We continuously develop and expand our robust pipeline to address patients' unmet medical needs. Our pursuit of new medicines is fueled by the scientific curiosity of our employees, a willingness to examine new ideas, and the pairing of existing information with novel concepts.

Please note that the medicines in the pipeline below are currently under clinical trial investigation and are not yet approved.

Pipeline Chart

* As of April 25, 2024

Pipeline Chart

5DXd ADCs

■T-DXd

Phase 1
(US/EU/Asia) HER2+ BC 2L+/1L
DESTINY-Breast07
(US/EU/Asia) HER2 low BC 
Chemo naïve/post chemo
DESTINY-Breast08
(JP/US/EU/Asia) HER2+ GC combo, 2L+/1L
DESTINY-Gastric03
(US/EU/Asia) HER2+ NSCLC
(durvalumab, volrustomig combo) 1L
DESTINY-Lung03
(US/EU) BC, NSCLC 
(pembrolizumab combo)
(US/EU/Asia) TNBC
(durvalumab combo)
BEGONIA
(US/EU/Asia) solid tumors
(saruparib combo) 
PETRA
Phase 2
(CN) HER2 expressing solid tumors
DESTINY-PanTumor03
Phase 3
(JP/US/EU/Asia) HER2+ BC 
adjuvant*1
DESTINY-Breast05　
(JP/US/EU/Asia) HER2 low BC 
chemo naïve
DESTINY-Breast06
(JP/US/EU/Asia) HER2+ BC 1L
DESTINY-Breast09
(JP/US/EU/Asia) HER2+ BC
neoadjuvant
DESTINY-Breast11
(JP/EU/Asia) HER2+ GC 2L
DESTINY-Gastric04
(JP/US/EU/Asia) NSCLC
(w/ HER2 exon 19 or exon 20 mutation) 1L 
DESTINY-Lung04
Regulatory Phase
(CN) HER2+ GC 3L
DESTINY-Gastric06
(CN) HER2 mutant NSCLC 2L+
DESTINY-Lung05
Breakthrough Designation (US) Breakthrough Designation (US)

*1 Adjuvant therapy for HER2 positive breast cancer patients with residual invasive disease following neoadjuvant therapy
BC: breast cancer, CRPC: castration-resistant prostate cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small celllung cancer, SCLC: small cell lung cancer, TNBC: triple negative breast cancer, ESCC: esophageal squamous cell carcinoma

■Dato-DXd

Phase 1
(JP/US) solid tumors
TROPION-PanTumor01
(CN) NSCLC, TNBC
TROPION-PanTumor02
(JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) 
TROPION-Lung02
(JP/US/EU) NSCLC (w/o AGA, durvalumab, rilvegostomig, volrustomig, and sabestomig combo) TROPION-Lung04
(US/EU/Asia) TNBC
(durvalumab combo)
BEGONIA
(JP/US/EU/Asia) solid tumors 
(saruparib combo)
PETRA
Phase 2
(JP/US/EU/Asia) solid tumors
TROPION-PanTumor03
(JP/US/EU/Asia) EGFR mutated 
NSCLC (osimertinib combo) 2L 
ORCHARD
(US/EU/Asia) resectable early-stage NSCLC (durvalumab combo) neoadjuvant 
NeoCOAST-2
Phase 3
(JP/US/EU/Asia) non-squamous NSCLC (w/o AGA, pembrolizumab combo) 1L 
TROPION-Lung07
(JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) 1L  
TROPION-Lung08
(JP/US/EU/Asia) in prep PD-L1 high nonsquamous NSCLC (w/o AGA, rilvegostomig combo) 1L
TROPION-Lung10
(JP/US/EU/Asia) in prep EGFR mutated NSCLC (osimertinib combo) 1L
TROPION-Lung14
(JP/US/EU/Asia) TNBC (PD-1/PD-L1 inhibitor ineligible) 1L
TROPION-Breast02
(JP/US/EU/Asia) TNBC 
adjuvant*2 (mono or durvalumab combo)
TROPION-Breast03
(JP/US/EU/Asia) TNBC neoadjuvant and adjuvant (durvalumab combo)
TROPION-Breast04
(JP/US/EU/Asia) PD-L1 positive TNBC 1L　(mono or durvalumab combo)
TROPION-Breast05
Regulatory Phase
(US/EU) NSCLC 2/3L
TROPION-Lung01
(JP/US/EU/Asia) BC*3  2/3L
TROPION-Breast01

