Last reviewed 2026-04-23 · How we verify

KW-2246 (fentanyl citrate)

KW-2246 is a fentanyl citrate formulation that binds to opioid receptors in the central nervous system to produce analgesia and pain relief.

KW-2246 is a fentanyl citrate formulation that binds to opioid receptors in the central nervous system to produce analgesia and pain relief. Used for Moderate to severe pain (specific indication under investigation in phase 3).

At a glance

Mechanism of action

Fentanyl is a synthetic opioid agonist that acts primarily on mu (μ) opioid receptors in the brain and spinal cord. By activating these receptors, it modulates pain perception and transmission, providing potent analgesia. KW-2246 represents a formulation or delivery approach of this well-established opioid mechanism, likely developed by Kyowa Kirin for specific clinical applications.

Approved indications

• Moderate to severe pain (specific indication under investigation in phase 3)

Common side effects

• Respiratory depression
• Constipation
• Nausea
• Dizziness
• Sedation
• Dependence/addiction risk

Key clinical trials

• A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients (PHASE3)
• A Phase III Clinical Study of KW-2246 (PHASE3)
• Clinical Study of KW-2246 in Patients With Cancer Pain (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• KW-2246 (fentanyl citrate) CI brief — competitive landscape report
• KW-2246 (fentanyl citrate) updates RSS · CI watch RSS
• Kyowa Kirin Co., Ltd. portfolio CI