Our Pipeline

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, 2025

Pipeline Chart

5DXd ADCs

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ENHERTUⓇ (T-DXd)


 Study Name Overview Notes Phase Region
Breast
 DESTINY-Breast08 HER2 low BC chemo naïve/post chemo Phase 1 US/EU/Asia
Lung
 DESTINY-Lung03 HER2 overexpressing non-squamous NSCLC (durvalumab,volrustomig and rilvegostomig combo) 1L Phase 1 US/EU/Asia
Lung BC, NSCLC (pembrolizumab combo) Phase 1 US/EU
Breast DESTINY-Breast07 HER2+ BC 2L+/1L Phase 1/2 US/EU/Asia
Gastric DESTINY-Gastric03 HER2 expressing GC combo, 2L+/1L Phase 1/2 JP/US/EU/Asia
Breast BEGONIA TNBC (durvalumab combo) Phase 1/2 US/EU/Asia
PETRA solid tumors (saruparib combo) Phase 1/2 JP/US/EU/Asia
Solid tumor DESTINY-PanTumor02 HER2 expressing solid tumors Phase 2 JP/US/EU/Asia
Solid tumor DESTINY-PanTumor03 HER2 expressing solid tumors Phase 2 CN
Breast DESTINY-Breast05 HER2+ BC adjuvant*1 Phase 3 JP/US/EU/Asia
Breast DESTINY-Breast09 HER2+ BC 1L Phase 3 JP/US/EU/Asia
Breast DESTINY-Breast11 HER2+ BC neoadjuvant Phase 3 JP/US/EU/Asia
Gastric DESTINY-Gastric04 HER2+ GC 2L Phase 3 JP/EU/Asia
Gastric DESTINY-Gastric05 HER2+ GC 1L (pembrolizumab combo) Phase 3 JP/US/EU/Asia
Gastric ARTEMIDE-Gastric01 HER2+ and PD-L1 CPS ≥1 GC 1L (rilvegostomig combo) Phase 3 JP/US/EU/Asia
Lung DESTINY-Lung04 HER2 mutant NSCLC 1L Phase 3 JP/US/EU/Asia
Lung DESTINY-Lung06 in prep HER2 overexpressing non-squamous NSCLC (w/o AGA, PD-L1 TPS < 50%) (pembrolizumab combo) Phase 3 TBA
Solid tumor DESTINY-BTC01 HER2 expressing BTC 1L (mono or rilvegostomig combo) Phase 3 JP/US/EU/Asia
Ovarian DESTINY-Ovarian01 in prep HER2 expressing ovarian cancer 1L maintenance (bevacizumab combo) Phase 3 JP
Breast DESTINY-Breast06 HR+ and HER2 low or HER2 ultralow BC chemo naïve
Breakthrough Therapy Designation (US)
Approved in US and EU 		Regulatory Phase JP/CN

DATROWAYⓇ (Dato-DXd)


 Study Name Overview Notes Phase Region
Solid tumor TROPION-PanTumor01 solid tumors Phase 1 JP/US
Lung TROPION-Lung02 NSCLC (w/o AGA, pembrolizumab combo) Phase 1 JP/US/EU/Asia
Lung TROPION-Lung04 NSCLC (w/o AGA, durvalumab, rilvegostomig, volrustomig and sabestomig combo) Phase 1 JP/US/EU/Asia
Breast BEGONIA TNBC (durvalumab combo) Phase 1/2 US/EU/Asia
PETRA solid tumors (saruparib combo) Phase 1/2 JP/US/EU/Asia
TROPION-PanTumor03 solid tumors Phase 2 JP/US/EU/Asia
Lung ORCHARD EGFR mutated NSCLC 2L (osimertinib combo) Phase 2 JP/US/EU/Asia
Lung NeoCOAST-2 resectable early-stage NSCLC neoadjuvant (durvalumab combo) Phase 2 US/EU/Asia
Lung TROPION-Lung07 non-squamous NSCLC (w/o AGA, PD-L1 TPS＜50%) 1L (pembrolizumab combo) Phase 3 JP/US/EU/Asia
Lung TROPION-Lung08 NSCLC (w/o AGA, PD-L1 TPS ≥50%) 1L (pembrolizumab combo) Phase 3 JP/US/EU/Asia
Lung TROPION-Lung10 non-squamous NSCLC (w/o AGA, PD-L TC 1 ≥50%) 1L (rilvegostomig combo) Phase 3 JP/US/EU/Asia
Lung TROPION-Lung12 Stage I adenocarcinoma NSCLC adjuvant (rilvegostomig combo) Phase 3 JP/US/EU/Asia
Lung TROPION-Lung14 EGFR mutated NSCLC 1L (osimertinib combo) Phase 3 JP/US/EU/Asia
Lung TROPION-Lung15 EGFR mutated NSCLC (progressed on prior EGFR TKI) 2L+ (mono or osimertinib combo) Phase 3 JP/US/EU/Asia
Lung AVANZAR NSCLC (w/o AGA) 1L (durvalumab combo) Phase 3 JP/US/EU/Asia
Breast TROPION-Breast02 TNBC (PD-1/PD-L1 inhibitor ineligible) 1L Phase 3 JP/US/EU/Asia
Breast TROPION-Breast03 TNBC adjuvant*1 (mono or durvalumab combo) Phase 3 JP/US/EU/Asia
Breast TROPION-Breast04 TNBC, HR low and HER2 negative BC neoadjuvant and adjuvant (durvalumab combo) Phase 3 JP/US/EU/Asia
Breast TROPION-Breast05 PD-L1 positive TNBC 1L (mono or durvalumab combo) Phase 3 JP/US/EU/Asia
Lung TROPION-Lung05*2 EGFR mutated NSCLC (after systemic therapies, incl. EGFR-directed therapy)
Breakthrough Therapy Designation (US)Project in oncology that has been submitted for approval in some countries/regions based on the results of Phase2 trials
 Regulatory Phase US
Breast TROPION-Breast01 HR+ and HER2 low or negative BC 2/3L Approved in US, EU and JP Regulatory Phase CN

Patritumab Deruxtecan (HER3-DXd)


 Study Name Overview Notes Phase Region
Lung NSCLC Phase 1 JP/US/EU/Asia
Lung EGFR mutated NSCLC, 1/2L (osimertinib combo) Phase 1 JP/US/Asia
Solid tumor HERTHENA-PanTumor02 CRC, BTC, HCC 2L+ Phase 1/2 US/EU/Asia
Lung KEYMAKER-U01 substudy 01A in prep Stage IV NSCLC 1L (pembrolizumab combo) Phase 1/2 US/EU/Asia
Breast HERTHENA-Breast01 HER2+ BC 2L+ Phase 1/2 JP/US/EU/Asia
Solid tumor HERTHENA-PanTumor01 Solid tumors Phase 2 JP/US/EU/Asia
Breast HERTHENA-Breast03 in prep high-risk early stage TNBC, HR low and HER2 negative BC neoadjuvant (pembrolizumab combo) Phase 2 US/EU/Asia
Lung KEYMAKER-U01 substudy 01G in prep Stage IV NSCLC 1L (pembrolizumab combo) Phase 2 US/EU/Asia
Lung HERTHENA-Lung02 EGFR mutated NSCLC 2L Phase 3 JP/US/EU/Asia
Lung
 HERTHENA-Lung01 EGFR mutated NSCLC 3L
Breakthrough Therapy Designation (US)Project in oncology that has been submitted for approval in some countries/regions based on the results of Phase2 trials
 Regulatory Phase US

Ifinatamab deruxtecan (I-DXd)


 Study Name Overview Notes Phase Region
Solid tumor IDeate-PanTumor01 ESCC, CRPC, squamous NSCLC, SCLC, etc. Phase 1/2 JP/US
Solid tumor IDeate-PanTumor02 solid tumors 2L+ Phase 1/2 JP/US/EU/Asia
Lung IDeate-Lung03 ES-SCLC, 1L
Orphan drug designation (designated in at least one country/region among JP, US)
 Phase 1/2 JP/US/EU
Solid tumor IDeate-Prostate02 in prep chemo-naïve metastatic CRPC Phase 1/2 TBA
Lung KEYMAKER-U01 substudy 01A in prep Stage IV NSCLC 1L (pembrolizumab combo) Phase 1/2 US/EU/Asia
Solid tumor KEYMAKER-U06 substudy 06E in prep ESCC 1L (pembrolizumab combo) Phase 1/2 TBA
Lung IDeate-Lung01 ES-SCLC 2L+
Orphan drug designation (designated in at least one country/region among JP, US)
 Phase 2 JP/US/EU/Asia
Lung KEYMAKER-U01 substudy 01H in prep non-squamous NSCLC 2L Phase 2 TBA
Lung KEYMAKER-U01 substudy 01I in prep non-squamous NSCLC 2L Phase 2 TBA
Lung IDeate-Lung02 ES-SCLC 2L
Orphan drug designation (designated in at least one country/region among JP, US)
 Phase 3 JP/US/EU/Asia
Solid tumor IDeate-Esophageal01 in prep ESCC 2L Phase 3 JP/US/EU/Asia
Solid tumor IDeate-Prostate01 in prep chemo-naïve metastatic CRPC Phase 3 TBA

Raludotatug deruxtecan (R-DXd)


