RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (China), Breakthrough Therapy (China), Commissioner's National Priority Voucher (United States), Conditional marketing approval (China), Orphan Drug (Japan)

Structure/Sequence

Molecular FormulaC29H29N9O2

InChIKeyYSGNGFPNTLERCR-UHFFFAOYSA-N

CAS Registry2728667-27-2

Clinical Trials associated with Zongertinib

NCT07195695

/ Not yet recruitingPhase 3

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

This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow.
In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation).
Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits.
Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.

Start Date05 Dec 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06692322

/ CompletedPhase 1

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)

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m^2 can take part. Women can only participate if they cannot get pregnant. This study includes people with mild liver problems, people with moderate liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild and moderate liver problems affect how the body handles a medicine called zongertinib.
Participants take zongertinib once as tablets. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study.
Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times. This also includes an overnight stay for 6 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the study staff regularly takes blood samples.

Start Date15 Jan 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

CTR20242277

/ RecruitingPhase 1/2

Beamion BCGC-1：一项评价口服zongertinib（BI 1810631）单药或联合其他药物用于治疗晚期HER2+转移性乳腺癌（mBC）和转移性胃癌、食管胃结合部癌或食管腺癌（mGEAC）患者的Ib期剂量递增和II期剂量优化、随机、开放性、多中心临床研究

[Translation] Beamion BCGC-1: A Phase Ib, dose-escalation and Phase II, dose-optimization, randomized, open-label, multicenter study evaluating oral zongertinib (BI 1810631) alone or in combination with other agents in patients with advanced HER2+ metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC)

本研究的目的是确定zongertinib与德曲妥珠单抗、恩美曲妥珠单抗或曲妥珠单抗（联合或不联合卡培他滨）联合治疗时对已扩散的不同类型HER2+癌症患者的最佳耐受剂量。另一个目的是检查zongertinib单药治疗或与其他治疗联合使用是否可以使肿瘤缩小。Zongertinib 能抑制HER2，而HER2 能促进癌细胞生长。

[Translation]

The goal of this study was to determine the best-tolerated dose of zongertinib in combination with trastuzumab dapoxetine, trastuzumab emtansine, or trastuzumab (with or without capecitabine) in patients with different types of HER2+ cancer that has spread. Another goal was to examine whether zongertinib, alone or in combination with other treatments, could shrink tumors. Zongertinib inhibits HER2, which drives cancer cell growth.

Start Date25 Oct 2024

Sponsor / Collaborator

Boehringer Ingelheim (China) Investment Co., Ltd.

[+5]

100 Clinical Results associated with Zongertinib

100 Translational Medicine associated with Zongertinib

100 Patents (Medical) associated with Zongertinib

Literatures (Medical) associated with Zongertinib

02 Nov 2025·Future Oncology

Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers

Article

Author: Erzen, Damijan ; Wang, Xian ; Hurvitz, Sara ; Acosta Eyzaguirre, Daniel ; Shitara, Kohei ; Yan, Min ; Yarza, Ramón ; Kitano, Shigehisa ; Simonelli, Matteo ; Deng, Ting ; Maier, Daniela ; Berz, David ; Zhang, Qingyuan ; Del Conte, Gianluca ; Aykut Yazgili, Sila ; Doger de Speville Uribe, Bernard Gaston ; Curigliano, Giuseppe ; Nakayama, Izuma

BACKGROUND:

Overexpression and/or amplification of human epidermal growth factor receptor 2 (HER2) is a recognized oncogenic driver in metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinomas (mGEAC). Although HER2-directed monoclonal antibodies, antibody - drug conjugates (ADCs), and tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of HER2-positive tumors, additional combination regimens and/or novel agents are needed to expand sequential therapy options and improve patient outcomes - particularly following treatment with trastuzumab deruxtecan (T-DXd). Zongertinib is a novel, irreversible, HER2-selective TKI that spares EGFR.

STUDY DESIGN:

Here, we detail the rationale and design of Beamion BCGC-1 (NCT06324357), an international Phase Ib/II open-label trial in which patients with previously treated HER2-positive mBC or mGEAC will receive zongertinib alone or in combination. Phase Ib (dose escalation) will determine the maximum tolerated dose of zongertinib plus trastuzumab emtansine (T-DM1), T-DXd, or trastuzumab ± capecitabine, in patients with HER2-positive mBC, and plus T-DXd in patients with HER2-positive mGEAC. Phase II (dose optimization) will assess two doses of zongertinib in combination regimens, or as monotherapy, in patients with mBC or mGEAC. The trial is actively recruiting in six countries globally.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT06324357.

01 Nov 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

The development of Zongertinib for HER2-mutant NSCLC

Review

Author: Park, Cathleen J ; Brazel, Danielle ; Nagasaka, Misako

Human epidermal growth factor receptor 2 (HER2) mutations are rare in NSCLC and the only FDA approved agent until recently, was trastuzumab deruxtecan in the second line setting. HER2 mutated NSCLC has historically shown worse prognosis compared to other NSCLC and represent an unmet clinical need. Almost 50 % of patients with HER2-mutated non-small cell lung cancer (NSCLC) have brain metastases at diagnosis. Thus, developing an efficacious agent with good blood brain penetration is key. Zongertinib is a HER2 selective tyrosine kinase inhibitor that covalently binds to HER2 receptors, including exon20ins mutations. Zongertinib is safe and effective for patients with HER2-mutated NSCLC based on initial results from preclinical studies and the phase I Beamion LUNG-1 trial showing promising response rates and safety profile ultimately leading to the FDA accelerated approval on August 8, 2025.

19 Oct 2025·BRITISH JOURNAL OF CANCER

Enhanced HER2 internalization by clathrin-dependent endocytosis in non-small cell lung cancer positive for HER2 mutations

Article

Author: Shibahara, Daisuke ; Shimauchi, Atsushi ; Tsutsumi, Hirono ; Ibusuki, Ritsu ; Otsubo, Kohei ; Yoneshima, Yasuto ; Tanaka, Kentaro ; Okamoto, Isamu ; Iwama, Eiji

BACKGROUND:

HER2-targeted antibody-drug conjugates (ADCs) have shown marked efficacy for HER2 mutation-positive non-small cell lung cancer (NSCLC). The intracellular trafficking of mutant HER2 has remained to be fully elucidated, however.

METHODS:

HER2 dynamics were examined in cells expressing wild-type (WT) or mutant HER2 with the use of live cell imaging and an in situ proximity ligation assay. Proteins related to mutant HER2 trafficking were identified by liquid chromatography and tandem mass spectrometry.

RESULTS:

HER2 internalization was enhanced in NSCLC cells expressing mutant HER2 compared with those expressing HER2(WT). Homodimers of HER2(WT) were localized mainly at the cell surface, whereas those of mutant HER2 were present mostly in the cytoplasm. Knockdown of EGFR or HER3 suppressed internalization of HER2(WT) but not that of mutant HER2. The enhanced internalization of mutant HER2 was mediated by clathrin-dependent endocytosis, as was reflected by increased binding of the ubiquitin ligase c-Cbl to mutant HER2 and its consequent ubiquitination, and was attenuated by treatment with zongertinib, a HER2-specific tyrosine kinase inhibitor.

CONCLUSIONS:

Upregulation of HER2 phosphorylation promotes internalization of mutant HER2 mediated by clathrin-dependent endocytosis, likely contributing to the efficacy of HER2-targeted ADCs in NSCLC positive for HER2 mutations.

News (Medical) associated with Zongertinib

07 Nov 2025

·www.prnewswire.com

Boehringer awarded FDA Commissioner's National Priority Voucher for HERNEXEOS® in HER2 lung cancer

