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 October 31, 2023

Pipeline Chart

 

5DXd-ADCs

 Phase 1 Phase 2 Phase 3
(US/EU/Asia) HER2+ BC 2L+/1L
DESTINY-Breast07		 (JP/US) solid tumors 
TROPION-PanTumor01		 (US/EU/Asia) TNBC 
(durvalumab combo)
BEGONIA		 (JP/US/EU/Asia) solid tumors 
TROPION-PanTumor03		 (JP/US/EU/Asia) HER2+ BC 
adjuvant*1
DESTINY-Breast05　
(US/EU/Asia) HER2 low BC 
Chemo naïve/ post chemo
DESTINY-Breast08		 (CN) NSCLC, TNBC
TROPION-PanTumor02		 (CN) HER2+ GC 3L
DESTINY-Gastric06		 (JP/US/EU/Asia) NSCLC (w/ AGA) 
TROPION-Lung05		 (JP/US/EU/Asia) HER2 low BC 
chemo naïve
DESTINY-Breast06
(JP/US/EU/Asia) HER2+ GC combo, 2L+/1L
DESTINY-Gastric03		 (JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) 
TROPION-Lung02		 (CN) HER2 mutant NSCLC 2L+
DESTINY-Lung05		 (US/EU/Asia) TNBC
(durvalumab combo)
BEGONIA		 (JP/US/EU/Asia) HER2+ BC 1L
DESTINY-Breast09
(US/EU/Asia) HER2+ NSCLC  (durvalumab, MEDI5752 combo) 1L
DESTINY-Lung03		 (JP/US/EU) NSCLC (w/o AGA, durvalumab, AZD2936 and MEDI5752 combo)
TROPION-Lung04		 (US/EU/Asia) NSCLC
(durvalumab combo) 2L+ 
HUDSON		 (JP/US/EU/Asia) EGFR mutated 
NSCLC (osimertinib combo) 2L 
ORCHARD		 (JP/US/EU/Asia) HER2+ BC
neoadjuvant
DESTINY-Breast11
(US/EU) BC, bladder
 (nivolumab combo)		 (JP/US/EU/Asia) solid tumors
(AZD5305 combo) 
PETRA		 (JP/US/EU/Asia) HER2+ CRC 3L
DESTINY-CRC02		 (US/EU/Asia) resectable early-stage NSCLC (durvalumab combo) neoadjuvant 
NeoCOAST-2		 (US/EU/Asia) HER2 low BC,
HER2 IHC 0 BC, 2/3L
DESTINY-Breast15
(US/EU) BC, NSCLC 
(pembrolizumab combo)		 (JP/US/EU/Asia) NSCLC (JP/US/EU/Asia) 
HER2 mutant tumor
DESTINY-PanTumor01		 (JP/US/EU/Asia) EGFR mutated 
NSCLC 3L 
HERTHENA-Lung01		 (JP/EU/Asia) HER2+ GC 2L
DESTINY-Gastric04
(US/EU/Asia) solid tumors 
(AZD5305 combo)
PETRA		 (JP/US) EGFR mutated NSCLC
(osimertinib combo)		 (US/EU/Asia) 
HER2 expressing tumor
DESTINY-PanTumor02		 DS-7300 (JP/US/EU/Asia) 
ES-SCLC		 (JP/US/EU/Asia) NSCLC
(w/ HER2 exon 19 or exon 20 mutation) 1L 
DESTINY-Lung04
DS-7300 (JP/US)　
ESCC, CRPC, squamous NSCLC, SCLC, etc.		 (JP/US) HER3+ BC (JP/US/EU/Asia) NSCLC 2/3L
TROPION-Lung01
DS-6000 (JP/US) 
Renal cell carcinoma, ovarian cancer		 (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) BC*2  2/3L
TROPION-Breast01
(JP/US/EU/Asia) TNBC (PD-1/PD-L1 inhibitor ineligible) 1L
TROPION-Breast02
(JP/US/EU/Asia) TNBC 
(mono or durvalumab combo) adjuvant*3 
TROPION-Breast03
(JP/US/EU/Asia) EGFR mutated 
NSCLC  2L 
HERTHENA-Lung02

T-DXd DS-7300 (I-DXd)    
Dato-DXd  DS-6000 (R-DXd)    
HER3-DXd    
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

*1 Adjuvant therapy for HER2 positive breast cancer patients with residual invasive disease following neoadjuvant therapy
*2 HR+, HER2 low or negative BC
*3 Adjuvant therapy for TNBC patients with residual invasive disease following neoadjuvant therapy
AGA: actionable genomic alterations, BC: breast cancer, CRC: colorectal cancer, CRPC: castration-resistant prostate cancer, ESCC: esophageal squamous cell carcinoma,
ES-SCLC: extensive stage-small cell lung cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, TNBC: triple negative breast cancer

Next Wave

 Phase 1 Phase 2 Phase 3 Filed
DS-1055 (JP/US) 
Anti-GARP antibody 
Solid tumors		 DS-7011 (US) 
Anti-TLR7 antibody 
Systemic lupus erythematosus 		 Valemetostat (DS-3201)(JP/US/EU/Asia) 
EZH1/2 inhibitor 
PTCL		 Pexidartinib (JP/Asia) 
CSF-1/KIT/FLT3 inhibitor 
Tenosynovial giant cell tumor		 Quizartinib (EU) 
FLT3 inhibitor 
AML 1L
DS-1594 (US) 
Menin-MLL binding inhibitor 
AML, ALL		 DS-2325 (EU) in prep  
KLK5 inhibitor
Netherton syndrome		 Valemetostat (DS-3201) (EU) 
EZH1/2 inhibitor 
BCL		 Esaxerenone (JP) 
MR blocker 
Diabetic nephropathy		 Mirogabalin (CN) 
α2δ ligands
Diabetic peripheral neuropathic pain
DS-9606 (US/EU) 
Target undisclosed ADC 
Solid tumors		 DS-1001 (JP) 
Mutant IDH1 inhibitor 
Glioma		 VN-0102/JVC-001 (JP) 
Measles mumps rubella combined vaccine		 DS-5670 (JP) 
COVID-19 mRNA vaccine (mutant strain) 
COVID-19 (booster vaccination, 12 years old and over)
DS-1103
Anti-SIRPα antibody
HER2 expressing or mutant advanced metastatic solid tumors,
HER2 low BC (ENHERTU® combo)		 DS-1211 (US/EU) 
TNAP inhibitor 
Pseudoxanthoma elasticum		 DS-5670 (JP)
COVID-19 mRNA vaccine (original strain),
COVID-19 (primary vaccination, 12 to 17 aged children)
DS-3939
Anti-TA-MUC1 ADC
Solid tumors		 VN-0200 (JP) 
RS virus vaccine 
RS virus infection		 DS-5670 (JP) 
COVID-19 mRNA vaccine (mutant strain)
COVID-19 (booster vaccination, 5 to 11 aged children) 
DS-1471
Anti-CD147 antibody
Solid tumors (in prep.)

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)  
Breakthrough Designation (US)  
ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, BCL: B cell lymphoma, LBCL: large B cell lymphoma, PTCL: peripheral T-cell lymphoma