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

Efficacy and safety of low-dose naltrexone (LDN) in fibromyalgia: a systematic review and meta-analysis. (PubMed, Ann Med Surg (Lond)) - "No serious adverse effects were reported in treatment group. There is need for more RCTs to support the evidence."

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

NEUROPATHIC PRURITUS RELIEVED BY EPIDURAL STEROID INJECTION: A CASE REPORT (ASRA-SPRING 2025) - "The patient was initially treated by dermatology for presumed seborrheic keratoses or xerosis using topical steroids, moisturizers, and dupilumab, but these treatments were ineffective...Adjunct therapies, including gabapentin and low-dose naltrexone, provided sustained symptom relief with minimal side effects...Additionally, the integration of dermatological insights into diagnosis and treatment highlights the importance of interdisciplinary collaboration in achieving optimal outcomes. Further studies are warranted to explore this treatment modality in NP."

Case report • Clinical • Anesthesia • Dermatology • Inflammation • Pain • Pruritus • Sleep Disorder • Urology

Efficacy of Low-Dose Naltrexone in Treating Patients with Fibromyalgia: systematic Review and Meta-Analysis. (PubMed, J Pain Palliat Care Pharmacother) - "Although LDN marginally reduced pain and symptom severity from baseline, these effects were not superior to placebo. This suggests that LDN may not provide significant clinical benefit over placebo in fibromyalgia management, warranting further research."

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

Therapeutic Uses and Efficacy of Low-Dose Naltrexone: A Scoping Review. (PubMed, Cureus) - "The articles selected presented clinical examples of LDN efficacy for a variety of medical conditions. These articles also helped to illuminate the current gaps in research, pointing to the need for larger clinical trials and proper dosing studies."

Journal • Review • Fibromyalgia • Genetic Disorders • Inflammation • Musculoskeletal Pain • Pain • Rheumatology • Substance Abuse

LoDoNaVasc: Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Eosinophilic Granulomatosis With Polyangiitis • Giant Cell Arteritis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

Effect of Naltrexone on Spinal and Supraspinal Pain Mechanisms and Functional Capacity in Women with Fibromyalgia: Exploratory Outcomes from the Randomized Placebo-Controlled FINAL Trial. (PubMed, CNS Drugs) - "We found a significant between-group difference in CPM change in favor of LDN. However, this difference was partly explained by a decrease in CPM in the placebo group. Sensitivity analyses showed no association between changes in CPM and clinical pain improvement, suggesting that the group-difference in CPM is a random finding."

Journal • Fatigue • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Low Dose Naltrexone for Treatment of Severe Hemochromatosis Pain (IARS-SOCCA 2025) - "Pharmacologically, he has tried various combinations of multimodal pain regimen—including acetaminophen, oxycodone, gabapentin, pregabalin, cyclobenzaprine, baclofen, tizanidine, carisoprodol, dexamethasone, and amitriptyline—with minimal to no pain relief...His current pain regimen includes LDN at 6 mg twice daily, gabapentin 900 mg three times daily, and duloxetine 60 mg daily... We present a patient with severe pain from hemochromatosis and arachnoiditis that was refractory to numerous interventions and medical treatments. Remarkably, noticeable pain improvement was achieved only with initiation of low-dose naltrexone (LDN). This case is noteworthy as there is no documented use of LDN specifically for hemochromatosis-associated pain and in this case it has been the only effective therapy trialed."

Anesthesia • CNS Disorders • Crohn's disease • Fatigue • Gastroenterology • Genetic Disorders • Hematological Disorders • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Orthopedics • Pain • Rheumatology • Urinary Incontinence

Low-Dose Naltrexone Use in Pain Reduction for Dysautonomia Patients: A Case Series (AAN 2025) - "Through retrospective chart review it is seen that LDN therapy is largely tolerated and safe touse. Patients experienced minimal to no side effects, and based on this case study, LDNappeared to reduce the severity of pain in dysautonomia patients seen in our tertiary careautonomic center. Additional studies would be needed to show the effects of LDN in a largersample size to make results more generalizable."

Clinical • CNS Disorders • Fibromyalgia • Gastrointestinal Disorder • Insomnia • Migraine • Musculoskeletal Pain • Neuralgia • Pain • Rheumatology • Sleep Disorder

IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone (clinicaltrials.gov) - P4 | N=3 | Terminated | Sponsor: Endeavor Health | Completed ➔ Terminated; There was a delay in recruitment initiation due to COVID-19 and internal logistical challenges. Following this delay, the principal investigator left the study site, and it was determined that the study should be terminated.

Trial termination • Interstitial Cystitis • Musculoskeletal Pain • Pain

Unexpected Increase in Bone Mineral Density With Rapamycin and Low-Dose Naltrexone: A Case Report of a 52-Year-Old Woman With Osteopenia. (PubMed, Cureus) - "Osteopenia and osteoporosis are prevalent bone disorders characterized by reduced bone mineral density (BMD), leading to an increased risk of fractures. This case report presents a 52-year-old Caucasian female patient with osteopenia who experienced an unexpected 15.9% increase in lumbar spine BMD within two years after enrolling in a clinical trial involving low-dose rapamycin and subsequently starting low-dose naltrexone. This case potentially opens novel treatment strategies for bone density improvement in aging populations."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Current and Evolving Concepts in the Management of Complex Regional Pain Syndrome: A Narrative Review. (PubMed, Diagnostics (Basel)) - "Additionally, there is ongoing debate regarding the efficacy of other treatments, such as free radical scavengers, alpha-lipoic acid (ALA), dimethyl fumarate (DMF), adenosine monophosphate-activated protein kinase (AMPK) activators such as metformin, and phosphodiesterase-5 inhibitors such as tadalafil. The controversies surrounding the mechanisms, diagnosis, and treatment of CRPS have prompted researchers to investigate new approaches aimed at enhancing understanding and management of the condition, with the goal of alleviating symptoms and reducing associated disabilities."

