Jascayd (nerandomilast)
An approved treatment for Idiopathic Pulmonary Fibrosis.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Nerandomilast wherever you encounter it, plus the key facts at a glance.
- Generic name
- Nerandomilast
- Brand name
- Jascayd
- Development code
- BI 1015550
- Drug class
- PDE4 inhibitor (PDE4B-preferring)
- Manufacturer
- Boehringer Ingelheim
- How it's taken
- 18mg by mouth twice a day, about 12 hours apart, with or without food.
A twice-daily pill approved by the FDA on October 7, 2025 for adults with idiopathic pulmonary fibrosis, the first new IPF drug in more than a decade, and on December 19, 2025 for progressive pulmonary fibrosis.
In its main IPF trial it slowed the loss of lung capacity over a year compared with placebo, and the result for the 18mg dose held whether patients also took nintedanib, pirfenidone or neither.
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Where Nerandomilast fits
The third drug approved for IPF, after pirfenidone and nintedanib in 2014, and the only one of the 3 that is a PDE4 inhibitor. It was tested on its own and on top of either older drug.
How Nerandomilast works
Inside cells, an enzyme family called phosphodiesterase 4 (PDE4) breaks down cAMP, a chemical messenger that helps keep inflammation and scar-forming activity in check. Nerandomilast blocks PDE4 and prefers one form of it, PDE4B, by at least ninefold in lab tests. With PDE4B blocked, cAMP stays higher in immune cells and in fibroblasts, the lung cells that lay down scar tissue, and the label describes the result as both antifibrotic and immunomodulatory.
Like the other IPF drugs, it slows the loss of lung function rather than reversing scarring that is already there.
Side effects and safety
- No routine lab monitoring is required by the label
- Tell your doctor about mood changes, depression or suicidal thoughts
- Report diarrhea that does not settle, especially if you also take nintedanib
Jascayd has no boxed warning, no contraindications and no separate warnings section in its label. In the main IPF trial the most common side effects, for the 18mg dose, the 9mg dose and placebo, were diarrhea (42%, 31% and 17%), COVID-19 (13%, 16% and 12%), upper respiratory infection (13%, 11% and 10%), depression-related symptoms, a group that includes suicidal thoughts (12%, 11% and 10%), weight loss (11%, 10% and 8%) and decreased appetite (9%, 9% and 5%).
Diarrhea was more common in people also taking nintedanib (62% on 18mg against 28% on placebo). Side effects led 15% of patients on 18mg to stop, against 11% on placebo. The trials excluded people with severe depression or suicidal thoughts or behavior, so mention any history of depression before starting[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Nerandomilast
18mg by mouth twice a day, about 12 hours apart, with or without food. Tablets can be swallowed whole or dispersed in about 100mL of water for people who have trouble swallowing. If 18mg is not tolerated, the dose can drop to 9mg twice a day, except in people also taking pirfenidone or a moderate CYP3A inducer, who stay on 18mg because pirfenidone lowers nerandomilast levels.
People taking a strong CYP3A inhibitor use 9mg twice a day, strong CYP3A inducers should be avoided, and it is not recommended with severe liver impairment or end-stage kidney disease (eGFR below 15)[1].
Prescribing Jascayd? REMS, monitoring and prior authorization criteria for prescribers
Availability and cost
Only available as the brand-name product.
Help paying for Jascayd
With private insurance, the drugmaker's copay card can lower what you pay for Jascayd. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. None of the 3 charity funds for Idiopathic Pulmonary Fibrosis were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Jascayd copay savings card: eligible patients with commercial insurance may pay as little as $0 a month. Not for Medicare, Medicaid or other government insurance.
For: private insurance · source - Insurance and case manager help
CareConnect4Me helps with insurance coverage questions and enrollment for Jascayd. Call 1-844-527-2293 (1-844-JASCAYD).
