NintedanibEdit
Nintedanib is an oral antifibrotic medication used to slow the progression of fibrosing interstitial lung diseases, most notably idiopathic pulmonary fibrosis. It is a small molecule tyrosine kinase inhibitor that targets multiple receptors involved in fibrogenesis, including VEGFR (vascular endothelial growth factor receptor), FGFR (fibroblast growth factor receptor), and PDGFR (platelet-derived growth factor receptor). By blocking these pathways, nintedanib reduces fibroblast proliferation and the deposition of extracellular matrix. The drug was developed by Boehringer Ingelheim and is marketed under the brand name Ofev. In IPF and other fibrosing ILDs, clinical trials have shown that nintedanib slows the decline in lung function and helps manage symptoms, though it does not cure the disease.
Nintedanib is approved for several fibrosing interstitial lung diseases (ILDs) beyond IPF, reflecting the common mechanism of progressive fibrosis across these conditions. The INBUILD trial demonstrated that nintedanib slows the rate of decline in forced vital capacity (FVC) in patients with progressive fibrosing ILD, supporting its use in chronic fibrosing diseases that share a progressive phenotype. In systemic sclerosis–associated ILD (SSc-ILD), the SENSCIS trial showed a similar effect on slowing FVC decline, which contributed to regulatory approvals in this indication. For patients and physicians, this class of medicines represents a way to slow deterioration of lung function even when the underlying cause of fibrosis cannot be fully cured.
Medical use
Idiopathic pulmonary fibrosis (IPF)
Nintedanib received regulatory approval for IPF based on clinical trials showing a reduction in the rate of decline of lung function. It is typically prescribed as part of a broader management plan that may include other medications, pulmonary rehabilitation, and lifestyle measures. For IPF, as with other indications, the aim is to preserve lung function and quality of life over time.
Fibrosing interstitial lung diseases with a progressive phenotype
Beyond IPF, nintedanib has been studied in chronic fibrosing ILDs with a progressive phenotype, including those associated with autoimmune or other etiologies. By slowing the progression of fibrosis, the therapy can help delay respiratory decline in patients who might otherwise experience steadily worsening lung function. See the discussions around INBUILD trial for the multinational study that established this broader use.
Systemic sclerosis–associated ILD (SSc-ILD)
In SSc-ILD, nintedanib is used to slow the rate of decline in lung function. The SENSCIS trial demonstrated a measurable benefit in reducing the annual rate of FVC loss, contributing to approvals for this indication. See discussions of SENSCIS trial for more detail.
Dosing and administration
The standard dose is 150 mg taken orally twice daily with food. Because of potential adverse effects and drug interactions, clinicians tailor dose and monitoring to individual patients, including considerations related to hepatic function and concomitant medications. Patients are typically advised to take the capsules consistently with meals to minimize gastrointestinal upset and to monitor liver function tests as part of routine safety assessment.
Mechanism of action
Nintedanib inhibits multiple tyrosine kinases involved in pathological fibrosis and angiogenesis, notably those linked to VEGFR, FGFR, and PDGFR. By dampening signaling through these pathways, the drug slows fibroblast activation, myofibroblast differentiation, and collagen deposition, which translates into a slower decline in lung function in several fibrosing ILDs.
Safety and adverse effects
Common adverse effects include diarrhea, nausea, abdominal pain, decreased appetite, weight loss, and elevations in liver enzymes. Because nintedanib is metabolized through hepatic pathways and interacts with transport proteins, it can interact with certain drugs—particularly strong inhibitors or inducers of P-glycoprotein (P-gp) and CYP3A4. Liver function monitoring is important, and dose adjustments or discontinuation may be required in the setting of hepatic impairment or significant liver enzyme elevations. The drug is contraindicated in pregnancy and requires careful consideration of risks and benefits in patients with hepatic disease or significant comorbidities. See product labeling and pharmacology references for comprehensive safety information.
Economic and policy considerations
From a policy and economic perspective, the availability of nintedanib brings into focus tensions between innovation and affordability. Proponents of robust intellectual property protections argue that patent exclusivity and the prospect of recouping development costs are essential to fund the research and development of new therapies like nintedanib, especially given the high costs and long timelines associated with bringing a complex antifibrotic drug to market. They contend that price controls or aggressive government settlements could dampen investment in future breakthroughs.
Critics from other angles argue that high prices restrict patient access and strain payer systems. In health systems that rely on public or mixed financing, cost-effectiveness analyses and value-based pricing become central to coverage decisions. Supporters of market-based pricing contend that competition, potential generics, and the overall reduction in disease burden justify higher initial prices, while acknowledging the need for patient assistance programs and fair access. Debates in this space often connect to broader conversations about how to balance incentives for innovation with ensuring affordable medicines for those who need them.
Advocates for patient access and reform sometimes push for faster regulatory approvals, transparent pricing, and policy tools that encourage dose optimization and real-world evidence of value. Proponents of a more permissive market environment argue that these measures, rather than broad price-fixing, better sustain a pipeline of new therapies. Critics of that stance may argue that excessive pricing harms patients and health systems alike, though the core point in this article emphasizes the view that strong IP protections and market mechanisms are the best way to sustain ongoing medical innovation.
See also discussions of Boehringer Ingelheim, Ofev, Idiopathic pulmonary fibrosis, Interstitital lung disease (see standard term: Interstitial lung disease), and related clinical trials such as INBUILD trial and SENSCIS trial for more context on this therapeutic class and its development.