Jascayd
Authorised
This medicine is authorised for use in the European Union
nerandomilast
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Jascayd is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). ‘Idiopathic’ means that the cause of the disease is unknown. IPF and PPF are rare lung diseases in which fibrous scar tissue continuously forms in the lungs, replacing healthy lung tissue and causing persistent cough, frequent lung infections, and severe shortness of breath.
Jascayd contains the active substance nerandomilast.
Jascayd can only be obtained with a prescription, and treatment should be started by a doctor with experience in managing IPF or PPF.
Jascayd is available as tablets to be taken by mouth twice a day. The doctor may reduce the dose if the patient experiences certain side effects or is taking certain other medicines.
For more information about using Jascayd, see the package leaflet or contact your doctor or pharmacist.
The active substance in Jascayd, nerandomilast, blocks the activity of an enzyme (a type of protein) called PDE4B. This enzyme is found in the lungs and plays an important role in fibrosis (the formation of fibrous scar tissue) and inflammation. By blocking PDE4B activity, Jascayd helps reduce further scarring and stiffening of the lungs, making it easier for the patient to breathe.
Jascayd was more effective than placebo at slowing disease progression in two main clinical studies involving a total of 2,355 patients with IPF or PPF.
The main measure of effectiveness was the decline in lung function over the course of 1 year of treatment, measured by forced vital capacity (FVC). FVC is the maximum amount of air a person can breathe out forcefully after taking in a deep breath; in IPF and PPF, FVC decreases as the patient’s condition gets worse.
In both studies, the FVC decrease was less pronounced in patients taking Jascayd than in patients taking placebo. In the study involving patients with IPF, the average decrease in FVC after 1 year was around 115 ml in patients taking 18 mg Jascayd twice a day and 139 ml in those taking 9 mg Jascayd twice a day, compared with 183 ml in patients taking placebo. In the study involving patients with PPF, these figures were around 99 ml and 85 ml, respectively, compared with around 166 ml for patients taking placebo.
Studies carried out with Jascayd are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions associated with Jascayd, see the package leaflet.
The most common side effects with Jascayd include diarrhoea (which may affect more than 1 in 10 people) and weight loss (which may affect up to 1 in 10 people).
Jascayd has been shown to be effective at slowing disease progression in patients with IPF and PPF. At the time of approval, there were limited treatment options for people with IPF or PPF. Both conditions can cause severe symptoms, including difficulty breathing, which can lead to hospitalisation and ultimately death within a few years of diagnosis. Since Jascayd works in a different way to medicines available for IPF and PPF at the time of approval, it represents a new treatment option for patients with these conditions. In terms of safety, the side effects of Jascayd are consistent with those seen with other medicines of the same class and can be managed with dose reductions, when appropriate.
The European Medicines Agency therefore decided that Jascayd’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jascayd have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Jascayd are continuously monitored. Suspected side effects reported with Jascayd are carefully evaluated and any necessary action is taken to protect patients.
Jascayd received a marketing authorisation valid throughout the EU on 15 July 2026.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Jascayd
- Active substance
- nerandomilast
- International non-proprietary name (INN) or common name
- nerandomilast
- Therapeutic area (MeSH)
- Idiopathic Pulmonary Fibrosis
- Anatomical therapeutic chemical (ATC) code
- L04AA61
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Jascayd is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF).
Jascayd is indicated for the treatment of adult patients with Progressive Pulmonary Fibrosis (PPF).
News on Jascayd
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