Last reviewed · How we verify
BF-200 ALA 10%
BF-200 ALA 10% is a Photodynamic therapy agent Small molecule drug developed by Biofrontera Bioscience GmbH. It is currently in Phase 2 development for Actinic keratosis (field treatment), Non-melanoma skin cancer precursor lesions. Also known as: Ameluz.
BF-200 ALA is a topical 5-aminolevulinic acid (ALA) formulation that generates reactive oxygen species upon light activation to destroy abnormal skin cells.
BF-200 ALA 10% is used in aminolevulinic acid-photodynamic therapy for treating and preventing facial actinic keratosis. This treatment involves applying BF-200 ALA 10% followed by exposure to a light source, such as BLU-U.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BF-200 ALA 10% |
|---|---|
| Also known as | Ameluz |
| Sponsor | Biofrontera Bioscience GmbH |
| Drug class | Photodynamic therapy agent |
| Target | Protoporphyrin IX (photosensitizer) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | Phase 2 |
Mechanism of action
BF-200 ALA is a photodynamic therapy (PDT) agent that penetrates skin tissue and is converted to protoporphyrin IX, a photosensitizer. Upon illumination with red light, protoporphyrin IX generates singlet oxygen and reactive oxygen species that induce apoptosis and necrosis in target cells, particularly actinic keratosis and other precancerous lesions.
Approved indications
- Actinic keratosis (field treatment)
- Non-melanoma skin cancer precursor lesions
Common side effects
- Erythema
- Edema
- Burning/pain at application site
- Photosensitivity
- Crusting/scaling
Key clinical trials
- 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)
- Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer (PHASE1, PHASE2)
- Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT). (PHASE3)
- A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma (PHASE1, PHASE2)
- Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses (PHASE2)
- The IMmunotherapy Pleural 5-ALA PDT (PHASE2)
- Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC) (PHASE2)
- Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BF-200 ALA 10% CI brief — competitive landscape report
- BF-200 ALA 10% updates RSS · CI watch RSS
- Biofrontera Bioscience GmbH portfolio CI
Frequently asked questions about BF-200 ALA 10%
What is BF-200 ALA 10%?
How does BF-200 ALA 10% work?
What is BF-200 ALA 10% used for?
Who makes BF-200 ALA 10%?
Is BF-200 ALA 10% also known as anything else?
What drug class is BF-200 ALA 10% in?
What development phase is BF-200 ALA 10% in?
What are the side effects of BF-200 ALA 10%?
What does BF-200 ALA 10% target?
Related
- Drug class: All Photodynamic therapy agent drugs
- Target: All drugs targeting Protoporphyrin IX (photosensitizer)
- Manufacturer: Biofrontera Bioscience GmbH — full pipeline
- Therapeutic area: All drugs in Dermatology/Oncology
- Indication: Drugs for Actinic keratosis (field treatment)
- Indication: Drugs for Non-melanoma skin cancer precursor lesions
- Also known as: Ameluz
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing