Nintedanib

Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3).

• 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) ].

• None None ( 4 )contraindicated

Recommended dosage: 150 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.2 ) Recommended dosage in patients with mild hepatic impairment (Child Pugh A): 100 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.3 , 8.6 ) Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions. ( 2.4 , 5.2 , 5.3 , 6 ) Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. ( 2.1 , 5.2 , 5.4 ) 2.1 Testing Prior to Nintedanib Capsules Administration Conduct liver function tests in all patients and a pregnancy test in females of reproductive potential prior to initiating treatment with Nintedanib Capsules [see Warnings and Precautions (5.2 , 5.4) ] . 2.2 Recommended Dosage The recommended dosage of Nintedanib Capsules is 150 mg taken orally twice daily administered approximately 12 hours apart. Administration Information Nintedanib Capsules should be taken with food [see Clinical Pharmacology (12.3) ] and swallowed whole with liquid. Nintedanib Capsules should not be chewed because of a bitter taste. Nintedanib Capsules should not be opened or crushed. If contact with the content of the capsule occurs, wash hands immediately and thoroughly. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known. Information for Missed Dose If a dose of Nintedanib Capsules is missed, the next dose should be taken at the next scheduled time.

Hepatic impairment: Nintedanib Capsules is not recommended for use in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily approximately 12 hours apart taken with food. Consider treatment interruption, or discontinuation for management of adverse reactions in these patients. ( 2.3 , 2.4 , 5.1 , 8.6 , 12.3 ) Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with nintedanib capsules, including cases of drug- induced liver injury. In the postmarketing period, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. Monitor ALT, AST, and bilirubin prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Temporary dosage reductions or discontinuations may be required. ( 2.1 , 2.4 , 5.2 ) Gastrointestinal disorders: Diarrhea, nausea, and vomiting have occurred with nintedanib capsules. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue Nintedanib Capsules if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment. ( 5.3 ) Embryo-Fetal toxicity: Can cause fetal harm.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Elevated Liver Enzymes and Drug-Induced Liver Injury [see Warnings and Precautions (5.2) ] Gastrointestinal Disorders [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Arterial Thromboembolic Events [see Warnings and Precautions (5.5) ] Risk of Bleeding [see Warnings and Precautions (5.6) ] Gastrointestinal Perforation [see Warnings and Precautions (5.7) ] Nephrotic Range Proteinuria [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC., DBA Dexcel Pharma USA, at 1-877-381-3336 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 the clinical trials of another drug and may not reflect the rates observed in practice. The safety of nintedanib capsules was evaluated in over 1000 IPF patients, and 332 patients with chronic fibrosing ILDs with a progressive phenotype. Over 200 IPF patients were exposed to nintedanib capsules for more than 2 years in clinical trials.

Lactation: Breastfeeding is not recommended. ( 8.2 ) Renal impairment: The safety and efficacy of nintedanib capsules have not been studied in patients with severe renal impairment and end-stage renal disease. ( 8.7 , 12.3 ) Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of nintedanib capsules. ( 8.8 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , nintedanib capsules can cause fetal harm when administered to a pregnant woman. There are no data on the use of nintedanib capsules during pregnancy. In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryo-fetal deaths and structural abnormalities at less than (rats) and approximately 5 times (rabbits) the maximum recommended human dose [see Data] . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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

The PK properties of nintedanib were similar in healthy volunteers, patients with IPF, patients with chronic fibrosing ILDs with a progressive phenotype, and cancer patients. The PK of nintedanib is linear.

In IPF trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non- serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. Overdosage was also reported in two patients in oncology studies who were exposed to a maximum of 600 mg twice daily for up to 8 days. Adverse events reported were consistent with the existing safety profile of nintedanib capsules. Both patients recovered. In case of overdosage, interrupt treatment and initiate general supportive measures as appropriate.

• Oct 15, 2014NDANDA205832Boehringer Ingelheim
• Apr 2, 2026ANDAANDA219819Dexcel
• Apr 2, 2026ANDAANDA219227Apotex
• Apr 2, 2026ANDAANDA216915Sandoz
• Apr 2, 2026ANDAANDA219283Dr Reddys
• Apr 2, 2026ANDAANDA212609Cipla

1. 1Diarrhoea9,71132%
2. 2Nausea4,56515%
3. 3Dyspnoea3,89213%
4. 4Cough3,10210%
5. 5Death3,05910%
6. 6Decreased Appetite2,99510%
7. 7Weight Decreased2,9139.7%
8. 8Fatigue2,8549.5%
9. 9Vomiting2,6758.9%
10. 10Idiopathic Pulmonary Fibrosis2,0126.7%
11. 11Constipation1,9736.6%
12. 12Headache1,9266.4%
13. 13Abdominal Pain Upper1,8336.1%
14. 14Asthenia1,6605.6%
15. 15Abdominal Discomfort1,5955.3%

The 10 most recently updated of 221 ClinicalTrials.gov registrations naming Nintedanib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
  Active not recruiting · Observational · 586 enrolled · Boehringer Ingelheim
  NCT04325217updated 2026-06-09
• Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
  Completed · Observational · 88 enrolled · Boehringer Ingelheim
  NCT05503030updated 2026-05-29
• A Comparison of a Medication Adherence Platform (FORTISKAP™) vs. Usual Care in Subjects on Oral Medications for the Treatment of Interstitial Lung Disease, Sarcoid and Pulmonary Hypertension
  Not yet recruiting · Observational · 100 enrolled · Cosmos Rx, Inc
  NCT07613216updated 2026-05-29
• High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib
  Completed · Interventional · 78 enrolled · University of British Columbia
  NCT02551068updated 2026-05-18
• Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
  Completed · Phase 1 · Interventional · 33 enrolled · Sunshine Lake Pharma Co., Ltd.
  NCT07588646updated 2026-05-15
• A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
  Recruiting · Phase 3 · Interventional · 92 enrolled · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
  NCT07335562updated 2026-05-15
• A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
  Recruiting · Phase 1 · Interventional · 57 enrolled · Endeavor Biomedicines, Inc.
  NCT07454291updated 2026-05-15
• Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
  Not yet recruiting · Phase 2 · Interventional · 60 enrolled · First Affiliated Hospital of Wenzhou Medical University
  NCT07583589updated 2026-05-13
• A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
  Completed · Observational · 18 enrolled · Boehringer Ingelheim
  NCT06200714updated 2026-05-13
• A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
  Recruiting · Phase 1 · Interventional · 24 enrolled · Mannkind Corporation
  NCT07344558updated 2026-05-05

Frequently asked questions

How does Nintedanib work?

Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3).

What is Nintedanib used for?

According to FDA labeling, Nintedanib carries indications including: 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) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nintedanib?

Nintedanib is classified as Other protein kinase inhibitors, Kinase Inhibitor, Protein Kinase Inhibitors, Receptor Tyrosine Kinase Inhibitors, Decreased Endothelial Proliferation.

What are the brand names for Nintedanib?

Nintedanib is marketed under brand names including Ofev.

What are the contraindications for Nintedanib?

Nintedanib labeling lists contraindications including: None None ( 4 ). Always consult the full prescribing information and a clinician.