Data updated: Jul 17, 2026
NINTEDANIB · EUGIA PHARMA SPECLTS
Trial Activity: Declining 10 active trials
Respiratory
Approved 2026-07-09
Development Insights
Boehringer Ingelheim conducting 38 trials (44%)
98 indications explored (Broad Platform)
→ idiopathic pulmonary fibrosis (14 trials)
→ healthy (12 trials)
→ carcinoma, non-small-cell lung (8 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2026-07-09
- Routes
- ORAL
- Dosage Forms
- CAPSULE
NINTEDANIB Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Jul 2026 ORIGINAL
Update
What NINTEDANIB Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2026) New
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Clinical Trial Registry
77 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04619680 ENDCOV-I results posted | GCO 20-2147 | Ph 4 | completed | The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19 |
| NCT06297096 NINTOC-TU | NIGRIR_004NINTOC-TU | Ph 3 | recruiting | Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease |
| NCT03377023 results posted | MCC-19406 | Ph 1, Ph 2 | active not recruiting | Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer |
| NCT01658462 VAROCE | VAROCE -1206 2012-002214-38 | Ph 2 | completed | Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer |
| NCT04976036 EPISTOP | 1199-0433 | Ph 2 | recruiting | Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Patients |
| NCT07454291 | ENV-IPF-104 | Ph 1 | recruiting | A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants |
| NCT07335562 Breakfree-SSc | CA061-1005 2025-524337-11, U1111-1330-3381 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis |
| NCT05799755 MINT | STUDY22090061 | Ph 4 | completed | Myositis Interstitial Lung Disease Nintedanib Trial |
| NCT02856425 PEMBIB | 2015-004511-21 2015/2329 | Ph 1 | completed | Trial Of Pembrolizumab And Nintedanib |
| NCT03805477 NINBOST2018 | 2018-00837; me17Hostettler | Ph 2 | recruiting | Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation |
| NCT06070610 results posted | 1305-0034 2023-505522-34-00, U1111-1292-0376 | Ph 1 | completed | A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood |
| NCT03513484 | NU 17H04 NCI-2018-00483, STU00206525 | Ph 1 | active not recruiting | Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia |
| NCT07015398 | NAL00-105 | Ph 1 | completed | A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants |
| NCT02863055 NEMO | EORTC-08112 | Ph 2 | terminated | Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma |
| NCT07162961 | New IVF | Ph 3 | not yet recruiting | Nintedanib for Improving Reproductive Outcomes in Adenomyosis |
| NCT03283007 INFINITx BOS | P160907 | Ph 3 | completed | Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 0p-1-2 |
| NCT02299141 results posted | 201412116 | Ph 2 | completed | Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer |
| NCT05065190 results posted | 1199-0434 | Ph 3 | completed | A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis |
| NCT02496585 results posted | 14-167 | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis |
| NCT06568458 | IM027-1026 | Ph 1 | completed | A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants |
| NCT05067517 | 2012199067 | Ph 3 | withdrawn | Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease |
| NCT06625489 | 222308 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese, Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib |
| NCT02231164 results posted | 1199.128 | Ph 3 | terminated | LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research |
| NCT02300298 results posted | 1199.90 | Ph 1 | completed | Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy |
| NCT02780700 results posted | 1199.251 | Ph 2 | terminated | Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] |
| NCT06479603 NINSARC | INT/IEC/2023/SPL-1214 | Ph 4 | recruiting | RCT of Nintedanib in Fibrotic Sarcoidosis |
| NCT06643091 NUCastle | APHP230820 | Ph 2 | not yet recruiting | Nintedanib Treatment in Unicentric Castleman Disease |
| NCT04971746 | GLPG4716-CL-101 2021-001718-12 | Ph 1 | completed | Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects |
| NCT02009579 | BGOG-cx1/ENGOT-cx1 | Ph 2 | completed | ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer |
| NCT04093024 InPedILD® results posted | 1199-0337 2018-004530-14 | Ph 3 | completed | A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD) |
| NCT02902484 results posted | STU 022016-083 | Ph 1, Ph 2 | terminated | Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer |
| NCT02225405 | 2013-0844 NCI-2014-02091, 2013-0844 | Ph 1 | completed | Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer |
| NCT03313180 results posted | 1199-0225 2016-003403-66 | Ph 3 | completed | A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis |
| NCT05644600 | D8960C00003 2022-003116-84 | Ph 1 | terminated | A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants. |
| NCT02399215 results posted | I 259114 NCI-2015-00238, I 259114 | Ph 2 | completed | Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors |
| NCT02788474 results posted | 1199.227 2015-003148-38 | Ph 4 | completed | Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment |
| NCT05817240 | ENV-IPF-102 | Ph 1 | completed | A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects |
| NCT03820726 results posted | 1199-0248 2018-000525-32 | Ph 3 | completed | A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
| NCT03562416 | 1199-0329 | Ph 2 | terminated | Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects |
| NCT03062943 LAM | IISS LAM | Ph 2 | completed | A Study of Nintedanib for LymphAngioleioMyomatosis (LAM) |
| NCT03287947 results posted | LCI-GI-APX-NIN-001 00021617 | Ph 2 | terminated | LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma |
| NCT05383131 | HEC585-P-04 / CRC-C2032 | Ph 1 | completed | To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers |
| NCT03292250 | KCSG-TRIUMPH | Ph 2 | completed | Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] |
| NCT01619085 results posted | 1199.33 2011-002766-21 | Ph 3 | completed | Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis |
| NCT02568449 results posted | 2015-010 NCI-2015-01412, 1506014121 | Ph 2 | completed | Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent |
| NCT04888715 | DW_DWN12088103 | Ph 1 | completed | To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers |
| NCT02808247 ANITA | EORTC-1506-STBSG 2016-002093-12 | Ph 2 | terminated | Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma |
| NCT02393755 results posted | I 265514 NCI-2015-00223, I 265514 | Ph 1, Ph 2 | completed | Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer |
| NCT03717012 results posted | 1199-0324 | Ph 4 | terminated | Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF) |
| NCT02668393 results posted | 1199.224 2015-000317-52 | Ph 1 | completed | Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma |
Showing 50 of 77 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NINTEDANIB FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment