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FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDsFDA approves a new drug to treat two types of progressive, scarring lung diseases

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Key Takeaway
Consider dose reduction to 100 mg twice daily for patients with mild hepatic impairment (Child Pugh A).

The FDA has approved nintedanib capsules, a kinase inhibitor, for two indications in adults: treatment of idiopathic pulmonary fibrosis (IPF) and treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. This approval provides a treatment option for patients with these progressive, fibrotic lung conditions. The recommended dosage is 150 mg taken orally twice daily, approximately 12 hours apart, with food. For patients with mild hepatic impairment (Child Pugh A), the recommended dosage is reduced to 100 mg twice daily. Treatment is not recommended for patients with moderate or severe hepatic impairment. Prior to treatment initiation, clinicians should conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. Dose modifications or interruptions may be necessary for the management of adverse reactions, including elevated liver enzymes.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

Nintedanib capsules are indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). They are also indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Dosing & Administration

The recommended dosage is 150 mg taken orally twice daily, approximately 12 hours apart, taken with food. The capsules should be swallowed whole with liquid and not chewed, opened, or crushed. For patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg orally twice daily. Treatment is not recommended for patients with moderate or severe hepatic impairment. Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions. If a dose is missed, the next dose should be taken at the next scheduled time; do not make up for a missed dose. The maximum daily dosage is 300 mg. Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential.

Key Clinical Trial Data

The clinical efficacy of nintedanib capsules has been studied in 1,231 patients with IPF in one phase 2 and two phase 3 studies. These were randomized, double-blind, placebo-controlled studies comparing treatment with nintedanib capsules 150 mg twice daily to placebo for 52 weeks. The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC). Time to first acute IPF exacerbation was a key secondary endpoint in the phase 3 studies and a secondary endpoint in the phase 2 study. Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has approved a new medication called nintedanib. It is a capsule taken by mouth to treat two specific types of serious lung diseases that cause scarring, known as fibrosis. These conditions are called idiopathic pulmonary fibrosis (IPF) and chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. The scarring makes the lungs stiff and hard to breathe.

This drug is specifically for adults who have been diagnosed with one of these progressive, scarring lung conditions. The approval means that doctors now have another treatment option to offer patients to help slow down the progression of lung scarring. It is important to understand that this drug is not a cure, but it is a tool to help manage these diseases.

As with any medication, there are important considerations. The drug can affect the liver, so doctors will perform blood tests before and during treatment. The dose may need to be adjusted for some patients, and it is not recommended for people with moderate or severe liver problems. Common side effects can include diarrhea and nausea.

The most important step for anyone with these lung conditions is to talk with their own doctor. A healthcare provider can explain if this new treatment is a suitable option based on an individual's specific health situation, other medications, and overall treatment goals.

What this means for you:
A new treatment option is now available for adults with certain progressive, scarring lung diseases.

Study Details

Study typeFda approval
PublishedApr 2026
View Original Abstract ↓
1 INDICATIONS AND USAGE Nintedanib capsules are a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsules are indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsules are indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies ( 14.2 )].
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