Zongertinib (BI 1810631) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials across Phase I through Phase III evaluate the efficacy, safety, and pharmacokinetics of zongertinib (BI 1810631), primarily sponsored by Boehringer Ingelheim in collaboration with organizations such as MedSIR. Key indications under investigation include non-small cell lung cancer, advanced breast cancer, HER2-mutated solid tumors, gastroesophageal adenocarcinomas, colorectal cancer, and pharmacokinetic profiles in healthy subjects and individuals with liver disease. Recruitment statuses span from completed pharmacokinetic evaluations to actively recruiting Phase II and Phase III studies, including trials within the Beamion program.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07195695	RECRUITING	Non-small Cell Lung Cancer	Boehringer Ingelheim	2026-01-16	PHASE3
NCT06324357	RECRUITING	Metastatic Breast Cancer; Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma; Colorectal Cancer	Boehringer Ingelheim	2024-06-28	PHASE1; PHASE2
NCT06581432	RECRUITING	Solid Tumours	Boehringer Ingelheim	2024-10-11	PHASE2
NCT07619066	NOT_YET_RECRUITING	Advanced Breast Cancer; Hormone Receptor Positive / HER2-negative Breast Cancer; HER2 Mutation	MedSIR	2026-10-04	PHASE2
NCT07486817	RECRUITING	Lung Cancer, Non-squamous, Non-small Cell	Boehringer Ingelheim	2026-06-04	PHASE2
NCT04886804	ACTIVE_NOT_RECRUITING	Neoplasm Metastasis; Non-Small Cell Lung Cancer	Boehringer Ingelheim	2021-07-02	PHASE1
NCT07789028	NOT_YET_RECRUITING	Healthy	Boehringer Ingelheim	2026-09-09	PHASE1
NCT06151574	ACTIVE_NOT_RECRUITING	Lung Cancer, Non-squamous, Non-small Cell	Boehringer Ingelheim	2024-02-09	PHASE3
NCT07649941	COMPLETED	Healthy	Boehringer Ingelheim	2026-06-22	PHASE1
NCT06692322	COMPLETED	Liver Diseases; Healthy	Boehringer Ingelheim	2025-01-15	PHASE1
NCT06494761	COMPLETED	Healthy	Boehringer Ingelheim	2024-07-30	PHASE1
NCT06504862	COMPLETED	Healthy	Boehringer Ingelheim	2024-08-20	PHASE1
NCT06360081	COMPLETED	Healthy	Boehringer Ingelheim	2024-04-30	PHASE1
NCT06075277	COMPLETED	Healthy	Boehringer Ingelheim	2023-10-19	PHASE1
NCT06028464	COMPLETED	Healthy	Boehringer Ingelheim	2023-09-11	PHASE1
NCT05879991	COMPLETED	Healthy	Boehringer Ingelheim	2023-08-10	PHASE1
NCT05833139	COMPLETED	Healthy	Boehringer Ingelheim	2023-04-14	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Zongertinib (BI 1810631) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zongertinib selectively and covalently binds to the kinase domain of human HER2, including wild-type receptors and exon 20 insertion mutations, while sparing wild-type EGFR signaling to suppress downstream oncogenic tyrosine phosphorylation cascades. This targeted covalent inhibition induces tumor cell growth arrest and apoptosis, providing a mechanistic rationale for its clinical activity against HER2-aberrant non-small cell lung cancer and advanced solid tumors.

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>).