Saudi regulator approves Jascayd for idiopathic pulmonary fibrosis
Saudi Arabia has approved Jascayd for adults with idiopathic pulmonary fibrosis following Phase III evidence showing reduced decline in lung function.
Jascayd (nerandomilast), a preferential PDE4B inhibitor, has been registered by the Saudi Food and Drug Authority for the treatment of adults with idiopathic pulmonary fibrosis.
The approval is supported by the 1,177-patient Phase III FIBRONEER-IPF trial, in which treatment produced statistically significant reductions in forced vital capacity decline compared with placebo.
Field | Content |
Article Type | Approvals |
Drug Name | Nerandomilast |
Brand Name | Jascayd |
Regulatory Authority | Saudi Food and Drug Authority |
Approval Type | Marketing approval |
Indication | Idiopathic pulmonary fibrosis |
Patient Population | Adults |
Therapy Areas | Pulmonology; respiratory disease |
Technology/Modality | Preferential PDE4B inhibitor |
Clinical Study | Phase III FIBRONEER-IPF |
Study Population | 1,177 patients |
Key Result | Jascayd demonstrated statistically significant reductions in decline of forced vital capacity versus placebo. |
Geography | Saudi Arabia |
What Happened | The Saudi Food and Drug Authority approved Jascayd for adults with idiopathic pulmonary fibrosis. |
Why It Matters | The approval introduces another treatment option for a progressive fibrotic lung disease associated with declining respiratory function. |
Supporting Context | The regulatory decision was supported by the Phase III FIBRONEER-IPF programme involving 1,177 patients. |
Potential Impact | Jascayd could broaden treatment choice for adults with IPF in Saudi Arabia and support wider regional uptake of the therapy. |
Key Takeaway | Jascayd has received Saudi marketing approval for adult idiopathic pulmonary fibrosis. |
What to Watch | Commercial launch, reimbursement and positioning alongside established antifibrotic therapies. |
Primary Source | Saudi Food and Drug Authority |
Relevant Date | 3 October 2026 |
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