Last reviewed 2026-04-20 · How we verify

Azophen (phenazone)

Phenazone (Azophen) is a marketed drug primarily indicated for the treatment of infective otitis media, with a key composition patent expiring in 2028. Its mechanism of action, inhibiting nicotinate phosphoribosyltransferase, sets it apart in the market. The primary risk is competition from same-class drugs like metamizole, which may limit its market share.

At a glance

Approved indications

• Infective otitis media

Common side effects

No common side effects on file.

Key clinical trials

• A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects (PHASE1)
• Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment (PHASE1)
• Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment (PHASE1)
• PK Study in Subjects With Severe Hepatic Impairment (PHASE1)
• Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke (PHASE2)
• Dose Finding Study of MCI-186 in Acute Ischemic Stroke (PHASE2)
• Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) (PHASE1)
• Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube (PHASE1)

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:

• Azophen CI brief — competitive landscape report
• Azophen updates RSS · CI watch RSS
• portfolio CI