U.S. FDA approves JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults

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Dec 22, 2025, 07:00 ET

INGELHEIM, Germany and RIDGEFIELD, Conn., Dec. 22, 2025

Progressive pulmonary fibrosis (PPF) is a life-threatening, progressive lung condition, causing a continuous decline in lung function.¹^,²
Affecting up to 100,000 people in the U.S. and up to 5.6 million worldwide, PPF is linked to an underlying clinical interstitial lung disease (ILD) diagnosis, such as autoimmune ILD or hypersensitivity pneumonitis.³^,⁴^,5
PPF is the second FDA-approved indication for JASCAYD, following the recent approval for idiopathic pulmonary fibrosis (IPF) in adults.⁵

/PRNewswire/ -- Boehringer Ingelheim's JASCAYD^® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults.⁵ This represents a new treatment option in the U.S. for this debilitating lung condition, with JASCAYD being the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication.^1,5 The FDA approval is based on results from the pivotal Phase III FIBRONEER^TM-ILD clinical trial, the largest clinical trial program in PPF to date.⁵ Results showed that JASCAYD effectively slowed lung function decline in PPF with similar permanent discontinuation rates to placebo.^5,⁶^*

^* In FIBRONEER™-ILD, adverse events led to permanent discontinuation of the trial regimen in 10.0% of the JASCAYD 18 mg group, 8.1% in the JASCAYD 9 mg group, and 10.2% in the placebo group.⁶

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"Progressive pulmonary fibrosis is linked to underlying clinical ILD diagnoses including autoimmune ILDs – which can be caused by disorders like rheumatoid arthritis or systemic sclerosis – as well as hypersensitivity pneumonitis, among other conditions," said Shervin Assassi, M.D., Prof., Director of Rheumatology, McGovern Medical School, UTHealth Houston. "These underlying conditions often lead to the lungs being overlooked, yet lung scarring may lead to debilitating and irreversible impact on lung function. This can have a detrimental effect on patients' lives and highlights the need for new treatment options that can help reduce the decline in lung function, as has been observed with JASCAYD."

The primary endpoint in FIBRONEER^TM-ILD was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at Week 52.^5,⁷ JASCAYD demonstrated a significantly smaller reduction in FVC decline from baseline compared to placebo.⁵ Specifically, the adjusted mean decline in absolute change from baseline in FVC in patients receiving JASCAYD 18 mg or 9 mg was -86 mL and -69 mL, respectively, versus -152 mL in the placebo group.⁵ The respective treatment difference compared with the placebo group was 65 mL (95% CI: 30, 101) and 83 mL (95% CI: 48, 118).⁵ The most common adverse reactions in patients with PPF treated with JASCAYD were generally consistent with those observed in patients with IPF.⁵

"Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The U.S. approval of JASCAYD is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "My gratitude goes to patients, investigators and our teams whose dedication made this milestone possible. We will now work closely with stakeholders to enable access and work tirelessly to ensure patients around the world can benefit from JASCAYD as quickly as possible."

"People living with progressive pulmonary fibrosis often carry a heavy burden that others don't always see," said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation. "A progressive disease condition process like PPF can worsen lung function quickly, and patients have been eagerly awaiting additional treatment options. The FDA approval of JASCAYD for PPF is a welcomed milestone for the community."

Additional FIBRONEER-ILD Data
In the FIBRONEER^TM-ILD clinical trial, the key secondary composite endpoint was the time to the first occurrence of any of the components of the composite endpoint over the blinded duration of the trial (up to 109 weeks): acute ILD exacerbation, hospitalization for respiratory cause, or death.⁵ Overall, there was no statistically significant treatment difference in the hazard ratio (HR) for the JASCAYD 18 mg or 9 mg groups compared to placebo for the key secondary composite endpoint (JASCAYD 18 mg or 9 mg groups, respectively, compared to placebo: HR 0.77 [95% CI: 0.59, 1.01] and HR 0.88 [95% CI: 0.68, 1.14]).⁵ Further results for JASCAYD 18 mg in respect to the key secondary endpoint components, from an exploratory analysis, include:

JASCAYD 18 mg showed a nominally significant reduction in the risk of acute ILD exacerbations over the blinded trial duration (up to 109 weeks) compared to placebo (HR 0.60 [95% CI: 0.38, 0.94]).⁵
JASCAYD 18 mg showed a numerical reduction in the risk of hospitalization for respiratory cause over the blinded trial duration (up to 109 weeks) compared to placebo (HR 0.82 [95% CI: 0.61, 1.11]).⁵

Additionally, a prespecified analysis of overall survival at the end of the FIBRONEER^TM-ILD trial showed a trend in favor of JASCAYD.⁵ The HRs for all-cause mortality until the end of the trial (up to 114 weeks) for JASCAYD 18 mg and 9 mg compared to placebo were 0.51 [95% CI: 0.34, 0.78] and 0.51 [95% CI: 0.34, 0.78], respectively.⁵ These results were not prespecified for multiplicity control.⁵

Overall, JASCAYD was well-tolerated in patients with PPF.⁵ Diarrhea was more common in patients using JASCAYD with concomitant nintedanib.⁵ In patients taking background nintedanib, diarrhea occurred 49%, 50%, and 37% of patients treated with JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively.⁵ In patients without concomitant use of background nintedanib, diarrhea occurred in 27%, 16%, and 16% of patients using JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively.⁵

Diarrhea was the most common adverse reaction associated with treatment discontinuation and occurred most frequently in patients treated with JASCAYD 18 mg or (4%) or JASCAYD 9 mg (3%) with background antifibrotic therapy, versus patients receiving placebo (1%) and background antifibrotic therapy.⁵Importantly, in patients not receiving concomitant nintedanib, diarrhea led to treatment discontinuation in 1% of patients treated with JASCAYD 18 mg and in no patients receiving JASCAYD 9 mg or placebo.⁵ In most patients treated with JASCAYD, diarrhea was of mild to moderate intensity and generally occurred within the first 3 months of treatment.⁵

There is no 'Warnings and Precautions' section in the FDA approved product label.⁵ Please see additional important safety information below.

About PPF
Progressive pulmonary fibrosis (PPF) affects up to 5.6 million people worldwide and up to 100,000 people in the U.S.^3,4It is linked to an underlying clinical ILD disease diagnosis, such as autoimmune ILDs, hypersensitivity pneumonitis, unclassifiable idiopathic interstitial pneumonia, or idiopathic nonspecific interstitial pneumonia, among other forms of ILD.⁵ PPF can also be caused by environmental exposure to asbestos, silica or other toxins, or result from an unknown cause.¹^,⁸ With progression, PPF can cause decreases in lung function.¹ On average, diagnosis is delayed by up to two years and up to half of those diagnosed remain untreated.⁹^,¹⁰

The following information is intended for U.S. audiences only:

What is JASCAYD?

JASCAYD is a prescription medicine used:
- to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF)
- to treat adults with a lung disease called progressive pulmonary fibrosis (PPF)
It is not known if JASCAYD is safe and effective in children

IMPORTANT SAFETY INFORMATION

Before you take JASCAYD, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems.
have liver problems.
are pregnant or plan to become pregnant. JASCAYD may cause loss of your pregnancy (miscarriage). It is not known if JASCAYD can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant while taking JASCAYD.
are breastfeeding or plan to breastfeed. It is not known if JASCAYD passes into your breastmilk. You and your healthcare provider should decide if you will take JASCAYD or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JASCAYD may affect the way other medicines work, and other medicines may affect how JASCAYD works. Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.

What are the possible side effects of JASCAYD?

The most common side effects of JASCAYD include: diarrhea, COVID-19, upper respiratory tract infection, depression, weight loss, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.

These are not all the possible side effects of JASCAYD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-JS-100017 12.19.2025

For U.S. Audiences, please see full Prescribing Information and Patient Information.

Boehringer Ingelheim's CareConnect4Me patient support program
Boehringer's goal is to make JASCAYD easily accessible in the U.S. through a comprehensive patient support program, CareConnect4Me™, that provides a broad range of access and clinical support solutions, including financial support services. For those in the U.S., visit JASCAYD.com or call 844-JASCAYD (1-844-527-2293) to learn more.

About Boehringer Ingelheim
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 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer-Ingelheim.com/US.

References

¹ Kondoh Y, Inoue Y. Progressive Pulmonary Fibrosis: Current Status in Terminology and Future Directions. Adv Ther. 2025;42(7):2988–3001.
² Cen Z, et al. Outcomes and predictors of progression in progressive pulmonary fibrosis. Ann Med. 2024;56(1):2406439.
³ Montero IE, Hernandez-Gonzalez F, Sellares J. Epidemiology and prognosis of progressive pulmonary fibrosis: a literature review. Pulm Ther. 2025;11(3):347-363. doi:10.1007/s41030-025-00302-5.
⁴ Cottin V, et al. The Burden of Progressive-Fibrosing Interstitial Lung Diseases. Front Med (Lausanne). 2022;9:799912.
⁵ JASCAYD^® (nerandomilast). Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2025. (Last updated: Dec 2025).
⁶ Maher TM, et al. (2025) Nerandomilast in patients with progressive pulmonary fibrosis. In: NEJM. 2025.
⁷ Twisk JWR et al. (1998). Tracking of lung function parameters and the longitudinal relationship with lifestyle. European Respiratory Journal. 12(3):627–634.
⁸ Raghu G, Remy-Jardin M, Richeldi L, et al. Am J Respir Crit Care Med. 2022;205(9). DOI: 10.1164/rccm.202202-0399ST.
⁹ Chaudhuri et al. Respiratory Research 2024; 25:364
¹⁰ Wijsenbeek M et al. Current Medical Research and Opinion 2019; 35 (11): 2015-2024