This is the development pipeline as of August 1, 2025
1. Oncology
As of August 1, 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, Adjuvant |
|
JP・KR・TW | In-house (Co-developed with BMS) |
|||
| 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・US・EU・KR・TW and others★ | License-in（Pfizer） | |||
| QINLOCK／ ripretinib |
KIT inhibitor | oral | GIST, 2nd KIT Exon 11+17/18 |
|
US・EU・KR・TW and others | In-house | |||
| ONO-4578 | PG receptor (EP4) antagonist | oral | Gastric cancer, 1L(with OPDIVO) |
|
JP・KR・TW | In-house | |||
| Colorectal cancer, 1L(with OPDIVO) |
|
JP・US・EU and others | |||||||
| 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 and others | License-in（Ionis） | |||
| ONO-4482／ relatlimab |
Anti-LAG-3 antibody | i.v. | Melanoma, 2L～(with OPDIVO) |
|
JP・US・EU and others | License-in（Co-developed with BMS） | |||
| ONO-7427 | Anti-CCR8 antibody | i.v. | Solid tumor(with OPDIVO) |
|
JP・US・EU and others | Co-developed with BMS | |||
| DCC-3116／ inlexisertib |
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-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
★：Development rights country: JP, KR
2. Areas other than Oncology
As of August 1, 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 |
|
US・KR and others★1 | |||||||
| VELEXBRU／ Tirabrutinib Hydrochloride |
Bruton‘s tyrosine kinase (BTK) inhibitor | oral | Steroid-resistant Pemphigus |
|
JP | In-house | |||
| Povetacicept | BAFF/APRILdual antagonist | s.c. | IgA Nephropathy |
|
JP・US・EU・KR・TW and others★2 | License-in（Vertex） | |||
| 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
★1：Development rights country: JP
★2：Development rights country: JP, KR