vardenafil / Generic mfg. - LARVOL DELTA

Vardenafil Nasal Spray in healthy volunteers including over 65's (15 days confinement in Sydney) (ANZCTR) - P1 | N=27 | Not yet recruiting | Sponsor: LTR Pharma Ltd

New P1 trial • Erectile Dysfunction

Effect of vardenafil in long-standing diabetic patients comparing different doses regarding erectile dysfunction, testosterone level and partner satisfaction. (PubMed, Arab J Urol) - "Testosterone levels were elevated in all doses, especially for higher doses of vardenafil. Vardenafil with doses of 10 mg once or 5 mg twice is an effective and valid option for long-standing type II diabetic patients with ED."

Journal • Diabetes • Erectile Dysfunction • Metabolic Disorders • Type 2 Diabetes Mellitus

Bioequivalence Assessment for Intranasal Rapid-Acting Drug Products. (PubMed, J Clin Pharmacol) - "To evaluate this approach, plasma concentration data from two crossover studies comparing intranasal vardenafil (5 and 3.8 mg) with an approved oral tablet (10 mg) were analyzed...This adapted BE approach may offer a more suitable method for intranasal and other rapid-acting products. With further validation, it could support regulatory approval and improve patient access to fast-acting therapies."

Clinical • Journal

Associations between phosphodiesterase type 5 inhibitors and vascular function: a systematic review and meta-analysis on randomized-controlled trials. (PubMed, Syst Rev) - "Compared with the placebo, PDE5is improved vascular parameters, indicating the potential of PDE5is for treating subclinical cardiovascular diseases. Further research is needed to confirm the role of the improvement on vascular parameters by PDE5isin preventing and treating cardiovascular diseases."

Journal • Retrospective data • Review • Cardiovascular • Erectile Dysfunction

Spatial and Temporal Tracking of Counterfeit Phosphodiesterase Type V Inhibitors Use Based on Wastewater Analysis. (PubMed, Environ Sci Technol) - "Among the three target compounds, neither tadalafil nor vardenafil was detected in any sample. Sildenafil, however, was found in 94.5% of the samples, with concentrations ranging from below the limit of quantification (LOQ) to 75.4 ng/L...Subpopulation analysis further revealed that college students (38.5 mg/d/1000 inh) and island residents (28.6 mg/d/1000 inh) had lower levels of use compared to the general population (85.1 mg/d/1000 inh). These results highlight the potential of wastewater-based drug surveillance in tracking consumption trends of nonprescribed and counterfeit pharmaceuticals, offering robust evidence to inform regulatory efforts and improve public risk perception."

Journal • Erectile Dysfunction

PDE-5 inhibitors in complex matrices: Recent updates on pretreatment and detection methods. (PubMed, J Chromatogr A) - "Common medications include sildenafil, tadalafil, and vardenafil. Among these, the use of high-resolution mass spectrometry is a current research hotspot. The review critically evaluates the advantages and limitations of existing methodologies, identifies future development directions, and supports the selection of efficient analytical strategies for specific sample matrices and research purposes."

Journal • Review • Erectile Dysfunction

Head-to-head Comparison of the Safety and Efficacy Profiles of Three Phosphodiesterase Type 5 Inhibitors through Patient-reported Outcomes of 130 000 Patients from a Direct-to-consumer Platform Database. (PubMed, Eur Urol Focus) - "PDE5i usage is associated with distinct efficacy and AE profiles in a large real-world dataset guiding treatment recommendations for urologists. Future DTC data might be used to complement clinical trial data."

Head-to-Head • Journal • Erectile Dysfunction

Cutting Costs, Not Care: New Models for Affordable Men's Health Medications. (PubMed, Urology) - "CPDC provides significant cost savings on men's health medications compared to Medicare and GoodRx."

Journal • Benign Prostatic Hyperplasia • Erectile Dysfunction • Infertility • Sexual Disorders

AI-assisted identification of a novel vardenafil analog (KD-027) adulterated in capsules. (PubMed, J Forensic Sci) - "However, the increased demand for pharmacological treatments, such as sildenafil, tadalafil, and vardenafil has led to the emergence of counterfeit drugs, posing a serious public health concern. In addition, evidence of coexisting E/Z tautomerism of KD-027 was observed in the NMR data. To the best of our knowledge, this is the first report to identify KD-027 in sexual enhancement products, providing its characteristic mass spectral fragments and NMR data, and demonstrating the utility of ChatGPT-4o in forensic investigations."

