Last reviewed 2026-04-20 · How we verify

Sulfamylon (MAFENIDE)

Mafenide (Sulfamylon), marketed by Rising, is an adjunctive therapy for second- and third-degree burns, competing in a class of older, off-patent sulfonamides. Its key strength lies in its unique mechanism of action, inhibiting carbonic anhydrase 12, which differentiates it from same-class competitors like sulfadiazine silver and sulfathiazole. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Adjunctive therapy for second- and third-degree burns

Common side effects

• pain on application or burning sensation
• diarrhea
• excoriation of new skin
• bleeding of skin
• rash
• itching
• facial edema
• swelling
• hive
• blisters
• erythema
• eosinophilia

Key clinical trials

• Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks (PHASE2,PHASE3)
• Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group (PHASE4)
• Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
• Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds (NA)
• Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns (NA)
• Vashe Wound Therapy Study (NA)

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:

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