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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 serious, scarring lung diseases in adults

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Key Takeaway
Consider nintedanib for adults with IPF or progressive fibrosing ILDs, with dose adjustment for mild hepatic impairment.

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 drug's efficacy in IPF was evaluated in three randomized, double-blind, placebo-controlled studies involving 1,231 patients, with the primary endpoint being the annual rate of decline in Forced Vital Capacity (FVC). The recommended dosage is 150 mg taken orally twice daily, approximately 12 hours apart, with food. Important pre-treatment requirements include liver function tests for all patients and a pregnancy test for females of reproductive potential. Dose adjustments are required for patients with mild hepatic impairment (Child Pugh A), and the drug is not recommended for patients with moderate or severe hepatic impairment.

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

Not reported in label.

Indication & Patient Population

Nintedanib Capsules is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). It is 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. Dose reduction to 100 mg twice daily, treatment interruption, or discontinuation should be considered for management of adverse reactions. Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. If a dose is missed, the next dose should be taken at the next scheduled time; do not make up for a missed dose. Do not exceed 300 mg daily.

Key Clinical Trial Data

The clinical efficacy of nintedanib capsules for IPF was studied in 1,231 patients in one phase 2 and two phase 3 studies. These were randomized, double-blind, placebo-controlled studies comparing 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 two phase 3 studies and a secondary endpoint in the phase 2 study. Trial data for the ILD indication is referenced but not detailed in the provided label text.

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 prescription medicine called nintedanib. It is a capsule taken by mouth to treat two serious lung conditions in adults. These conditions, called idiopathic pulmonary fibrosis and chronic fibrosing interstitial lung diseases, cause scarring in the lungs that gets worse over time and makes breathing difficult. This drug is specifically for adults whose lung disease is in a progressive, or worsening, phase.

This approval is based on studies involving over 1,200 patients. The main goal of the studies was to see if the drug could slow the decline in a key measure of lung function. The recommended dose is 150 mg taken twice a day with food. Before starting, doctors will run liver tests, and female patients of childbearing age will need a pregnancy test. The dose may need to be adjusted for patients with mild liver problems, and it is not recommended for those with moderate or severe liver issues.

For people living with these challenging conditions, this FDA decision means there is now an additional treatment option available. It represents another tool that doctors can consider when managing these progressive diseases. However, it is important to understand that this is not a cure, and its effectiveness can vary from person to person.

The most important step for any patient is to have a detailed conversation with their own healthcare provider. Only a doctor who knows your full medical history can determine if this new medication is a suitable and safe option for your specific situation. They can explain the potential benefits and risks in the context of your overall care plan.

What this means for you:
This provides a new treatment option for serious, scarring lung diseases, but patients must consult their doctor.

Study Details

Study typeFda approval
PublishedApr 2026
View Original Abstract ↓
1 INDICATIONS AND USAGE Nintedanib Capsules is 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 is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib Capsules is 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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