Journal • Sexual Disorders

A single-center, open-label, randomized, single-dose, double-cycle, double-crossover bioequivalence trial of vardenafil hydrochloride tablets in healthy subjects under fasting and postprandial conditions (ChiCTR) - P=N/A | N=104 | Not yet recruiting | Sponsor: The Affiliated Panyu Central Hospital, Guangzhou Medical University; The Affiliated Panyu Central Hospital, Guangzhou Medical University

New trial • Erectile Dysfunction

Beyond Erectile Dysfunction: Investigating the Protective Effect of PDE-5 Inhibitors Against Gastric Cancer (ACG 2025) - "We included adult males aged 60 and above who have been taking Sildenafil, Tadalafil, and Vardenafil from January 1, 2015, to April 30, 2025, and a matched cohort not taking PDE5i. There were 795,289 patients taking PDE5i and 9,513,128 not taking PDE5i before matching. After matching, there were 794,925 patients in both cohorts. Patients on PDE5i were found to have a statistically significant reduction in rates of gastric cancer (OR 0.7, 95%CI 0.65-0.76, p < 0.001)."

Colon Cancer • Colorectal Cancer • Erectile Dysfunction • Gastric Cancer • Gastrointestinal Cancer • Infectious Disease • Oncology • Solid Tumor

PDE5A+ cancer-associated fibroblasts enhance immune suppression in gastric cancer. (PubMed, Gut) - "Our study elucidates the intricate role of PDE5A+ CAFs in shaping the immunosuppressive TME in GC, providing mechanistic insights and therapeutic potential for combating this aggressive malignancy."

IO biomarker • Journal • Gastric Cancer • Oncology • Solid Tumor • CAFs • CD8 • CXCL12 • CXCR4 • LAG3 • PDE5A

Erectile Dysfunction Drugs as Potential Therapy for Cognitive Decline: Preclinical and Translational Evidence. (PubMed, Cells) - "Phosphodiesterase type 5 inhibitors (PDE5-Is), such as sildenafil and vardenafil, are widely used to treat ED by elevating cyclic guanosine monophosphate (cGMP) levels and enhancing vascular function. Emerging evidence suggests that PDE5-Is may also benefit cognitive function by promoting neurovascular coupling, synaptic plasticity, and neuroprotection. This review synthesizes clinical, preclinical, and mechanistic studies on PDE5-Is in the context of learning, memory, and Alzheimer's disease, highlighting their potential as therapeutic agents for cognitive impairment."

Journal • Preclinical • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Erectile Dysfunction

Vardenafil vs. Sildenafil for the Treatment of Persistent Pulmonary Hypertension in Newborns. (PubMed, Indian J Pediatr) - No abstract available

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Using real-world data platforms for virtual clinical trials: a direct comparison of the safety and efficacy of three phosphodiesterase type 5 inhibitors in >130,000 patients (DGU 2025) - "Patients with ED received treatment with sildenafil, tadalafil, or vardenafil via a digital health platform. Tadalafil showed significantly higher rates of adverse events (35.0% vs. 47.4%, chi-square p <0.0001), with fewer adverse events in the 5 mg daily dosage compared to the on-demand dosage. Real-world data can complement clinical trials and provide new insights into the treatment of ED."

Clinical • Real-world • Real-world evidence • Erectile Dysfunction

Are there relevant differences regarding the expectations of partners compared to those of our patients in penile rehabilitation programs after nerve-sparing prostatectomy? (DGU 2025) - "Materials and We conducted a prospective study using questionnaires that were sent to the patients and their partners from three different studies on penile rehabilitation after nsRP with a regular dose of different PDE5 inhibitors (sildenafil/vardenafil/tadalafil). Although 91% of the patients believe in the concept of penile rehabilitation, only 62% of the patients / 41% of the participants expected a partial or complete recovery of EF after nsRP. Satisfaction with the recovery of EF was significantly different 2 years after nsRP, at 64% vs. 45%."

Clinical • Prostate Cancer

ENHANCEMENT AND EVALUATION OF VARDENAFIL HYDROCHLORIDE TRIHYDRATE ABSORPTION IN ORODISPERSIBLE FORMULATION: ESTABLISHMENT OF IN VITRO , IN VIVO CORRELATION AND BIOEQUIVALENCE STUDY. (PubMed, Chem Biol Interact) - "In comparison to the reference, the optimized formulation also showed better maximum concentration (Cmax) and a shorter time to achieve maximum concentration (Tmax). Overall, the optimized vardenafil orodispersible tablet showed improved peak concentration, quicker absorption, and comparable bioavailability to the reference formulation."

Journal • Preclinical • Erectile Dysfunction

Hyperprolactinemia-associated erectile dysfunction: retrospective cohort evaluating the effect of prolactin normalization on IIEF-5. (PubMed, Neuro Endocrinol Lett) - "Our results confirmed the positive impact of resolving the primary endocrine cause on overall sexual health. These findings underscore the importance of comprehensive hormonal assessment in the management of male sexual dysfunction, including measurement of PRL levels. While hyperprolactinemia is a relatively uncommon cause of ED, its treatment-whether pharmacological or surgical-can lead to PRL normalization and a marked improvement in erectile function. The combined use of PDE5I and hyperprolactinemia treatment represents an effective therapeutic approach that should be considered in the care of men with ED."

Journal • Retrospective data • Endocrine Cancer • Endocrine Disorders • Erectile Dysfunction • Sexual Disorders • PRL

Oral drug treatments of erectile dysfunction: a AFU/SFMS systematic review. (PubMed, Fr J Urol) - "PDE5Is are effective first-line treatments for ED, with similar efficacy and safety profiles. The choice of PDE5I should be tailored to the patient's needs, comorbidities, and lifestyle preferences. Future studies should address specific subpopulations to optimize clinical practice guidelines."

Journal • Review • Back Pain • Dyspepsia • Erectile Dysfunction • Genito-urinary Cancer • Infectious Disease • Musculoskeletal Pain • Oncology • Pain • Prostate Cancer • Solid Tumor

Unveiling research landscapes in erectile dysfunction: a bibliometric analysis comparing basic scientific research and clinical studies. (PubMed, Sex Med Rev) - "Bibliometric analyses can provide an in-depth analysis in distinguishing ED literature. There is a need to foster multi-center international collaborations and new emphasis on novel technology and recent scientific advances."

Journal • Erectile Dysfunction • Sexual Disorders • Urology

Toward Natural Products-Based Drug Development for Erectile Dysfunction: A Molecular Candidate from Plant Tribulus terrestris Identified by an Integrated In Silico Study. (PubMed, OMICS) - "Conventional pharmacological interventions for erectile dysfunction (ED) primarily rely on the phosphodiesterase-5 (PDE5) inhibitors such as sildenafil, tadalafil, vardenafil, and avanafil that have side effects despite their therapeutic effects. Importantly, diosgenin,dehydro, a saponin obtained from T. terrestris, was identified as a particularly promising candidate for PDE5 inhibition by virtue of its higher negative binding affinity and, therefore, displaying a potential in drug discovery and development for ED. In addition, in silico pharmacokinetic analysis and toxicity assessments support the prospects of these T. terrestris-derived phytochemicals for future in vitro and in vivo research for innovation in ED therapeutics."

Journal • Erectile Dysfunction

Analysis of Phosphodiesterase-5 (PDE5) Inhibitors in Modulating Inflammatory Markers in Humans: A Systematic Review and Meta-Analysis. (PubMed, Int J Mol Sci) - "Phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil, tadalafil, and vardenafil, are primarily prescribed for erectile dysfunction and pulmonary hypertension. PDE5 inhibitors may exert anti-inflammatory effects in long-term use by reducing vascular inflammation and enhancing cGMP signalling. These findings support further investigation of PDE5 in chronic inflammatory conditions."

Journal • Retrospective data • Review • Cardiovascular • Erectile Dysfunction • Hypertension • Inflammation • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CXCL8 • ICAM1 • IL10 • IL6 • TNFA • VCAM1

Vardenafil and Tamsulosin in the Management of Ureteral Stent-Related Symptoms: A Prospective Comparative Study. (PubMed, Urol Res Pract) - "Side effects were mild, with retrograde ejaculation and hypotension in the tamsulosin group and headaches in the vardenafil group. Vardenafil showed promising results in controlling stent-related symptoms and can be considered an alternative or adjunct medication to tamsulosin in the management of stent-related symptoms; however, this needs further exploration in larger, multi-center studies to validate these findings and optimize patient outcomes in clinical practice."

Journal • Hypotension • Pain

Pharmacokinetics of an oral versus intranasal delivered formulation of the phosphodiesterase type 5 inhibitor vardenafil in healthy men - A Phase 1, Randomized, Open-label, Single-dose, Two-period, Two-treatment, Cross-over Study. (PubMed, Eur J Pharm Sci) - "In healthy men, intranasally delivered vardenafil is associated with more rapid Tmax, but similar plasma concentrations without bioequivalence being statistically proven. This differential pharmacokinetic profile has potentially important clinical implications in treating men with ED."

Journal • P1 data • PK/PD data • Erectile Dysfunction

Synergy between oral PDE5 inhibitors and topically applied nitric oxide microparticles on the erectile response in a rat model of cavernous nerve injury. (PubMed, Int J Impot Res) - "One week post-surgery animals were administered PDE5i via oral gavage (sildenafil 0.05 mg/kg (N = 9), tadalafil 0.005 mg/kg (N = 8), vardenafil 0.01 mg/kg (N = 7), avanafil 0.1 mg/kg (N = 8) or untreated (N = 5) followed by topical application of 250 mg NO-MP to the penile dermis. No significant changes in maximal ICP/BP, duration of erectile response or baseline ICP/BP were observed. These results suggest that combining NO-MP with PDE5i may provide a promising approach for treating ED after radical prostatectomy."

Journal • Preclinical • Erectile Dysfunction