Wednesday, July 8, 2026

Drug profile · INN

nintedanib

nintedanib (OFEV) is a vascular endothelial growth factor receptor inhibitor. Associated with Boehringer Ingelheim Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EX09
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — nintedanib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
4
Data quality
0.89

Quick answer

nintedanib (OFEV) is a vascular endothelial growth factor receptor inhibitor. Associated with Boehringer Ingelheim Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN nintedanib
Brand OFEV
Mechanism Vascular endothelial growth factor receptor inhibitor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EX09

Mechanism of action

Vascular endothelial growth factor receptor inhibitor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. 1199-0378 Phase 3 · Boehringer Ingelheim · Childhood Interstitial Lung Disease
  2. Nintedanib Phase 3 · Boehringer Ingelheim · Idiopathic Pulmonary Fibrosis
  3. Nintedanib Phase 3 · Boehringer Ingelheim · Lung Diseases, Interstitial
  4. APHP220273 Phase 2 · PARItec · Adult patients aged 18 and over with unicentric hyalino-vasc

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is nintedanib?

nintedanib (OFEV) is a vascular endothelial growth factor receptor inhibitor. Associated with Boehringer Ingelheim Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for nintedanib?

OFEV is a marketed brand name for nintedanib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of nintedanib?

nintedanib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.