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 Jan 31, 2025

Pipeline Chart

5DXd ADCs

 (US/EU/Asia) HER2 low BC
Chemo naïve/post chemo
DESTINY-Breast08
(US/EU/Asia) HER2+ NSCLC
(durvalumab, volrustomig and
rilvegostomig combo) 1L
DESTINY-Lung03
(US/EU) BC, NSCLC
(pembrolizumab combo)
(JP/US) solid tumors
TROPION-PanTumor01
(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
(JP/US/EU/Asia) NSCLC (JP/US/Asia) EGFR mutated NSCLC, 1/2L
(osimertinib combo)
 (JP/US)
renal cell carcinoma, ovarian cancer
(US/EU/Asia) TNBC
(US/EU/Asia) HER2+ BC 2L+/1L
DESTINY-Breast07
(JP/US/EU/Asia) HER2 expressing GC
combo, 2L+/1L
DESTINY-Gastric03
(US/EU/Asia) TNBC
(durvalumab combo)
BEGONIA
(US/EU/Asia) solid tumors
(saruparib combo)
PETRA
(US/EU/Asia) TNBC
(durvalumab combo)
BEGONIA
(JP/US/EU/Asia) solid tumors
(saruparib combo)
PETRA
(US/EU/Asia) CRC, BTC, HCC 2L+
MK-1022-011
(JP/US/EU/Asia) in prep StageIV NSCLC 1L
(pembrolizumab combo)
KEYMAKER-U01 Substudy 01A
(JP/US/EU/Asia) in prep HER2+ BC
HERTHENA-Breast01
(JP/US) ESCC, CRPC,
squamous NSCLC, SCLC, etc.
IDeate-PanTumor01
(JP/US/EU/Asia) ES-SCLC, 1L
IDeate-Lung03
(JP/US/EU/Asia) solid tumors 2L+
IDeate-PanTumor02
 (JP/US/EU/Asia) in prep StageIV NSCLC 1L
(pembrolizumab combo)
KEYMAKER-U01 Substudy 01A
(US/EU/Asia) in prep ES-SCLC 2L
KEYNOTE-B98
(JP/US/EU/Asia)
HER2 expressing solid tumors
DESTINY-PanTumor02
(CN) HER2 expressing solid tumors
DESTINY-PanTumor03
(JP/US/EU/Asia) solid tumors
TROPION-PanTumor03
(JP/US/EU/Asia) EGFR mutated
NSCLC 2L (osimertinib combo)
ORCHARD
(US/EU/Asia) resectable early-stage
NSCLC neoadjuvant (durvalumab combo)
NeoCOAST-2
(JP/US/EU/Asia) Solid tumors
HERTHENA-PanTumor01
(US/EU/Asia) in prep Stage iV NSCLC 1L
(pembrolizumab combo)
KEYMAKER-U01 substudy 01G
(JP/US/EU/Asia) ES-SCLC 2L+
IDeate-Lung01
(TBA) in prep ESCC, 1L
(pembrolizumab combo)
KEYMAKER-U06 substudy 06E
(TBA) in prep non-squamous NSCLC 2L
KEYMAKER-U01 substudy 01H
(TBA) in prep non-squamous NSCLC 2L
KEYMAKER-U01 substudy 01I
(JP/US/EU/Asia) solid tumors
REJOICE-PanTumor01
(TBA) in prep non-squamous NSCLC 2L
KEYMAKER-U01 substudy 01H
(TBA) in prep non-squamous NSCLC 2L
KEYMAKER-U01 substudy 01I
 
(JP/US/EU/Asia) HER2+ BC
adjuvant*1
DESTINY-Breast05
(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) HER2+ GC 1L
(pembrolizumab combo)
DESTINY-Gastric05
(JP/US/EU/Asia) HER2+ and PD-L1 CPS ≥1
GC 1L (rilvegostomig combo
ARTEMIDE-Gastric01
(JP/US/EU/Asia) HER2 mutant NSCLC 1L
DESTINY-Lung04
(JP/US/EU/Asia) in prep HER2 expressing
BTC 1L (mono or rilvegostomig combo)
DESTINY-BTC01
(JP/US/EU/Asia) non-squamous NSCLC
(w/o AGA, PD-L1<50%) 1L
(pembrolizumab combo)
TROPION-Lung07
(JP/US/EU/Asia) NSCLC (w/o AGA, PD-L1≥50%) 1L (pembrolizumab combo)
TROPION-Lung08
(JP/US/EU/Asia) non-squamous NSCLC (w/o AGA, PD-L1≥50%) 1L (rilvegostomig combo)
TROPION-Lung10
(JP/US/EU/Asia) Stage I adenocarcinoma
NSCLC adjuvant (rilvegostomig combo)
TROPION-Lung12
 (JP/US/EU/Asia) EGFR mutated NSCLC 1L (osimertinib combo)
TROPION-Lung14
(JP/US/EU/Asia) EGFR mutated NSCLC
(progressed on prior EGFR TKI) 2L+ 
(mono or osimertinib combo)
TROPION-Lung15
(JP/US/EU/Asia) NSCLC (w/o AGA) 1L
(durvalumab combo)
AVANZAR
(JP/US/EU/Asia) TNBC (PD-1/PD-L1 inhibitor ineligible) 1L
TROPION-Breast02
(JP/US/EU/Asia) TNBC adjuvant※1 (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
(JP/US/EU/Asia) EGFR mutated NSCLC 2L
HERTHENA-Lung02
(JP/US/EU/Asia) ES-SCLC 2L
IDeate-Lung02
(JP/US/EU/Asia) in prep ESCC 2L
IDeate-Esophageal01
   
