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BF-200 ALA 1%
BF-200 ALA 1% is a photosensitizer Small molecule drug developed by Biofrontera Bioscience GmbH. It is currently in Phase 2 development for Actinic keratosis, Superficial basal cell carcinoma.
BF-200 ALA 1% is a topical photosensitizer that, when activated by light, generates reactive oxygen species to induce cell death in targeted tissues.
Aminolevulinic acid (ALA) 1% is used in photodynamic therapy for conditions such as actinic keratosis. The therapy involves the use of blue light to activate the ALA, which is administered to the affected area.
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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).
| 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 1% |
|---|---|
| Sponsor | Biofrontera Bioscience GmbH |
| Drug class | photosensitizer |
| Target | protoporphyrin IX (PpIX) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 2 |
Mechanism of action
The active ingredient, aminolevulinic acid (ALA), is converted into protoporphyrin IX (PpIX) within cells. Upon illumination with specific wavelengths of light, PpIX becomes excited and produces reactive oxygen species, leading to photodynamic damage and cell death, particularly in rapidly dividing cells such as those found in certain skin conditions and cancers.
Approved indications
- Actinic keratosis
- Superficial basal cell carcinoma
Common side effects
- Local skin reactions (e.g., erythema, edema, crusting)
- Pain during illumination
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.
| 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 1% CI brief — competitive landscape report
- BF-200 ALA 1% updates RSS · CI watch RSS
- Biofrontera Bioscience GmbH portfolio CI
Frequently asked questions about BF-200 ALA 1%
What is BF-200 ALA 1%?
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What is BF-200 ALA 1% used for?
Who makes BF-200 ALA 1%?
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What are the side effects of BF-200 ALA 1%?
What does BF-200 ALA 1% target?
Related
- Drug class: All photosensitizer drugs
- Target: All drugs targeting protoporphyrin IX (PpIX)
- Manufacturer: Biofrontera Bioscience GmbH — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Actinic keratosis
- Indication: Drugs for Superficial basal cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing