Hernexeos

(Zongertinib)

Phase 3Small molecule

Boehringer Ingelheim

Hernexeos is one of 61 small molecule programs targeting Metastatic Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Metastatic Breast CancerRecruiting

Solid TumoursRecruiting

Neoplasm MetastasisRecruiting

Lung Cancer, Non-Squamous, Non-Small CellRecruiting

Metastatic Breast CancerPreclinical

Recruiting

Solid TumoursPhase 2

Recruiting

Neoplasm MetastasisPhase 1

Recruiting

Lung Cancer, Non-Squamous, Non-Small CellPhase 3

Recruiting

Competition

Competitive Landscape

46 competitors in Metastatic Breast Cancer

#DrugCompanyPhaseTrials

Kisqali

Novartis

Approved

6 2

Femara

Novartis

Approved

3 3

Nolvadex

AstraZeneca

Approved

2 4

Faslodex

FFresenius Kabi USA, LLC

Approved

8 5

Arimidex

IIstituto Clinico Humanitas

Approved

3 6

Zoladex

TTerSera Therapeutics LLC

Approved

1 7

Herceptin

Roche

Phase 3

5 8

Taxol

Teva

Phase 3

3 9

Abraxane

Bristol-Myers Squibb

Phase 3

3 10

Aromasin

Pfizer

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 3Active, not recruiting

Lung Cancer, Non-Squamous, Non-Small Cell

NCT06151574

Q4 2028

Phase 2Recruiting

Solid Tumours

NCT06581432

Q1 2029

PreclinicalRecruiting

Metastatic Breast Cancer

NCT06324357

Q3 2029

Phase 2Recruiting

Lung Cancer, Non-Squamous, Non-Small Cell

NCT07486817

Phase 1Recruiting

Neoplasm Metastasis

NCT04886804

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT07195695·400 enrolled

A Phase 1a/1b Of Zanidatamab In Combination With Zongertinib In HER2-Mutated Non-Small Cell Lung Cancer (NSCLC)

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07899801·24 enrolled

Lung Cancer, Non-squamous, Non-small Cell2 trials

Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations

Active, not recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT06151574·428 enrolled

Beamion 44: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT07486817·60 enrolled

Midazolam1 trial

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06494761·16 enrolled

Metformin1 trial

A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06504862·32 enrolled

CAR1 trial

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06028464·16 enrolled

6 more indications

ESS1 trial

A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05879991·15 enrolled

Liver Diseases1 trial

Pharmacokinetics, Safety and Tolerability of Zongertinib Following Oral Administration in Male and Female Participants of Non-childbearing Potential With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants of Non-childbearing Potential With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06692322·29 enrolled

Metastatic Breast Cancer1 trial

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Preclinical·NCT06324357·910 enrolled

Solid Tumours1 trial

Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT06581432·588 enrolled

Neoplasm Metastasis1 trial

Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04886804·554 enrolled

Unspecified4 trials

A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05833139·16 enrolled

A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06360081·56 enrolled

A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06075277·16 enrolled

Show 1 more trial

The Effect of Multiple Oral Doses of Bosentan on the Single Oral Dose Pharmacokinetics of Zongertinib in Healthy Male Subjects (an Open-label, Two-treatment, Two-period Fixed Sequence Trial)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT07649941·16 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 8, 2025

HERNEXEOS

NDA NDA219042

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Zongertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zongertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zongertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219042). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Hernexeos. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Boehringer Ingelheim

Patent Landscape[5]

Patent Cliff

Nov 15, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12171739Nov 15, 2026

11608343Jul 21, 2041

Hernexeos

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q4 2028

Q1 2029

Q3 2029

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Lung Cancer, Non-squamous, Non-small Cell2 trials

Midazolam1 trial

Metformin1 trial

CAR1 trial

ESS1 trial

Liver Diseases1 trial

Metastatic Breast Cancer1 trial

Solid Tumours1 trial

Neoplasm Metastasis1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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