Zongertinib is named as an intervention in 6 current clinical trials in our China, UK and USA registers. 4 are recruiting patients now. The most common phase is Phase 2. The lead sponsor is Boehringer Ingelheim. The most-studied condition is Lung Cancer, Non-squamous, Non-small Cell. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Zongertinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A TWO-STAGE, SINGLE-ARM, PHASE II STUDY OF ZONGERTINIB PLUS FULVESTRANT IN PARTICIPANTS WITH HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER HARBORING HER2 MUTATIONS (AGATHA)
2026-525328-10-00 · Neoplasms
|
Phase 2 | Authorised | Medica Scientia Innovation Research S.L | Spain, Italy, Germany |
|
FINACCESS - Finnish National Study for Early Access to Cancer Therapies
2025-524769-26-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Ongoing | HUS-yhtymae | Finland |
| Lead sponsor | Trials |
|---|---|
| Boehringer Ingelheim | 6 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 6 | 4 |
| Clinical trials in UK | 5 | 3 |
| Clinical trials in USA | 5 | 3 |
| EU register (CTIS) | 2 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
6 current trials in our China, UK and USA registers name Zongertinib (also registered as BI 1810631) as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.
Yes. 4 of the 6 trials are recruiting: 4 with sites in China, 3 with sites in UK and 3 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
The lead sponsor is Boehringer Ingelheim. The number in brackets is how many trials each organisation leads.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Zongertinib works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Zongertinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Zongertinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.