nintedanib: Clinical Trials

175 trials of nintedanib, newest first

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123 completed, 18 terminated, 9 unknown, 6 not yet recruiting. 62 Phase 2, 59 Phase 1, 25 Phase 3, 11 Phase 4, 1 Not applicable.

By phase and status

PhaseTrialsStatus
Phase 262Completed 37, Terminated 10, Unknown 6, Recruiting 3, Withdrawn 3, Not yet recruiting 2, Active not recruiting 1
Phase 159Completed 48, Terminated 6, Active not recruiting 2, Recruiting 2, Withdrawn 1
Phase 325Completed 17, Not yet recruiting 2, Terminated 2, Unknown 2, Recruiting 1, Withdrawn 1
Phase 411Completed 7, Not yet recruiting 1, Recruiting 1, Terminated 1, Unknown 1
Not applicable1Terminated 1

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Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
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
BMS-986353, Fludarabine, Cyclophosphamide - Systemic Sclerosis
Phase 3Not yet recruitingJuno Therapeutics, Inc., a Bristol-Myers Squibb Company922027-02-032026-09-18
Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis
Antifibrotic therapy - Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
Not yet recruitingBristol-Myers Squibb402026-08-012026-07-23
Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Nintedanib,Dextromethorphan, Nintedanib,Placebo - Idiopathic Pulmonary Fibrosis (IPF)
Phase 2Not yet recruitingFirst Affiliated Hospital of Wenzhou Medical University602026-05-122026-05-13
A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer
Tislelizumab and nintedanib - Limited-stage Small Cell Lung Cancer (LS-SCLC)
Phase 4Not yet recruitingThe Affiliated Hospital of Qingdao University202026-05-012026-03-20
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
taladegib, nintedanib, pirfenidone - Idiopathic Pulmonary Fibrosis
Phase 1RecruitingEndeavor Biomedicines, Inc.572026-04-282026-05-15
Nintedanib for Improving Reproductive Outcomes in Adenomyosis
Nintedanib, Progesterone - Adenomyosis of Uterus
Phase 3Not yet recruitingSun Yat-sen University3282025-09-012025-09-09
Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
Tocilizumab, Nintedanib, Standard therapy - Systemic Sclerosis, Interstitial Lung Disease
Phase 3RecruitingNational Institute of Geriatrics, Rheumatology and Rehabilitation, Poland862025-07-012026-04-08
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
NAL ER, Pirfenidone, Nintedanib - Healthy Participants
Phase 1CompletedTrevi Therapeutics1322025-06-302025-10-10
A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis
Ofev® - Interstitial Lung Diseases, Systemic Sclerosis Associated Interstitial Lung Disease
Active not recruitingBoehringer Ingelheim20002025-06-172025-12-08
Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib
Nintedanib 150 MG [Ofev] - Drug Interactions
Phase 1CompletedPureTech242024-12-172026-08-13
Nintedanib Treatment in Unicentric Castleman Disease
Nintedanib - Castleman Disease
Phase 2Not yet recruitingAssistance Publique - Hôpitaux de Paris132024-11-012024-10-15
Real-life-persistence to Antifibrotic Treatments
Nintedanib, Pirfenidone - Idiopathic Pulmonary Fibrosis
CompletedBoehringer Ingelheim106462024-10-162026-04-15
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
Part A: Placebo, Nintedanib, GSK3915393 - Idiopathic Pulmonary Fibrosis
Phase 1CompletedGlaxoSmithKline502024-10-072025-02-18
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
Nintedanib, BMS 986278 - Healthy Participants
Phase 1CompletedBristol-Myers Squibb712024-09-192025-03-14
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Nintedanib - NSCLC, Nintedanib
UnknownSecond Hospital of Shanxi Medical University402024-08-242024-08-26
A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
Nintedanib - Idiopathic Pulmonary Fibrosis, Diarrhoea
CompletedBoehringer Ingelheim182024-07-162026-05-13
RCT of Nintedanib in Fibrotic Sarcoidosis
Nintedanib, Standard of care - Sarcoidosis, Pulmonary
Phase 4RecruitingPost Graduate Institute of Medical Education and Research, Chandigarh1202024-06-302024-10-23
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Nintedanib, gefitinib, erlotinib, afatinib, osimertinib - Non-small Cell Lung Cancer, EGFR Gene Mutation
Phase 1 / Phase 2RecruitingChina Medical University Hospital202024-02-232025-01-23
Safety of Nintedanib in Real World in China
nintedanib, pirfenidone - Pulmonary Fibrosis
WithdrawnBoehringer Ingelheim2023-12-292024-12-10
Prospective Clinical Study of Nintedanib to Inhibit Endometrial Fibrosis to Prevent Recurrence of Uterine Adhesions
Nintedanib 100 MG [Ofev], Nintedanib 150 MG [Ofev] - Uterine Adhesions
Phase 2 / Phase 3UnknownSixth Affiliated Hospital, Sun Yat-sen University902023-12-012022-12-02

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Conditions studied

Idiopathic Pulmonary Fibrosis (36)  ·  Lung Diseases, Interstitial (20)  ·  Carcinoma, Non-Small-Cell Lung (18)  ·  Pulmonary Fibrosis (11)  ·  Ovarian Neoplasms (8)  ·  Neoplasms (7)  ·  Colorectal Neoplasms (5)  ·  Recurrence (4)  ·  Scleroderma, Systemic (4)  ·  Breast Neoplasms (3)  ·  Carcinoma, Hepatocellular (3)  ·  Glioblastoma (3)  ·  Prostatic Neoplasms (3)  ·  Radiation Pneumonitis (3)  ·  Small Cell Lung Carcinoma (3)

Sponsors

Boehringer Ingelheim (86)  ·  European Organisation for Research and Treatment of Cancer - EORTC (4)  ·  Roswell Park Cancer Institute (4)  ·  Assistance Publique - Hôpitaux de Paris (3)  ·  Aktion Bronchialkarzinom e.V. (2)  ·  Bristol-Myers Squibb (2)  ·  Endeavor Biomedicines, Inc. (2)  ·  Hospices Civils de Lyon (2)  ·  M.D. Anderson Cancer Center (2)  ·  Memorial Sloan Kettering Cancer Center (2)  ·  Post Graduate Institute of Medical Education and Research, Chandigarh (2)  ·  Sunshine Lake Pharma Co., Ltd. (2)  ·  AA Secord (1)  ·  AHS Cancer Control Alberta (1)  ·  ARCAGY/ GINECO GROUP (1)

Countries

United States (59)  ·  Germany (44)  ·  France (39)  ·  United Kingdom (29)  ·  Spain (26)  ·  Belgium (24)  ·  Italy (24)  ·  Canada (21)  ·  Japan (21)  ·  Poland (18)  ·  Australia (17)  ·  Netherlands (16)  ·  South Korea (15)  ·  China (14)  ·  Czechia (13)

Top investigators

Lisa Lancaster, M.D. (2)  ·  Prof. Dr. Martin Wolf, MD (2)  ·  Prof. Dr. Rudolf M. Huber, MD (2)  ·  Alain Vergnenegre, MD (1)  ·  Andrea Marseille, +4961327714188 (1)  ·  Angeles A Secord, MD (1)  ·  Anish Ambaram, M.D. (1)  ·  Benedict Brockway, M.D. (1)  ·  Bhanu Singh, M.D. (1)  ·  Catherina Chang, M.D. (1)  ·  Chia-Chi Lin, Ph.D (1)

Results publications

PMID 37185961, PMID 33902584, PMID 31914963, PMID 32217654, PMID 24834811, PMID 24836310, PMID 26400368, PMID 27672117, PMID 28039616, PMID 28388260, PMID 28526798, PMID 29500603, PMID 30176872, PMID 30729456, PMID 30971229, PMID 33239000, PMID 37294870, PMID 12172553, PMID 23625328, PMID 24411639, PMID 24556663, PMID 24591665, PMID 25312396, PMID 25338318, PMID 25504994, PMID 25795637, PMID 26512876, PMID 26590673, PMID 26603056, PMID 27133759, PMID 27627050, PMID 28184431, PMID 28652319, PMID 28664834, PMID 28702806, PMID 28889759, PMID 28993537, PMID 29018526, PMID 29946005, PMID 30010751, PMID 30073583, PMID 30167310, PMID 30220235, PMID 30224318, PMID 30603797, PMID 31103412, PMID 31112379, PMID 31126332, PMID 31326319, PMID 31365829

NIH funding

2015 (12), 2008 (4), 2009 (4), 2018 (4), 2016 (3), P30CA016056 (3), 2019 (2), 2014 (1), 2023 (1), 2025 (1), P30CA022453 (1), P30CA060553 (1), U10CA027469 (1), U10CA180868 (1)