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OPC-6535
OPC-6535 is a selective antagonist of the P2X7 receptor, which modulates purinergic signaling involved in inflammatory and immune responses.
OPC-6535 is a selective antagonist of the P2X7 receptor, which modulates purinergic signaling involved in inflammatory and immune responses. Used for Neuropathic pain.
At a glance
| Generic name | OPC-6535 |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | P2X7 receptor antagonist |
| Target | P2X7 |
| Modality | Small molecule |
| Therapeutic area | Neurology / Pain |
| Phase | Phase 3 |
Mechanism of action
P2X7 is an ATP-gated ion channel expressed on immune cells that plays a role in inflammasome activation and pro-inflammatory cytokine release. By blocking P2X7, OPC-6535 reduces excessive inflammatory responses and may provide therapeutic benefit in conditions driven by aberrant immune activation. This mechanism is being explored in neuropathic pain and other inflammatory conditions.
Approved indications
- Neuropathic pain
Common side effects
Key clinical trials
- A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis (PHASE2)
- To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients (PHASE2)
- A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease (PHASE2, PHASE3)
- A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease (PHASE2)
- Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (PHASE2)
- FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis (PHASE3)
- FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis (PHASE3)
- CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OPC-6535 CI brief — competitive landscape report
- OPC-6535 updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI