Sevabertinib clinical trials
Sevabertinib is named as an intervention in 3 current clinical trials in our China, USA, France, Spain, Italy, Denmark, Switzerland, Canada, Japan, South Korea, Australia, UK, Germany, Netherlands, Belgium, Sweden, Poland, Austria, Czechia, Portugal, Turkey, Brazil, Mexico, Taiwan, Singapore and Israel registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Bayer (2). The most-studied condition is Advanced Non-small Cell Lung Cancer, HER2 Mutation.
Where Sevabertinib is approved
All regulators →Of the three regulators tracked here, the first to approve Sevabertinib was the US, on 19 Nov 2025. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Sevabertinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Sevabertinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 14 Nov 2043 (US 12679836).
- Latest patent on the drug substance itself: 14 Nov 2043 (US 12679836).
- Exclusivity NCE: New chemical entity, until 19 Nov 2030.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Sevabertinib works
All drug targets →- Non-small cell lung carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL6068074, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13491, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Sevabertinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Sevabertinib
3 trialsRegisters 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.
Conditions studied with Sevabertinib
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Bayer | 2 |
| Ruijin Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Sevabertinib trials
How many clinical trials are testing Sevabertinib?
3 current trials in our China, USA, France, Spain, Italy, Denmark, Switzerland, Canada, Japan, South Korea, Australia, UK, Germany, Netherlands, Belgium, Sweden, Poland, Austria, Czechia, Portugal, Turkey, Brazil, Mexico, Taiwan, Singapore and Israel registers name Sevabertinib (also registered as BAY2927088) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Sevabertinib trials recruiting patients?
Yes. 3 of the 3 trials are recruiting: 3 with sites in China, 2 with sites in USA, 2 with sites in France, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Denmark, 2 with sites in Switzerland, 2 with sites in Canada, 2 with sites in Japan, 2 with sites in South Korea, 2 with sites in Australia, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Netherlands, 1 with sites in Belgium, 1 with sites in Sweden, 1 with sites in Poland, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Portugal, 1 with sites in Turkey, 1 with sites in Brazil, 1 with sites in Mexico, 1 with sites in Taiwan, 1 with sites in Singapore and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Sevabertinib clinical trials?
Bayer (2) and Ruijin Hospital (1). The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Sevabertinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Sevabertinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Sevabertinib (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.