Low-Dose Naltrexone

ApprovedSmall molecule

SStanford University

Low-Dose Naltrexone is one of 138 small molecule programs targeting Fatigue. It is currently in Approved.

Indications

Total Trials

Active Trials

137

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pervasive Developmental DisorderActive, not recruiting

Complex Regional Pain SyndromeActive, not recruiting

Interstitial CystitisActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

FibromyalgiaActive, not recruiting

Lichen PlanopilarisActive, not recruiting

Pervasive Developmental DisorderPhase 1/Phase 2

Active, not recruiting

Complex Regional Pain SyndromeApproved

Active, not recruiting

Interstitial CystitisApproved

Active, not recruiting

Inflammatory Bowel DiseasePhase 2

Active, not recruiting

FibromyalgiaPreclinical

Active, not recruiting

Lichen PlanopilarisPhase 2

Active, not recruiting

Competition

Competitive Landscape

152 competitors in Fibromyalgia

#DrugCompanyPhaseTrials

Low-Dose Naltrexone

SStanford University

Approved

5 2

Xyrem

Jazz Pharmaceuticals

Phase 3

1 3

Epidiolex

Jazz Pharmaceuticals

Phase 3

1 4

Namenda

AbbVie

Phase 3

1 5

Lexapro

AbbVie

Phase 3

1 6

Neurontin

VViatris Specialty LLC

Phase 3

3 7

Prozac

VVitae Pharmaceuticals Inc., an Allergan affiliate

Phase 3

1 8

DS-5565

Daiichi Sankyo

Phase 3

4 9

Ultram

WWim Janssens

Phase 3

1 10

Genotropin

EMD Serono

Phase 3

—

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Trial

NCT06366724

Post-ApprovalRecruiting

Pain

NCT05537935

Q2 2028

Phase 2Not yet recruiting

ME/CFS

NCT07285473

Q4 2028

Post-ApprovalNot yet recruiting

Study completion

NCT05363514

Clinical

Trials by Indication[1]

Fibromyalgia5 trials

Cost-utility and Physiological Effects of LDN in Patients With Fibromyalgia

Active, not recruiting·FFundació Sant Joan de Déu·Phase 4·NCT04739995·99 enrolled

Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism?

Completed·RRigshospitalet, Denmark·Phase 4·NCT02806440·58 enrolled

Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

Withdrawn·SStanford University·N/A·NCT00855972

Show 2 more trials

LDN and tDCS in Fibromyalgia

Completed·CCentro Universitario La Salle·Phase 2/3·NCT04502251·92 enrolled

Effects of Low Dose Naltrexone in Fibromyalgia

Completed·SStanford University·N/A·NCT00568555·53 enrolled

Alcohol2 trials

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

Completed·—·Phase 2·NCT04052139·45 enrolled

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

Completed·—·Phase 1/2·NCT03278886·11 enrolled

Pervasive Developmental Disorder1 trial

Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)

Unknown status·HHadassah Medical Organization·Phase 1/2·NCT00318162·50 enrolled

Aging1 trial

The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging

Withdrawn·AAgelessRx··NCT05307627

Fatigue1 trial

Low-dose Naltrexone for Post-COVID Fatigue Syndrome

Completed·LLuis Nacul·Phase 2·NCT05430152·160 enrolled

10 more indications

Interstitial Cystitis1 trial

IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone

Terminated·EEndeavor Health·Phase 4·NCT04313972·3 enrolled

Pain1 trial

Low Dose Naltrexone for Pain in Patients With HIV

Recruiting·EEmory University·Phase 4·NCT05537935·60 enrolled

Immune1 trial

Low Dose Naltrexone (LDN) Immune Monitoring

Completed·UUniversity of Alabama at Birmingham·N/A·NCT02107014·9 enrolled

Inflammatory Bowel Disease1 trial

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Withdrawn·SSanta Barbara Cottage Hospital·Phase 2·NCT01810185

Complex Regional Pain Syndrome1 trial

Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome

Enrolling by invitation·HHospital for Special Surgery, New York·Phase 4·NCT06306157·40 enrolled

Lichen Planopilaris1 trial

Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia

Completed·WWashington University School of Medicine·Phase 2·NCT04409041·43 enrolled

Trial1 trial

LIFT: Life Improvement Trial

Recruiting·—·Phase 2·NCT06366724·160 enrolled

ME/CFS1 trial

Low-Dose Naltrexone For ME/CFS: Dose-Finding

Not yet recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT07285473·75 enrolled

Immunotherapy1 trial

Quantum-Synaptic Immunotherapy Mapping Using Low-Frequency Electromagnetic Resonance and Machine Learning-Based Cytokine Forecasting

Enrolling by invitation·TTruway Health, Inc.·Phase 1/2·NCT07221565·120 enrolled

Unspecified1 trial

Low Dose Naltrexone Use in Patients With POTS

Not yet recruiting·UUniversity of Calgary·Phase 4·NCT05363514·80 enrolled

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Low-Dose Naltrexone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Low-Dose Naltrexone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Low-Dose Naltrexone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Stanford University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SStanford University

Low-Dose Naltrexone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2028

Q4 2028

Trials by Indication[1]

Fibromyalgia5 trials

Alcohol2 trials

Pervasive Developmental Disorder1 trial

Aging1 trial

Fatigue1 trial

Interstitial Cystitis1 trial

Pain1 trial

Immune1 trial

Inflammatory Bowel Disease1 trial

Complex Regional Pain Syndrome1 trial

Lichen Planopilaris1 trial

Trial1 trial

ME/CFS1 trial

Immunotherapy1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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