Pulmozyme (dornase alfa) / Roche - LARVOL DELTA

FIB-TB: Efficacy and Safety of Intrapleural Fibrinolytic Therapy in Tuberculous Pleural Effusion Versus Non-Tuberculous Pleural Infection (clinicaltrials.gov) - P=N/A | N=160 | Not yet recruiting | Sponsor: National University of Malaysia

New trial • Infectious Disease • Respiratory Diseases

Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD) (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Ludwig-Maximilians - University of Munich | Unknown status ➔ Recruiting | Trial completion date: Jan 2026 ➔ Jul 2028 | Trial primary completion date: Dec 2025 ➔ Mar 2028

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Inflammation • Ischemic stroke

REACT: Rethinking Early Airway Clearence Therapies (clinicaltrials.gov) - P=N/A | N=405 | Not yet recruiting | Sponsor: Nicole Hamblett

New trial • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

PI2025_843_0088: EPISSOC : Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standard of Care for the management of complicated pleural infections (clinicaltrialsregister.eu) - P2/3 | N=244 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire Amiens Picardie

New P2/3 trial • Infectious Disease

FLO: Flush, Lyse, Operate (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Dartmouth-Hitchcock Medical Center

New P4 trial • Infectious Disease

RESET: Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months (clinicaltrials.gov) - P2 | N=304 | Recruiting | Sponsor: Fondation Ophtalmologique Adolphe de Rothschild | Trial completion date: Oct 2027 ➔ Sep 2028 | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2027 ➔ Mar 2028

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase) (clinicaltrials.gov) - P2 | N=330 | Completed | Sponsor: University of Melbourne | Recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

Investigator Initiated Study to Assess the Safety of Combination of CLS-015 With Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive Large B Cell Lymphoma at Lymphodepletion. (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Tel-Aviv Sourasky Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy of daily IV administration of dornase alfa for up to 14 days post subarachnoid haemorrhage on functional independence at 6 months: a multicentre open-label randomised controlled trial of the PROBE type Probe (clinicaltrialsregister.eu) - P2/3 | N=304 | Recruiting | Sponsor: Hopital Fondation Adolphe De Rothschild | Phase classification: P1/2 ➔ P2/3

Phase classification • Hematological Disorders • Subarachnoid Hemorrhage

I-SPY_COVID: I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (clinicaltrials.gov) - P2 | N=1500 | Active, not recruiting | Sponsor: QuantumLeap Healthcare Collaborative | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Pleural Irrigation With Normal Saline Versus Intrapleural Fibrinolytic (clinicaltrials.gov) - P=N/A | N=40 | Completed | Sponsor: National University of Malaysia | Recruiting ➔ Completed | N=78 ➔ 40

Enrollment change • Trial completion • Infectious Disease • CRP

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: University Hospital, Strasbourg, France | Initiation date: Nov 2018 ➔ Mar 2019

Trial initiation date • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Oct 2021 ➔ Nov 2022 | Trial primary completion date: Oct 2021 ➔ Oct 2022

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: University Hospital, Strasbourg, France

New P3 trial • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Sep 2024 ➔ Sep 2027

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Sep 2024 ➔ Dec 2024

Trial completion date • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

TRAUMADOR: Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Nov 2022 ➔ Sep 2024 | Trial primary completion date: Oct 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Critical care • Mood Disorders • Respiratory Diseases

Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target) (clinicaltrials.gov) - P2 | N=39 | Completed | Sponsor: Fondation Ophtalmologique Adolphe de Rothschild | Trial completion date: Nov 2025 ➔ Aug 2025 | Recruiting ➔ Completed

Trial completion • Trial completion date • Cardiovascular • Ischemic stroke

DACT-GCT: Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer. (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: National Cancer Institute, Slovakia

New P2 trial • Germ Cell Tumors • Oncology

RESET: Efficacy of Daily IV Administration of Dornase Alfa Up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence At 6 Months (clinicaltrials.gov) - P2 | N=304 | Not yet recruiting | Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

New P2 trial • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

Vabysmo, Hemlibra Drive Roches Sales in Q3 & First 9 Months of 2024 (Yahoo Finance) - "Immuno-oncology drug Tecentriq’s (for advanced lung cancer, urothelial cancer and breast cancer) sales grew 1% to CHF 2.7 billion....Asthma drug Xolair generated sales of CHF 1.7 billion, up 11% year over year....Pulmozyme (cystic fibrosis) sales were flat year over year at CHF 329 million."

Sales • Asthma • Breast Cancer • Cystic Fibrosis • Lung Cancer • Urothelial Cancer

A Study of the Comparability of the Pharmacodynamic, Toxicological, and Pharmacokinetic Properties of the Reference Drug Pulmozyme® and the Biosimilar Drug Tigerase®. (PubMed, Dokl Biochem Biophys) - "The pharmacokinetic parameters of the drugs in the blood serum, bronchi, and lungs, as well as the main physiological parameters (body weight and temperature, the state of the cardiovascular, respiratory, excretory systems, hematological and biochemical blood parameters, pathomorphological changes in internal organs (including the state of the cornea), and mortality rates) were investigated in comparative studies of subchronic toxicity in juvenile and mature rats with 28-day inhalation at doses of 0.2 mg/kg for mature animals and 0.26 mg/kg for juvenile animals (the dose was 6 times higher than the dose recommended for clinical use). The results of the studies allow us to conclude that the drugs are comparable in enzymatic, mucolytic (secretolytic) DNase activity, safety profile and main pharmacokinetic parameters."

Journal • PK/PD data • Cardiovascular • Cystic Fibrosis • Genetic Disorders • Hematological Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and tolerability of dornase alfa biosimilar in children and adults with cystic fibrosis (ECFS 2024) - "There was no statistically significant decrease in FEV 1 data during the study period, and in children and adolescents there was a tendency of increase in FEV 1 . Child patients tolerated DA well; in adults, AEs were observed, which in most cases did not require discontinuation of the drug. In 2 children ADAs were identified."

Clinical • Cystic Fibrosis • Dysphonia • Genetic Disorders • Immunology • Otorhinolaryngology • Pain • Pulmonary Disease • Respiratory Diseases • Xerostomia

SIMPLIFY-DN: Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study (clinicaltrials.gov) - P=N/A | N=477 | Completed | Sponsor: Nicole Hamblett

New trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases