Hernexeos

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Metastatic Breast CancerSolid TumoursNeoplasm MetastasisLung Cancer, Non-Squamous, Non-Small Cell

48 competitors in Metastatic Breast Cancer

#DrugCompanyPhaseTrials

1

Kisqali

Novartis

Approved

62

Femara

Novartis

Approved

23

Nolvadex

AstraZeneca

Approved

14

Faslodex

FFresenius Kabi USA, LLC

Approved

85

Arimidex

IIstituto Clinico Humanitas

Approved

26

Zoladex

TTerSera Therapeutics LLC

Approved

17

Ibrance

Pfizer

Phase 3

68

Fotivda

Roche

Phase 3

29

Aromasin

Pfizer

Phase 3

110

Abraxane

Bristol-Myers Squibb

Phase 3

1Show 36 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

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

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·Phase 2·NCT07486817·60 enrolled

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·Phase 3·NCT06151574·428 enrolled

CAR1 trial

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

Completed·Boehringer Ingelheim·Phase 1·NCT06028464·16 enrolled

Liver1 trial

A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems

Completed·Boehringer Ingelheim·Phase 1·NCT06692322·29 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·Phase 1·NCT06504862·32 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·Phase 1·NCT06494761·16 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·Phase 1·NCT05879991·15 enrolled

Non-Small Cell Lung Cancer1 trial

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·Phase 3·NCT07195695·400 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·Preclinical·NCT06324357·768 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·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

Active, not recruiting·Boehringer Ingelheim·Phase 1·NCT04886804·554 enrolled

Unspecified4 trials

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

Completed·Boehringer Ingelheim·Phase 1·NCT06075277·16 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·Phase 1·NCT06360081·56 enrolled

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

Completed·Boehringer Ingelheim·Phase 1·NCT05833139·16 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·Phase 1·NCT07649941·16 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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