For: private insurance, Medicare, Medicaid, TRICARE, no insurance · source
Good to know: CareConnect4Me is Boehringer Ingelheim's support program for Jascayd and Ofev. Boehringer's pages load in the browser only, so offer details were confirmed from Boehringer's own page listings.
Charity funds for Idiopathic Pulmonary Fibrosis
- From a charity · The Assistance FundIdiopathic Pulmonary Fibrosis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
Every program and charity fund for Idiopathic Pulmonary Fibrosis →
Access and eligibility
Approved for adults with idiopathic pulmonary fibrosis and for adults with progressive pulmonary fibrosis. Safety and effectiveness in children have not been established. The IPF trial required people to be 40 or older with an FVC of at least 45% of predicted.
Source: Jascayd copay savings card
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Nerandomilast treatment timeline for idiopathic pulmonary fibrosis
Tap how long you have been on Nerandomilast to drop your pin on the road. Your answers stay on this device.
Stage 1 of 5 · Start to 1 mo
Your first month
You are in your first weeks on Jascayd. The usual dose is 18mg by mouth twice a day, about 12 hours apart, with or without food. In its main trial, lung function still declined on Jascayd, only more slowly than on placebo. It has not been shown to reverse scarring that is already in the lungs. The label does not recommend Jascayd for people with severe liver disease or end-stage kidney disease.
Coming up
Diarrhea was the most common side effect in the main trial, reported in 42% of people on 18mg and 17% on placebo. It was more common in people also taking nintedanib (Ofev), at 62% on 18mg. If you miss a dose, skip it and take the next one at your usual time. Do not take more than two 18mg tablets in 1 day.
Get in touch with your pulmonologist if you notice
- Breathing that gets clearly worse over days to a few weeks, which can be a sign of an IPF flare (acute exacerbation)
- Thoughts of harming yourself or suicide (get help right away)
- Taking more Jascayd than prescribed (call your doctor or Poison Help at 1-800-222-1222, or go to the emergency room)
- Becoming pregnant, or thinking you might be pregnant (tell your pulmonologist right away)
- Should I keep taking nintedanib or pirfenidone along with Jascayd?
- Do any of my medicines, vitamins or herbal products change how Jascayd works?
- What should I do if I get diarrhea?
- How should we keep an eye on my mood while I take Jascayd?
- When is my next lung function test?
Every stage of Nerandomilast treatment at a glance
Your first month Start to 1 mo
You are in your first weeks on Jascayd. The usual dose is 18mg by mouth twice a day, about 12 hours apart, with or without food. In its main trial, lung function still declined on Jascayd, only more slowly than on placebo. It has not been shown to reverse scarring that is already in the lungs. The label does not recommend Jascayd for people with severe liver disease or end-stage kidney disease.
Diarrhea was the most common side effect in the main trial, reported in 42% of people on 18mg and 17% on placebo. It was more common in people also taking nintedanib (Ofev), at 62% on 18mg. If you miss a dose, skip it and take the next one at your usual time. Do not take more than two 18mg tablets in 1 day.
Months 1 to 3 1 mo to 3 mo
You have taken Jascayd for 1 to 3 months. In the main trial, diarrhea generally started within the first 3 months and was usually mild to moderate. Diarrhea was also the most common reason people stopped the medicine, in 6% of people on 18mg.
If 18mg twice a day is too hard to tolerate, the label allows a lower dose of 9mg twice a day. That lower dose is not used with pirfenidone or with medicines called moderate CYP3A inducers, because they lower Jascayd levels. In the trial, the 9mg dose did not show a benefit in people also taking pirfenidone. People taking a strong CYP3A inhibitor, a type of medicine that raises Jascayd levels, take 9mg twice a day. Strong CYP3A inducers, which lower Jascayd levels, should be avoided.
Months 3 to 12 3 mo to 1 yr
You are working toward 1 year on Jascayd. The main trial measured forced vital capacity (FVC), the amount of air you can blow out, at 52 weeks. Over that year, FVC fell by an average of 106mL on 18mg, compared with 170mL on placebo.
