Nerandomilast

Nerandomilast is an inhibitor of phosphodiesterase 4 (PDE4) with at least nine-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C, and PDE4D based on in vitro data. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP).

• JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients.

• None. None.contraindicated

Recommended Dosage : 18 mg orally twice daily approximately 12 hours apart with or without food. ( 2.1 ) Reduce JASCAYD to 9 mg twice daily for patients who are unable to tolerate 18 mg twice daily, except in patients taking concomitant pirfenidone. ( 2.1 , 7.1 ) Swallow tablets whole or dispersed in water. ( 2.1 ) See full prescribing information for dosage modification for concomitant use with CYP3A inhibitors and administration instructions for patients who have difficulty swallowing tablets. ( 2.2 , 2.3 ) 2.1 Recommended Dosage The recommended dosage of JASCAYD is 18 mg twice daily, administered orally (swallow tablets whole or dispersed in water) approximately 12 hours apart, with or without food. Reduce JASCAYD to 9 mg twice daily for patients who are unable to tolerate 18 mg twice daily, except in patients who concomitantly use JASCAYD with pirfenidone. Recommended Dosage for Concomitant Use with Pirfenidone Recommended dosage of JASCAYD is 18 mg twice daily when used concomitantly with pirfenidone. Do not reduce dosage to 9 mg twice daily [see Drug Interactions (7.1) ]. Administration Instructions Swallow JASCAYD tablets whole or dispersed in water [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ]. Missed Dose(s) If a dose of JASCAYD is missed, advise the patient to take the next dose at the next scheduled time. Advise the patient to not make up for a missed dose. Maximum Recommended Dosage The maximum recommended dosage of JASCAYD is 18 mg twice daily.

Most common adverse reactions (≥5%) are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions for Idiopathic Pulmonary Fibrosis The safety of JASCAYD was based on a randomized, placebo-controlled, double-blind trial (FIBRONEER-IPF), which included 1,177 adult patients with IPF who were randomized in a 1:1:1 ratio to receive JASCAYD 9 mg twice daily, JASCAYD 18 mg twice daily, or matching placebo. Patients received JASCAYD or placebo with or without background antifibrotic treatment (nintedanib or pirfenidone) for at least 52 weeks [see Clinical Studies (14.1) ] . The median duration of exposure was 14 months in each treatment arm. Discontinuation due to adverse reactions occurred more frequently in patients treated with JASCAYD (with or without background antifibrotic treatment) 18 mg (15%) and 9 mg (12%) compared to placebo (11%). The most frequent adverse reaction leading to discontinuation of JASCAYD 18 mg and 9 mg was diarrhea (6% and 2%, respectively).

8.1 Pregnancy Risk Summary There are no available data on JASCAYD use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are maternal and fetal risks associated with untreated idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) during pregnancy (Clinical Considerations). Based on findings from animal reproduction studies, JASCAYD may increase the risk for fetal loss. In an embryo-fetal development study in rats, oral administration of nerandomilast to pregnant rats during organogenesis at an exposure approximately 5 times the maximum recommended human dose (MRHD) of 36 mg/day resulted in an increase in embryo-fetal losses (see Data ) . Advise pregnant women and females of reproductive potential of the potential risk of fetal loss. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage in clinically recognized pregnancies is 15% to 20%.

Metabolism

Nerandomilast exposure increased in a dose proportional manner following administration of single doses of 0.0032 to 2.6 times a single dose of 18 mg and multiple doses of 0.056 to 1 times the maximum recommended dose of 18 mg twice daily. Following administration of multiple doses of 18 mg twice daily, C max increases 1.3-fold and AUC tau increases 1.38-fold.

In the event of an overdosage with JASCAYD, monitor the patient for any signs or symptoms of adverse reactions and provide appropriate symptomatic treatment. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

• Oct 7, 2025NDANDA218764Boehringer Ingelheim

1. 1Diarrhoea19034%
2. 2Headache6612%
3. 3Nausea6411%
4. 4Fatigue6211%
5. 5Dizziness569.9%
6. 6Dyspnoea498.6%
7. 7Prescribed Underdose407.1%
8. 8Cough376.5%
9. 9Decreased Appetite366.3%
10. 10Back Pain284.9%
11. 11Weight Decreased264.6%
12. 12Death223.9%
13. 13Abdominal Pain Upper203.5%
14. 14Vomiting193.4%
15. 15Abdominal Discomfort173.0%

The 10 most recently updated of 34 ClinicalTrials.gov registrations naming Nerandomilast as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
  Recruiting · Phase 3 · Interventional · 1,700 enrolled · Boehringer Ingelheim
  NCT06238622updated 2026-06-11
• A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
  Recruiting · Phase 3 · Interventional · 400 enrolled · Boehringer Ingelheim
  NCT06806592updated 2026-06-10
• A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
  Not yet recruiting · Phase 3 · Interventional · 448 enrolled · Boehringer Ingelheim
  NCT07497087updated 2026-06-10
• A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
  Recruiting · Phase 3 · Interventional · 80 enrolled · Boehringer Ingelheim
  NCT07201922updated 2026-06-09
• FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
  Not yet recruiting · Phase 3 · Interventional · 466 enrolled · Boehringer Ingelheim
  NCT07540988updated 2026-06-09
• A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
  Not yet recruiting · Phase 3 · Interventional · 35 enrolled · Boehringer Ingelheim
  NCT07366034updated 2026-05-12
• This is a Trial Designed to Evaluate the Combination of Nerandomilast With Mycophenolate Across a Wide Variety of Pulmonary Fibrosis Subtypes, With the Aim of Providing Clinicians With Assurance That This is an Appropriate Therapeutic Combination.
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · University of British Columbia
  NCT07570888updated 2026-05-11
• A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
  Recruiting · Phase 2 · Interventional · 20 enrolled · Boehringer Ingelheim
  NCT06241560updated 2026-04-29
• Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
  Recruiting · Phase 3 · Interventional · 196 enrolled · Argyrios Tzouvelekis
  NCT07299695updated 2026-03-16
• Platform Clinical Study for Conquering Scleroderma
  Recruiting · Phase 2 · Interventional · 400 enrolled · Scleroderma Research Foundation, Inc.
  NCT06195072updated 2026-02-04

Frequently asked questions

How does Nerandomilast work?

Nerandomilast is an inhibitor of phosphodiesterase 4 (PDE4) with at least nine-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C, and PDE4D based on in vitro data. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP).

What is Nerandomilast used for?

According to FDA labeling, Nerandomilast carries indications including: JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nerandomilast?

Nerandomilast is classified as Selective immunosuppressants, Phosphodiesterase 4 Inhibitors, Decreased Cytokine Activity.

What are the brand names for Nerandomilast?

Nerandomilast is marketed under brand names including Jascayd.

What are the contraindications for Nerandomilast?

Nerandomilast labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.