(JP/EU) HR+ and HER2 low or HER2 ultralow BC chemo naïve
DESTINY-Breast06
(US) EGFR mutated NSCLC (after systemic therapies, incl. EGFR-directed therapy)
TROPION-Lung05*2
(EU/CN) HR+ and HER2 low or HER2 negative BC 2/3L
TROPION-Breast01
(US) EGFR mutated
NSCLC 3L
HERTHENA-Lung01
 

:Orphan drug designation (designated in at least one country/region among JP, US)
:Breakthrough Designation (US)
:Project in oncology that is planned to be submitted for approval in some countries/regions based on the results of Phase2 trials
※1 Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy
*2 Supported by data from TROPION-Lung01, TROPION-PanTumor01
AGA: actionable genomic alterations, BTC: biliary tract cancer, BC: breast cancer, CPS: combined positive score, ES-SCLC: extensive stage-small cell lung cancer, GC: gastric cancer, HR: hormone receptor, NSCLC: non-small cell lung cancer, TKI: tyrosine kinase inhibitor, TNBC: triple negative breast cancer, TPS: tumor proportion score

Next Wave

Oncology Specialty Medicine Vaccine

DS-1055 (JP/US)
Anti-GARP antibody
Solid tumors
DS-9606 (US/EU)
CLDN6-directed ADC
Solid tumors
DS-1103 (US/EU)
Anti-SIRPα antibody
HER2 expressing or mutant solid tumors, HER2 low BC (T-DXd combo)
DS-1471 (JP)
Anti-CD147 antibody
Solid tumors
Valemetostat (JP/US)
EZH1/2 inhibitor, HER2+ GC,
HER2 low BC (T-DXd combo)
and non-squamous NSCLC (Dato-DXd combo)
DS-2243 (US/EU) in prep
HLA-A*02/NY-ESO directed bispecific T-cell engager
Solid tumors
DS-3939 (JP/US/EU/Asia)
TA-MUC1-directed ADC
Solid tumors
MK-6070 (DS3280) (US)
DLL3 directed tri-specific T-cell engager
DLL3 expressing advanced cancer
MK-6070 (DS3280) (TBA) in prep
DLL3 directed tri-specific T-cell engager
ES-SCLC, 2L (I-DXd combo)
MK-6070-002
Valemetostat (JP/US/Asia)
EZH1/2 inhibitor
NSCLC (w/o AGA and PD-L1 TPS ≥50%) 1L
(pembrolizumab combo)
DS-7011 (JP/US/EU/Asia)
Anti-TLR7 antibody
Systemic lupus erythematosus
DS-2325 (EU)
KLK5 inhibitor
Netherton syndrome

Valemetostat (EU)
EZH1/2 inhibitor
BCL
DS-1001 (JP)
Mutant IDH1 inhibitor
Glioma
Pexidartinib (JP)
CSF-1/KIT/FLT3 inhibitor
Tenosynovial giant cell tumor
DS-1211 (US/EU)
TNAP inhibitor
Pseudoxanthoma elasticum
   
Pexidartinib (Asia)
CSF-1/KIT/FLT3 inhibitor
Tenosynovial giant cell tumor
Quizartinib (JP/US/EU/Asia)
FLT3 inhibitor
FLT3-ITD negative AML, 1L
QuANTUM-Wild
Esaxerenone (JP)
MR blocker
Diabetic nephropathy
DS-5670 (JP)
COVID-19 mRNA vaccine (mutant strain), COVID-19
(booster vaccination, 5 to 11 aged children)
VN-0102/JVC-001 (JP)
Mixed measles-mumps-rubella vaccine

:Orphan drug designation (designated in at least one country/region among JP, US and EU)
:Fast Track Designation (US)
:Rare Pediatric Disease Designation (US)
AML: acute myeloid leukemia, BC: breast cancer, BCL: B cell lymphoma, ES-SCLC: extensive-stage small cell lung cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, TBA: to be announced, TPS: tumor proportion score