RIDGEFIELD, Conn., Nov. 7, 2025 /PRNewswire/ -- The U.S. Food & Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNPV) for HERNEXEOS® (zongertinib tablets), currently under investigation for first-line use in treatment-naïve patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). The CNPV program aims to shorten the review process from what normally takes 10-12 months to 1-2 months, while maintaining FDA's rigorous safety and efficacy standards. "We are grateful to the FDA for this recognition and for the opportunity to bring HERNEXEOS, a potential new first-line treatment option, to patients with advanced HER2 NSCLC through the CNPV program, an innovative FDA pilot initiative," said Jean-Michel Boers, U.S. Country Managing Director, President and Chief Executive Officer, Boehringer Ingelheim USA. "As a company, we are proud to be among those leading the way in advancing science where the need is urgent. We commend the FDA for its innovative efforts to streamline review for medicines like HERNEXEOS, a breakthrough-designated therapy, so that they can reach patients as quickly as possible." This recognition underscores the potential of HERNEXEOS to meet critical patient needs for this rare and aggressive cancer. HER2 (ERRB2) mutations are found in approximately 2-4% of NSCLC cases and are linked to poor prognosis.1 The estimated 5-year survival rate historically has been less than 10% for metastatic disease. There remains a high unmet need for these patients as they have limited treatment options. 2,3,4 Boehringer recently reported positive results from the Beamion LUNG-1 trial evaluating zongertinib in treatment-naïve patients with advanced NSCLC at ESMO 2025. The company is pursuing regulatory submission for HERNEXEOS as a first-line treatment. The FDA nominated HERNEXEOS for the CNPV program. The FDA is currently reviewing the therapy under the Accelerated Approval pathway and previously granted Breakthrough Therapy Designation for HERNEXEOS for use in a first-line setting. About non-small cell lung cancer (NSCLC) Lung cancer claims more lives than any other cancer type1 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.1 The condition is often diagnosed at a late stage,2 and fewer than 3 in 10 patients are alive five years after diagnosis.2 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.6,7,8 There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).9 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.10 What is HERNEXEOS (zongertinib tablets)? HERNEXEOS is a prescription medicine used to treat adult patients with non-small cell lung cancer (NSCLC): that has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene, and cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received prior treatment. Your healthcare provider will perform a test to make sure HERNEXEOS is right for you. It is not known if HERNEXEOS is safe and effective in children. IMPORTANT SAFETY INFORMATION Before taking HERNEXEOS, tell your healthcare provider about all your medical conditions, including if you: have liver problems. have heart problems. have lung or breathing problems other than lung cancer. are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS. You should use an effective form of birth control during treatment with HERNEXEOS and for 2 weeks after your last dose. Talk to your healthcare provider about birth control methods that might be right for you during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant while taking HERNEXEOS. are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. What are the possible side effects of HERNEXEOS? HERNEXEOS may cause serious side effects, including: Liver problems. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you have symptoms of a liver problem, which may include: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea colored) urine pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal feeling very tired Heart problems, including decreased pumping of blood from the heart and an abnormal heartbeat. Your healthcare provider should check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have symptoms of a heart problem which may include: feeling like your heart is pounding or racing dizziness tiredness feeling lightheaded shortness of breath Lung problems. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever. The most common side effects of HERNEXEOS include diarrhea, increased liver function tests, rash, fatigue, and nausea. HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of HERNEXEOS. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1800FDA1088. CL--100061 07.09.2025 For U.S. Healthcare Professionals, please see full Prescribing Information. About HERNEXEOS® (zongertinib tablets) HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2). HERNEXEOS was recently approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. About Boehringer Ingelheim in Oncology We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim's generational commitment to driving scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer's ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more at . About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at . MPR-US-103883 Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021 May 3;1(2):58-73. National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival Rates. (Accessed: October 2025). Belaroussi, Y. et al. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023.13, 9584. Simeone, J. C. et al. Treatment patterns and overall survival in metastatic non-small-cell lung cancer in a real-world US setting. Fut. Oncol. Lond. Engl. 2019. 15(30), 3491–3502. International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed: October 2025). Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388 Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204. Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858. Arcila, M. E. et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin. cancer Res. an Off. J. Am. Assoc. Cancer Res. 18, 4910–4918 (2012). Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997. SOURCE Boehringer Ingelheim 21% more press release views with Request a Demo

Drug ApprovalAccelerated ApprovalBreakthrough TherapyClinical Result

07 Nov 2025

·pharma.economictimes.indiatimes.com

US FDA awards six more fast-track vouchers to speed drug reviews

Bengaluru: The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo Nordisk , special vouchers that will speed up the review of their medicines, bringing the total number of recipients to 15. The vouchers went to treatments for cancer, obesity, tuberculosis and sickle cell disease. Among the selected products are Novo's oral version of weight-loss drug Wegovy and Lilly's experimental obesity pill orforglipron. The vouchers are part of the Commissioner's National Priority Voucher, a pilot program launched in June to accelerate FDA decisions for drugs that address key public health or national security needs. Companies that receive a voucher can expect a decision within one to two months, compared to the typical 10 to 12 months. The announcement coincided with the Trump administration unveiling pricing agreements with the two drugmakers for their weight-loss treatments. In exchange for lowering prices for Medicare and Medicaid, both companies received priority review vouchers. Michael Leuchten, an analyst at Jefferies, said the vouchers are "unlikely to favor Novo." Leuchten added that since approval for Novo's oral Wegovy is already anticipated before year-end, "the benefit of this voucher appears more modest to Novo." Shares of Lilly closed up just over 1%, while U.S.-listed shares of Novo Nordisk fell 4% on Thursday. The recipients also included Vertex Pharmaceuticals' gene therapy Casgevy for sickle cell disease, GSK's dostarlimab for rectal cancer, Johnson & Johnson's bedaquiline for drug-resistant tuberculosis in young children, and Boehringer Ingelheim's zongertinib for a type of lung cancer. FDA Commissioner Marty Makary said the vouchers are awarded to companies that commit to making their drugs more affordable, manufacturing them in the U.S., or addressing unmet health needs. "We are pioneering new ways of bringing these cures and meaningful treatments to the market faster," he said. The FDA announced its first batch of nine vouchers in October. (Reporting by Kamal Choudhury in Bengaluru; Editing by Alan Barona)

Priority ReviewGene TherapyFast Track

06 Nov 2025

·www.fiercebiotech.com

FDA reveals 2nd round of \'national priority\' voucher winners, including obesity giants Lilly and Novo

FDA Commissioner Marty Makary, M.D., launched a new \"national priority voucher\" program in June, and the agency began accepting applications in July. \n The FDA has released the second batch of recipients for the new \"national priority voucher\" program, with executives for two of the beneficiaries appearing in the Oval Office with President Donald Trump earlier today.Eli Lilly’s star oral GLP-1 candidate orforglipron and Novo Nordisk’s Wegovy (semaglutide) were named voucher winners in a Nov. 6 release from the FDA. Executives from both companies stood alongside Trump at a press conference today highlighting their new pricing deals with the White House. The other recipients are Boehringer Ingelheim’s zongertinib for HER2 lung cancer, which was recently approved as Hernexeos in August; Johnson & Johnson’s tuberculosis med bedaquiline, sold as Sirturo; GSK’s monoclonal antibody Jemperli (dostarlimab) for rectal cancer; and sickle cell disease gene therapy Casgevy (exagamglogene autotemcel), developed by Vertex Pharmaceuticals and CRISPR Therapeutics.“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” FDA Commissioner Marty Makary, M.D., said in the release. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”Makary launched the priority program in June, and the agency began accepting applications in July. The program is designed to cut the typical 10- to 12-month review timeline down to just one or two months for medicines that align with U.S. national priorities.The accelerated reviews will be enabled by a one-day meeting of multidisciplinary experts, the FDA said in the release, mimicking a tumor board where medical experts get together to discuss a patient’s cancer.The first group of recipients was announced less than a month ago, on Oct. 17. That batch included a hearing loss gene therapy from Regeneron; Merck’s fertility drug pergoveris, which is already approved in 74 countries but not yet in the U.S.; and Sanofi’s Tzield (teplizumab), a drug for Type 1 diabetes.The vouchers are nontransferable but can be retained if a company changes ownership. They can be tied to a specific investigational drug or can also carry an “undesignated” status and be used for a biopharma’s novel drug of choice. The FDA hasn\'t specified the classification of any national priority voucher winners. Even in its short life, the FDA’s priority voucher program has attracted its fair share of criticism.“The priority voucher program is not a ‘common sense’ approach as the FDA Commissioner claims, but a dangerous one,” Robert Steinbrook, M.D., health research group director at advocacy group Public Citizen, said in a June 18 statement. “Research has shown that when the FDA rushes to review and approve new drugs, there is a higher likelihood that these drugs will have safety problems after approval. The voucher program will only be a boon for Big Pharma at the expense of the American public and will likely bypass the agency’s advisory committee process that allows for outside independent input.”And at least one expert has suggested the program could land the FDA in legal hot water.“I think it is possible that it can end up in litigation to the extent that it is not clear why certain applicants were chosen,” Komal Karnik Nigam, a lawyer with global firm Hogan Lovells, told Regulatory Focus on July 24. “Given the amount of interest that we have seen for this program it seems possible there may be some kind of litigation in the future in terms of who did and who did not receive one of these vouchers.”