In the trial, FVC still dropped on average while people took Jascayd, so some decline on your own tests can happen during treatment. Ask your pulmonologist when your next lung function tests are due. Bring a list of any side effects so you can weigh them together against how your lungs are doing.
Year 2 1 yr to 2 yr
You have taken Jascayd for more than a year. In the main trial, people kept taking the study medicine until the last person reached 52 weeks. Blinded treatment lasted up to 91 weeks, which is about 21 months. Half of the people in each group took it for 14 months or longer.
The trial also counted IPF flares, hospital stays for breathing problems and deaths over up to 91 weeks. It did not find a clear difference between Jascayd and placebo for those events, or for survival. Keep asking your team how your lung function is changing over time.
Past 2 years 2 yr on
You have taken Jascayd for more than 2 years. The main trial followed people for up to 109 weeks, about 2 years, so published data on longer use are limited. A follow-up study called FIBRONEER-ON is looking at longer-term use in people from the earlier trials.
ClinicalTrials.gov lists April 2027 as the estimated date for FIBRONEER-ON's main results to be collected. Keep up regular visits and lung function tests with your pulmonologist. Tell your team about any new diarrhea, weight loss or mood changes, even after years on treatment.
This timeline shows typical patterns from the prescribing information, guidelines and published studies. Your own treatment may differ, and your pulmonologist is the source of truth for your plan. Last checked against the FDA label on .
Clinical trial results
The IPF approval rested on FIBRONEER-IPF (NCT05321069), which randomized 1,177 adults with IPF to 18mg, 9mg or placebo twice daily, with or without background nintedanib or pirfenidone. At 52 weeks, forced vital capacity (FVC, how much air the lungs can blow out) fell an average of 106mL on 18mg and 122mL on 9mg against 170mL on placebo, differences of 64mL and 48mL[1].
The trial was published in the New England Journal of Medicine in 2025[5]. The progressive pulmonary fibrosis approval rested on FIBRONEER-ILD, a trial of 1,178 adults in which FVC declines were 65mL and 83mL smaller than placebo on the 18mg and 9mg doses[1][6].
Development history
Boehringer Ingelheim developed nerandomilast under the code BI 1015550. The FDA approved it as Jascayd for adults with idiopathic pulmonary fibrosis on October 7, 2025[2], which Boehringer described as the first new IPF treatment in over a decade[4], and for adults with progressive pulmonary fibrosis on December 19, 2025[3]. Boehringer also makes nintedanib (Ofev), one of the 2 IPF drugs approved in 2014.
Explore Idiopathic Pulmonary Fibrosis trials
Other Idiopathic Pulmonary Fibrosis treatments
IPF now has 3 approved antifibrotic drugs, pirfenidone (Esbriet and generics), nintedanib (Ofev and generics since April 2026) and nerandomilast (Jascayd). All 3 slow the decline in lung function. Inhaled treprostinil (Tyvaso) is under FDA review for IPF, with United Therapeutics expecting the review to finish in late April 2027.
Common questions about Nerandomilast
▸What is Nerandomilast (Jascayd)?
A twice-daily pill approved by the FDA on October 7, 2025 for adults with idiopathic pulmonary fibrosis, the first new IPF drug in more than a decade, and on December 19, 2025 for progressive pulmonary fibrosis. In its main IPF trial it slowed the loss of lung capacity over a year compared with placebo, and the result for the 18mg dose held whether patients also took nintedanib, pirfenidone or neither.
▸How does Nerandomilast work?
Inside cells, an enzyme family called phosphodiesterase 4 (PDE4) breaks down cAMP, a chemical messenger that helps keep inflammation and scar-forming activity in check. Nerandomilast blocks PDE4 and prefers one form of it, PDE4B, by at least ninefold in lab tests. With PDE4B blocked, cAMP stays higher in immune cells and in fibroblasts, the lung cells that lay down scar tissue, and the label describes the result as both antifibrotic and immunomodulatory. Like the other IPF drugs, it slows the loss of lung function rather than reversing scarring that is already there.
