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 July 31, 2023

Pipeline Chart

5DXd-ADCs
Next Wave

5DXd-ADCs

Phase 1		Phase 2		Phase 3	Filed
(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	(JP/EU) HER2 mutant NSCLC 2L+ DESTINY-Lung01/Lung02
(US/EU/Asia) HER2 low BC Chemo naïve/ post chemo DESTINY-Breast08	(CN) NSCLC, TNBC TROPION-PanTumor02	(CN) HER2+ GC 3L DESTINY-Gastric0	(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 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) HER2+ CRC 3L DESTINY-CRC01	(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+ CRC 3L DESTINY-CRC02	(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)	(JP/US/EU/Asia) HER2 mutant tumor DESTINY-PanTumor01	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	(US/EU/Asia) HER2 expressing tumor DESTINY-PanTumor02		(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 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
	Dato-DXd		DS-6000
	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 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	DS-1211 (US/EU) TNAP inhibitor Pseudoxanthoma elasticum	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 (US) KLK5 inhibitor Netherton syndrome	Valemetostat (DS-3201) (EU) EZH1/2 inhibitor BCL	DS-5670 (JP) COVID-19 mRNA vaccine (mutant strain), COVID-19 (primary vaccination, 5 to 11 aged children) (in prep.)	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-0200 (JP) RS virus vaccine RS virus infection	VN-0102/JVC-001 (JP) Measles mumps rubella combined vaccine	DS-5670 (JP) COVID-19 mRNA vaccine (original strain) COVID-19 (booster vaccination)
DS-1103 Anti-SIRPα antibody HER2 expressing or mutant advanced metastatic solid tumors, HER2 low BC (ENHERTU® combo)				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 (in prep.)				DS-5670 (JP) COVID-19 mRNA vaccine (mutant strain) COVID-19 (booster vaccination, 12 years old and over)
DS-1471 Anti-CD147 antibody Solid tumors (in prep.)				DS-5670 (JP) COVID-19 mRNA vaccine (mutant strain), COVID-19 (booster vaccination, 5 to 11 aged children)

	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