datopotamab deruxtecan
Trade name: Datroway
mAbapprovedADC
Approved
Jan 17, 2025
Clinical trial activity
42 trials · 19 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
36
Phase 3
17
Phase 4
0
Earliest trial started Jan 31, 2018 (NCT03401385)
Timeline
2010s
- Jan 1, 2018
Daiichi Sankyo — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Daiichi Sankyo — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2020
Daiichi Sankyo — Earliest Phase 3 Sponsor(trial)
- Jan 17, 2025
Earliest FDA Approval
- Jan 17, 2025
Daiichi Sankyo — Marketing Organization
Indications
Approved for
Studied for
- Biliary Tract Neoplasms · Phase 3
- Brain Neoplasms · Phase 2
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Merkel Cell · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Renal Cell · Phase 1/Phase 2
- Carcinoma, Transitional Cell · Phase 2
- Cholangiocarcinoma · Phase 2
- Colorectal Neoplasms · Phase 2
- Endometrial Neoplasms · Phase 3
- Esophageal Neoplasms · Phase 3
- Lung Neoplasms · Phase 2
- Melanoma · Phase 1/Phase 2
- Neoplasms · Phase 1
- Ovarian Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Small Cell Lung Carcinoma · Phase 3
- Squamous Cell Carcinoma of Head and Neck · Phase 1/Phase 2
- Stomach Neoplasms · Phase 3
- Triple Negative Breast Neoplasms · Phase 2
Mechanism of action
- Tumor-associated calcium signal transducer 2BINDING AGENT
Tumor-associated calcium signal transducer 2 binding agent
TACSTD2 inhibitor
- DNA topoisomerase IINHIBITOR
DNA topoisomerase I inhibitor
Approval history
- approvedJan 17, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
- Payload
- Unclear
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5314706 ↗
- ChEMBLCHEMBL4297939 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07221253 | Phase 3 | Dec 31, 2025 | AstraZeneca |
| NCT07069595 | Phase 2 | Nov 30, 2025 | AstraZeneca, Translational Breast Cancer Research Consortium, University of North Carolina at Chapel Hill |
| NCT07291037 | Phase 3 | Oct 31, 2025 | AstraZeneca, Daiichi Sankyo |
| NCT07128290 | Phase 2 | Oct 30, 2025 | Federation Francophone de Cancerologie Digestive |
| NCT06954480 | Phase 2 | Oct 27, 2025 | AstraZeneca, University of London |
| NCT07161414 | Phase 1 | Oct 21, 2025 | AstraZeneca, Parexel |
| NCT06996782 | Phase 1/Phase 2 (Phase 2) | Oct 13, 2025 | AstraZeneca |
| NCT07098338 | Phase 2 | Aug 7, 2025 | AstraZeneca, Daiichi Sankyo |
| NCT07115043 | Phase 1/Phase 2 (Phase 2) | Jul 29, 2025 | AstraZeneca |
| NCT07069712 | Phase 2 | Jul 17, 2025 | AstraZeneca, Parexel |
| NCT06921785 | Phase 3 | May 6, 2025 | AstraZeneca |
| NCT06676917 | Phase 2 | Apr 30, 2025 | Daiichi Sankyo, Medical University of Vienna, MedSIR |
| NCT06868277 | Phase 3 | Apr 15, 2025 | AstraZeneca |
| NCT06764875 | Phase 3 | Mar 28, 2025 | AstraZeneca |
| NCT06989112 | Phase 3 | Mar 27, 2025 | AstraZeneca, Daiichi Sankyo, European Network for Gynaecological Oncological Trial |
| NCT06822543 | Phase 2 | Feb 24, 2025 | AstraZeneca, Latin American Cooperative Oncology Group, Merck |
| NCT06533826 | Phase 2 | Jan 31, 2025 | AstraZeneca, Harvard University, Translational Breast Cancer Research Consortium |
| NCT06569225 | Phase 2 | Dec 15, 2024 | Hamilton Health Sciences Corporation, University of Toronto |
| NCT06692738 | Phase 3 | Dec 2, 2024 | AstraZeneca |
| NCT06630130 | Phase 2 | Dec 1, 2024 | Sungkyunkwan University |
Showing 20 of 42 trials
Page 1 / 3
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 33 | 22 | 4 | 2020 |
| Daiichi Sankyo | For profit | 20 | 8 | 4 | 2018 |
| Merck | For profit | 4 | 0 | 3 | 2020 |
| Harvard University | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Medical University of Vienna | Academic/Hospital | 2 | 1 | 1 | 2023 |
| Parexel | For profit | 2 | 0 | 2 | 2025 |
| Translational Breast Cancer Research Consortium | Academic/Hospital | 2 | 0 | 1 | 2025 |
| European Network for Gynaecological Oncological Trial | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Federation Francophone de Cancerologie Digestive | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Hamilton Health Sciences Corporation | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Institut Gustave Roussy | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Latin American Cooperative Oncology Group | Academic/Hospital | 1 | 1 | 1 | 2025 |
| MedSIR | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Presage Biosciences | For profit | 1 | 1 | 1 | 2024 |
| Sungkyunkwan University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Universidad Autonoma de Barcelona | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of London | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Toronto | Academic/Hospital | 1 | 1 | 1 | 2024 |
19 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Daiichi Sankyo | For profit | MKTG | Jan 17, 2025 |