drugset
Drugs / Zongertinib
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Zongertinib

also known as BI 1810631

Small molecule targets ERBB2 via inhibition

Developed for
non-small cell lung carcinoma · breast cancer · cancer · colorectal cancer · esophageal adenocarcinoma · female breast carcinoma · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma
+2 more · hormone receptor-positive breast cancer · metastatic neoplasm
Investigated by
Boehringer Ingelheim · MedSIR

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) HERNEXEOS — 2026-02-26 fda.gov ↗
Approved US (FDA) HERNEXEOS — 2025-08-08 fda.gov ↗

Trials 17 · a red edge is where a trial was stopped

today
US approved 2025
NCT07619066 · Ph 2 NCT07649941 · Ph 1 NCT07486817 · Ph 2 NCT07195695 · Ph 3 NCT06692322 · Ph 1 NCT06581432 · Ph 2 NCT06504862 · Ph 1 NCT06494761 · Ph 1 NCT06324357 · Ph 1/2 NCT06360081 · Ph 1 NCT06151574 · Ph 3 NCT06075277 · Ph 1 NCT06028464 · Ph 1 NCT05879991 · Ph 1 NCT05833139 · Ph 1 NCT05380947 · Ph 1 NCT04886804 · Ph 1
20222023202420252026202720282029203020312032
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT07649941 Jun → Aug 2026 overdue — Boehringer Ingelheim Recruiting No outcome recorded
Phase 1 NCT06692322 Jan → Jun 2025 liver disorder Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06504862 Aug → Oct 2024 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06494761 Jul → Oct 2024 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06360081 Apr → Jun 2024 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06075277 Oct 2023 → Jan 2024 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06028464 Sep → Dec 2023 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT05879991 Aug → Oct 2023 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT05833139 Apr → Jun 2023 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT05380947 Jun → Sep 2022 — Boehringer Ingelheim Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT06324357 Jun 2024 → Jan 2029 expected breast cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 Boehringer Ingelheim Recruiting No outcome recorded
Phase 23 trials
Phase 2 NCT07619066 Oct 2026 → Sep 2028 expected female breast carcinoma, hormone receptor-positive breast cancer MedSIR Not yet recruiting No outcome recorded
Phase 2 NCT07486817 Jun 2026 → Aug 2027 expected non-small cell lung carcinoma Boehringer Ingelheim Recruiting No outcome recorded
Phase 2 NCT06581432 Oct 2024 → Dec 2027 expected cancer Boehringer Ingelheim Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07195695 Jan 2026 → Feb 2032 expected non-small cell lung carcinoma Boehringer Ingelheim Recruiting No outcome recorded
Phase 3 NCT06151574 Feb 2024 → Sep 2026 expected non-small cell lung carcinoma Boehringer Ingelheim Active not recruiting No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as Zongertinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT07619066 ↗
15

NCT06581432 ↗

NCT05833139 ↗

NCT06324357 ↗

NCT06360081 ↗

NCT07195695 ↗

NCT05879991 ↗

NCT06075277 ↗

NCT04886804 ↗

NCT06504862 ↗

NCT07649941 ↗

NCT06028464 ↗

NCT06494761 ↗

NCT06151574 ↗

NCT07486817 ↗

NCT06692322 ↗
Known as BI 1810631 “Zongertinib (BI 1810631)” NCT07619066 ↗
1

NCT05380947 ↗
Action Inhibit “selectively inhibits HER2 while sparing wild-type epidermal growth factor receptor (EGFR)” PMID 41985129 ↗ Apr 2026
Modality Small molecule “Zongertinib is an irreversible tyrosine kinase inhibitor” PMID 41348300 ↗ Dec 2025
Route Oral “BI 1810631 orally twice daily (BID) or once daily (QD) at escalating doses” PMID 36528522 ↗ Nov 2022
Target ERBB2 “selectively inhibits HER2 while sparing wild-type epidermal growth factor receptor (EGFR)” PMID 41985129 ↗ Apr 2026