IO biomarker • Journal • Review • Musculoskeletal Pain • Pain • TLR4

LIFT: Life Improvement Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Mar 2026 ➔ Sep 2026

Enrollment open • Trial completion date • Trial primary completion date

Low-Dose Naltrexone for Pediatric Chronic Pain and Inflammatory States: Perioperative Considerations. (PubMed, Paediatr Anaesth) - No abstract available

Journal • Pain • Pediatrics

Evaluation of Low-Dose Naltrexone for Chronic Pain Management. (PubMed, J Pain Palliat Care Pharmacother) - "Low-dose naltrexone was generally well-tolerated with 32% (13 of 41) of Veterans reporting adverse effects including vivid dreams, drowsiness, dizziness, and nausea. Low-dose naltrexone resulted in a small decrease in pain, although may be considered after a patient has failed multiple lines of therapy for additional pain control after a risk versus benefits discussion."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Fibromyalgia • Multiple Sclerosis • Musculoskeletal Pain • Pain • Rheumatology • Substance Abuse

Vulvar Lichen Sclerosus: A Literature Review with Consideration of Integrative Therapies. (PubMed, Integr Med (Encinitas)) - "Additionally, some VLS patients and practitioners report improvements with diet and lifestyle changes, nutritional supplements, low-dose naltrexone, botanical medicines, and other integrative treatments, although clinical research on these integrative therapies for VLS is generally lacking. This review aims to describe VLS in adult women, summarize the recently published literature, and provide a clinical overview that includes evidence-based integrative therapies."

Journal • Review • Dermatology • Gynecologic Cancers • Immunology • Oncology • Pain • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Vulvar Cancer

Low-dose Naltrexone for Post-COVID Fatigue Syndrome (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Luis Nacul | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Fatigue • Novel Coronavirus Disease • CRP • IFNG • IL6

Low-dose naltrexone as a treatment for vulvodynia: A case series. (PubMed, Case Rep Womens Health) - "All patients reported subjective improvement in their symptoms without side-effects. Additional research is needed on the efficacy of LDN for chronic pelvic pain conditions such as vulvodynia as well as the long-term safety profile of such use."

Journal • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Fibromyalgia: do I tackle you with pharmacological treatments? (PubMed, Pain Rep) - "Food and Drug Administration-approved medications for fibromyalgia treatment include serotonin and noradrenaline reuptake inhibitors, such as duloxetine, and pregabalin (an anticonvulsant), which target neurotransmitter modulation and central sensitization. Effect of analgesics, especially tramadol, on pain is weak, mainly on short term. Low-dose naltrexone and ketamine are gaining attention due their action on neuroinflammation and depression modulation, but treatment protocols have not been validated. Moreover, some treatments should be avoided due to the high risk of abuse and severe side effects, especially opioids, steroids, and hormonal replacement."

Journal • Review • CNS Disorders • Depression • Fatigue • Fibromyalgia • Inflammation • Musculoskeletal Pain • Pain • Psychiatry • Rheumatology • Sleep Disorder

Diagnostic Difficulties of Erosive Lichen Planus in a Pediatric Patient. (PubMed, Diagnostics (Basel)) - "He was later started on systemic therapy in the form of methotrexate and low-dose naltrexone to address his symptoms and disease presentation. This case highlights the complexities of diagnosis and management of ELP in pediatric patients. A multidisciplinary approach and regular follow-up are necessary to manage symptoms, prevent complications, and improve quality of life."

Journal • Dermatology • Dermatopathology • Gastrointestinal Disorder • Inflammation • Lichen Planus • Pain • Pediatrics

Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Medical College of Wisconsin

New P2 trial • Central Neuropathic Pain • CNS Disorders • Neuralgia • Orthopedics • Pain

An Update on the Off-Label Uses of Low-Dose Naltrexone in Dermatology. (PubMed, J Drugs Dermatol) - No abstract available

Journal • Dermatology

Low Dose Naltrexone Use for Pain Management in the Inpatient Setting (ASHP 2024) - "Learning Objectives: Describe the role of low dose naltrexone for pain management in the inpatient setting."

Clinical • Pain

Effects of LowDose Naltrexone on Inflammatory Markers and Concomitant Steroid and Analgesic Use in Rheumatoid Arthritis Patients (ASHP 2024) - No abstract available

Clinical • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

Clinical Efficacy and Safety of LowDose Naltrexone LDN in Fibromyalgia A Scoping Review (ASHP 2024) - No abstract available

Clinical • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Review of LowDose Naltrexone for the Treatment of Fibromyalgia (ASHP 2024) - No abstract available

Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology