This is the development pipeline as of May 8, 2026
1. Oncology
As of May 8, 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 | In-house (Co-developed with BMS) |
|||
| NSCLC, Neo-adjuvant・Adjuvant(with chemo) |
|
JP・KR・TW | |||||||
| Rhabdoid tumor, 2L |
|
JP | |||||||
| Richter transformation, 2L |
|
JP | |||||||
| ONO-4059／ tirabrutinib hydrocloride |
BTK inhibitor | oral | PCNSL, 1L, 2L～ |
|
US | In-house | |||
| PCNSL, 2L～ |
|
US | |||||||
| QINLOCK／ ripretinib |
KIT inhibitor | oral | GIST, 2L KIT Exon 11+17/18 |
|
US・EU・KR・TW and others | In-house | |||
| GIST, 4L |
|
JP | |||||||
| ONO-0530／ sapablursen |
Antisense oligonucleotide targeting TMPRSS6 | s.c. | Polycythemia Vera |
|
JP・US・EU・KR・TW and others | License-in（Ionis） | |||
| 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-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. | 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） | |||
| 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. Areas other than Oncology
As of May 8, 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 | cGVHD |
|
US | In-house | |||
| 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-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-2020 | Epigenetic Regulation | oral | Alzheimer’s Disease |
|
JP・US | In-house | |||
| Agitation Associated with Dementia Due to Alzheimer's Disease |
|
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 | i.v. | Psychiatric disorders |
|
JP | In-house | ||||
| ONO-3310 | oral | Kidney disease |
|
JP | In-house | ||||
| ONO-6414 | oral | Autoimmune disease |
|
US | In-house | ||||
- * Ⅰ:Phase 1、Ⅱ:Phase 2、Ⅲ:Phase 3:、F:Filed
★1：Development rights country: JP
★2：Development rights country: JP, KR
★3：P IIb/III