Our Pipeline

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

57
Clinical trial sites in the U.S.
5
Clinical trials ongoing in the U.S.

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
Get in touch to learn more.
Explore what it’s like to work at ONO PHARMA USA.