*2 Adjuvant therapy for TNBC patients withresidual invasive disease following neoadjuvant therapy
*3 HR+, HER2 low or negative BC
BC: breast cancer, CRPC: castration-resistant prostate cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small celllung cancer, SCLC: small cell lung cancer, TNBC: triple negative breast cancer

■HER3-DXd ■DS-7300 (I-DXd) ■DS-6000 (R-DXd)

Phase 1
(JP/US/EU/Asia) NSCLC
(JP/US/Asia) EGFR mutated NSCLC, 1/2L
(osimertinib combo) 
(JP/US)
ESCC, CRPC, squamous NSCLC, SCLC, etc.
IDeate-PanTumor01
(JP/US/EU/Asia) in prep
ES-SCLC, 1L
IDeate-PanTumor03
(JP/US)
Renal cell carcinoma, ovarian cancer
Phase 2
(JP/US/EU/Asia)
melanoma SCCHN, HER2 negative GC, 2L+
HERTHENA-PanTumor01 
(JP/US/EU/Asia)
ES-SCLC, 2L
IDeate-Lung01
(JP/US/EU/Asia)
solid tumors, 2L+
(JP/US/EU/Asia)
ovarian cancer
REJOICE-Ovarian01
Phase 3
(JP/US/EU/Asia)
EGFR mutated NSCLC 2L
HERTHENA-Lung02
(JP/US/EU/Asia) in prep
ES-SCLC, 2L+
IDeate-Lung02
Regulatory Phase
(US)
EGFR mutated NSCLC 3L
HERTHENA-Lung01
Project in oncology that is planned to be submitted for approval in some countries/regions based on the results of phase 2 trials
 
Breakthrough Designation (US) Breakthrough Designation (US) Orphan drug designation (designated in at least one country/region among JP, US and EU)　 Orphan drug designation (designated in at least one country/region among JP, US and EU

BC: breast cancer, CRPC: castration-resistant prostate cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small celllung cancer, SCLC: small cell lung cancer, TNBC: triple negative breast cancer

Next Wave

■Oncology ■Specialty Medicine ■Vaccine

Phase 1
DS-1055 (JP/US)
Anti-GARP antibody 
Solid tumors
DS-9606 (US/EU)
Target undisclosed ADC
Solid tumors
DS-1103
Anti-SIRPα antibody
HER2 expressing or mutant solid tumors, HER2 low BC
DS-3939
Anti-TA-MUC1 ADC
Solid tumors
DS-1471
Anti-CD147 antibody
Solid tumors
Valemetostat
EZH1/2 inhibitor, HER2+ GC (T-DXd combo) and
NSQ NSCLC (Dato-DXd combo)
DS-7011 (US)
Anti-TLR7 antibody
Systemic lupus erythematosus
DS-2325 (EU)
KLK5 inhibitor
Netherton syndrome  
Phase 2
Valemetostat (EU)
EZH1/2 inhibitor
BCL
DS-1001 (JP)
Mutant IDH1 inhibitor
Glioma
DS-1211 (US/EU)
TNAP inhibitor
Pseudoxanthoma elasticum
VN-0200 (JP)
RS virus vaccine
RS virus infection
Phase 3
Pexidartinib (JP/Asia)
CSF-1/KIT/FLT3 inhibitor
Tenosynovial giant cell tumor
Esaxerenone (JP)
MR blocker
Diabetic nephropathy
DS-5670 (JP)
COVID-19 mRNA vaccine (mutant strain), COVID-19
(booster vaccination, 5 to 11 aged children)
DS-5670 (JP)
COVID-19 mRNA vaccine (mutant strain), COVID-19
(single dose,12 years old and over)
Regulatory Phase
Valemetostat (JP)
EZH1/2 inhibitor
PTCL 
Mirogabalin (CN)
α2δ ligands
Diabetic peripheral neuropathic pain
VN-0102/JVC-001 (JP)
Mixed measles-mumps-rubella vaccine
Oncology
Specialty Medicine
Vaccine
Project in oncology that is planned to be submitted for approval in some countries/regions based on the results of phase 2 trials
SAKIGAKE Designation (JP) Orphan drug designation (designated in at least one country/region among JP, US, and EU
Rare Pediatric Disease Designation (US) Fast Track Designation (US)  
ALL: acute lymphoblastic leukemia, BCL: B cell lymphoma, LBCL: large B cell lymphoma, PTCL: peripheral T-cell lymphoma