Last reviewed 2026-04-20 · How we verify

Ameluz

At a glance

Approved indications

• Actinic keratosis
• Fluorescent stain
• Non-Hyperkeratotic Actinic Keratoses

Common side effects

• Erythema
• Pain/Burning
• Irritation
• Edema
• Pruritus
• Exfoliation
• Scab
• Induration
• Vesicles
• Paresthesia
• Hyperalgesia
• Reaction Discomfort

Serious adverse events

• Allergic Contact Dermatitis
• Severe Pain/Burning

Key clinical trials

• Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions (PHASE2)
• Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma (PHASE2)
• Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT) (NA)
• Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA） (PHASE3)
• Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp (PHASE3)
• Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401) (PHASE1)
• 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (EARLY_PHASE1)
• Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma (EARLY_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:

• Ameluz CI brief — competitive landscape report
• Ameluz updates RSS · CI watch RSS
• Sherrif Ibrahim portfolio CI