HERNEXEOS (zongertinib)
Hernexeos helps patients with advanced or spreading non-squamous non-small cell lung cancer that cannot be removed by surgery. It is used for adults whose tumors contain specific HER2 (ERBB2) mutations and who have already undergone previous systemic therapy. This medication provides a targeted option for managing this specific type of lung cancer once other treatments have been tried.
How HERNEXEOS Works
Hernexeos works by blocking the activity of the HER2 protein, a kinase involved in cell growth. By binding to this target, the drug stops the signaling processes and phosphorylation that allow cancer cells with specific mutations to multiply and spread.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-08-08
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
HERNEXEOS Approval History
What HERNEXEOS Treats
1 indicationsHERNEXEOS is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
HERNEXEOS Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
HERNEXEOS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in HERNEXEOS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HERNEXEOS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to HERNEXEOS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04886804 | 1479-0001 2020-004563-47, 2024-511246-39-00 | Ph 1 | active not recruiting | Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) |
| NCT06151574 | 1479-0008 2023-504308-27-00, U1111-1294-1407 | Ph 3 | active not recruiting | Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment |
| NCT07195695 | 1479-0032 U1111-1320-6149, 2025-521284-12-00 | Ph 3 | recruiting | Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations |
| NCT06581432 | 1479-0009 2023-510429-14-00, U1111-1302-3333 | Ph 2 | recruiting | Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations |
| NCT06324357 | 1479-0012 | Ph 1, Ph 2 | recruiting | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread |
| NCT07486817 | 1479-0044 2025-523567-38-00, U1111-1327-3020 | Ph 2 | not yet recruiting | Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab |
| NCT06504862 results posted | 1479-0015 2024-510628-38-00, U1111-1302-1171 | Ph 1 | completed | A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood |
| NCT06494761 results posted | 1479-0014 2023-510263-35-00, U1111-1301-9035 | Ph 1 | completed | A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body |
| NCT06028464 results posted | 1479-0011 2022-503046-50-00 | Ph 1 | completed | A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood |
| NCT05879991 results posted | 1479-0006 2022-503047-17-00, U1111-1291-2883 | Ph 1 | completed | A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body |
| NCT06075277 results posted | 1479-0010 2022-502860-19-00, U1111-1291-3312 | Ph 1 | completed | A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food |
| NCT05833139 results posted | 1479-0004 2022-003757-63 | Ph 1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HERNEXEOS FDA Label Details
Indications & Usage
FDA Label (PDF)HERNEXEOS is indicated for the treatment of Non-Small Cell Lung Cancer.
HERNEXEOS Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for HERNEXEOS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 2 active patents
Trial Analysis
- • 12 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment