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The Saudi Press Agency reported that the Saudi Food and Drug Authority approved the registration of Jascayd (nerandomilast) for the treatment of adult patients with idiopathic pulmonary fibrosis. The SFDA reached its decision after completing a comprehensive evaluation of the drug’s efficacy safety and quality. Idiopathic pulmonary fibrosis is a progressive scarring of lung tissue that worsens breathing over time and has limited treatment options. The authority’s move aligns with its role in accelerating access to therapies for rare diseases under national health initiatives.
Clinical data cited by the SFDA came primarily from the Phase 3 FIBRONEER-IPF trial that randomised 1,177 patients to Jascayd 9 milligrams twice daily Jascayd 18 milligrams twice daily or placebo for 52 weeks. The decline in forced vital capacity measured 115 millilitres for the 18-milligram dose and 139 millilitres for the 9-milligram dose against 184 millilitres in the placebo arm. Both doses achieved statistically significant reductions in the rate of lung function loss according to the SFDA assessment. These results were reinforced by an earlier Phase 2 study in 147 patients that demonstrated a positive effect on forced vital capacity after 12 weeks.
The SFDA listed diarrhoea nausea weight loss decreased appetite and back pain as the most commonly reported adverse reactions. The authority noted that the safety profile remained consistent with observations from international trials. Jascayd is an oral preferential phosphodiesterase 4B inhibitor developed by Boehringer Ingelheim that exerts antifibrotic and immunomodulatory effects. The Saudi registration follows similar approvals in other markets and forms part of broader regulatory efforts to address unmet needs in respiratory medicine.
The U.S. Food and Drug Administration approved the drug for idiopathic pulmonary fibrosis in October 2025 describing it as the first new therapy in more than a decade for the condition. Boehringer Ingelheim has since secured additional approvals including in China where the National Medical Products Administration cleared the treatment weeks after the U.S. decision. Regulatory reviews continue in the European Union Japan and several other countries with further authorisations anticipated through 2026. The SFDA approval expands patient access within the kingdom where specialists manage care for this rare progressive disease.
Estimates from international health bodies place the global burden of idiopathic pulmonary fibrosis and related progressive fibrosing lung diseases in the millions of patients. The SFDA emphasised that its orphan drug pathway had facilitated earlier engagement with the developer before full registration. This latest decision builds on the authority’s January 2026 orphan designation for the same product which had streamlined the subsequent marketing application. Healthcare providers in Saudi Arabia are expected to incorporate the new option into treatment protocols for eligible adults.
The SFDA continues to monitor post-approval data for all registered medicines to ensure ongoing safety and effectiveness. Boehringer Ingelheim has indicated that Jascayd will be made available through appropriate distribution channels in the Saudi market. The development reflects coordinated regulatory alignment across multiple jurisdictions on a therapy that slows but does not cure the underlying fibrosis.
