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 | |||
---|---|---|---|---|---|---|---|---|---|
Ⅰ | Ⅱ | Ⅲ | 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 | |||
---|---|---|---|---|---|---|---|---|---|
Ⅰ | Ⅱ | Ⅲ | 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