ALKS41.75+2.98%
20y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Oct 26, 2007
approval
$ALKS41.75+2.98%
19y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Mar 22, 2010
approval
$ALKS41.75+2.98%
17y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Mar 22, 2010
approval
$ALKS41.75+2.98%
17y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Aug 18, 2010
approval
$ALKS41.75+2.98%
16y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Oct 12, 2010
approval
$ALKS41.75+2.98%
16y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Mar 28, 2013
approval
$ALKS41.75+2.98%
14y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Jul 29, 2013
approval
$ALKS41.75+2.98%
13y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Jul 29, 2013
approval
$ALKS41.75+2.98%
13y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Jan 7, 2014
approval
$ALKS41.75+2.98%
13y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Feb 9, 2014
approval
$ALKS41.75+2.98%
13y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Apr 17, 2014
approval
$ALKS41.75+2.98%
12y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Aug 29, 2014
approval
$ALKS41.75+2.98%
12y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Jan 26, 2015
approval
$ALKS41.75+2.98%
12y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Dec 8, 2015
approval
$ALKS41.75+2.98%
11y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Jan 19, 2016
approval
$ALKS41.75+2.98%
11y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
May 19, 2016
approval
$ALKS41.75+2.98%
10y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
May 20, 2016
approval
$ALKS41.75+2.98%
10y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Dec 9, 2016
approval
$ALKS41.75+2.98%
10y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Dec 12, 2016
approval
$ALKS41.75+2.98%
10y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Dec 28, 2018
approval
$ALKS41.75+2.98%
8y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Jun 7, 2019
approval
$ALKS41.75+2.98%
7y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Sep 6, 2019
approval
$ALKS41.75+2.98%
7y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
May 8, 2020
approval
$ALKS41.75+2.98%
6y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Mar 4, 2021
approval
$ALKS41.75+2.98%
6y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
May 6, 2021
approval
$ALKS41.75+2.98%
5y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Sep 30, 2022
approval
$ALKS41.75+2.98%
4y ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
Dec 22, 2025
approval
$ALKS41.75+2.98%
10mo ago
VIVITROL (NALTREXONE) — FDA approval
naltrexone ER
→
view all 28 catalysts →

Trials studying naltrexone ER

  • phase2Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Personsnot yet recruitingn=250
  • phase4A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)completedn=226
  • phase4Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)active not recruitingn=8,600
  • phase3Combination Gerotherapeutic Interventions for Healthspan Improvementactive not recruitingn=30
  • phase3Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disordernot yet recruitingn=240
  • phase1iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteersnot yet recruitingn=33
  • phase4A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in Americacompletedn=500
  • phase2Phase II Clinical Study on the Efficacy and Safety of Naltrexone Implant in Patients With Alcohol Use Disordercompletedn=210

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 15, 2029
~3.0 years out

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

patents (1)

  • Oct 15, 2029method-of-use (U-1123)US 79194993.0y

News(4)

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    biospace · 2mo ago
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    stat · 2mo ago
  • Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda
    Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.
    biopharma_dive · 3mo ago
  • Are Republicans turning against medications for treating opioid addiction?
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    stat · 3mo ago
brand
Vivitrol
trade names
Celupan, Trexal, Vivitrol
generic
naltrexone
MOA
Opioid receptors; mu/kappa/delta antagonist
indication
Autism Spectrum Disorder (ASD)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 13m ago
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