Imunorix (pidotimod) / Almirall - LARVOL DELTA

An Italian multidisciplinary Delphi Consensus on new insights about the clinical relevance of Pidotimod. (PubMed, Multidiscip Respir Med) - "In addition, there was agreement about the use of pidotimod in specific situations, including combined therapy (antibiotics plus pidotimod) for pneumonia, Down syndrome, COVID-19, PFAPA, wheezing, and urinary infections. In conclusion, pidotimod is a safe and effective drug helpful in preventing recurrent respiratory infections in susceptible patients and as an adjuvant in managing patients with infections."

Journal • Developmental Disorders • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Pneumonia • Respiratory Diseases • Urology

From Legacy to Innovation: Pidotimod's Expanding Therapeutic Horizon. (PubMed, Mediterr J Hematol Infect Dis) - "In this review, we examine pidotimod's pharmacodynamics, summarize clinical evidence from recent studies, and explore its evolving role in modern therapeutic strategies for infectious diseases. Given its safety profile and oral administration, pidotimod holds significant promise not only for preventing infections but also as part of a broader immunomodulatory approach in complex disease management."

IO biomarker • Journal • Review • Allergic Rhinitis • Chronic Obstructive Pulmonary Disease • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • IFNG • IL2

Pidotimod alleviated experimental autoimmune encephalomyelitis by regulating the balance of splenic lymphocytes. (PubMed, BMC Immunol) - "The present study preliminarily explored the effects and potential immunomodulator mechanisms of pidotimod in treating EAE mice. Results indicated that pidotimod treatment decreased the percentages of CD4+ IFN-γ+ Th1 cells, CD4+ IL-17+ Th17 cells, CD8+ IL-17+ Tc17 cells and B220+ TNF-α+ B cells, while increasing the percentages of CD4+ CD25+ Foxp3+ Tregs and CD8+ Foxp3+ Tregs in the spleen at the peak stage of EAE. Additionally, pidotimod reduced leukocyte infiltration into the spinal cord and brain, as well as demyelination in the spinal cord. These findings suggest that the neuroprotective effects of pidotimod in EAE mice may be its ability to regulate the balance of splenic lymphocytes."

Journal • CNS Disorders • Immunology • Multiple Sclerosis • CD4 • CD8 • FOXP3 • IFNG • IL17A • IL2RA • ISG20 • TNFA

Dextran-based prodrug-nanoassemblies responsively releasing pidotimod and camptothecin for anti-breast cancer. (PubMed, Drug Dev Ind Pharm) - "In 4T1 breast cancer model, the CPT-SS-DEX-PTD NPs displayed synergistic anti-tumor efficacy and lower side effects of CPT due to the combination of chemo-immunotherapy. The dextran-based pH/GSH-responsive prodrug-nanoassemblies with synergistic therapy efficacy and low systemic toxicity may offer a novel strategy for breast cancer therapy."

Journal • Breast Cancer • Oncology • Solid Tumor

Pidotimod plus recombinant human interferon α-2b suppository boosts HPV clearance in high-risk patients following loop electrosurgical excision procedure. (PubMed, Am J Transl Res) - "PDT plus rh-IFN-α2b suppository can effectively improve HPV negative conversion, accelerate vaginal microecology recovery, and modulate serum inflammatory responses in high-risk HPV patients after LEEP."

Journal • Human Papillomavirus Infection • Infectious Disease • Inflammation • Oncology • IFNA1 • IFNG • IL12A • IL4

Clinical Efficacy of Pidotimod-Assisted Erythromycin in Treating Lobar Pneumonia in Children Over 3 Years Old. (PubMed, Br J Hosp Med (Lond)) - "Additionally, there was no significant difference in the incidence of adverse reactions in both groups (p > 0.05). Conclusion Pidotimod-assisted erythromycin treatment can significantly improve the treatment efficiency in children with lobar pneumonia, improving clinical signs and symptoms and enhancing the cellular immune function without increasing the risk of adverse drug reactions."

Journal • Retrospective data • Asthma • Cough • Immunology • Infectious Disease • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • CD4 • CD8

Pidotimod in pediatrics: new evidence and future perspectives. (PubMed, Multidiscip Respir Med) - "The present review presents and discusses the most recent studies conducted in children with asthma, allergic rhinitis, recurrent respiratory infections and acute infections. Lastly, pidotimod is safe and well-tolerated in children."