Drug ApprovalGene TherapyAccelerated Approval

100 Deals associated with Zongertinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 mutant non-small cell lung cancer	China	Boehringer Ingelheim International GmbH	26 Aug 2025
HER2-positive Non-squamous non-small cell lung cancer	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	08 Aug 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-small cell lung cancer stage IIIB	Phase 3	United States	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	China	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Japan	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Argentina	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Austria	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Belgium	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Brazil	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Canada	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Chile	Boehringer Ingelheim GmbH	05 Dec 2025
Non-small cell lung cancer stage IIIB	Phase 3	Denmark	Boehringer Ingelheim GmbH	05 Dec 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06028464 (CTgov)	Phase 1	-	16	Zongertinib (Zongertinib Alone (Reference, R))	cwjjqcaejp(opjgecfcej) = jfxtruwdbi mubaouhegl (gfxuwmpnrw, NA) View more	-	05 Nov 2025
				Carbamazepine+Zongertinib (Zongertinib+Carbamazepine (Test, T))	cwjjqcaejp(opjgecfcej) = brozrdfxsm mubaouhegl (gfxuwmpnrw, NA) View more
NCT05380947 (CTgov)	Phase 1	-	13	BI 1810631 (TF1 Fasted (R))	hkbceaofxs(mtnmuijuyp) = cbmhpsmwjf vjzzdtchch (zuvilutwyr, 52.7) View more	-	04 Nov 2025
				BI 1810631 (NF Fasted (T1))	hkbceaofxs(mtnmuijuyp) = ddpgphvglq vjzzdtchch (zuvilutwyr, 18.8) View more
NCT04886804 (Beamion LUNG-1, ESMO2025)	Phase 1	HER2 mutant non-small cell lung cancer HER2-mutant	53	Zongertinib (HER2 aberration-positive solid tumors)	wxihcznxqi(nopyxokmvo) = tvrkhuguhg pqkhzgibqm (vtoartzrrj ) View more	Positive	17 Oct 2025
				Zongertinib (previously treated HER2-mutant NSCLC)	dvvucjgitx(hxjwkmhuhe) = rmlmibkiuz pkciyfddxy (zzjjnjvzvx )
NCT04886804 (Beamion LUNG 1, ESMO2025)	Phase 1	HER2 mutant non-small cell lung cancer First line HER2-mutant	74	Zongertinib 120 mg	yrlzrxaunh(crzmhddgvo) = zrqipooliy zxfjdgvycv (stwwnzfequ, 66 - 85) View more	Positive	17 Oct 2025
NCT06360081 (CTgov)	Phase 1	-	56	Zongertinib (Zongertinib Test Treatment (T))	vaxikthmhq(feskiksnhx) = rsjkygilrf tvyzieenkh (nkhbojojcg, NA) View more	-	22 Sep 2025
				Zongertinib (Zongertinib Reference Treatment (R))	vaxikthmhq(feskiksnhx) = xihgwwecjl tvyzieenkh (nkhbojojcg, NA) View more
NCT06075277 (CTgov)	Phase 1	-	16	Zongertinib (Zongertinib iCF Fed (Test (T)))	qrljamiwyl(ywveigwgdm) = frxsfxdsqh ftsydhpsko (mjldipdsvs, NA) View more	-	22 Sep 2025
				Zongertinib (Zongertinib iCF Fasted (Reference (R)))	qrljamiwyl(ywveigwgdm) = ypnrfyeuwl ftsydhpsko (mjldipdsvs, NA) View more
NCT05833139 (CTgov)	Phase 1	-	16	Zongertinib (Zongertinib Alone)	eamhavhbyi(eejduwuxtx) = umpakbatxz izgqffaviw (jahrojpifu, NA) View more	-	22 Sep 2025
				Itraconazole+Zongertinib (Zongertinib + Itraconazole)	eamhavhbyi(eejduwuxtx) = efujyphnba izgqffaviw (jahrojpifu, NA) View more
NCT05879991 (CTgov)	Phase 1	-	15	zongertinib (C-14) (Part A - Zongertinib (C-14) (T1))	lxzjioaxsz(dtkzypbmbd) = boecfvclus yvjkcuomoh (rabbwgosvx, 16.8) View more	-	22 Sep 2025
				zongertinib (C-14) (Part B - Zongertinib (T2), Then Zongertinib (C-14) (R))	prloyzedrb(znoinjgrto) = aatnogmekw jzaehivimm (tapljunbvm, NA) View more
NCT04886804 (Beamion LUNG-1, WCLC2025) Manual	Phase 1	HER2 mutant non-small cell lung cancer Second line \| Last line \| Third line HER2-mutant	75	Zongertinib 120 mg (stable/asymptomatic BMs at baseline)	jahacsxwmk(ligcvhxgac) = dlsdvjrexd tzdbgfrxhp (ckalbvodcp, 46 - 79) View more	Positive	09 Sep 2025
				Zongertinib 120 mg (without BMs at baseline)	jahacsxwmk(ligcvhxgac) = kbrxdqwpuh tzdbgfrxhp (ckalbvodcp, 61 - 85) View more
NCT04886804 (Beamion LUNG-1, FDA_CDER) Manual	Phase 1	HER2-positive Non-squamous non-small cell lung cancer ERBB2 Mutation (Activating)	71	HERNEXEOS	dlvblwfpzw(jujbkdzdbg) = chmmajubqn nqkbvsstbx (gpnxfvzsob, 63 - 83) View more	Positive	08 Aug 2025
				HERNEXEOS (previous treatment with platinum-based chemotherapy and a HER2-targeted ADC)	dlvblwfpzw(jujbkdzdbg) = kiaqbghslk nqkbvsstbx (gpnxfvzsob, 29 - 61) View more

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