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: Europe
Company Founding Year: 1885
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 |
|---|---|---|---|---|---|---|---|---|
NCT07229716 |
HRS-9813-105 | P1 |
Not yet recruiting |
Pulmonary Fibrosis |
2026-04-01 |
2025-11-18 |
Primary Endpoints|Treatments |
|
NCT06717100 |
LYT-100-2024-03 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2025-02-17 |
88% |
2026-01-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT03513484 |
NU 17H04 | P1 |
Active, not recruiting |
Acute Myeloid Leukemia |
2023-12-11 |
50% |
2025-10-23 |
Primary Completion Date|Primary Endpoints|Treatments |
jRCT2031250504 |
jRCT2031250504 | P2 |
Recruiting |
Pterygium |
2026-12-31 |
|||
NCT04976036 |
EPISTOP | P2 |
Recruiting |
Epistaxis|Telangiectasia, Hereditary Hemorrhagic|Telangiectasis |
2026-12-01 |
12% |
2026-03-12 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT02496585 |
NCT02496585 | P2 |
Completed |
Radiation Pneumonitis|Lung Cancer |
2024-04-12 |
24% |
2025-08-27 |
Primary Endpoints|Treatments |
2016-000521-38 |
NEMO | P2 |
Active, not recruiting |
Mesothelioma |
2020-10-30 |
2022-03-13 |
Treatments |
|
NCT05285982 |
InPedILD®-ON | P3 |
Completed |
Lung Diseases, Interstitial |
2025-08-13 |
18% |
2026-03-05 |
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 |
Scleroderma, General|Lung Diseases, Interstitial |
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 |
|
2016-003403-66 |
SENSCIS (R)-ON | P3 |
Completed |
Scleroderma, General|Lung Diseases, Interstitial |
2023-01-25 |
46% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments |
2018-000525-32 |
Nintedanib in PF-ILD (extension) | P3 |
Active, not recruiting |
Lung Diseases, Interstitial |
2022-04-17 |
44% |
2025-07-07 |
Treatments |
2019-002593-31 |
2019-002593-31 | P2 |
Completed |
Telangiectasia, Hereditary Hemorrhagic |
2023-03-24 |
2025-06-26 |
Treatments |
|
2024-515743-27-00 |
1199-0378 | P3 |
Active, not recruiting |
Lung Diseases, Interstitial |
2025-08-11 |
18% |
2025-05-02 |
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 |
NCT06568458 |
IM027-1026 | P1 |
Completed |
Healthy Volunteers |
2025-02-27 |
50% |
2025-03-18 |
|
ACTRN12624000825550 |
ACTRN12624000825550 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2024-11-26 |
2026-02-15 |
Treatments |
|
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 |
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 |
NCT05065190 |
NCT05065190 | P3 |
Completed |
Lung Diseases, Interstitial |
2024-04-30 |
11% |
2025-05-21 |
Primary Endpoints |
NCT03313180 |
SSc-ILD | P3 |
Completed |
Lung Diseases, Interstitial |
2023-01-25 |
46% |
2024-02-21 |
Primary Endpoints|Treatments |