 Study Name Overview Notes Phase Region
OvarianSolid tumor renal cell carcinoma, ovarian cancer Phase 1 JP/US
Lung KEYNOTE-B98 ES-SCLC 2L Phase 1/2 US/EU/Asia
Ovarian REJOICE-Ovarian02 in prep ovarian cancer, relapsed after platinum-based chemo. (carboplatin, paclitaxel, bevacizumab combo)
Orphan drug designation (designated in at least one country/region among JP, US)
 Phase 1/2 TBA
Solid tumor REJOICE-GI01 in prep gastrointestinal cancers Phase 2 US/EU/Asia
Solid tumor REJOICE-PanTumor01 solid tumors Phase 2 JP/US/EU/Asia
Lung KEYMAKER-U01 substudy 01H in prep non-squamous NSCLC 2L Phase 2 TBA
Lung KEYMAKER-U01 substudy 01I in prep non-squamous NSCLC 2L Phase 2 TBA
Ovarian REJOICE-Ovarian01 platinum-resistant ovarian cancer 2L+
Orphan drug designation (designated in at least one country/region among JP, US)
 Phase 2/3 JP/US/EU/Asia
  • Breast
    Breast
  • Lung
    Lung
  • Colorectal
    Colorectal
  • Ovarian
    Ovarian
  • Hematologic
    Hematologic
  • Gastric
    Gastric
  • Solid tumor
    Solid tumor
Orphan drug designation (designated in at least one country/region among JP, US)：Orphan drug designation (designated in at least one country/region among JP, US)
Breakthrough Therapy Designation (US)：Breakthrough Therapy Designation (US)
Project in oncology that has been be submitted for approval in some countries/regions based on the results of Phase2 trials：Project in oncology that has been 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, CRPC: castration-resistant prostate cancer, ESCC: esophageal squamous cell carcinoma, ES-SCLC: extensive stage-small cell lung cancer, GC: gastric cancer, HCC: hepatocellular carcinoma, HR: hormone receptor, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, TBA: to be announced, TC: tumor cells, TKI: tyrosine kinase inhibitor, TNBC: triple negative breast cancer, TPS: tumor proportion score



Next Wave

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Oncology


 Study Name Overview Notes Phase Region
Solid tumor DS-1055 Anti-GARP antibody
Solid tumors		 Phase 1 JP/US
Solid tumor DS-9606 CLDN6-directed ADC Solid tumors Phase 1 US/EU
Breast DS-1103 Anti-SIRPα antibody
HER2 expressing or mutant solid tumors, HER2 low BC (T-DXd combo)		 Phase 1 US/EU
Solid tumor DS-1471 Anti-CD147 antibody
Solid tumors		 Phase 1 JP
GastricBreastLung Valemetostat EZH1/2 inhibitor, HER2+ GC, HER2 low BC (T-DXd combo) and non-squamous NSCLC (Dato-DXd combo) Phase 1 JP/US
Solid tumor DS-2243 HLA-A*02/NY-ESO directed bispecific T-cell engager
Solid tumors		 Phase 1 US/EU/Asia
Solid tumor DS-3939 TA-MUC1-directed ADC
Solid tumors		 Phase 1/2 JP/US/EU/Asia
Solid tumor MK-6070 (DS3280) DLL3 directed tri-specific T-cell engager
DLL3 expressing advanced cancer		 Phase 1/2 US
MK-6070 (DS3280) DLL3 directed tri-specific T-cell engager ES-SCLC, 2L (I-DXd combo) MK-6070-002 Phase 1/2 US/EU/Asia
Lung Valemetostat EZH1/2 inhibitor
NSCLC (w/o AGA and PD-L1 TPS ≥50%) 1L (pembrolizumab combo)		 Phase 1/2 JP/US/Asia
Solid tumor Valemetostat EZH1/2 inhibitor
BCL		 Phase 2 EU
Solid tumor DS-1001 Mutant IDH1 inhibitor
Glioma		 Phase 2 JP
Solid tumor Pexidartinib CSF-1/KIT/FLT3 inhibitor
Tenosynovial giant cell tumor 		Phase 2 JP
Solid tumor Pexidartinib CSF-1/KIT/FLT3 inhibitor
Tenosynovial giant cell tumor 		Phase 3 Asia
Hematologic Quizartinib FLT3 inhibitor
FLT3-ITD negative AML, 1L QuANTUM-Wild
Orphan drug designation (designated in at least one country/region among JP, US and EU)
 Phase 3 JP/US/EU/Asia
Hematologic Quizartinib FLT3 inhibitor
FLT3-ITD positive AML 1L
QuANTUM-First		 Regulatory CN

Specialty medicine


 Study Name Overview Notes Phase Region
DS-7011 Anti-TLR7 antibody
Systemic lupus erythematosus		 Phase 1/2 JP/US/EU/Asia
DS-2325 KLK5 inhibitor
Netherton syndrome
Orphan drug designation (designated in at least one country/region among JP, US and EU) Fast Track Designation (US) Rare Pediatric Disease Designation (US)
Phase 1/2 EU
DS-1211 TNAP inhibitor
Pseudoxanthoma elasticum
Orphan drug designation (designated in at least one country/region among JP, US and EU)
 Phase 2 US/EU

Vaccine


 Study Name Overview Notes Phase Region
VN-0102／JVC-001 Mixed measles-mumps-rubella vaccine Regulatory JP
  • Breast
    Breast
  • Lung
    Lung
  • Colorectal
    Colorectal
  • Ovarian
    Ovarian
  • Hematologic
    Hematologic
  • Gastric
    Gastric
  • Solid tumor
    Solid tumor
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)
Fast Track Designation (US)：Fast Track Designation (US)
Rare Pediatric Disease Designation (US)：Rare Pediatric Disease Designation (US)
AGA: actionable genomic alterations, 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, TPS: tumor proportion score