roflumilast / Generic mfg. - LARVOL DELTA

Real-world initiation and persistence of roflumilast and azithromycin in chronic obstructive pulmonary disease (ERS 2026) - "In Swedish clinical practice, both therapies are infrequently initiated, often late after eligibility, and discontinued within the first year."

Clinical • Real-world • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Quality of life, dyspnea and safety with roflumilast in Greek patients with severe Chronic Obstructive Pulmonary Disease (COPD): "ARGO" real-life study in Greece. (ERS 2026) - P=N/A | "In 38 patients (5.1%) a total of 29 adverse reactions were observed during the study period, predominantly gastrointestinal disorders (62%), alongside 23 adverse events. Conclusions In this real-world study, roflumilast was associated with clinically meaningful improvements in quality of life and dyspnea, with a favorable tolerability profile, in Greek patients with severe COPD."

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Pulmonary Disease • Respiratory Diseases

Low concentrations of ensifentrine show superior anti-inflammatory activity to roflumilast in COPD airways (ERS 2026) - "No significant effects were detected in airway epithelium. Detailed results are shown in Figure 1.ConclusionsAt low, clinically relevant concentrations, the anti-inflammatory profile of ensifentrine in COPD airways is superior to that of roflumilast, supporting its potential to reduce exacerbations via inhalation."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • CXCL8 • IL1B • IL33 • IL6 • TGFB1 • TNFA • TSLP

Clinical Effectiveness of Roflumilast in Patients With Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. (PubMed, Cureus) - "Roflumilast produces statistically significant but modest improvements in lung function in patients with COPD; its effects on exacerbations, quality of life, and mortality remain uncertain, given substantial heterogeneity across studies. These findings support current guideline recommendations restricting roflumilast use to specific patient phenotypes, and further large-scale trials in more homogeneous populations are warranted to clarify its role in COPD management."

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

ALDH2 regulates oxaliplatin sensitivity via PDE4B in p53-mutant colorectal cancer. (PubMed, Int J Med Sci) - "Importantly, pharmacological inhibition of PDE4B using the clinically approved drug roflumilast effectively restored oxaliplatin-induced apoptosis and reversed chemoresistance in ALDH2-deficient, p53-mutant CRC cells. This study identifies a previously unrecognized, p53 status-dependent ALDH2-PDE4B regulatory axis that governs oxaliplatin sensitivity in colorectal cancer. Our findings highlight ALDH2 as a potential predictive biomarker for oxaliplatin response in p53-mutant CRC and suggest that targeting PDE4B may represent a promising strategy to overcome chemoresistance in this molecular context."

Journal • P53mut • Colorectal Cancer • Oncology • Solid Tumor • ALDH2 • TP53

ROFLUMILAST AFTER GENERIC ENTRY: PRICING TRENDS AND IMPLICATIONS FOR COPD (CHEST 2026) - No abstract available

Pricing • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

ROFLUMILAST VS AZITHROMYCIN FOR PREVENTION OF COPD EXACERBATION: A RETROSPECTIVE COMPARATIVE STUDY USING TRINETX DATA (CHEST 2026) - No abstract available

Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

1314: Beyond Inhalers: COPD Exacerbation Risk Reduction (CHEST 2026) - "3. Identify treatable traits for patients with COPD who would preferentially benefit from azithromycin or roflumilast."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

1309: Update on the Changing Treatment Landscape of Severe COPD (CHEST 2026) - "The expanding use of triple inhaler therapy has generated debate, and choosing between azithromycin and roflumilast is a key decision point in patients who remain symptomatic despite optimized inhaled therapy. 3. Describe emerging therapeutic and interventional approaches."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Phosphodiesterase 4 Inhibitor Roflumilast Ameliorates Polytrauma-Induced Acute Kidney Injury by Attenuating HMGB1 and Renal Inflammatory Pathways in Rats. (PubMed, Int J Mol Sci) - "Roflumilast also significantly reduced levels of circulating High Mobility Group Box 1 (HMGB1) (p < 0.05) and the proinflammatory cytokine macrophage inflammatory protein-1 alpha (MIP-1α) (p < 0.05). These findings suggest that roflumilast is a promising therapeutic agent for mitigating trauma-induced AKI."

Journal • Preclinical • Acute Kidney Injury • Anesthesia • Chronic Obstructive Pulmonary Disease • Hematological Disorders • Immunology • Inflammation • Musculoskeletal Diseases • Nephrology • Orthopedics • Pulmonary Disease • Renal Disease • Respiratory Diseases • Systemic Inflammatory Response Syndrome • CCL3 • HMGB1 • KIM1

Formulation and Box-Behnken optimization of roflumilast loaded ultradeformable nanotransethosomal gel: physicochemical characterization, stability, dermal permeation, and antipsoriatic efficacy in an imiquimod-induced psoriasis model. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "In vivo studies revealed significant PASI score reduction (3.50 ± 0.52 on day 7), enhanced inflammatory biomarker suppression, and improved epidermal repair versus pimecrolimus cream (4.50 ± 0.66, p < 0.01). The optimised roflumilast-loaded ultradeformable transethosomal gel demonstrated improved skin penetration, sustained drug release, and superior preclinical antipsoriatic activity. Further clinical studies are warranted to establish long-term safety and therapeutic efficacy."

Journal • Dermatology • Immunology • Psoriasis

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

Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype (clinicaltrials.gov) - P4 | N=70 | Not yet recruiting | Sponsor: Sidra Aziz

HEOR • New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Roflumilast for Ulcers in Behçet's disease: Case report and review (EADV 2026) - No abstract available

Case report • Clinical • Review • Rare Diseases

Safety and Efficacy of Oral Roflumilast for Chronic Hand Eczema (HERO): A Double-Blind Randomized Controlled Trial (EADV 2026) - No abstract available

Clinical • Atopic Dermatitis • Contact Dermatitis • Dermatology • Immunology

Roflumilast Inhibits Fibrogenic Activation in Human Intestinal Myofibroblasts via Inhibition of Myocardin-Related Transcription Factor/Serum Response Factor Signaling. (PubMed, Int J Mol Sci) - "Additionally, rolipram and roflumilast significantly attenuated TGF-β1-induced phosphorylation of Smad2. These findings indicate that PDE4 inhibitors, particularly roflumilast, effectively suppress TGF-β1-induced fibrogenic activation in HIMFs by modulating MRTF/SRF and Smad-dependent pathways, highlighting the value of roflumilast for further preclinical investigation as a potential therapeutic strategy for intestinal fibrosis."

Journal • Fibrosis • Immunology • ACTA2 • COL1A1 • MRTFA • TGFB1

Oral Roflumilast in Lichen Planus: A Prospective Real-World Case Series of Ten Adults. (PubMed, Australas J Dermatol) - "The most frequent adverse events were insomnia (50%) and loose stools (30%), and two patients (20%) discontinued treatment because of adverse events. These preliminary prospective real-world findings suggest that oral roflumilast may represent a potential therapeutic option for LP and support further controlled studies to define the role of PDE4 inhibition and optimal dosing in this condition."

Journal • Real-world evidence • CNS Disorders • Dermatology • Dermatopathology • Insomnia • Lichen Planus • Pruritus • Sleep Disorder

A Breath of Life Beyond Bronchodilation: Early Data on Hemodynamic and Functional Outcomes With Ensifentrine Nebulization in Severe COPD-associated Pulmonary Hypertension. (PubMed, Open Respir Med J) - "• The combination of ensifentrine with roflumilast was well tolerated. In this retrospective study, ensifentrine was safe and was associated with modest improvements in pulmonary hemodynamics and functional status in patients with severe COPD with pre-capillary PH. These preliminary findings warrant confirmation in larger, prospective, controlled trials."

Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

The evolving landscape of phosphodiesterase inhibitors in atopic dermatitis management. (PubMed, Expert Opin Pharmacother) - "Approved agents such as crisaborole, roflumilast, and difamilast demonstrate moderate efficacy and favorable safety, mainly in mild-to-moderate AD. Emerging therapies, including apremilast, orismilast, and lotamilast, show variable results and remain under investigation...However, their efficacy is generally lower than that of biologics and JAK inhibitors. Their future role will likely depend on use as adjunctive or personalized therapies rather than replacement of high-efficacy systemic treatments."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pediatrics

Physicochemical properties of phosphodiesterase-4 inhibitor orismilast and implications for new inhibitor design. (PubMed, J Invest Dermatol) - No abstract available

Journal • Dermatology • Inflammation

Validation and testing of an in vitro model to study medical treatments for anterior urethral stricture disease: assessing the potential efficacy of phosphodiesterase-4 (PDE4) inhibition and testosterone. (PubMed, Urology) - "Urethral FBs and ECs can be cultured from healthy and strictured surgical specimens, enabling in vitro research. PDE4 inhibitors and T may be non-cytotoxic alternatives or additions to paclitaxel for aUSD."

Journal • Preclinical • Urology • TGFB1

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) (clinicaltrials.gov) - P4 | N=41 | Completed | Sponsor: Jacob Pontoppidan Thyssen | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Sep 2025

Trial completion • Trial completion date • Atopic Dermatitis • Contact Dermatitis • Dermatology • Immunology

Comparative effectiveness of azithromycin versus roflumilast in patients with chronic obstructive pulmonary disease: emulated target trial. (PubMed, BMJ) - "Among patients with active COPD, azithromycin use was associated with a reduced likelihood of moderate or severe COPD exacerbations compared with roflumilast use. Although this study did not assess the comparative safety of these agents, it provides evidence on treatment outcomes that may complement forthcoming data from a large randomised controlled trial."

Clinical • HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

UCLA study compares two COPD treatments to guide patient care (UCLA) - "For patients who experience frequent exacerbations while on maximal inhaler therapy, clinical guidelines recommend one of two treatment options: azithromycin or roflumilast...According to the new study, published in BMJ, maintenance azithromycin, taken as long-term preventive therapy to prevent future flare-ups, seemed to perform slightly better than roflumilast in protecting against COPD exacerbations. Patients taking azithromycin had a 17% lower risk of experiencing their first moderate or severe flare-up; an 11% lower rate of flare-ups over one year of follow-up; and a slightly lower risk (6%) of being hospitalized or dying from any cause compared to roflumilast...The findings of this study highlight differences in treatment effectiveness that may help guide clinical decision making when considered alongside safety evidence and forthcoming data from a large randomized controlled trial."

Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology

Degradable porous PLGA/PCL membrane enable a lung alveoli-on-a-chip for modeling particulate-induced alveolar injury. (PubMed, Biofabrication) - "Pharmacological modulation with roflumilast-N-oxide (RNO), a phosphodiesterase-4 (PDE4) inhibitor, selectively attenuated oxidative stress and inflammatory responses, with limited effects on barrier integrity. Together, this work establishes degradable PLGA/PCL membranes as tunable interface materials for lung-on-a-chip systems, where structural evolution during degradation directly governs transport and barrier function. The resulting platform provides a physiologically relevant approach for studying particulate toxicity and therapeutic modulation at the alveolar interface."

Journal • Inflammation • Respiratory Diseases