XR-NTX

Phase 3Small molecule

NNYU Langone Health

XR-NTX is one of 13 small molecule programs targeting Opioid Use Disorder (OUD). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Opioid Use Disorder (OUD)Active, not recruiting

Methamphetamine DependenceActive, not recruiting

Opioid Use Disorder (OUD)Phase 2

Active, not recruiting

Methamphetamine DependencePhase 3

Active, not recruiting

Competition

Competitive Landscape

11 competitors in Methamphetamine Dependence

#DrugCompanyPhaseTrials

Provigil

NNuvo Research GmbH

Approved

9 2

Minipress

Abilify

3 4

Campral

Suboxone

Acetadote

AArbor Pharmaceuticals, Inc.

Risperdal

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Prometrium

XR-NTX

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Opioid Use Disorder (OUD)

NCT04464980

Q2 2027

Phase 3Active, not recruiting

Methamphetamine Dependence

NCT06233799

Q3 2028

Post-ApprovalRecruiting

Study completion

NCT05028062

Clinical

Trials by Indication[1]

Buprenorphine2 trials

Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

Completed·NNYU Langone Health·Phase 4·NCT04219540·675 enrolled

Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Active, not recruiting·FFriends Research Institute, Inc.·Phase 2/3·NCT04408313·240 enrolled

Treatment1 trial

Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care

Completed·NNYU Langone Health·Phase 4·NCT01893827·237 enrolled

Opioid Use Disorder1 trial

Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)

Completed·UUniversity of California, Los Angeles·Phase 3·NCT02110264·151 enrolled

Opioid Use Disorder (OUD)1 trial

NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Active, not recruiting·NNYU Langone Health·Phase 2·NCT04464980·1,516 enrolled

Methamphetamine Dependence1 trial

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

Active, not recruiting·NNational Institute on Drug Abuse (NIDA)·Phase 3·NCT06233799·360 enrolled

1 more indication

Unspecified3 trials

Naltrexone in AUD Reward Drinkers

Recruiting·UUniversity of Pennsylvania·Phase 4·NCT05028062·60 enrolled

Harm Reduction With Pharmacotherapy (HaRP)

Completed·UUniversity of Washington·Phase 2·NCT01932801·308 enrolled

Long-acting Naltrexone for Pre-release Prisoners

Completed·FFriends Research Institute, Inc.·Phase 3·NCT02867124·240 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for XR-NTX. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — XR-NTX compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for XR-NTX. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — NYU Langone Health company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNYU Langone Health

XR-NTX

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2028

Trials by Indication[1]

Buprenorphine2 trials

Treatment1 trial

Opioid Use Disorder1 trial

Opioid Use Disorder (OUD)1 trial

Methamphetamine Dependence1 trial

Unspecified3 trials

References

Drug Info

Quick Facts

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