Idiopathic Pulmonary Fibrosis Treatments

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Brand Name

Jascayd

Generic Name
Nerandomilast
View Brand Information
FDA approval date: October 07, 2025
Form: Tablet

What is Jascayd (Nerandomilast)?

JASCAYD is a phosphodiesterase 4 inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients.
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Related Clinical Trials

An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)

Summary: This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether ner...

A Double Blind, Randomized, Placebo-controlled Exploratory Trial to Investigate the Efficacy and Safety of Nerandomilast Over 24 Months When Administered in Individuals With Interstitial Lung Abnormalities and a Family History of Pulmonary Fibrosis to Reduce the Risk of Worsening (DROP-FPF)

Summary: This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis...

A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)

Summary: Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with syste...

Brand Information

JASCAYD (nerandomilast)
1DOSAGE FORMS AND STRENGTHS
Tablets:
  • 9 mg, light yellow, oval, biconvex, film-coated tablets debossed with the Boehringer Ingelheim company symbol on one side and "F9" on the other side.
  • 18 mg, light red, oval, biconvex, film-coated tablets debossed with the Boehringer Ingelheim company symbol on one side and "F18" on the other side.
2CONTRAINDICATIONS
None.
3OVERDOSAGE
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.
4DESCRIPTION
JASCAYD (nerandomilast tablets), for oral administration, contain nerandomilast, a phosphodiesterase 4 (PDE4) inhibitor. The chemical name of nerandomilast is [1-[[(5R)-2-[4-(5-chloropyrimidin-2-yl)-1-piperidyl]-5-oxo-6,7-dihydrothieno[3,2-d]pyrimidin-4-yl]amino]cyclobutyl]methanol. Nerandomilast has one chiral center and is the R-stereoisomer. Its structural formula is:
Chemical Structure
Nerandomilast is a white to off-white to light yellow powder with an empirical formula of C
Each film-coated tablet of JASCAYD contains 9 mg or 18 mg of nerandomilast and the following inactive ingredients: croscarmellose sodium, ferric oxide red (18 mg tablets only), ferric oxide yellow (9 mg tablets only), ferrosoferric oxide (18 mg tablets only), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, and talc. Each JASCAYD tablet contains less than 5 mg of sodium.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
JASCAYD tablets are supplied as follows:
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy
Advise female patients to contact their healthcare provider if they become pregnant or suspect they may be pregnant during treatment with JASCAYD. Advise female patients of the potential risk of fetal loss
Missed Dose
Inform patients that if they miss a dose of JASCAYD, they should take the next dose at the next scheduled time. Advise patients to not make up for a missed dose or exceed the recommended dosage of 18 mg twice daily
7PRINCIPAL DISPLAY PANEL - 9 mg Tablet Bottle Carton
NDC 0597-2465-41
Jascayd
9 mg
Rx only
60 tablets
Boehringer
PRINCIPAL DISPLAY PANEL - 9 mg Tablet Bottle Carton
8PRINCIPAL DISPLAY PANEL - 18 mg Tablet Bottle Carton
NDC 0597-7313-21
Jascayd
18 mg
Rx only
60 tablets
Boehringer
PRINCIPAL DISPLAY PANEL - 18 mg Tablet Bottle Carton