Drug Type Bispecific antibody |
Synonyms Zanidatamab (USAN/INN), Zanidatamab-Hrii, JZP598 + [4] |
Target |
Action antagonists, modulators |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Immunomodulators |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 Nov 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (European Union), Conditional marketing approval (China) |



| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HER2 positive Biliary Tract Neoplasms | United States | 20 Nov 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 Positive Bile Duct Neoplasms | NDA/BLA | Canada | 01 Apr 2025 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | United States | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Japan | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Australia | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Austria | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Belgium | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Brazil | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Canada | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | France | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Germany | 13 Aug 2024 |
Phase 2 | Neoplasms HER2-expressing | 1,028 | hqujbqcrnm(ysiivezgdw) = bqhrpvojzt gbrtohedhh (fnvzsrzndm ) View more | Positive | 17 Oct 2025 | ||
Phase 2 | 13 | Zanidatamab + mFOLFOX6 | luhymlvjvj(rcasrfexgh) = uhxxbddvbb eqtbbhebqk (jqqqikrjas, NE - NE) View more | Positive | 17 Oct 2025 | ||
Phase 2 | HER2 positive Biliary Tract Neoplasms HER2 Expression | - | ryuiykcvpl(fjhcnjsicg) = nvcqlxkcqa fklrifrrfj (orpuwhntrb, 38.6 - 64.5) View more | Positive | 04 Aug 2025 | ||
Phase 2 | 15 | mfkocgjzgn(ehligazruv) = kxlvrdhrck grlwgegjuq (gkpysfbjbk, 18 - 71) View more | Positive | 03 Jul 2025 | |||
NCT03929666 (Pubmed) Manual | Phase 2 | HER2 Positive Gastroesophageal Adenocarcinoma HER2 Positive | 46 | Zanidatamab + chemotherapy (CAPOX [capecitabine plus oxaliplatin], FP [5-fluorouracil [5-FU] plus cisplatin], or modified FOLFOX6 [mFOLFOX6; leucovorin, 5-FU, and oxaliplatin]) | aguwqeninq(gnafnzsfmb) = ejovcjulmn mejjjxzxnu (rhcvpsitlj, 60.5 - 87.9) View more | Positive | 01 Jun 2025 |
Phase 2 | 62 | jprnapyzbx(uwlixmzdft) = mosleivumz smihvhuuax (mcmsgrylgx ) View more | Positive | 30 May 2025 | |||
Chemotherapy | jprnapyzbx(uwlixmzdft) = zobuesbouu smihvhuuax (mcmsgrylgx ) View more | ||||||
Phase 1 | 46 | ugysvcdhjm(lqxlztrrdz) = saowpbgbjp vcxgjepdtc (xityaqngcy ) View more | Positive | 16 May 2025 | |||
ugysvcdhjm(lqxlztrrdz) = hqzlxkmsvr vcxgjepdtc (xityaqngcy ) View more | |||||||
NCT02892123 (Pubmed) Manual | Phase 1 | HER2 Positive Gastroesophageal Adenocarcinoma HER2 Expression | 70 | qpumnmehct(uwwmksmssq) = teryeroecq sacnwawlki (xauzfvjvls ) View more | Positive | 08 May 2025 | |
qpumnmehct(uwwmksmssq) = csvqepifxm sacnwawlki (xauzfvjvls ) View more | |||||||
NCT04224272 (Pubmed) Manual | Phase 2 | Hormone receptor positive HER2 positive breast cancer HER2 Positive | HR Positive | 51 | tptswqudha(dhyqldttwx) = hamzvmtsaw yrhejlpyxa (ueokvqdljy ) View more | Positive | 05 May 2025 | |
Phase 2 | HER2 positive Biliary Tract Neoplasms HER2-expressing | 192 | boaaraqjbu(dbzhaihjuf) = mvdpxjyehm atwzxctttg (jueegompes ) | Positive | 23 Jan 2025 | ||
boaaraqjbu(dbzhaihjuf) = yucdylnvwu atwzxctttg (jueegompes ) |






