Our Pipeline - Research & Development

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
Next Wave

5DXd ADCs

Phase 1	Phase 2	Phase 3	Regulatory Phase
(US/EU/Asia) HER2+ BC 2L+/1L DESTINY-Breast07	(CN) HER2 expressing solid tumors DESTINY-PanTumor03	(JP/US/EU/Asia) HER2+ BC adjuvant*1 DESTINY-Breast05	(CN) HER2+ GC 3L DESTINY-Gastric06
(US/EU/Asia) HER2 low BC Chemo naïve/ post chemo DESTINY-Breast08	(JP/US/EU/Asia) solid tumors TROPION-PanTumor03	(JP/US/EU/Asia) HER2 low BC chemo naïve DESTINY-Breast06	(CN) HER2 mutant NSCLC 2L+ DESTINY-Lung05
(JP/US/EU/Asia) HER2+ GC combo, 2L+/1L DESTINY-Gastric03	(JP/US/EU/Asia) EGFR mutated NSCLC (osimertinib combo) 2L ORCHARD	(JP/US/EU/Asia) HER2+ BC 1L DESTINY-Breast09	(US/EU) NSCLC 2/3L TROPION-Lung01
(US/EU/Asia) HER2+ NSCLC (durvalumab, volrustomig combo) 1L DESTINY-Lung03	(US/EU/Asia) resectable early-stage NSCLC (durvalumab combo) neoadjuvant NeoCOAST-2	(JP/US/EU/Asia) HER2+ BC neoadjuvant DESTINY-Breast11	(JP/US/EU/CN) BC*3 2/3L TROPION-Breast01
(US/EU) BC, NSCLC (pembrolizumab combo)	(JP/US/EU/Asia) melanoma SCCHN, HER2 negative GC, 2L+ HERTHENA-PanTumor01	(JP/EU/Asia) HER2+ GC 2L DESTINY-Gastric04	(US) EGFR mutated NSCLC 3L HERTHENA-Lung01
(US/EU/Asia) TNBC (durvalumab combo) BEGONIA	(JP/US/EU/Asia) ES-SCLC, 2L IDeate-Lung01	(JP/US/EU/Asia) NSCLC (w/ HER2 exon 19 or exon 20 mutation) 1L DESTINY-Lung04
(US/EU/Asia) solid tumors (saruparib combo) PETRA	(JP/US/EU/Asia) solid tumors, 2L+	(JP/US/EU/Asia) nonsquamous NSCLC (w/o AGA, pembrolizumab combo) 1L TROPION-Lung07
(JP/US) solid tumors TROPION-PanTumor01	(JP/US/EU/Asia) ovarian cancer REJOICE-Ovarian01	(JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) 1L TROPION-Lung08
(CN) NSCLC, TNBC TROPION-PanTumor02		(JP/US/EU/Asia) in prep PD-L1 high nonsquamous NSCLC (w/o AGA, rilvegostomig combo) 1L TROPION-Lung10
(JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) TROPION-Lung02		(JP/US/EU/Asia) in prep EGFR mutated NSCLC (osimertinib combo) 1L TROPION-Lung14
(JP/US/EU) NSCLC (w/o AGA, durvalumab, rilvegostomig, volrustomig, and sabestomig combo) TROPION-Lung04		(JP/US/EU/Asia) TNBC (PD-1/PD-L1 inhibitor ineligible) 1L TROPION-Breast02
(US/EU/Asia) TNBC (durvalumab combo) BEGONIA		(JP/US/EU/Asia) TNBC adjuvant*2 (mono or durvalumab combo) TROPION-Breast03
(JP/US/EU/Asia) solid tumors (saruparib combo) PETRA		(JP/US/EU/Asia) TNBC neoadjuvant and adjuvant (durvalumab combo) TROPION-Breast04
(JP/US/EU/Asia) NSCLC		(JP/US/EU/Asia) PD-L1 positive TNBC 1L　(mono or durvalumab combo) TROPION-Breast05
(JP/US/Asia) EGFR mutated NSCLC, 1/2L (osimertinib combo)		(JP/US/EU/Asia) EGFR mutated NSCLC 2L HERTHENA-Lung02
(JP/US) ESCC, CRPC, squamous NSCLC, SCLC, etc. IDeate-PanTumor01		(JP/US/EU/Asia) in prep, ES-SCLC, 2L+ IDeate-Lung02
(JP/US/EU/Asia) in prep ES-SCLC, 1L IDeate-Lung03
(JP/US) renal cell carcinoma, ovarian cancer

	T-DXd		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)

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 Adjuvant therapy for TNBC patients with residual invasive disease following neoadjuvant therapy
*3 HR+, HER2 low or negative BC
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, SCCHN: squamous cell carcinoma of head and neck, SCLC: small cell lung cancer, TNBC: triple negative breast cancer

Next Wave

Phase 1		Phase 2	Phase 3	Regulatory Phase
DS-1055 (JP/US) Anti-GARP antibody Solid tumors	DS-7011 (US) Anti-TLR7 antibody Systemic lupus erythematosus	Valemetostat (EU) EZH1/2 inhibitor BCL	Pexidartinib (JP/Asia) CSF-1/KIT/FLT3 inhibitor Tenosynovial giant cell tumor	Valemetostat (JP) EZH1/2 inhibitor PTCL
DS-9606 (US/EU) Target undisclosed ADC Solid tumors	DS-2325 (EU) KLK5 inhibitor Netherton syndrome	DS-1001 (JP) Mutant IDH1 inhibitor Glioma	Esaxerenone (JP) MR blocker Diabetic nephropathy	Mirogabalin (CN) α2δ ligands Diabetic peripheral neuropathic pain
DS-1103 Anti-SIRPα antibody HER2 expressing or mutant solid tumors, HER2 low BC		DS-1211 (US/EU) TNAP inhibitor Pseudoxanthoma elasticum	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
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 (single dose,12 years old and over)
DS-1471 Anti-CD147 antibody Solid tumors
Valemetostat EZH1/2 inhibitor, HER2+ GC (T-DXd combo) and NSQ NSCLC (Dato-DXd combo)

	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