This is the development pipeline as of July 31, 2026
1. Oncology
As of July 31, 2026
| Product
Name/ Development Code/ Generic Name |
Mechanism | Dosage Form | Target Indication | Phase* | Area | Licensor | |||
|---|---|---|---|---|---|---|---|---|---|
| Ⅰ | Ⅱ | Ⅲ | F | ||||||
| OPDIVO/ nivolumab | Anti-PD-1 antibody | i.v. | Hepatocellular carcinoma, adjuvant |
|
JP, US, EU, KR, TW | License-in (co-developed with BMS) | |||
| Non-small cell lung cancer (NSCLC), neo-adjuvant/adjuvant (with chemo) |
|
JP, KR, TW | |||||||
| Rhabdoid tumor, 2L |
|
JP | |||||||
| Richter transformation, 2L |
|
JP | |||||||
| Unresectable anaplastic thyroid cancer |
|
JP | |||||||
| QINLOCK/ ripretinib | KIT inhibitor | oral | Gastrointestinal stromal tumor (GIST), 2L KIT Exon 11+17/18 |
|
US, EU, KR, TW and others | In-house | |||
| GIST, 4L |
|
JP | |||||||
| 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 | |||||||
| ONO-4059/ tirabrutinib hydrocloride | BTK inhibitor | oral | Primary central nervous system lymphoma (PCNSL), ≥2L |
|
US | In-house | |||
| PCNSL, 1L, ≥2L |
|
US | |||||||
| Relapsed or refractory secondary central nervous system lymphoma (SCNSL) |
|
JP | |||||||
| ONO-0530/ sapablursen | Antisense oligonucleotide targeting TMPRSS6 | s.c. | Polycythemia Vera |
|
JP, US, EU, KR, TW 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 | Advanced Malignancies (with ripretinib) |
|
US, EU | In-house | |||
| DCC-3009 | Pan-KIT inhibitor | oral | GIST |
|
US | In-house | |||
| ONO-4685/ besufetamig | PD-1×CD3 bispecific antibody | i.v. | T-cell lymphoma, 2L |
|
JP, US | In-house | |||
| ONO-4538HSC | Anti-PD-1 antibody | s.c. | Pediatric malignant solid tumor, epithelioid sarcoma (combination with vorhyaluronidase alfa) |
|
JP | License-in (co-developed with BMS) | |||
| Solid tumor (combination with vorhyaluronidase alfa) |
|
JP | |||||||
| ONO-8250 | iPSC-derived HER2 CAR T-cell therapy | i.v. | HER2-expressing solid tumor |
|
US | In-house (co-dveloped with Fate) | |||
| ONO-7428 | Anti-ONCOKINE-1 antibody | i.v. | Solid tumor |
|
JP | License-in (NEX-I) | |||
| DCC-2812 | GCN2 activator | oral | Renal cell carcinoma, urothelial cancer, castration-resistant prostate cancer |
|
US | In-house | |||
| ONO-7429 | Anti-L1CAM ADC | i.v. | Solid tumor |
|
JP | License-in (LigaChem) | |||
- * Ⅰ:Phase 1、Ⅱ:Phase 2、Ⅲ:Phase 3:、F:Filed
★：Development rights country: JP
2. Non-oncology
As of July 31, 2026
| Product
Name/ Development Code/ Generic Name |
Mechanism | Dosage Form | Target Indication | Phase* | Area | Licensor | |||
|---|---|---|---|---|---|---|---|---|---|
| Ⅰ | Ⅱ | Ⅲ | F | ||||||
| ROMVIMZA/ vimseltinib | CSF-1R inhibitor | oral | Chronic graft versus host disease (cGVHD) |
|
US | In-house | |||
| Tenosynovial giant cell tumor (TGCT) |
|
JP | |||||||
| ONO-2017/ cenobamate | Inhibition of voltage-gated sodium currents/positive allosteric modulator of GABAA ion channel | oral | Partial-onset seizures |
|
US, KR and others★1 | License-in (SKBP) | |||
| Partial-onset seizures (pediatric) |
|
JP | |||||||
| Primary generalized tonic-clonic seizures |
|
JP | |||||||
| VELEXBRU/tirabrutinib hydrochloride | BTK inhibitor | oral | Steroid-resistant pemphigus |
|
JP | In-house | |||
| ONO-8531/ povetacicept | BAFF/APRIL dual antagonist | s.c. | IgA Nephropathy |
|
JP, US, EU, KR, TW and others★2 | License-in (Vertex) | |||
| Primary membranous nephropathy |
★3
|
US, EU, KR and others | |||||||
| ONO-5532/ Gel-One | Cross-linked hyaluronate | intra-articular injection | Knee osteoarthritis |
|
JP | License-in (Seikagaku) | |||
| Hip osteoarthritis |
|
JP | |||||||
| 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 | |||
| Fibromyalgia |
|
JP | |||||||
| Hunner type interstitial cystitis |
|
JP | |||||||
| Major depressive disorder |
|
JP | |||||||
| Social anxiety disorder |
|
JP | |||||||
| ONO-4685/ besufetamig | 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 | |||
| ONO-2416 | oral | Psychiatric disease |
|
JP | In-house | ||||
| ONO-3310 | oral | Kidney disease |
|
JP | In-house | ||||
| ONO-6414 | oral | Autoimmune disease |
|
US | In-house | ||||
| ONO-3401 | oral | Neurological disease |
|
JP | In-house | ||||
- * Ⅰ:Phase 1、Ⅱ:Phase 2、Ⅲ:Phase 3:、F:Filed
EU: European Country
★1：Development rights country: JP
★2：Development rights country: JP, KR
★3：P IIb/III