UK MHRA approves Boehringer Ingelheim’s nerandomilast (Jascayd®) for idiopathic and progressive pulmonary fibrosis, expanding treatment options for fibrotic lung disease.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved nerandomilast (Jascayd) for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), providing a new treatment option for two serious chronic lung diseases characterized by progressive scarring of lung tissue. The approval, announced on July 8, 2026, authorizes the use of the oral antifibrotic therapy in adults with these conditions, where progressive fibrosis leads to worsening lung function, breathlessness, and reduced quality of life.
Addressing Progressive Fibrotic Lung Disease
Idiopathic Pulmonary Fibrosis is a chronic, irreversible interstitial lung disease of unknown cause that results in progressive fibrosis and declining respiratory function. Progressive Pulmonary Fibrosis refers to a group of fibrosing interstitial lung diseases that continue to worsen despite appropriate management, ultimately leading to progressive loss of lung function. Treatment options for both conditions remain limited, making the availability of additional therapies an important development for patients and healthcare providers.
PDE4B Inhibitor Designed to Slow Fibrosis
Nerandomilast is a preferential phosphodiesterase 4B (PDE4B) inhibitor with antifibrotic and immunomodulatory properties. The therapy works by reducing the activity of inflammatory cytokines and pro-fibrotic growth factors involved in the development of lung fibrosis, helping slow the progression of fibrotic lung disease. Rather than reversing existing scarring, the medicine is intended to reduce the rate of further lung damage and slow the decline in lung function.
The medicine is available only on prescription and is recommended at a dose of 18 mg taken orally twice daily. Treatment should be initiated by physicians experienced in the diagnosis and management of pulmonary fibrotic diseases, with patients using the medicine according to the prescribing recommendations.
Approval Supported by Phase III FIBRONEER Program
The MHRA approval is supported by findings from the global Phase III FIBRONEER clinical development program, including the FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) studies. These pivotal trials evaluated nerandomilast in patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, respectively.
The studies demonstrated that nerandomilast significantly slowed the decline in forced vital capacity (FVC), a standard measure of lung function commonly used to assess disease progression in pulmonary fibrosis. The results supported the medicine’s benefit in slowing disease progression across both approved indications.
MHRA Highlights Unmet Clinical Need
Commenting on the approval, Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, said nerandomilast provides a new treatment option for adults living with IPF and PPF. He noted that the authorization reflects the agency’s commitment to ensuring patients have access to safe and effective medicines where unmet clinical needs exist and added that the MHRA will continue to closely monitor the medicine’s safety and effectiveness following its approval.
Safety Profile
According to the MHRA, the most frequently reported adverse reactions associated with nerandomilast are diarrhoea and weight loss, each occurring in more than one in ten patients. Patients who experience adverse effects are advised to consult their doctor, pharmacist, or nurse and report suspected side effects through the MHRA’s Yellow Card Scheme, which supports ongoing post-marketing safety surveillance.
Regulatory Details
The marketing authorization for nerandomilast was granted to Boehringer Ingelheim Limited International GmbH on 8 July 2026. The MHRA said detailed prescribing information, including the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), will be available through the agency’s Products website following the approval.
Expanding Treatment Options for Pulmonary Fibrosis
The approval of nerandomilast introduces a new oral therapeutic option for adults with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, two conditions associated with irreversible lung scarring and progressive respiratory decline. By targeting key pathways involved in fibrosis and demonstrating the ability to slow the loss of lung function in Phase III clinical trials, nerandomilast expands the treatment landscape for patients living with progressive fibrotic lung diseases while offering clinicians an additional evidence-based therapeutic option.
What This Means for Patients
The MHRA approval of nerandomilast provides adults with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis with an additional treatment option aimed at slowing disease progression. While the medicine is not a cure and does not reverse existing lung scarring, it may help slow the decline in lung function, potentially allowing patients to maintain daily activities for longer as part of their overall disease management plan. Treatment should be initiated and monitored by healthcare professionals experienced in managing pulmonary fibrotic diseases.
Reference
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.