Vivitrol

(Naltrexone hydrochloride)

Phase 2Small molecule

Teva

Vivitrol is one of 83 small molecule programs targeting Corneal Ulcer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Corneal UlcerActive, not recruiting

ObesityNot yet recruiting

EffectivenessRecruiting

Corneal UlcerPreclinical

Active, not recruiting

ObesityPhase 1

Not yet recruiting

EffectivenessPhase 2

Recruiting

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Synthroid

IInstitut Jerome Lejeune

Phase 3

1 2

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 3

Cagrisema

Novo Nordisk

Phase 3

5 4

Berobenatide

Pfizer

Phase 3

3 5

Eloralintide

Eli Lilly

Phase 3

10 6

Belantamab Mafodotin-Blmf

Novo Nordisk

Phase 3

1 7

Efsubaglutide Alfa

SShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Phase 3

1 8

Vivitrol

Teva

Phase 2

2 9

Semaglutide or Tirzepatide

NNational and Kapodistrian University of Athens

Phase 3

1 10

Avapro

Sanofi

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Effectiveness

NCT05955313

Q4 2027

Phase 1Not yet recruiting

Obesity

NCT07224087

Q2 2031

PreclinicalNot yet recruiting

Obesity

NCT07398404

Clinical

Trials by Indication[1]

Obesity2 trials

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

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

Oxycodone1 trial

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

Completed·EEnsysce Biosciences·Phase 1·NCT05090280·111 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

10 more indications

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

Alcohol1 trial

Optimizing Pharmacotherapy for Bipolar Alcoholics

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

Effectiveness1 trial

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

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

Smokers1 trial

Naltrexone and Patch for Smokers

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

Vasculitis1 trial

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

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

Eating Disorder1 trial

Oral Naltrexone In Pediatric Eating Disorders

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

Tics1 trial

Pharmacokinetics of SP-104

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

Naltrexone1 trial

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

Completed·SSan Diego State University·Phase 1·NCT05007561·217 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 20, 1984

REVIA

NDA NDA018932

Apr 13, 2006

VIVITROL

NDA NDA021897

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]
OpenFDA — FDA approval records (NDA NDA021897). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Teva

Vivitrol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2031

Trials by Indication[1]

Obesity2 trials

Oxycodone1 trial

Methamphetamine1 trial

Oral1 trial

MPA1 trial

Injury1 trial

Alcohol1 trial

Effectiveness1 trial

Smokers1 trial

Vasculitis1 trial

Eating Disorder1 trial

Tolerance1 trial

Tics1 trial

Corneal Ulcer1 trial

Naltrexone1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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