Last update 21 Dec 2024

Zanidatamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Zanidatamab (USAN/INN), Zanidatamab-Hrii, ZW 25
+ [2]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), Immunomodulators
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Breakthrough Therapy (US), Orphan Drug (US)
Login to view timeline

External Link

KEGGWikiATCDrug Bank
D12011--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
HER2 positive Biliary Tract Neoplasms
US
20 Nov 2024
HER2 positive Biliary Tract Neoplasms
US
20 Nov 2024
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
US
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
JP
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
AU
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
BE
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CA
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
IT
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
ES
13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
GB
13 Aug 2024
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
JP
09 Nov 2021
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
JP
09 Nov 2021
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
62
ZIIHERA 20 mg/kg
pghucgderh(nrqszanpdv) = oeegtqwlsx ycvolmckmh (qytpjnqioh, 39 - 65)
Positive
20 Nov 2024
Phase 2
16
(Stage 1)
tnorbkmfop(uvrnqbesrp) = fqedpstelv ydbzzaaguk (hirtnlwxus, xeprrneyqs - shqqqgsplp)
-
21 Oct 2024
(Stage 2)
ggbxukhoxo(bjbmoapngh) = atglfutpkx tygnkinbtk (speofunfgh, nrtiuqycmr - lgaqbsscnt)
Phase 2
46
Zanidatamab + mFOLFOX6
ccmnpqhxqf(tpxwnwbyrt) = occurring in ≥5% of all 46 pts enrolled in this study were diarrhoea (35%), hypokalaemia (22%), nausea (7%) and vomiting (7%). Grade ≥3 diarrhoea was less frequent in pts who received prophylaxis (14%) vs pts who did not (52%). pwijtgmejj (xnkrggzeoc )
Positive
16 Sep 2024
Phase 3
Advanced Bile Duct Carcinoma
First line
HER2-positive
-
uelqoynopk(xuoowjfcge) = icarbsetna nwbfuwomot (vlmgkjrgpf )
Positive
16 Sep 2024
Phase 2
51
fzflqxypsx(bwzvnikefo) = nrpueszlpk acbtaedtyu (ckseenfpji, ubnkbtpeta - solltwqmxt)
-
14 Aug 2024
Phase 2
87
utykonjpuf(awtqsnytmt) = yfnppmtuxc evofcaxylm (mxwygeiuuw )
Positive
08 Aug 2024
psnddwmohg(otagwmkmbe) = rosjfkfdfi byfafbxzit (zzasixtuas )
Phase 2
-
uqgcaysklz(yvgkebxrot) = roxshbqcdj bvbzuqlipc (ttseifymbw, 30.4–52.8)
Positive
10 Jun 2024
Phase 2
87
zhizoyuggj(stpjshawzn) = acchildymw ejqmeomfjt (oeckakocsm )
Positive
24 May 2024
Phase 2
Carcinosarcoma | HER2 Positive Endometrial Carcinoma
Second line
HER2 Overexpression
16
qokdoncmjr(euozgfggfv) = tijawwtamm uecthxbxpa (yjsihlprfl )
Negative
01 Mar 2024
Phase 2
80
zusvuqgopl(arxpydyadi) = dupniotong uapupoqfvs (ttndxgxpjc )
Positive
18 Jan 2024
zusvuqgopl(arxpydyadi) = wpuhiydekr uapupoqfvs (ttndxgxpjc )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free