Clinical Trials

Multiple clinical trials evaluate nintedanib across Phase 1, combined Phase 1/2, procedural, and post-authorization safety settings. Sponsored by industry entities such as Boehringer Ingelheim alongside academic medical institutions, these studies target idiopathic and general pulmonary fibrosis, treatment-related diarrhea, healthy volunteers, and EGFR-mutated or TKI-resistant non-small cell lung cancer. Recruitment statuses across these protocols include completed, actively recruiting, not yet recruiting, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06200714 Recruiting
Idiopathic Pulmonary Fibrosis|Diarrhoea
Boehringer Ingelheim
 2024-04-30 --
NCT05676112 Withdrawn
Pulmonary Fibrosis
Boehringer Ingelheim|China-Japan Friendship Hospital
 2023-12-29 --
NCT06070610 Completed
Healthy
Boehringer Ingelheim
 2023-11-08 Phase 1
NCT05755308 Not yet recruiting
Idiopathic Pulmonary Fibrosis
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2023-10 Not Applicable
NCT06071013 Not yet recruiting
Non-small Cell Lung Cancer|EGFR Gene Mutation|EGFR-TKI Resistant Mutation
China Medical University Hospital
 2023-09-28 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Nintedanib Ethanesulfonate Salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nintedanib functions as a multi-target receptor tyrosine kinase inhibitor that binds competitively to VEGFR1/2/3, FGFR1/2/3, and PDGFRα/β, thereby blocking receptor autophosphorylation and downstream intracellular signal transduction pathways. By suppressing pro-angiogenic and pro-fibrotic kinase signaling, the compound inhibits the proliferation, migration, and survival of endothelial cells and fibroblasts, thereby attenuating aberrant extracellular matrix deposition and tumor vascularization in pulmonary fibrosis and non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.