Drugs / Zongertinib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | HERNEXEOS | — | 2026-02-26 | fda.gov ↗ |
| Approved | US (FDA) | HERNEXEOS | — | 2025-08-08 | fda.gov ↗ |
| Filed | China (NMPA) | — | HER2-mutated advanced non-small cell lung cancer | 2025-01-15 | “已向国家药品监督管理局（NMPA）药品审评中心（CDE）递交在研肺癌创新药zongertinib的上市许可申请并获得受理。” cttq.com ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials · 2 met primary | ||||||
| Phase 1 | NCT07789028 | Sep → Dec 2026 expected | — | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 1 | NCT07649941 | Jun → Jul 2026 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06692322 | Jan → Jun 2025 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06504862 | Aug → Oct 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06494761 | Jul → Oct 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06360081 | Apr → Jun 2024 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 1 | NCT06075277 | Oct 2023 → Jan 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06028464 | Sep → Dec 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05879991 | Aug → Oct 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05833139 | Apr → Jun 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05380947 | Jun → Sep 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT04886804 | Jul 2021 → Dec 2026 expected | metastatic neoplasm, non-small cell lung carcinoma | Boehringer Ingelheim | Active not recruiting | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06324357 | Jun 2024 → Jan 2029 expected | breast cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07619066 | Oct 2026 → Sep 2028 expected | female breast carcinoma, hormone receptor-positive breast cancer | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07486817 | Jun 2026 → Aug 2027 expected | non-small cell lung carcinoma | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 2 | NCT06581432 | Oct 2024 → Nov 2028 expected | cancer | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07195695 | Jan 2026 → Feb 2032 expected | non-small cell lung carcinoma | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT06151574 | Feb 2024 → Dec 2026 expected | non-small cell lung carcinoma | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Boehringer Ingelheim | Results Boehringer Ingelheim's oncology portfolio shows strong promise across multiple cancers at ASCO 2026 prnewswire.com ↗
New patient-reported outcomes data shows improved function and reduced symptom burden with HERNEXEOS® (zongertinib tablets) as an initial treatment option in HER2 ( ERBB2 )-mutant advanced non-small cell lung cancer (NSCLC) |
| 2026-05-21 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 重磅！圣赫途®一线适应症在华获批，成为国内首个HER2突变肺癌一线靶向疗法 cttq.com ↗
5月21日，中国生物制药（1177.HK）与勃林格殷格翰共同宣布，双方在中国大陆联合推广的圣赫途®（中文通用名：宗艾替尼片，英文通用名：zongertinib）获得中国国家药品监督管理局（NMPA）批准，单药适用于治疗存在HER2（ERBB2）酪氨酸激酶结构域激活突变的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。 |
| 2026-04-16 | Boehringer Ingelheim | Results /C O R R E C T I O N -- Boehringer Ingelheim/ prnewswire.com ↗
The confirmed objective response rate (ORR) was 76%, with 11% of patients achieving a complete response and 65% of patients achieving a partial response. |
| 2025-11-07 | Boehringer Ingelheim | Regulatory Boehringer awarded FDA Commissioner's National Priority Voucher for HERNEXEOS® in HER2 lung cancer prnewswire.com ↗
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). |
| 2025-10-17 | Boehringer Ingelheim | Results Boehringer's HERNEXEOS® demonstrated a 77% objective response rate in treatment-naïve patients with advanced HER2 (ERBB2)-mutant NSCLC prnewswire.com ↗
HERNEXEOS demonstrated efficacy with a confirmed objective response rate (ORR) of 77%. |
| 2025-09-03 | Boehringer Ingelheim | Regulatory FDA grants HERNEXEOS® Breakthrough Therapy Designation for first line use in HER2 (ERBB2)-mutant advanced NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced HERNEXEOS ® (zongertinib tablets) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain activating mutations. |
| 2025-05-22 | Boehringer Ingelheim | Results Boehringer Ingelheim Showcases Bold Vision for the Future of Cancer Care at ASCO 2025 prnewswire.com ↗
Patient-reported outcomes from the Beamion LUNG-1 study in previously treated patients with HER2 (ERRB2)-mutant advanced non-small cell lung cancer (NSCLC) reported physical function and disease-related symptom improvement while being treated with zongertinib |
| 2025-04-29 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 重磅！Zongertinib在HER2突变晚期非小细胞肺癌患者中展现持久且具有临床意义的疗效 cttq.com ↗
客观缓解率（ORR）达71%（95% CI：60-80），其中7%为完全缓解，64%为部分缓解，疾病控制率（DCR）高达96%。 |
| 2025-04-28 | Boehringer Ingelheim | Results Boehringer's new zongertinib data demonstrates durable and clinically meaningful results in patients with HER2 (ERBB2)-mutant advanced NSCLC prnewswire.com ↗
Previously unreported results, including median duration of response (DoR) of 14.1 months and median progression-free survival (PFS) of 12.4 months, indicate the potential for zongertinib to impact clinical practice |
| 2025-02-19 | Boehringer Ingelheim | Regulatory Boehringer's zongertinib receives Priority Review from U.S. FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer prnewswire.com ↗ |
| 2025-01-16 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 祝贺！肺癌重磅创新药zongertinib在华成功递交上市许可申请 cttq.com ↗
1月15日，中国生物制药战略合作伙伴勃林格殷格翰宣布公司已向国家药品监督管理局（NMPA）药品审评中心（CDE）递交在研肺癌创新药zongertinib的上市许可申请并获得受理。 |
| 2024-12-10 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results BEAMION LUNG-1研究的最新数据：zongertinib展现振奋人心的疗效，为HER2突变非小细胞肺癌经治患者带来希望 cttq.com ↗
经中心审查确认，zongertinib（剂量为每日120毫克，单次服用，n=75例患者）展现出卓越疗效：客观缓解率（ORR）为71%，疾病控制率（DCR）高达93%。 |
| 2024-09-09 | Boehringer Ingelheim | Results Boehringer's zongertinib shows encouraging efficacy and tolerability profile in previously treated HER2 mutated lung cancer patients prnewswire.com ↗
With a confirmed objective response rate (ORR) of 66.7%, 97.5% CI (53.8–77.5), (p<0.0001) as assessed by blinded independent central review (BICR), the primary endpoint was met for Cohort 1 (120 mg; n=75). |
| 2024-08-27 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim to unveil groundbreaking oncology research at WCLC, demonstrating strength of portfolio prnewswire.com ↗
The U.S. FDA and China's CDE have granted zongertinib Breakthrough Therapy Designation for patients with HER2-mutated NSCLC and who have received prior systemic therapy. |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zongertinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06075277 ↗ |
| Known as | BI 1810631 | “Zongertinib (BI 1810631)” NCT07619066 ↗ |
| Action | Inhibit | “selectively inhibits HER2 while sparing wild-type epidermal growth factor receptor (EGFR)” PMID 41985129 ↗ Apr 2026 |
| Modality | Small molecule | “Zongertinib is an irreversible tyrosine kinase inhibitor” PMID 41348300 ↗ Dec 2025 |
| Route | Oral | “BI 1810631 orally twice daily (BID) or once daily (QD) at escalating doses” PMID 36528522 ↗ Nov 2022 |
| Target | ERBB2 | “selectively inhibits HER2 while sparing wild-type epidermal growth factor receptor (EGFR)” PMID 41985129 ↗ Apr 2026 |