Our Pipeline

ONO is investigating additional molecules across our four focus areas in clinical trials around the world.

Lab technician
92
Clinical trial sites in the U.S.
7
Clinical trials ongoing in the U.S.

Pipeline updated as of July 22, 2024.

Combination with nivolumab

Mechanism

Disease Area

Country

Licensor

Development Phase

Immunology
Phase 1
Phase 2
Phase 3
Filing
Approval
P1
P2
P3
F
A

ONO-4685

PD-1 x CD3 bispecific antibody

ONO-4685

Target Disease

Autoimmune disease

Why This Disease Focus?

  • Autoimmune diseases, of which there are more than 100, can be challenging to manage.  
  • Antibody therapies are a promising strategy for treating a range of immune system diseases.

Goal of Program

PD-1 x CD3 bispecific antibody

PD-1 is a receptor that is expressed on activated T cells, which inhibits activation signals of the immune system. CD3 is a component of T-cell activating receptor. ONO-4685 was designed by ONO’s Research Center of Immunology, and is a bispecific antibody that targets both PD-1 and CD3. Outside the U.S., clinical trials to investigate ONO-4685 are underway.

*This molecule is not approved by any regulatory authority for any use.

Program Phase

Country

Licensor

Development Phase

Phase 1
Phase 2
Phase 3
Filing
Approval

Japan

EU

In-House

ONO-4059 (tirabrutinib)

BTK inhibitor

ONO-4059 (tirabrutinib)

Target Disease

Pemphigus

Why This Disease Focus?

  • Autoimmune diseases occur when the immune system mistakenly attacks the body’s own cells.  
  • Pemphigus is an autoimmune disease that causes painful or itchy blistering of the skin and the mucus membranes that line the mouth, nose, throat, eyes, and genitals.  
  • While certain medications like corticosteroids can control symptoms, unmet need remains, since some patients do not respond to standard treatments.

Goal of Program

BTK inhibitor

ONO-4059 is a BTK inhibitor. In autoimmune diseases, B cell receptors, which play important roles in immunity, may be overly active. Outside the U.S., ONO-4059 is being investigated for pemphigus.

*This molecule is not approved by the FDA for any use.

Program Phase

Country

Licensor

Development Phase

Phase 1
Phase 2
Phase 3
Filing
Approval

Japan

In-House

INNOVATION AROUND THE WORLD

Our Global Pipeline

ONO is investigating additional therapeutics across our four focus areas globally.

Go to Global Site

Our Global Pipeline
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