Product Description
Nintedanib is an approved treatment for IPF, which reduces the rate of decline in forced vital capacity (FVC). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33902584/)
Mechanisms of Action: Apoptosis Inhibitor, VEGF Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Cyprus | Czech | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 28
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Bronchiolitis|COVID-19|Lung Diseases, Interstitial|Non-Small-Cell Lung Cancer|Pneumonia|Pulmonary Fibrosis|Scleroderma, General
Phase 2: Epistaxis|Lung Cancer|Mesothelioma|Pterygium|Radiation Pneumonitis|Telangiectasia, Hereditary Hemorrhagic|Telangiectasis
Phase 1: Acute Myeloid Leukemia|Healthy Volunteers|Idiopathic Pulmonary Fibrosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
jRCT2031250504 |
jRCT2031250504 | P2 |
Recruiting |
Pterygium |
2026-12-31 |
|||
NCT04976036 |
EPISTOP | P2 |
Recruiting |
Epistaxis|Telangiectasia, Hereditary Hemorrhagic|Telangiectasis |
2026-07-01 |
12% |
2025-04-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT07229716 |
HRS-9813-105 | P1 |
Not yet recruiting |
Pulmonary Fibrosis |
2026-04-01 |
2025-11-18 |
Primary Endpoints|Treatments |
|
NCT05285982 |
InPedILD®-ON | P3 |
Completed |
Lung Diseases, Interstitial |
2025-07-14 |
21% |
2025-10-15 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT06717100 |
LYT-100-2024-03 | P1 |
Not yet recruiting |
Idiopathic Pulmonary Fibrosis |
2025-02-01 |
88% |
2024-12-05 |
Primary Endpoints|Treatments |
NCT02496585 |
NCT02496585 | P2 |
Completed |
Lung Cancer|Radiation Pneumonitis |
2024-04-12 |
24% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT03513484 |
NU 17H04 | P1 |
Active, not recruiting |
Acute Myeloid Leukemia |
2023-12-11 |
50% |
2025-10-23 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04541680 |
NINTECOR | P3 |
Recruiting |
Pulmonary Fibrosis|COVID-19 |
2023-10-11 |
27% |
2024-06-26 |
Primary Endpoints|Treatments |
CTR20180930 |
CTR20180930 | P3 |
Completed |
Lung Diseases, Interstitial|Scleroderma, General |
2023-03-03 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Trial Status |
|
2018-001747-31 |
INFINITX BOS | P3 |
Active, not recruiting |
Bronchiolitis |
2022-10-09 |
2022-03-13 |
Treatments |
|
2020-002114-40 |
NINTECOR | P3 |
Active, not recruiting |
Pneumonia|COVID-19 |
2022-02-28 |
2022-03-13 |
Treatments |
|
2016-000521-38 |
NEMO | P2 |
Active, not recruiting |
Mesothelioma |
2020-10-30 |
2022-03-13 |
Treatments |
|
NCT07015398 |
NAL00-105 | P1 |
Completed |
Healthy Volunteers |
2025-09-12 |
50% |
2025-10-11 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-515743-27-00 |
1199-0378 | P3 |
Active, not recruiting |
Lung Diseases, Interstitial |
2025-08-11 |
21% |
2025-05-02 |
Treatments |
NCT06568458 |
IM027-1026 | P1 |
Completed |
Healthy Volunteers |
2025-02-27 |
50% |
2025-03-18 |
|
ACTRN12624000825550 |
ACTRN12624000825550 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2024-11-26 |
2025-01-28 |
Patient Enrollment|Primary Completion Date|Treatments|Trial Status |
|
NCT06625489 |
NCT06625489 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2024-11-25 |
88% |
2025-02-19 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT05065190 |
NCT05065190 | P3 |
Completed |
Lung Diseases, Interstitial |
2024-04-30 |
11% |
2025-05-21 |
Primary Endpoints |
NCT06070610 |
U1111-1292-0376 | P1 |
Completed |
Healthy Volunteers |
2023-12-14 |
12% |
2025-12-03 |
Primary Endpoints|Treatments |
NCT05817240 |
ENV-IPF-102 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2023-06-11 |
23% |
2023-07-06 |
Primary Endpoints |
NCT05830799 |
VP-C21-012 | P1 |
Completed |
Healthy Volunteers |
2023-05-11 |
23% |
2025-01-04 |
Patient Enrollment|Primary Endpoints|Treatments |
2019-002593-31 |
2019-002593-31 | P2 |
Completed |
Telangiectasia, Hereditary Hemorrhagic |
2023-03-24 |
2025-06-26 |
Treatments |
|
2016-003403-66 |
SENSCIS (R)-ON | P3 |
Completed |
Scleroderma, General|Lung Diseases, Interstitial |
2023-01-25 |
46% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments |
NCT03313180 |
SSc-ILD | P3 |
Completed |
Lung Diseases, Interstitial |
2023-01-25 |
46% |
2024-02-21 |
Primary Endpoints|Treatments |
2018-000525-32 |
Nintedanib in PF-ILD (extension) | P3 |
Active, not recruiting |
Lung Diseases, Interstitial |
2022-04-17 |
44% |
2025-07-07 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/08/2025 |
News Article |
PureTech Announces Successful End-of-Phase 2 Meeting with FDA for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis |
|
11/03/2025 |
News Article |
Avalyn to Participate in Multiple Upcoming Investor Conferences in November |
|
10/30/2025 |
News Article |
Rosen Law Firm Encourages Tvardi Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation – TRVD |
|
10/24/2025 |
News Article |
Rosen Law Firm Encourages Tvardi Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation – TVRD |