▸What are the side effects of Nerandomilast?
Jascayd has no boxed warning, no contraindications and no separate warnings section in its label. In the main IPF trial the most common side effects, for the 18mg dose, the 9mg dose and placebo, were diarrhea (42%, 31% and 17%), COVID-19 (13%, 16% and 12%), upper respiratory infection (13%, 11% and 10%), depression-related symptoms, a group that includes suicidal thoughts (12%, 11% and 10%), weight loss (11%, 10% and 8%) and decreased appetite (9%, 9% and 5%). Diarrhea was more common in people also taking nintedanib (62% on 18mg against 28% on placebo). Side effects led 15% of patients on 18mg to stop, against 11% on placebo. The trials excluded people with severe depression or suicidal thoughts or behavior, so mention any history of depression before starting[1].
▸How is Nerandomilast taken?
18mg by mouth twice a day, about 12 hours apart, with or without food. Tablets can be swallowed whole or dispersed in about 100mL of water for people who have trouble swallowing. If 18mg is not tolerated, the dose can drop to 9mg twice a day, except in people also taking pirfenidone or a moderate CYP3A inducer, who stay on 18mg because pirfenidone lowers nerandomilast levels. People taking a strong CYP3A inhibitor use 9mg twice a day, strong CYP3A inducers should be avoided, and it is not recommended with severe liver impairment or end-stage kidney disease (eGFR below 15)[1].
▸Is Nerandomilast FDA approved?
Yes, Nerandomilast (Jascayd) is FDA approved (2025) for the treatment of Idiopathic Pulmonary Fibrosis.
▸What is Jascayd?
Jascayd is the brand name of nerandomilast, a twice-daily pill from Boehringer Ingelheim. The FDA approved it on October 7, 2025 for adults with idiopathic pulmonary fibrosis and on December 19, 2025 for adults with progressive pulmonary fibrosis. It slows the decline in lung function and works differently from pirfenidone and nintedanib, by blocking an enzyme called PDE4B.
▸Can Jascayd be taken with Ofev or pirfenidone?
Yes. The main IPF trial allowed patients to stay on nintedanib (Ofev) or pirfenidone, and results for the 18mg dose were consistent in each group. With pirfenidone the dose should stay at 18mg twice daily, because pirfenidone lowers nerandomilast levels. With nintedanib, diarrhea was more common, occurring in 62% of patients on 18mg.
▸What are the most common side effects of Jascayd?
In the main IPF trial, the most common side effects on the 18mg dose were diarrhea (42% against 17% on placebo), COVID-19, upper respiratory infection, depression-related symptoms including suicidal thoughts (12% against 10%), weight loss and decreased appetite. The label has no boxed warning and no contraindications.
▸Does Jascayd reverse lung scarring?
No approved IPF drug reverses scarring. In the FIBRONEER-IPF trial, lung capacity measured as FVC fell 106mL over a year on the 18mg dose against 170mL on placebo, meaning the drug slowed the decline rather than stopping or reversing it.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed. JASCAYD (nerandomilast) tablets, for oral use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa1b14c6-957f-d326-5099-911bfe33e391
- U.S. Food and Drug Administration · 2025-10-07. NDA 218764 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218764Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2025-12-19. NDA 220449 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/220449Orig1s000ltr.pdf
- Boehringer Ingelheim · 2025-10. FDA approves JASCAYD (nerandomilast) as first new treatment for IPF in over a decade. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade
- New England Journal of Medicine · 2025. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. https://www.nejm.org/doi/full/10.1056/NEJMoa2414108
- New England Journal of Medicine · 2025. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. https://www.nejm.org/doi/full/10.1056/NEJMoa2503643
- ClinicalTrials.gov. A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (FIBRONEER-IPF). https://clinicaltrials.gov/study/NCT05321069