AMELUZ (aminolevulinic acid hydrochloride)
Ameluz helps patients with mild-to-moderate actinic keratoses located on the face and scalp. This topical gel is used in combination with photodynamic therapy using a specific red light source, such as the BF-RhodoLED or RhodoLED XL lamp. It is designed to address both individual lesions and broader areas of skin affected by these growths.
How AMELUZ Works
This drug works by converting into a photoactive compound called protoporphyrin IX once it is absorbed into the skin. When this compound is exposed to specific wavelengths of red light, it reacts with oxygen to create reactive oxygen species. These molecules damage and ultimately destroy the targeted skin cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-05-10
- Patent Cliff
- 2043
- Routes
- TOPICAL
- Dosage Forms
- GEL
AMELUZ Approval History
What AMELUZ Treats
1 indicationsAMELUZ is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Actinic Keratosis
AMELUZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMELUZ
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06907485 | STUDY22120058 | Ph 2 | not yet recruiting | A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients |
| NCT07053852 | BF-BBL-01 | Ph 1 | completed | Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage |
| NCT04815083 results posted | SBI-CIP 20-002 | Ph 3 | terminated | Fluorescence Imaging of Carcinoma During Breast Conserving Surgery |
| NCT03963102 | PDT AK v1 | Ph 4 | terminated | Duration of Ameluz Application in Acral Actinic Keratoses Response |
| NCT00978081 | CDR0000650536 UPCC-18308, IRB #809093 | Ph 1 | completed | Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors |
| NCT02409732 results posted | D15043 28525 | Ph 4 | completed | Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis |
| NCT00571558 | NCI-2009-00842 NCI-2009-00842, CDR0000579270 | Ph 1 | terminated | Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMELUZ FDA Label Details
Indications & Usage
FDA Label (PDF)AMELUZ is indicated for the treatment of Actinic Keratosis.
AMELUZ Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for AMELUZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 3 active patents
Trial Analysis
- • 7 total trials
- • Stage: Declining
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment