roflumilast / Generic mfg. - LARVOL DELTA

Effectiveness and Safety of Roflumilast in the Treatment of Psoriasis: A Systematic Review and Meta-Analysis.. (PubMed, Curr Drug Saf) - "This meta-analysis represents the first investigation into the efficacy and safety of roflumilast for treating psoriasis. Results suggest that roflumilast is both effective and well-tolerated in managing psoriasis. However, additional robust clinical trials are needed to validate these observations."

Clinical • Journal • Retrospective data • Dermatology • Immunology • Psoriasis

Topical roflumilast 0.3% cream for mild hidradenitis suppurativa: A prospective case series. (PubMed, JAAD Case Rep) - No abstract available

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Pruritus

Relative Efficacy of Immunomodulatory Monotherapies for Psoriasis of the Scalp: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We are the first to provide comparative evidence on the efficacy of newly investigated agents such as deucravacitinib, tildrakizumab, roflumilast and icotrokinra. In general, the IL-17 inhibitors (bimekizumab, ixekizumab, secukinumab, brodalumab) and IL-23 inhibitors (icotrokinra, guselkumab, tildrakizumab) were effective depending upon the outcome and time-point being considered. At 16 weeks, for PSSI-100, ixekizumab 150 mg at weeks 0, 2, 4, 8, and 12 ranked highest; at 16 weeks, for Sc-PGA 0/1 bimekizumab 320 mg every 4 weeks ranked highest; at 8 weeks, for PSSI-100 ixekizumab 80 mg every 2 weeks ranked highest; at 8 weeks, for Sc-PGA 0/1 secukinumab 300 mg at weeks 1, 2, 3 and then every 4 weeks ranked highest. Small-molecule therapies (apremilast, deucravacitinib, roflumilast) improved scalp psoriasis modestly. Our work would guide the design of future studies and clinical decision-making."

Clinical • Journal • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A • IL23A

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov) - P4 | N=10 | Not yet recruiting | Sponsor: University of California, San Francisco

New P4 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Refractory erythema annulare centrifugum treated with roflumilast (AAD 2026) - No abstract available

Dermatology

Integrating synthesis, pharmacological evaluation, and molecular dynamics simulation of novel 8-substituted theophylline hybrids as potential PDE-4B inhibitors, bronchodilators and antibacterial. (PubMed, Bioorg Chem) - "Notably, 17 k displayed superior oral pharmacokinetic properties, high lipophilicity, moderate solubility, and optimal molecular size, comparable to theophylline and roflumilast (standard PDE-4B inhibitor). These findings identify 17 k as a promising lead for the development of orally active dual-acting agents for asthma management."

Journal • Asthma • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases

Successful Treatment of Extragenital Lichen Sclerosus With Roflumilast 0.3% Cream: A Report of Two Cases. (PubMed, Cureus) - "Topical roflumilast has been approved by the US Food and Drug Administration (FDA) for an expanding number of indications in dermatology, including plaque psoriasis, atopic dermatitis, and, most recently, seborrheic dermatitis. We present two cases of symptomatic EGLS, who both demonstrated clinical improvement using roflumilast 0.3% cream as early as one month of follow-up."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • Seborrheic Dermatitis

PDE4 Inhibitor-Responsive Dermatoses: An Emerging Concept in Dermatology. (PubMed, J Clin Aesthet Dermatol) - "This suggests that PDE4 inhibitors may assume a similar complementary framework for treating "PDE4 inhibitor-responsive dermatoses." Certain formulations of PDE4 inhibitors (including apremilast, crisaborole, and roflumilast) have undergone rigorous investigation in clinical trials and demonstrated robust efficacy and safety in many dermatologic conditions, achieving United States Food and Drug Administration approval for atopic dermatitis, psoriasis, and seborrheic dermatitis. Herein, we summarize the clinical evidence supporting the emerging concept of "PDE4 inhibitor-responsive dermatoses" and propose that PDE4 inhibition offers an additional pathway to achieving desired clinical outcomes."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • Seborrheic Dermatitis

"Beyond Corticosteroids: A Systematic Review and Meta-analysis of Novel Therapies for Hypersensitivity Pneumonitis". (PubMed, Respir Med) - "Due to heterogeneity and limited high-quality evidence, definitive conclusions about novel therapies in HP remain elusive. However, rituximab and MMF showed promising results. Long-term randomized trials with standardized endpoints are needed to guide therapeutic decisions."

Journal • Retrospective data • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

First-Line Combination of R-CHOP with the PDE4 Inhibitor Roflumilast for High-Risk DLBCL. (PubMed, Cancers (Basel)) - P1 | "These initial findings suggest that roflumilast may be an alternative agent able to inhibit BCR/PI3K activity and angiogenesis in DLBCL, and that the testing of Ro+R-CHOP in a larger series of genetically characterized tumors is warranted. This study was registered at ClinicalTrials.gov, number NCT03458546."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Molecular Docking-Assisted Fluorescence Enhancement of Roflumilast Through Micellization: Whiteness and Greenness Evaluation With Pharmaceutical and Milk Applications. (PubMed, Luminescence) - "The technique exhibited satisfactory linearity in the range of 400-1200 ng/mL with a high correlation coefficient value of 0.9996, showing high sensitivity with low detection and quantification limits of 161.0 and 185.0 ng/mL, respectively, with excellent accuracy and precision. The method's sustainability was evaluated using the green analytical procedure index, Eco-Scale, and whiteness assessment, indicating that the proposed method is eco-friendly."

Journal

Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database. (PubMed, J Pharm Pharm Sci) - "Clinicians should remain vigilant for AEs that differ by gender and route to enable early intervention and improve prognosis. The findings highlight personalized safety management, while underscoring the necessity of prospective studies to validate results and further characterize roflumilast's safety profile."

Adverse events • Journal • Real-world evidence • Cardiovascular • Chronic Obstructive Pulmonary Disease • Cough • Dermatology • Immunology • Pain • Psoriasis • Psychiatry • Pulmonary Disease • Respiratory Diseases • Suicidal Ideation

Trends in Inhibitors, Structural Modifications, and Structure-Function Relationships of Phosphodiesterase 4: A Review. (PubMed, Biomolecules) - "Although synthetic PDE4 inhibitors such as roflumilast and apremilast exhibit significant therapeutic efficacy, their clinical application is often limited by dose-dependent adverse effects. Their lower toxicity, favorable biocompatibility, and structural diversity enable fine-tuning of potency and selectivity through rational modification. Integrating structural insights derived from crystallographic and computational studies with the optimization of natural compounds offers a sustainable and effective strategy for the development of safer, isoform-selective PDE4-targeted therapies."

Journal • Review • Immune Modulation • Immunology • Inflammation

TRPS1 confers paclitaxel resistance in TNBC through dual activation of the PDE4D-cAMP-AKT pathway and microtubule destabilization. (PubMed, Breast Cancer Res) - No abstract available

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TRPS1

Ulcerative pyoderma gangrenosum in a 78-year-old woman treated with brodalumab: A case report. (PubMed, SAGE Open Med Case Rep) - "The patient was refractory to corticosteroids, dapsone, and roflumilast, and developed recurrent Gram-negative infections. Brodalumab may offer a safe and effective treatment option in refractory pyoderma gangrenosum, particularly in patients with contraindications to conventional therapies. This case supports further evaluation of IL-17 pathway inhibition in neutrophilic dermatoses."

Journal • Cardiovascular • Dermatology • Infectious Disease • Oncology • Pyoderma Gangrenosum • Sarcoma • Solid Tumor • Venous Thromboembolism • IL17A • IL17RA

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR) (clinicaltrials.gov) - P3 | N=3973 | Terminated | Sponsor: Chiesi Farmaceutici S.p.A. | Active, not recruiting ➔ Terminated; Strategic decision by Sponsor; not due to safety reasons

Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Rationale and Design of the Roflumilast or Azithromycin to Prevent COPD Exacerbations Clinical Trial. (PubMed, Chronic Obstr Pulm Dis) - "We employed human-centered design principles to improve the usability of study activities from the perspective of participants, study staff, and treating clinicians. The final study design offered the option for patients with COPD and chronic bronchitis at high-risk of hospitalization or death to be remotely consented, prescribed a medication according to the randomized treatment allocation, and complete virtual follow-up study visits in a decentralized clinical trial."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Organoid chip based automatic system for long-term quantifying ciliary beating under drug intervention. (PubMed, Anal Chim Acta) - "This strategy eliminates HDCO loss via on-chip integration of all procedures, resolving the conflict between limited samples and multi-condition tests. It improves tracking accuracy by avoiding organoid displacement/overlapping, overcoming multi-well-plate limitations. The system's low cost and high reproducibility accelerate drug screening (e.g., roflumilast) and enable precise study of cilia physiology, laying a key technical foundation for cilia-related disease research and clinical translation."

Journal

A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

Biomarker • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data. (PubMed, Front Drug Saf Regul) - "Most events occurred early, underscoring the need for close monitoring during treatment initiation. The use of multiple disproportionality methods enhances signal detection robustness and supports ongoing pharmacovigilance in clinical practice."

Adverse events • Journal • Real-world evidence • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Immunology • Insomnia • Pain • Peptic Ulcer • Psychiatry • Pulmonary Disease • Respiratory Diseases • Sleep Disorder • Suicidal Ideation

The role of ciliary function in airway epithelial defense against Pseudomonas aeruginosa. (PubMed, Med Microbiol Immunol) - No abstract available

Journal • Infectious Disease • Respiratory Diseases

Basic Science and Pathogenesis. (PubMed, Alzheimers Dement) - "Using PDE inhibitors as treatment continues to show promise across increasing medical applications. Although present PDEIs benefit patients we need new studies that make these inhibitors more selective for specific isoforms and with fewer unwanted effects to create improved therapeutic drugs. Emerging technology in drug discovery including artificial intelligence and personalized treatment methods will guide the creation of better and safer PDE inhibitors to treat many diseases."

Journal • Review • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Erectile Dysfunction • Hypertension • Hypotension • Immunology • Oncology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge (clinicaltrials.gov) - P2 | N=45 | Active, not recruiting | Sponsor: Children's Hospital Medical Center, Cincinnati | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Mar 2026 | Trial primary completion date: Jun 2025 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • Fragile X Syndrome • Genetic Disorders • FMR1

ROFLU-AD12: Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Nora Mohamed Abdelrazik

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Hidden Within: Pulmonary Nocardiosis in an Immunocompetent COPD Patient. (PubMed, P R Health Sci J) - "This report presents the case of an 86-year-old man with chronic obstructive pulmonary disease (COPD) managed since 2018 with inhaled corticosteroids, long-acting muscarinic antagonists, long-acting beta-agonists, and roflumilast...Despite treatment with piperacillin/tazobactam and methylprednisolone, his condition worsened, necessitating bronchoscopy...The patient showed clinical improvement with TMP-SMX therapy, with follow-up imaging indicating partial resolution. Continued outpatient care is scheduled, emphasizing vigilance in managing high-risk COPD patients, particularly in tropical regions such as Puerto Rico."

Journal • Chronic Obstructive Pulmonary Disease • Critical care • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases