Ofev (nintedanib)
An approved treatment for Idiopathic Pulmonary Fibrosis and Systemic Sclerosis.
The same compound appears under different names depending on the context. Here is how to identify Nintedanib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Nintedanib
- Brand name
- Ofev
- Development code
- BIBF 1120
- Drug class
- Kinase inhibitor (antifibrotic)
- Manufacturer
- Boehringer Ingelheim (generics from several makers since 2026)
- How it's taken
- 150 mg by mouth twice a day, about 12 hours apart, taken with food and swallowed whole, never chewed, opened or crushed.
A twice-daily capsule approved in October 2014 for idiopathic pulmonary fibrosis and later for systemic sclerosis-associated interstitial lung disease and other progressive fibrosing lung diseases. In its IPF trials it roughly halved the yearly loss of lung capacity compared with placebo. Generic versions were approved in April 2026.
Where Nintedanib fits
One of the 2 original IPF drugs from 2014, alongside pirfenidone, and the only one of the 3 approved IPF drugs also approved for lung scarring from systemic sclerosis and other progressive fibrosing lung diseases.
How Nintedanib works
Scarring in IPF is driven by fibroblasts, cells that multiply and pile up collagen when growth signals keep telling them to. Nintedanib blocks the receptors for several of those signals, including PDGF, FGF and VEGF, from inside the cell. With those signals muted, fibroblasts multiply and lay down scar more slowly, which shows up as a slower loss of lung capacity. It does not reverse scarring that has already formed.
Mechanism: Oral kinase inhibitor that blocks growth-factor receptors (PDGFR, FGFR and VEGFR) that drive fibroblasts to multiply and lay down scar tissue
Side effects and safety
- Liver injury. Liver enzyme and bilirubin rises can happen, rarely severe or fatal. Blood tests before starting, regularly for the first 3 months, then periodically.
- Diarrhea, nausea and vomiting. Very common. Treat early with fluids and anti-diarrhea medicine; the dose may be lowered or paused.
- Harm to an unborn baby. Pregnancy test before starting and highly effective contraception during treatment.
- Arterial blood clots, bleeding and bowel perforation. Use caution in people at higher heart risk, with bleeding risk or with recent abdominal surgery.
- Liver tests before starting, regularly for the first 3 months, then periodically
- Pregnancy test before starting in women who could become pregnant
The most common side effects in the IPF trials, against placebo, were diarrhea (62% against 18%), nausea (24% against 7%), abdominal pain (15% against 6%), liver enzyme elevation (14% against 3%), vomiting (12% against 3%), decreased appetite (11% against 5%) and weight loss (10% against 3%). The label warns about liver injury, including rare fatal cases, and requires liver blood tests before starting, regularly for the first 3 months and periodically after that. It can harm an unborn baby, so a pregnancy test comes first and women who could become pregnant need highly effective contraception. Other warnings cover blood clots in arteries, bleeding and tears in the stomach or intestine[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Nintedanib
150 mg by mouth twice a day, about 12 hours apart, taken with food and swallowed whole, never chewed, opened or crushed. People with mild liver impairment take 100 mg twice a day, and it is not recommended with moderate or severe liver impairment. The dose can drop to 100 mg twice a day or be paused to manage side effects[1].
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Help paying for Ofev
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Ofev copay program: eligible patients with commercial insurance who enroll in CareConnect4Me may pay as little as $0. Not for Medicare, Medicaid or other government insurance.
For: private insurance · source - Insurance and case manager help
CareConnect4Me helps with insurance coverage questions for Ofev. Call 1-866-673-6366. Generic nintedanib capsules were approved in April 2026 and may cost less depending on your plan.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance · source
Good to know: CareConnect4Me is Boehringer Ingelheim's support program for Ofev and Jascayd. Generic nintedanib from several makers was approved on April 2, 2026.
- From a charity · The Assistance FundIdiopathic Pulmonary Fibrosis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…” - From a charity · The Assistance FundSystemic Sclerosis fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.”
Access and eligibility
Approved for adults with idiopathic pulmonary fibrosis, adults with chronic fibrosing interstitial lung diseases with a progressive phenotype, and adults with systemic sclerosis-associated interstitial lung disease. The US label covers adults only.
Source: Ofev CareConnect4Me
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
In 2 identical Phase 3 trials, INPULSIS-1 (NCT01335464) and INPULSIS-2 (NCT01335477), adults with IPF lost 115 mL and 114 mL of forced vital capacity a year on nintedanib against 240 mL and 207 mL on placebo, differences of 125 mL and 94 mL. An earlier Phase 2 trial showed a similar effect[1][3]. Later trials supported approvals for systemic sclerosis-associated interstitial lung disease in 2019 and chronic fibrosing lung diseases with a progressive phenotype in 2020[1].
Development history
Boehringer Ingelheim developed nintedanib under the code BIBF 1120. The FDA approved it as Ofev for idiopathic pulmonary fibrosis on October 15, 2014, the same day it approved pirfenidone, making them the first 2 IPF drugs[2]. Approvals followed for systemic sclerosis-associated interstitial lung disease on September 6, 2019 and for chronic fibrosing interstitial lung diseases with a progressive phenotype on March 9, 2020[1]. The FDA approved the first generic nintedanib capsules from 5 companies, including Cipla and Sandoz, on April 2, 2026[4].
Explore Idiopathic Pulmonary Fibrosis and Systemic Sclerosis trials
Other Idiopathic Pulmonary Fibrosis & Systemic Sclerosis treatments
IPF has 3 approved antifibrotic drugs, pirfenidone, nintedanib and nerandomilast (Jascayd, approved October 2025). All 3 slow the decline in lung function. Nerandomilast was tested on top of nintedanib, and diarrhea was more common with the combination.
Common questions about Nintedanib
▸What is Nintedanib (Ofev)?
A twice-daily capsule approved in October 2014 for idiopathic pulmonary fibrosis and later for systemic sclerosis-associated interstitial lung disease and other progressive fibrosing lung diseases. In its IPF trials it roughly halved the yearly loss of lung capacity compared with placebo. Generic versions were approved in April 2026.
▸How does Nintedanib work?
Scarring in IPF is driven by fibroblasts, cells that multiply and pile up collagen when growth signals keep telling them to. Nintedanib blocks the receptors for several of those signals, including PDGF, FGF and VEGF, from inside the cell. With those signals muted, fibroblasts multiply and lay down scar more slowly, which shows up as a slower loss of lung capacity. It does not reverse scarring that has already formed.
▸What are the side effects of Nintedanib?
The most common side effects in the IPF trials, against placebo, were diarrhea (62% against 18%), nausea (24% against 7%), abdominal pain (15% against 6%), liver enzyme elevation (14% against 3%), vomiting (12% against 3%), decreased appetite (11% against 5%) and weight loss (10% against 3%). The label warns about liver injury, including rare fatal cases, and requires liver blood tests before starting, regularly for the first 3 months and periodically after that. It can harm an unborn baby, so a pregnancy test comes first and women who could become pregnant need highly effective contraception. Other warnings cover blood clots in arteries, bleeding and tears in the stomach or intestine[1].
▸How is Nintedanib taken?
150 mg by mouth twice a day, about 12 hours apart, taken with food and swallowed whole, never chewed, opened or crushed. People with mild liver impairment take 100 mg twice a day, and it is not recommended with moderate or severe liver impairment. The dose can drop to 100 mg twice a day or be paused to manage side effects[1].
▸Is Nintedanib FDA approved?
Yes, Nintedanib (Ofev) is FDA approved (2014) for the treatment of Idiopathic Pulmonary Fibrosis and Systemic Sclerosis.
▸Is there a generic version of Ofev?
Yes. The FDA approved the first generic nintedanib capsules on April 2, 2026, from 5 companies including Cipla, Sandoz, Apotex, Dr. Reddy's and Dexcel. Ask your pharmacist or insurer which version your plan covers.
▸Why does Ofev cause diarrhea?
Diarrhea is the most common side effect, reported in 62% of IPF trial patients against 18% on placebo. It usually starts early and is managed with fluids, anti-diarrhea medicine such as loperamide, and if needed a lower dose of 100 mg twice daily or a pause. Taking each dose with food is part of the label's instructions.
▸What blood tests do I need on Ofev?
The label calls for liver tests (ALT, AST and bilirubin) before starting, at regular intervals during the first 3 months and periodically after that, plus a pregnancy test before starting for women who could become pregnant.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed. OFEV (nintedanib) capsules, for oral use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9
- U.S. Food and Drug Administration · 2014-10-15. NDA 205832 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205832Orig1s000ltr.pdf
- New England Journal of Medicine · 2014. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. https://www.nejm.org/doi/full/10.1056/NEJMoa1402584
- U.S. Food and Drug Administration. First Generic Drug Approvals. https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals