Clinical Trials

Pyrotinib is undergoing evaluation in several clinical trials sponsored by Jiangsu HengRui Medicine Co. Ltd. and RemeGen Co. Ltd. to assess its use in advanced non-small cell lung cancer and pharmacokinetic properties. Phase 1 clinical trials involving healthy volunteers investigate drug-drug interactions with fluconazole and efavirenz across completed and unknown recruitment statuses. Additionally, multiple clinical trials in Phase 1/2 evaluate combination therapies with SHR-A1811 and RC48-ADC for advanced non-small cell lung cancer, encompassing actively recruiting and planned studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05745740 Not yet recruiting
Non-small Cell Lung Cancer
RemeGen Co. Ltd.
 2024-04 Phase 1|Phase 2
NCT05482568 Recruiting
Advanced Non-small Cell Lung Cancer
Jiangsu HengRui Medicine Co. Ltd.
 2022-09-15 Phase 1|Phase 2
NCT04850651 Completed
Healthy Subjects
Jiangsu HengRui Medicine Co. Ltd.
 2021-04-16 Phase 1
NCT04680091 Unknown status
Healthy Subjects Drug-drug Interaction Pyrotinib
Jiangsu HengRui Medicine Co. Ltd.
 2020-11-12 Phase 1

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

Check the Pyrotinib dimaleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyrotinib dimaleate selectively and irreversibly binds to the intracellular catalytic domains of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), thereby blocking receptor auto-phosphorylation and downstream pro-survival signaling pathways. This targeted kinase inhibition leads to cell cycle arrest and apoptosis, providing the mechanistic basis for its clinical investigation in EGFR- and HER2-driven malignancies such as 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>).

Jump to

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