Lodonal (naltrexone low dose oral) / Biostax Corp, Statera BioPharma - LARVOL DELTA

Extemporaneous Preparation and Effectiveness of Low-Dose Naltrexone for the Treatment of Uremic Pruritus: A Literature Review and Case Report. (PubMed, Pharmacy (Basel)) - "Low-dose naltrexone provided symptomatic improvement in individuals with severe uremic pruritus when difelikefalin was inaccessible. While limited to a single case, this report highlights the potential role of naltrexone and underscores the need for further research to establish its safety and efficacy."

Journal • Chronic Kidney Disease • Dermatology • Nephrology • Pain • Pruritus • Renal Disease

Utilizing Low Dose Naltrexone to Treat Abdominal Pain in a Patient with Sclerosing Mesenteritis: A Case Report (ASRA-FALL 2025) - "Low-dose naltrexone (LDN), an emerging treatment with immunomodulatory and analgesic properties, has shown promise in inflammatory conditions. We present a case in which LDN monotherapy significantly improved pain and symptoms in a patient with SM."

Case report • Clinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain

Low Dose Naltrexone Versus Gabapentinoid Standard of Care Treatment for Fibromyalgia: A Retrospective Cohort Study (ASRA-FALL 2025) - "• There was a significant decrease in LDN VAS pain scores when compared to gabapentinoid VAS pain scores. • The median pain reduction was LDN = –1.83 versus gabapentinoid = 0 (p= 0.03). • Fewer LDN patients (10%) reported side effects compared to gabapentinoid patients (70%) (p= 0.02)."

Retrospective data • CNS Disorders • Fibromyalgia • Inflammation • Musculoskeletal Pain • Pain • Rheumatology

Using Low Dose Naltrexone, Buprenorphine, and Naloxone in Chronic Pain Management (ASRA-FALL 2025) - No abstract available

Pain

Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Arkansas

New P2 trial • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Longitudinal Patient-Reported Outcome Trajectories in Long COVID: Findings From the STOP-PASC Clinical Trial. (PubMed, Open Forum Infect Dis) - "The STOP-PASC randomized, placebo-controlled trial of nirmatrelvir/ritonavir (NMV/r) in adults with Long COVID showed no overall treatment effect...Worsening groups had higher proportions of NMV/r-treated participants and greater prevalence of cardiovascular symptoms and low-dose naltrexone use...NMV/r showed no clear benefit across subgroups. These findings emphasize the need for validated, Long COVID-specific PRO instruments and targeted therapeutic trials tailored to Long COVID subtypes."

Clinical • Journal • Cardiovascular • Fatigue • Infectious Disease • Novel Coronavirus Disease

QSIT: Quantum-Synaptic Immunotherapy Mapping Using Low-Frequency Electromagnetic Resonance and Machine Learning-Based Cytokine Forecasting (clinicaltrials.gov) - P1/2 | N=120 | Enrolling by invitation | Sponsor: Truway Health, Inc.

New P1/2 trial • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Efficacy And Safety of Low-dose Naltrexone In Fibromyalgia: An Updated Systematic Review And Meta-Analysis of Randomized Controlled Trials (RCTs) (ACR Convergence 2025) - "The findings of our analysis indicate that LDN may effectively reduce pain symptoms in patient with fibromyalgia while maintaining the favorable safety profile."

Retrospective data • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Perioperative Management of the Patient on Low Dose Naltrexone (LDN) (ASA 2025) - "There is no abstract associated with this presentation."

Clinical • Addiction (Opioid and Alcohol) • Anesthesia • Pain

Low-dose naltrexone for treatment of dermatologic conditions: a clinical review. (PubMed, J Am Acad Dermatol) - "LDN is commonly compounded by a pharmacy which may pose barriers to access. In this clinical review, we describe updated and practical uses of LDN in inflammatory dermatologic conditions, associated side effects, cost barriers, and comparisons to standard naltrexone doses."

IO biomarker • Journal • Review • Dermatology • Dermatomyositis • Dermatopathology • Genetic Disorders • Hidradenitis Suppurativa • Immunology • Lichen Planus • Myositis • Pruritus • Psoriasis • TLR4

Authors' response to comments on "Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis". (PubMed, Korean J Pain) - No abstract available

Journal • Retrospective data • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Comments on "Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis". (PubMed, Korean J Pain) - No abstract available

Journal • Retrospective data • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

The efficacy and safety of low-dose naltrexone in the treatment of lichen planopilaris and frontal fibrosing alopecia: A systematic review. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Alopecia • Fibrosis • Immunology • Lichen Planus

Co-administration of low-dose-Naltrexone and Carbamazepine remarkedly ameliorate allodynia and cognitive deficit in a rat model of trigeminal neuralgia. (PubMed, Sci Rep) - "The TN group exhibited a lower TAC level compared to the sham group, and TAC levels were improved in the TN (CBZ 100 + LDN) and TN (LDN) groups. The data indicate that combining CBZ with LDN effectively reduces mechanical allodynia in TN rats, while LDN may also improve anxiety, depression, and cognitive impairment caused by chronic TN pain."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Neuralgia • Pain • Psychiatry

Extended-release cannabinoid nanoparticles for chronic pain, anxiety, addiction, and CNS disorders (ACS-Fall 2025) - "Progress has been made on several fronts on the use of cannabinoids for medical use such as Charlotte's Web (CW) being used for childhood epilepsy through development by patient advocacy groups, and as a FDA-approved drug, Epidiolex® (Jazz Pharmaceuticals/GW Pharma) for a rare form of childhood epilepsy, Dravet syndrome. Sativex® (Jazz Pharmaceuticals/GW Pharma), a drug containing equal proportions of D9-THC and CBD, is approved as a second-line treatment for Multiple Sclerosis (MS) associated spasticity in over 24 other countries outside of the US...We are progressing an extended release combination product of CBD and low dose Naltrexone in biodegradable polymer nanoparticles through rigorous Phase 2 clinical trials. With a total addressable target market of $93 billion for pain, addiction, anxiety and other CNS-related indications, our innovations are positioned to make a transformative impact in cannabinoid-based medicine."

