Naltrexone hydrochloride

Phase 3Small molecule

EEnsysce Biosciences

Naltrexone hydrochloride is one of 141 small molecule programs targeting Corneal Ulcer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

140

Competitors

Pipeline

Status by Indication[3][1]

Indication

Corneal UlcerActive, not recruiting

Eating DisorderActive, not recruiting

VasculitisActive, not recruiting

ObesityNot yet recruiting

Smoking CessationActive, not recruiting

Corneal UlcerPreclinical

Active, not recruiting

Eating DisorderPhase 2/Phase 3

Active, not recruiting

VasculitisPhase 2

Active, not recruiting

ObesityPhase 1

Not yet recruiting

Smoking CessationPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

392 competitors in Obesity

#DrugCompanyPhaseTrials

Naltrexone hydrochloride

EEnsysce Biosciences

Phase 3

2 2

Actemra

Roche

Preclinical

2 3

Colcrys

Alnylam Pharmaceuticals

Amidate

Calciferol

Alnylam Pharmaceuticals

Adenocard

Activella

Cetrotide

2 9

Oxycontin

PProtega

Preclinical

1 10

Advil

KKenvue Brands

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Effectiveness

NCT05955313

Q3 2027

Phase 1Recruiting

Opioids

NCT05007561

Q4 2027

Phase 1Not yet recruiting

Obesity

NCT07224087

Q2 2031

PreclinicalNot yet recruiting

Obesity

NCT07398404

Clinical

Trials by Indication[1]

Obesity2 trials

A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Not yet recruiting·YYale University·Preclinical·NCT07398404·64 enrolled

Development of a Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Not yet recruiting·YYale University·Phase 1·NCT07224087·20 enrolled

Tics1 trial

Pharmacokinetics of SP-104

Completed·SScilex Pharmaceuticals, Inc.·Phase 1·NCT05002946·18 enrolled

Smokers1 trial

Naltrexone and Patch for Smokers

Completed·UUS Department of Veterans Affairs·N/A·NCT00018213

Effectiveness1 trial

Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia

Recruiting·MMedical University of Lublin·Phase 2·NCT05955313·300 enrolled

Vasculitis1 trial

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

Completed·UUniversity of Pennsylvania·Phase 2·NCT03482479·60 enrolled

10 more indications

Alcohol1 trial

Optimizing Pharmacotherapy for Bipolar Alcoholics

Completed·UUniversity of Miami·Phase 1/2·NCT00302133·88 enrolled

Eating Disorder1 trial

Oral Naltrexone In Pediatric Eating Disorders

Terminated·RRosemary Claire Roden·Phase 2/3·NCT05073679·9 enrolled

Methamphetamine1 trial

Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM

Completed·GGlenn-Milo Santos·Phase 2·NCT04791969·60 enrolled

Oral1 trial

Evaluation of Oral PF614 Relative to OxyContin (PF614-102)

Completed·EEnsysce Biosciences·Phase 1·NCT05043766·84 enrolled

MPA1 trial

Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)

Completed·EEnsysce Biosciences·Phase 1·NCT02454712·64 enrolled

Injury1 trial

Self-Injury: Diagnosis and Treatment

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00065936·37 enrolled

Oxycodone1 trial

Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)

Completed·EEnsysce Biosciences·Phase 1·NCT05090280·111 enrolled

Opioids1 trial

Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences

Recruiting·—·Phase 1·NCT05007561·210 enrolled

Tolerance1 trial

The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations

Completed·TTimothy Smith·Phase 1·NCT03879460·15 enrolled

Corneal Ulcer1 trial

The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer

Completed·MMinia University·N/A·NCT05924893·50 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Naltrexone hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naltrexone hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naltrexone hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Ensysce Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: EEnsysce Biosciences

Naltrexone hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q2 2031

Trials by Indication[1]

Obesity2 trials

Tics1 trial

Smokers1 trial

Effectiveness1 trial

Vasculitis1 trial

Alcohol1 trial

Eating Disorder1 trial

Methamphetamine1 trial

Oral1 trial

MPA1 trial

Injury1 trial

Oxycodone1 trial

Opioids1 trial

Tolerance1 trial

Corneal Ulcer1 trial

References

Drug Info

Quick Facts

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