Naltrexone Pill

Phase 3Small molecule

YYale University

Naltrexone Pill is one of 114 small molecule programs targeting Alcohol Use Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

113

Competitors

Pipeline

Status by Indication[3][1]

Indication

Alcohol Use DisorderUnknown status

HypoglycemiaActive, not recruiting

KetamineRecruiting

Bipolar DisorderRecruiting

Bariatric SurgeryRecruiting

Alcohol Use DisorderPhase 3

Unknown status

HypoglycemiaPreclinical

Active, not recruiting

KetaminePhase 2

Recruiting

Bipolar DisorderPhase 3

Recruiting

Bariatric SurgeryPhase 3

Recruiting

Competition

Competitive Landscape

89 competitors in Bipolar Disorder

#DrugCompanyPhaseTrials

Geodon

Pfizer

Approved

7 2

Abilify

Otsuka

Approved

20 3

Lithobid

SSolvay Pharmaceuticals

Approved

20 4

Namenda

AbbVie

Approved

4 5

Risperdal

WWim Janssens

Approved

14 6

Celexa

AbbVie

Approved

2 7

Lithobid

SSolvay Pharmaceuticals

Approved

10 8

Tegretol

Novartis

Approved

1 9

Zofran

Novartis

Approved

1 10

Ozempic

Novo Nordisk

Approved

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

Timeline

Expected Milestones

Q1 2028

Phase 2/3Recruiting

Bariatric Surgery

NCT05157698

Q4 2028

Phase 2Recruiting

Ketamine

NCT05940324

Q1 2029

Post-ApprovalRecruiting

Bipolar Disorder

NCT07213466

Phase 3Recruiting

Alcohol Use Disorder

NCT05827159

Clinical

Trials by Indication[1]

Alcohol Use Disorder2 trials

Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

Completed·—·Phase 2/3·NCT05093296·62 enrolled

Emergency Department-Initiated Medications for Alcohol Use Disorder

Recruiting·YYale University·Phase 3·NCT05827159·240 enrolled

Eating Disorder2 trials

Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders

Completed·YYale University·Phase 2/3·NCT03946111·3 enrolled

Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

Completed·YYale University·N/A·NCT02317744·22 enrolled

Loss-of-control Eating2 trials

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Maintenance Treatment (Stage 2a)

Completed·YYale University·Preclinical·NCT04605081·24 enrolled

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)

Completed·YYale University·Preclinical·NCT04599478·92 enrolled

Psoriasis1 trial

Efficacy of Low Dose Naltrexone in Psoriasis

Completed·JJinnah Postgraduate Medical Centre·Phase 1·NCT04250792·42 enrolled

Altitude1 trial

Effects of Naltrexone on Nocturnal Breathing Patterns at Altitude

Completed·VVA Loma Linda Health Care System·Phase 4·NCT05037032·16 enrolled

7 more indications

Hypoglycemia1 trial

Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Completed·YYale University·N/A·NCT01462227·17 enrolled

Bariatric Surgery1 trial

Pharmacological and Behavioral Treatment After Bariatric Surgery

Recruiting·YYale University·Phase 2/3·NCT05157698·160 enrolled

Alcohol Drinking1 trial

Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

Completed·YYale University·Phase 2·NCT01519063·75 enrolled

Bipolar Disorder1 trial

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Recruiting·MMayo Clinic·Phase 4·NCT07213466·100 enrolled

Fibromyalgia1 trial

Fibromyalgia and Naltrexone: The FINAL Study

Completed·OOdense University Hospital·Phase 2·NCT04270877·99 enrolled

Ketamine1 trial

Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)

Recruiting·SStanford University·Phase 2·NCT05940324·150 enrolled

Unspecified1 trial

Bridging ED to Outpatient AUD Therapy With Naltrexone

Unknown status·AAlbert Einstein Healthcare Network·Phase 4·NCT05228418·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Naltrexone Pill. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naltrexone Pill compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naltrexone Pill. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Yale University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: YYale University

Naltrexone Pill

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q4 2028

Q1 2029

Trials by Indication[1]

Alcohol Use Disorder2 trials

Eating Disorder2 trials

Loss-of-control Eating2 trials

Psoriasis1 trial

Altitude1 trial

Hypoglycemia1 trial

Bariatric Surgery1 trial

Alcohol Drinking1 trial

Bipolar Disorder1 trial

Fibromyalgia1 trial

Ketamine1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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