Addiction (Opioid and Alcohol) • Cachexia • CNS Disorders • Epilepsy • Glaucoma • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Movement Disorders • Multiple Sclerosis • Muscle Spasticity • Ophthalmology • Pain • Psychiatry

Low Dose Naltrexone for Refractory Cancer Pain: Case Series of Initial Safety and Effectiveness. (PubMed, J Pain Symptom Manage) - "Early follow-up indicates potential benefits for patients with refractory cancer pain with LDN being well-tolerated, with a low incidence of adverse events."

Journal • Breast Cancer • CNS Disorders • Insomnia • Oncology • Pain • Sleep Disorder • Solid Tumor

Low Dose Naltrexone for Pain in Patients With HIV (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Emory University | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Neuralgia • Pain

LoDoNaVasc: Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting

Enrollment closed • Eosinophilic Granulomatosis With Polyangiitis • Giant Cell Arteritis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

Managing Burning Mouth Syndrome: Current and Future Directions. (PubMed, Drugs) - "Current management strategies range from addressing underlying systemic or local factors to utilizing established systemic or topical pharmacologic options (such as benzodiazepines, capsaicin, anticonvulsants, antidepressants), new off-label treatments (including low-dose naltrexone), supplements (such as alpha lipoic acid and phytotherapeutics), alongside non-pharmacological approaches aimed at addressing pain symptoms and enhancing pain-coping skills (such as nerve blocks, cognitive behavioral therapy, and transcranial magnetic stimulation). This review synthesizes the current evidence supporting both established and newly investigated therapies and discusses future research directions to improve outcomes for individuals affected by this chronic pain condition. Ultimately, the best management approach should be based on the most robust evidence-based findings, tailored to the underlying etiopathogenetic mechanisms, and individualized to address patient contributing..."

Journal • Review • Pain

Low-dose naltrexone as an adjunctive treatment in major depressive disorder. (ANZCTR) - P4 | N=72 | Terminated | Sponsor: University of Auckland | Recruiting ➔ Terminated

Trial termination • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • CRP • CXCL8

Low-Dose Naltrexone for Managing Pain and Autonomic Symptoms in Patients With Dysautonomia. (PubMed, Cureus) - "Future studies are needed to understand how LDN can impact autonomic symptoms on an individual level. With further investigation, we might discover predictors of a strong therapeutic effect from LDN in patients with dysautonomia."

Journal • Cardiovascular • CNS Disorders • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology • TLR4

Prevalence and treatment response of neuropsychiatric disorders in mast cell activation syndrome. (PubMed, Brain Behav Immun Health) - "Many of the disorders with increased prevalences were statistically greater compared to corresponding controls.In self-reported ratings for effects on health status (0 = no benefit, 10 = maximum benefit), mean (SD) response was 6.3 (2.5) for antihistamines, 5.6 (3.2) for low-dose naltrexone, and 5.6 (3.1) for benzodiazepines. MCAS subjects have significantly elevated odds ratios for many neuropsychiatric disorders and may see improvement of symptoms using MCAS-targeted therapies, suggesting that mast cell dysregulation affects the brain and peripheral nervous systems and contributes to neuropsychiatric symptoms. Certain mast cell mediators, specific genetic predisposition, and life experiences could determine which disorder is apt to develop or worsen."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Epilepsy • Fatigue • Immunology • Insomnia • Mental Retardation • Migraine • Mood Disorders • Movement Disorders • Musculoskeletal Pain • Obsessive-Compulsive Disorder • Otorhinolaryngology • Pain • Post-traumatic Stress Disorder • Psychiatry • Restless Legs Syndrome • Schizophrenia • Sleep Disorder • Suicidal Ideation • Tourette Syndrome

The analgesic effect of very low-dose naltrexone (VLDN) was not enhanced by repetitive transcranial magnetic stimulation (rTMS) in rats with temporomandibular joint arthritis. (PubMed, Odontology) - "VLDN might be useful as an adjunctive pharmacological therapy for relieving hypernociception resulting from inflammatory facial pain. Further investigations may contribute to the understanding of the action mechanisms of naltrexone."

Journal • Preclinical • Immunology • Musculoskeletal Diseases • Pain • Rheumatology • BDNF • IL4 • TNFA

Use of low-dose naltrexone in the management of post-traumatic trigeminal neuropathic pain: a retrospective case series. (PubMed, Quintessence Int) - "Based on our retrospective extended case series, LDN appears to be a safe and effective medication for use in chronic PTTNP. These results, highlight the need for future studies to elucidate LDN's analgesic mechanism of actions and to decisively demonstrate the analgesic effect of LDN in larger cohorts using randomized, double blinded, placebo controlled clinical studies."

Journal • Retrospective data • CNS Disorders • Epilepsy • Musculoskeletal Diseases • Neuralgia • Pain

Low Dose Naltrexone In The Management Of Chronic Pain Syndrome: A Meta-Analysis Of Randomized Controlled Clinical Trials. (PubMed, Curr Pain Headache Rep) - "LDN is better than placebo in fibromyalgia pain management, and LDN is similar to active controls in chronic pain management."

Clinical • Journal • Retrospective data • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology