Ohtuvayre (ensifentrine nebulized) / Verona Pharma, Ligand, Nuance Biotech - LARVOL DELTA

Ensifentrine vs placebo for chronic obstructive pulmonary disease: a systematic review and meta-analysis of randomized clinical trials. (PubMed, Expert Rev Respir Med) - "Larger RCTs are needed to integrate this bronchodilator benefit with patient-centered outcomes. CRD42024571928."

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

RPL554-CO-303: Effect of Ensifentrine Treatment on CAT Score (clinicaltrials.gov) - P3 | N=20 | Completed | Sponsor: Verona Pharma plc | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Dec 2024

Trial completion • Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Anti-Inflammatory Activity of Ensifentrine, a Novel, Selective Dual Inhibitor of Phosphodiesterase (PDE)3 and PDE4. (PubMed, Respiration) - "This manuscript describes further evidence that ensifentrine is a selective dual inhibitor of both human PDE3 and PDE4 enzymes and that this drug has significant anti-inflammatory activity in vivo in both allergic guinea pigs and non-human primates. This dual bronchodilator and anti-inflammatory activity of ensifentrine makes it a promising strategy as a novel inhaled "bifunctional" drug for the treatment of obstructive and inflammatory diseases of the respiratory tract."

Journal • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Genetic Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CFTR

Ritedose Adds Seventh Syntegon Packaging Line to Expand Single Vial Packaging Capabilities, Support Production of new COPD Drug Ohtuvayre (PRNewswire) - "Anticipating a rising need for individually wrapped vial medication manufacturing, The Ritedose Corporation, Inc. (Ritedose) is adding a seventh Syntegon packaging line to its state-of-the-art manufacturing facility that will double the company's capacity....The new Syntegon packaging system doubles Ritedose's capacity to deliver individually wrapped vial medications to patients. The packaging line will be able to process between 160 million and 170 million vials annually....The Syntegon Packaging line will support Ritedose's manufacturing efforts for Verona Pharma plc's Ohtuvayre, a new novel product for Chronic Obstructive Pulmonary Disease (COPD)....Ritedose expects the packaging line to be in service by early summer of 2025. The automated system is currently undergoing Site Acceptance Testing at The Ritedose facility."

Commercial • Chronic Obstructive Pulmonary Disease

Novel advances in chronic obstructive pulmonary disease treatment: Ensifentrine. (PubMed, J Pak Med Assoc) - No abstract available

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

Tissue Distribution of 14C-Ensifentrine, a Novel Phosphodiesterase (PDE)3 and PDE4 Inhibitor, in Rats Following a Single Intravenous Dose (ATS 2025) - No abstract available

Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Anti-inflammatory and Parasympathetic Bronchorelaxant Effects of Ensifentrine in Combination With Inhaled Therapies in a Human Ex Vivo Model of COPD (ATS 2025) - No abstract available

Combination therapy • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Ensifentrine Improved Respiratory Symptoms and Quality of Life in Patients With COPD and Concomitant Type 2 Diabetes (ATS 2025) - No abstract available

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Diabetes • Immunology • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

Integrating green analytical chemistry and analytical quality by design: an innovative approach for RP-UPLC method development of ensifentrine in bulk and inhalation formulations. (PubMed, BMC Chem) - "This study presents a sensitive and robust RP-UPLC method for quantifying Ensifentrine, combining AQbD and GAC principles. The method, validated according to ICH guidelines, also ensures environmental sustainability. This approach sets a precedent for future analytical method development in pharmaceutical sciences with a focus on sustainability."

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

Ensifentrine as a Novel Treatment for Chronic Obstructive Pulmonary Disease: A Meta-Analysis (ATS 2025) - No abstract available

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

Efficacy Of Ensifentrine In Chronic Obstructive Pulmonary Disease (copd): A Meta-analysis Of Randomized Controlled Trials (ATS 2025) - No abstract available

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

Ensifentrine Improved Patient-reported Outcomes, Including Dyspnea, in Patients With COPD and Concomitant Cardiac Disorders (ATS 2025) - No abstract available

Clinical • Patient reported outcomes • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Effects of Ensifentrine, a Dual Phosphodiesterase (PDE)3 and PDE4 Inhibitor, on Lung Fibrosis in a Rat Bleomycin Model (ATS 2025) - No abstract available

Preclinical • Fibrosis • Immunology • Respiratory Diseases

Ensifentrine Reduced Exacerbation Rate Regardless of FEV1 Improvement: A Post-hoc Pooled Analysis (ATS 2025) - No abstract available

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

Ensifentrine Versus Placebo for Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis of Randomized Clinical Trials (ATS 2025) - No abstract available

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

Ensifentrine Monotherapy Reduced Dyspnea and Improved Quality of Life in Patients With Symptomatic, Moderate-to-Severe COPD (ATS 2025) - No abstract available

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

Ensifentrine Improved Lung Function and Reduced Exacerbations in Patients With COPD and Concomitant Cardiac Disorders (ATS 2025) - No abstract available

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Ensifentrine Monotherapy Improved Lung Function and Reduced Exacerbation Rate and Risk in Symptomatic Patients With Moderate-to-Severe COPD (ATS 2025) - No abstract available

Clinical • Monotherapy • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Synergistic Bronchorelaxant Effects of Ensifentrine in Combination With Inhaled Therapies in a Human Ex Vivo Model of COPD (ATS 2025) - No abstract available

Combination therapy • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Ensifentrine Improved Lung Function and Reduced Exacerbation Rate in Patients With COPD and Concomitant Type 2 Diabetes (ATS 2025) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Diabetes • Immunology • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

OHTUVAYRE (ensifentrine) Now Available Through PromptCare (EIN News) - "PromptCare, a leader in specialty pharmacy and respiratory services, is now an authorized distributor of OHTUVAYRE (ensifentrine), an FDA-approved maintenance treatment for adults with chronic obstructive pulmonary disease (COPD)....Available through exclusive limited distribution, OHTUVAYRE is a selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 ('PDE3 and PDE4')), providing bronchodilator and non-steroidal anti-inflammatory effects in a single inhaled ampoule."

Commercial • Chronic Obstructive Pulmonary Disease

RPL554-CO-303: Effect of Ensifentrine Treatment on CAT Score (clinicaltrials.gov) - P3 | N=20 | Active, not recruiting | Sponsor: Verona Pharma plc | Trial completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Development of a rat airway organoids model for studying chronic obstructive pulmonary disease. (PubMed, Tissue Cell) - "Inflammatory markers responded differently, with ensifentrine and erdosteine significantly reducing cytokine levels. These results demonstrate that rat airway organoids replicate important aspects of human COPD pathology, thus providing an accessible, ethical, and clinically relevant alternative to human tissues and traditional animal models to enhance our understanding of COPD pathogenesis and evaluate potential treatments."

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

Effect of Ensifentrine on Sputum Markers of Inflammation in COPD (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Verona Pharma plc | Trial completion date: Dec 2024 ➔ Jun 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Verona Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "In the second half of 2025, the Company plans to start a dose-ranging Phase 2b trial to assess the safety and efficacy of a fixed-dose nebulized combination of ensifentrine with glycopyrrolate...In 2025, the Company plans to progress the regulatory activities for potential marketing authorization application submissions for Ohtuvayre for the maintenance treatment of COPD in the European Union and in the UK. In mid-2025, the Company’s development partner in Greater China, Nuance Pharma, is expected to report results from its pivotal Phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in China."

Approval • P2b data • P3 data • Chronic Obstructive Pulmonary Disease • Pulmonary Disease • Respiratory Diseases