Drugs / Zanidatamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Ziihera | — | 2025-06-27 | europa.eu ↗ |
Trials 30 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05868226 | Feb 2023 → Dec 2028 expected | HER2 positive breast carcinoma, hormone receptor-positive breast cancer, metastatic malignant neoplasm, triple-negative breast carcinoma | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 1 | NCT02892123 | Sep 2016 → Oct 2024 | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07494448 | Jul 2026 → Dec 2027 expected | HER2 positive breast carcinoma | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07477444 | Jun 2026 → Jun 2028 expected | gastroesophageal cancer | Universitaire Ziekenhuizen KU Leuven | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05027139 | Sep 2021 → Aug 2025 | carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT04276493 | Mar 2020 → Dec 2023 | breast cancer, gastric cancer, gastroesophageal cancer | BeiGene | Completed | No outcome recorded |
| Phase 218 trials | ||||||
| Phase 2 | NCT07685704 | Jul 2026 → Jun 2028 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Zhifeng Zhao, PhD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07631871 | Jun 2026 → Dec 2029 expected | colorectal neoplasm, endometrium neoplasm, head and neck neoplasm, ovarian neoplasm +3 | Haihua Yuan | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07290985 | May 2026 → Jun 2028 expected | gastroesophageal adenocarcinoma | American Association for Cancer Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07405476 | Apr 2026 → Dec 2028 expected | colon carcinoma, rectal carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT07176312 | Jan 2026 → Mar 2029 expected | gastroesophageal adenocarcinoma, metastatic carcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT07243938 | Jan 2026 → Jul 2028 expected | gastroesophageal junction adenocarcinoma, rectal carcinoma | Tao Zhang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07273981 | Jan 2026 → Jun 2028 expected | gastroesophageal junction adenocarcinoma | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07192068 | Oct 2025 → Mar 2028 expected | colorectal carcinoma, endometrial cancer, head and neck cancer, non-small cell lung carcinoma +1 | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT07296705 | Oct 2025 → Dec 2027 expected | urinary bladder carcinoma | Fujian Medical University Union Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06695845 | Jan 2025 → Dec 2026 expected | HER2 positive breast carcinoma, colorectal cancer, endometrial cancer, esophageal cancer +7 | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06043427 | Apr 2024 → Jun 2026 overdue | gastroesophageal adenocarcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05270889 | Apr 2022 → Jun 2024 | — | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05035836 | Nov 2021 → Dec 2028 expected | HER2 positive breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04466891 | Oct 2020 → Jul 2023 | digestive system carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04513665 | Aug 2020 → Mar 2024 | endometrial cancer, uterine carcinosarcoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04224272 | Jun 2020 → Apr 2023 | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03929666 | Aug 2019 → Aug 2025 | gastroesophageal adenocarcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06435429 | Aug 2024 → Apr 2028 expected | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06282575 | Jul 2024 → Dec 2028 expected | biliary tract cancer | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05152147 | Dec 2021 → Jul 2026 overdue | esophageal adenocarcinoma, gastric neoplasm, gastroesophageal adenocarcinoma | Jazz Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04164199 | Dec 2019 → May 2026 | cancer | BeOne Medicines | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04578444 | — | carcinoma | Jazz Pharmaceuticals | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06253871 Background | Mar 2024 → Dec 2027 expected | HER2 positive breast carcinoma, gastroesophageal cancer, metastatic malignant neoplasm in the brain, non-small cell lung carcinoma +1 | Iambic Therapeutics, Inc | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06324357 Background | Jun 2024 → Jan 2029 expected | breast cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07102381 Comparator | Sep 2025 → Jan 2028 expected | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zanidatamab | “IAM1363 monotherapy OR IAM1363 in combination with capecitabine + trastuzumab OR IAM1363 in combination with capecitabine + zanidatamab OR IAM1363 in combination with T-Dxd OR...” NCT06253871 ↗32“Zanidatamab (ZW25), a humanized, bispecific antibody that simultaneously binds the 2 distinct HER2 epitopes bound by trastuzumab and pertuzumab, has demonstrated safety and...” PMID 38262242 ↗ Jan 2024 “Zanidatamab, a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody” PMID 40473445 ↗ Jun 2025 |
| Known as | Zanidatamab-hrii | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650256 ↗ |
| Known as | Ziihera | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650256 ↗ |
| Known as | ZW25 | “This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents...” NCT02892123 ↗ |
| Action | Deplete | “Zanidatamab is an antibody designed to destroy cancer cells that have higher-than-normal HER2 protein or gene levels.” PMID 39114870 ↗ Aug 2024 |
| Modality | Monoclonal antibody | “Zanidatamab is a humanised, bispecific monoclonal antibody directed against two non-overlapping domains of HER2.” PMID 36400106 ↗ Nov 2022 |
| Route | Intravenous | “Zanidatamab: IV Infusion” NCT01042379 ↗ |
| Target | ERBB2 | “Zanidatamab is a humanised, bispecific monoclonal antibody directed against two non-overlapping domains of HER2.” PMID 36400106 ↗ Nov 2022 |