Journal • Allergic Rhinitis • Allergy • Asthma • Immunology • Infectious Disease • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases

Tandem Mass Spectrometry Approaches for Differentiation and Quantification Pidotimod and Its Three Isomers in the Gas Phase. (PubMed, Chirality) - "Additionally, the logarithm of the CuII complexes' characteristic fragment ion abundance ratio demonstrated a strong linear relationship with enantiomeric excess (ee). This study presents a novel strategy for chiral drug quality control that eliminates chromatographic separation."

Journal

Reappraisal of Pidotimod: an immunomodulatory agent with 30-year evidence. (PubMed, Minerva Med) - "Preliminary experience suggests that Pidotimod can shorten the duration of COVID-19 infection and reduce clinical severity by modulating the immune response, as well as prevent vaccination-related adverse events. In conclusion, the immunomodulatory properties of Pidotimod indicate that it may be a valuable option in managing patients with respiratory infections and other immune-mediated disorders, including allergy, chronic obstructive pulmonary disease, and asthma."

Immunomodulating • Journal • Allergic Rhinitis • Allergy • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Nephrology • Novel Coronavirus Disease • Pneumonia • Psychiatry • Pulmonary Disease • Respiratory Diseases

Analysis of Factors and T-Lymphocyte Subset Changes in Pediatric Recurrent Respiratory Infections Post-Pidotimod Treatment. (PubMed, Altern Ther Health Med) - "Daily outdoor activity among children, family members' history of smoking, parental allergy history, education level, and micronutrient intake emerged as independent factors influencing pediatric RRTIs. Furthermore, PI was identified as a significant treatment option for RRTIs."

Journal • Allergy • Cough • Immunology • Infectious Disease • Pediatrics • Respiratory Diseases • CD4 • CD8

Investigation on the Efficacy of Two Food Supplements Containing a Fixed Combination of Selected Probiotics and β-Glucans or Elderberry Extract for the Immune System: Modulation on Cytokines Expression in Human THP-1 and PBMC. (PubMed, Foods) - "We compared formulations with single ingredients, with bacterial lipopolysaccharide (LPS) and the drug pidotimod; cytokines expression level was evaluated testing different concentrations of samples at two exposure times...Probiotics were shown to play a major role, but β-glucans and elderberry extract exerted a synergistic activity. This work demonstrated that combining selected probiotics with other natural products having immunomodulatory properties is an interesting strategy to develop innovative formulations in the sector of food supplements."

Journal • CXCL8 • IL10 • IL2 • IL6

Are monoclonal antibodies effective in patients with severe obesity in SARS-CoV-2 infected? (PubMed, Immun Inflamm Dis) - "Our study found that there are no differences in the therapeutic response between obese and nonobese patients with SARS-CoV-2 infection undergoing MonoAbs therapy, in fact, none of them underwent hospitalization. Furthermore, the effect of the immunostimulant Pidotimod and cholecalciferol may have contributed to the resolution of COVID-19 symptoms in these patients."

Journal • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity • Respiratory Diseases

New Therapeutic Options in Mild Moderate COVID-19 Outpatients. (PubMed, Microorganisms) - "In the first phase of disease, pidotimod can represent an effective, low-cost, weapon, without restrictions of use, that is able to prevent a second aggressive phase and promote faster virological recovery."

Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Immunostimulants versus placebo for preventing exacerbations in adults with chronic bronchitis or chronic obstructive pulmonary disease. (PubMed, Cochrane Database Syst Rev) - "In participants with chronic bronchitis or COPD, we are moderately confident that treatment with immunostimulants is associated with a small reduction in the likelihood of having an exacerbation and a moderate reduction in the requirement for antibiotics. Low numbers of events limit interpretation of the effect of immunostimulants on all-cause and respiratory-related mortality. We are uncertain whether immunostimulants improve quality of life, and whether they are associated with a reduction in exacerbation and respiratory-related hospitalisation durations, although immunostimulants were generally associated with a positive effect direction in the studies that examined these outcomes. Immunostimulants appear to be safe and well-tolerated, and are not associated with an increased risk of adverse events."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial. (PubMed, Pediatr Investig) - "The safety profile did not significantly differ among the groups. YPF granules were noninferior to the active control drug pidotimod oral solution for the treatment of RRTI in children, and were superior to placebo, with a high safety profile."

Clinical • Journal • Asthma • Immune Modulation • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases

Podotimod in pediatric recurrent respiratory tract infections: a cost-utility analysis. (PubMed, BMC Pulm Med) - "In conclusion our study shows that PDT is a cost-effective strategy to reduce the incidence rate of recurrent respiratory tract infections in children. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines."

HEOR • Journal • Infectious Disease • Pediatrics • Respiratory Diseases

Improving BNT162b2 mRNA Vaccine Tolerability without Efficacy Loss by Pidotimod Supplementation. (PubMed, Mediterr J Hematol Infect Dis) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

P-CRESCENT: Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI) (clinicaltrials.gov) - P4 | N=338 | Completed | Sponsor: Almirall, S.A. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases

Efficacy and Safety of Pidotimod in Persistent Asthma: A Randomized Triple-Blinded Placebo-Controlled Trial. (PubMed, Indian Pediatr) - "Addition of pidotimod for 8 weeks to standard ICS therapy did not enhance asthma control compared to placebo."

Clinical • Journal • Allergy • Asthma • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases

Anti-Inflammatory Effects of Immunostimulation in Patients with COVID-19 Pneumonia. (PubMed, J Clin Med) - "Immunomodulation exerted by PDT and systemic corticosteroids may foster a restoration in the innate response to the viral infection. These results should be confirmed in larger RCTs."

Clinical • Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CCL11 • IFNG • IL4

Pidotimod increases inflammation in wounded zebrafish embryos. (PubMed, Fish Shellfish Immunol) - "However, we did not observe protection of uropathogenic Escherichia coli or Mycobacterium marinum infected zebrafish larvae following PDT treatment. This study provides a new platform for PDT research, which is worthy of further research to identify further effects of PDT therapy."

Journal • Immunology • Infectious Disease • Inflammation • IL1B

Treatment of Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine: A Multicenter Randomized, Parallel Controlled Trial. (PubMed, Chin J Integr Med) - "ZMTM combined with Western medicines showed a better therapeutic effect in the treatment of psoriasis vulgaris without obvious adverse reaction. (Trial Registration No. ChiCTR-IOR-16008159)."

Clinical • Journal • Dermatology • Immunology • Mood Disorders • Psoriasis • Psychiatry

Effects of adjuvant pidotimod therapy on levels of inflammatory factors and expressions of serum GM-CSF and KL-6 in elderly patients with mycoplasma pneumonia. (PubMed, Am J Transl Res) - "Adjuvant pidotimod therapy in the treatment of elderly patients with mycoplasma pneumonia can ameliorate patients' inflammatory responses and pulmonary functions, and reduce the serum GM-CSF and KL-6 factor levels, as well as the recurrence rate. Moreover, the combined medication is safe, and no significant increase in toxicity was found."

Clinical • Journal • Infectious Disease • Inflammation • Oncology • Pneumonia • Respiratory Diseases • CSF2 • CXCL8 • IL6 • TNFA

Expert Opinion on Usage of Pidotimod in Adult Patients with Chronic Obstructive Pulmonary Disease: An Indian Perspective. (PubMed, J Assoc Physicians India) - "Modulation of the immune system with Pidotimod along with standard-of-care (SOC) treatment has proven efficacious in the past two decades in patients with recurrent respiratory tract infections (RRTIs), bronchitis, COPD, and pneumonia. In this article, we have reviewed the current unmet needs in the management of COPD in India and evaluated the usage of Pidotimod in adult COPD patients based on expert panel discussion."

Clinical • Journal • Acute Respiratory Distress Syndrome • Chronic Obstructive Pulmonary Disease • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Whether immunostimulants are effective in susceptible children suffering from recurrent respiratory tract infections: a modeling analysis based on literature aggregate data. (PubMed, J Clin Pharmacol) - "OM-85 BV and pidotimod reduced the incidence of respiratory tract infections by 0.21 (95% CI: 0.16, 0.26) and 0.19 (95% CI: 0.17, 0.21) compared to placebo per month, respectively...Pidotimod and OM-85 BV can effectively reduce the incidence of respiratory tract infections in susceptible children, with no significant increase in the incidence of drug-related adverse events when compared with placebo [RR values were 1.07 (95% CI: 0.66, 1.71) and 1.31 (95% CI: 0.54, 3.19), respectively]. This study provides quantitative support for the application of immunostimulants for the prevention of recurrent respiratory tract infections in children."

Clinical • Journal • Infectious Disease • Pediatrics • Respiratory Diseases