Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Sold as Hernexeos. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Zongertinib (sold as Hernexeos), first approved Aug 8, 2025, with 1 new use approved and 0 published complete response letters.
First approved: Aug 8, 2025
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $11.3M
First approved in Japan: Sep 19, 2025
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 1 month after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Hernexeos, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent HER2 (ERBB2 ) mutation-positive non-small cell lung… · Nippon Boehringer Ingelheim Co., Ltd. · Sep 19, 2025
Clinical Trials
11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Boehringer Ingelheim