JASCAYD™ receives Health Canada authorization for a new, well-tolerated oral treatment for adults with IPF and PPF
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- This marks the first new treatment approved for IPF in Canada in over a decade and for PPF in more than five years.1,2
BURLINGTON, ON, Oct. 13, 2026 /CNW/ -- Boehringer Ingelheim Canada announced that JASCAYD™ (nerandomilast) has received authorization from Health Canada for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF).
JASCAYD™ is the first phosphodiesterase 4B (PDE4B) inhibitor authorized in Canada for these indications and represents an important new treatment option for Canadians living with these progressive and life-limiting fibrosing lung diseases.3 JASCAYD™ is the first treatment in over a decade to demonstrate efficacy in IPF and the first alternative treatment option for PPF in more than five years.1,2 It also shows a favorable tolerability and safety profile with low discontinuation rates across both conditions in the phase III clinical trials.1,2
The authorization is supported by results from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD trials, the largest Phase III clinical program conducted across IPF and PPF to date.1,2 In both the FIBRONEER™-IPF and FIBRONEER™-ILD trials, the primary endpoint was met: nerandomilast successfully slowed lung function decline, measured by absolute change in forced vital capacity (FVC) from baseline to week 52 compared to placebo.1,2 While the key secondary endpoint was not met in either trial, a numerical reduction in mortality was observed across both trials, reaching nominal significance in FIBRONEER™-ILD.1,2 Nerandomilast demonstrated a favorable safety and tolerability profile with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.1,2
Canadian prevalence estimates suggest that more than 17,000 people may be living with IPF.4
IPF and PPF are rare, progressive lung diseases, causing irreversible lung scarring that severely restricts breathing.5,6 Despite the life-threatening nature of these conditions that have a prognosis worse than many cancers,7,8,9 many people delay initiating therapy or discontinue therapy due to gastrointestinal side effects and/or photosensitivity.10,11,13 In IPF specifically, approximately half of those who stop therapy do so within six months.12
Dr. Martin Kolb, MD, PhD, Professor of Medicine, Division of Respirology, McMaster University
"Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are rare, progressive diseases with limited treatment options. In IPF, we have seen little clinical trial success over the past decade. The authorization of JASCAYD™ is welcome news and provides an important new and better tolerated treatment option for patients living with IPF and PPF."
Sharon Lee, CEO, Canadian Pulmonary Fibrosis Foundation (CPFF)
"People living with pulmonary fibrosis have waited more than a decade for a new treatment option. During that time, patients and families have faced the daily challenges of a disease that affects their independence, quality of life and plans for the future. The authorization of JASCAYD™ brings renewed hope to our community. We are grateful to the researchers and clinical trial participants who made this advancement possible, and we will continue working toward equitable access for Canadians who need it."
Dr. Rasha Eldesouky Abouelabbas, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd.
"The authorization of JASCAYD™ marks an important milestone for patients, caregivers and healthcare professionals. We are proud to bring a new treatment option to Canadians living with IPF and PPF and remain committed to advancing lung health innovation for people affected by serious lung diseases."
About nerandomilast
JASCAYD™ (nerandomilast) is an oral PDE4B inhibitor with antifibrotic and immunomodulatory effects authorized in multiple countries worldwide for the treatment of adults with IPF and adults with PPF.
Boehringer Ingelheim is also exploring the potential of nerandomilast in two rheumatic diseases: systemic sclerosis (SSc) and myositis (IIM).
About IPF and PPF
Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are both conditions with irreversible build-up of scar tissue in the lungs, affecting the lungs' ability to take in and transfer oxygen into the bloodstream.6,7,13 Signs and symptoms of IPF and PPF include a persistent dry cough and shortness of breath on exertion.7,14
In IPF, the root cause of pulmonary fibrosis is not known.14 In PPF, the scarring of the lungs may be linked to an existing condition (e.g. rheumatoid arthritis or systemic sclerosis), result from exposure to inhaled substances (e.g. asbestos or mold), or due to an unknown cause (idiopathic).6
About Boehringer Ingelheim (Canada) Ltd.
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at www.boehringer-ingelheim.com/ca.
References
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1 Maher T et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025;392(22):2203-2214. |
2 Richeldi L, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025;392(22):2193-2202. |
3 JASCAYD™ (nerandomilast) Product Monograph. Canada. (Last updated: Oct 2026). |
4 Hopkins, Robert & Burke, Natasha & Fell, Charlene & Dion, Genevieve & Kolb, Martin. (2016). Epidemiology and survival of idiopathic pulmonary fibrosis from national data in Canada. European Respiratory Journal. 48. ERJ-01504. 10.1183/13993003.01504-2015. |
5 Kondoh Y, Inoue Y. Progressive Pulmonary Fibrosis: Current Status in Terminology and Future Directions. Adv Ther. 2025;42(7):2988–3001. |
6 van Cleemput, J, et al. Idiopathic Pulmonary Fibrosis for Cardiologists: Differential Diagnosis, Cardiovascular Comorbidities, and Patient Management. Adv Ther. 2019;36, 298–317. |
7 Cen Z, et al. Ann Med. 2024;56(1):2406439. |
8 Siegel RL, et al. A Cancer Journal for Clinicians. 2024;74(1):12–49. |
9 Vancheri C, et al. Eur Respir J. 2010;35(3):496–504. |
10 Esbriet SmPC -- Roche, 2014. |
11 Ofev SmPC -- Boehringer Ingelheim, 2025 (Last updated: Oct 2025). |
12 Levra S et al. Biomedicines. 2022;10(12):3229. |
13 Upagupta C, et al. Eur Respir Rev. 2018;27:180033. |
14 Grant-Orser A, et al. BMJ Open Respir Res. 2024;11:e002333. |
SOURCE Boehringer Ingelheim Canada Ltd.
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