Development Pipeline

This is the development pipeline as of April 23, 2025

1. Oncology

As of April 23, 2025

Product Name/
Development Code/
Generic Name
Mechanism Dosage Form Target Indication Phase* Area Licensor
F
Opdivo
Intravenous
Infusion
Anti-PD-1 antibody i.v. Hepatocellular carcinoma, 1L(with Yervoy)
 
 
 
 
 
JP In-house
(Co-developed with BMS)
 
 
 
 
 
KR・TW
Hepatocellular carcinoma, Adjuvant
 
 
 
 
 
JP・KR・TW
MSI-H/dMMR Colorectal cancer, 1L(with Yervoy)
 
 
 
 
 
JP
NSCLC, Neo-adjuvant・Adjuvant(with chemo)
 
 
 
 
 
JP・KR・TW
Bladder cancer, Neo-adjuvant・Adjuvant(with chemo)
 
 
 
 
 
JP・KR・TW
Gastric cancer,1L(with Yervoy/chemo)
 
 
 
 
 
JP・KR・TW
Rhabdoid tumor, 2L
 
 
 
 
 
JP
Richter transformation, 2L
 
 
 
 
 
JP
BRAFTOVI BRAF Inhibitor oral BRAF-mutant colorectal cancer,1L(with cetuximab and FOLFOX)
 
 
 
 
 
JP License-in(Pfizer)
QINLOCK/
ripretinib
KIT inhibitor oral GIST, 2nd KIT Exon 11+17/18
 
 
 
 
 
NA・SA・EU・AU・KR・TW In-house
ONO-4578 PG receptor (EP4) antagonist oral Gastric cancer, 1L(with OPDIVO)
 
 
 
 
 
JP・KR・TW In-house
Colorectal cancer, 1L(with OPDIVO)
 
 
 
 
 
US
NSCLC, 2L(with OPDIVO)
 
 
 
 
 
JP
Hormone receptor-positive, HER2-negative breast cancer, 1L
 
 
 
 
 
JP
ONO-4059/
tirabrutinib
Bruton‘s tyrosine kinase (BTK) inhibitor oral PCNSL, 2L~
 
 
 
 
 
US In-house
PCNSL, 1L
 
 
 
 
 
US
ONO-0530/
sapablursen
Antisense oligonucleotide targeting TMPRSS6 s.c. Polycythemia Vera
 
 
 
 
 
US・EU etc. License-in(Ionis)
ONO-4482/
relatlimab
Anti-LAG-3 antibody i.v. Melanoma, 2L~(with OPDIVO)
 
 
 
 
 
JP・US・EU License-in(Co-developed with BMS)
ONO-7427 Anti-CCR8 antibody i.v. Solid tumor(with OPDIVO)
 
 
 
 
 
JP・US・EU Co-developed with BMS
DCC-3116 ULK inhibitor oral Solid tumor(with sotorasib)
 
 
 
 
 
US In-house
Advanced Malignancies(with ripretinib)
 
 
 
 
 
US
DCC-3084 Pan-RAF inhibitor oral Advanced Malignancies
 
 
 
 
 
US In-house
DCC-3009 Pan-KIT inhibitor oral GIST
 
 
 
 
 
US In-house
ONO-7475/
tamnorzatinib
Axl/Mer inhibitor oral EGFR-mutated NSCLC, 1L(with Osimertinib)
 
 
 
 
 
JP In-house
ONO-7913/
magrolimab
Anti-CD47 antibody i.v. Pancreatic cancer, 1L(with OPDIVO)
 
 
 
 
 
JP License-in(Gilead)
Colorectal cancer, 1L(with OPDIVO)
 
 
 
 
 
JP
ONO-4685 PD-1×CD3 bispecific antibody i.v. T-cell lymphoma, 2L
 
 
 
 
 
JP・US In-house
ONO-4538HSC Anti-PD-1 antibody s.c. Solid tumor
 
 
 
 
 
JP License-in(Co-developed with BMS)
ONO-8250 iPSC-derived HER2 CAR T-cell therapy i.v. HER2-expressing Solid tumor
 
 
 
 
 
US In-house(Co-developed with Fate)
ONO-7428 Anti-ONCOKINE-1 antibody i.v. Solid tumor
 
 
 
 
 
JP License-in(NEX-I)
  • Ⅰ:Phase 1、Ⅱ:Phase 2、Ⅲ:Phase 3:、F:Filed
  • NA : North America, SA : South America, AU : Australia, EU : European Country

2. Areas other than Oncology

As of April 23, 2025

Product Name/
Development Code/
Generic Name
Mechanism Dosage Form Target Indication Phase* Area Licensor
F
DCC-3014/
vimseltinib
CSF-1R inhibitor oral TGCT
 
 
 
 
**
EU In-house
cGVHD
 
 
 
 
 
US
ONO-2017/
cenobamate
Inhibition of voltage-gated sodium currents/positive allosteric modulator of GABAA ion channel oral Primary generalized tonic-clonic seizures
 
 
 
 
 
JP License-in(SKBP)
Partial-onset seizures
 
 
 
 
 
JP
VELEXBRU/
Tirabrutinib
Hydrochloride
Bruton‘s tyrosine kinase (BTK) inhibitor oral Steroid-resistant Pemphigus
 
 
 
 
 
JP In-house
ONO-2808 S1P5 receptor agonist oral Multiple System Atrophy
 
 
 
 
 
JP・US In-house
ONO-2020 Epigenetic Regulation oral Alzheimer’s Disease
 
 
 
 
 
JP・US In-house
Agitation Associated with Dementia Due to Alzheimer's Disease
 
 
 
 
 
JP
ONO-1110 Endocannabinoid regulation oral Postherpetic Neuralgia
 
 
 
 
 
JP In-house
Major Depressive Disorder
 
 
 
 
 
JP
Fibromyalgia
 
 
 
 
 
JP
Social Anxiety Disorder
 
 
 
 
 
JP
Hunner Type Interstitial Cystitis
 
 
 
 
 
JP
ONO-4685 PD-1×CD3 bispecific antibody i.v. Autoimmune disease
 
 
 
 
 
JP・EU In-house
ONO-4915 PD-1×CD19 bispecific antibody i.v./s.c. Autoimmune disease
 
 
 
 
 
JP In-house
  • Ⅰ:Phase 1、Ⅱ:Phase 2、Ⅲ:Phase 3:、F:Filed
  • EMA Filing accepted