> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/datopotamab-deruxtecan-7c3e1007-5db7-4633-bfdb-335de1c23f10
> Record changed: 2026-10-13

# Datopotamab deruxtecan

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

Drug type

Antibody drug conjugate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

## Names and chemistry

**Drug type**

Antibody drug conjugate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

**Drug name**

Datopotamab deruxtecan

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

### Other names (36)

- adc ds 1062a
- ADC DS-1062A
- anti trop2 dxd antibody drug conjugate ds 1062a
- ANTI-TROP2/DXD ANTIBODY-DRUG CONJUGATE DS-1062A
- dato dxd
- Dato-DXd
- datopotamab deruxtecan
- Datopotamab deruxtecan
- Datopotamab Deruxtecan
- Datopotamab deruxtecan (Dato-DXd)
- Datopotamab Deruxtecan (Dato-DXd)
- datopotamab deruxtecan \[INN\]
- DATOPOTAMAB DERUXTECAN \[USAN\]
- Datopotamab deruxtecan \[WHO-DD\]
- datopotamab deruxtecan dlnk
- Datopotamab deruxtecan dlnk \[WHO-DD\]
- datopotamab deruxtecan dlnk who dd
- datopotamab deruxtecan inn
- datopotamab deruxtecan usan
- datopotamab deruxtecan who dd
- Datopotamab Deruxtecan-DLNK
- Datopotamab deruxtecan-dlnk (Dato-DXd)
- datroway
- DATROWAY
- ds 1062

And 11 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L01FX35

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

**CAS registry numbers**

- 2238831-60-0

**ChEMBL ID**

CHEMBL4297939

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297939)

**RxNorm IDs (RxCUI)**

- 2703033

**FDA ingredient codes (UNII)**

- GD2OWY1DTK

## Regulatory information

### European Union

**Status**

Authorised

**Status date**

4 Apr 2025

**Authorisation date**

4 Apr 2025

**Approved indications**

Breast cancerDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.

**Product number**

EMEA/H/C/006547

**Authorisation holder**

Daiichi Sankyo Europe GmbH

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Breast Neoplasms

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/datroway)

### Other regulatory facts

**Patents**

0

**Designations**

2

**First in class**

No

**Fast track**

No

**Breakthrough designation**

Yes

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

## Pharmacology

### Drug classification

**Pharmacology name**

datopotamab deruxtecan

**Type**

Antibody

**Drug name stem**

\-mab; -tecan

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (3)

- **Mechanism**  
Tumor-associated calcium signal transducer 2 binding agent

**Action type**  
BINDING\_AGENT

**Target**  
Tumor-associated calcium signal transducer 2

**Protein identifier**  
P09758
- **Action**  
Binding

**Action type**  
Binding

**Target**  
tumor associated calcium signal transducer 2

**Gene symbol**  
TACSTD2

**Protein identifier**  
P09758
- **Mechanism**  
DNA topoisomerase I inhibitor

**Action type**  
Inhibitor

**Target**  
DNA topoisomerase 1

**Protein identifier**  
P11387

### Open Targets mechanisms (2)

- **Mechanism**  
Tumor-associated calcium signal transducer 2 binding agent

**Action type**  
BINDING AGENT

**Target**  
Tumor-associated calcium signal transducer 2
- **Mechanism**  
DNA topoisomerase I inhibitor

**Action type**  
Inhibitor

**Target**  
DNA topoisomerase 1

### Investigated indications (8)

- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003869

**Subject identifier**  
D001943
- **Condition**  
Hemangiosarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003968

**Subject identifier**  
D006394
- **Condition**  
Triple Negative Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005537

**Subject identifier**  
D064726
- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Lung Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008903

**Subject identifier**  
D008175

### Open Targets indications (32)

- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003863

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003869
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002447

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002974

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0003060

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005070

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005140

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005494

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005575

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006003

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006047

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0007254
- **Condition identifier**  
MONDO\_0007254

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0007576

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0008170

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008315

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008433

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0008903

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0009831

**Highest recorded phase**  
1

And 7 more, listed on the interactive page.

### Trial references (24)

- NCT01042379  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01042379)
- NCT03401385  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03401385)
- NCT05104866  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05104866)
- NCT05374512  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05374512)
- NCT05629585  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629585)
- NCT05866432  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05866432)
- NCT06103864  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06103864)
- NCT06112379  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112379)
- NCT03742102  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03742102)
- NCT03944772  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03944772)
- NCT04484142  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04484142)
- NCT04526691  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04526691)
- NCT04612751  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04612751)
- NCT04656652  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04656652)
- NCT05061550  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05061550)
- NCT05555732  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05555732)
- NCT05687266  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05687266)
- NCT06350097  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350097)
- NCT06357533  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06357533)
- NCT06417814  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06417814)
- NCT04940325  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04940325)
- NCT05417594  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05417594)
- NCT06176261  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06176261)
- NCT06244485  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06244485)

## Chemical properties

**Prodrug**

No

**Inorganic**

No

**Natural product**

No

### Sequences (4)

- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
QVQLVQSGAEVKKPGASVKVSCKASGYTFTTAGMQWVRQAPGQGLEWMGWINTHSGVPKYAEDFKGRVTISADTSTSTAYLQLSSLKSEDTAVYYCARSGFGSSYWYFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- **Component**  
Disulfide bridges

**Sequence**  
22-96 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 148-204 $ 148''-204'' $ 224-214' $ 224''-214''' $ 230-230'' $ 233-233'' $ 265-325 $ 265''-325'' $ 371-429 $ 371''-429''
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
DIQMTQSPSSLSASVGDRVTITCKASQDVSTAVAWYQQKPGKAPKLLIYSASYRYTGVPSRFSGSGSGTDFTLTISSLQPEDFAVYYCQQHYITPLTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- **Component**  
Glycosylation sites (N)

**Sequence**  
451 $ 451''

## National Drug Codes

- 65597-801

## Related records

### Trials (47)

- [A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer](https://trialight.com/data/trial/a-phase-iii-randomised-study-to-evaluate-dato-dxd-and-e686a63e-e154-4541-9257-c890ab5f83d0.md)
- A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
- A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
- A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
- A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
- [A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors](https://trialight.com/data/trial/a-study-of-azd3470-a-prmt5-inhibitor-given-as-monotherapy-a149dcf4-f4d6-4334-a82f-2f92ad0af0eb.md)
- [A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors](https://trialight.com/data/trial/a-study-of-cln-619-alone-and-in-combination-with-ab3889da-c2fc-42ea-9116-1f8a95302189.md)
- A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)
- A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
- A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
- [A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)](https://trialight.com/data/trial/a-study-of-dato-dxd-with-or-without-durvalumab-versus-3cb6b909-4ecb-4ab6-8ea2-206cf5254fd4.md)
- A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
- A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
- [A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)](https://trialight.com/data/trial/a-study-of-novel-combinations-in-non-small-cell-lung-cancer-958e5dd8-d8b5-4241-9ced-06c481038d67.md)
- A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
- A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
- A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
- An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
- DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

### In development for (8)

- Angiosarcoma Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2
- Neoplasm Phase 3
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3
- [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 2

### Targets (2)

- [TACSTD2](https://trialight.com/data/target/tacstd2-dcd01535-775a-5186-8b63-b561f4a468af.md) Tumor-associated calcium signal transducer 2 binding agent
- [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) DNA topoisomerase I inhibitor

---

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