drug · small molecule
aminolevulinic acid hydrochloride
Marketedupdated 3mo agoby $BFRI Biofrontera Inc.🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 7 approved and 13 investigational indications.
all catalysts(0)
nothing on the calendar yet
Trials studying aminolevulinic acid hydrochloride
- phase3Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
- phase3Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
- phase1Clinical 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)
- phase2A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients
- phase3Study 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).
- phase1Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
- phase2Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults
- phase2Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Brain Tumors
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 4, 2027
~1.1 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (13)
- Dec 8, 2043formulationUS 12280146
- Oct 15, 2040method-of-use (U-3303)US 11235169
- Jan 12, 2038method-of-use (U-3163)US 10357567
- Jan 12, 2038method-of-use (U-3163)US 11077192
- Jan 12, 2038method-of-use (U-3163)US 11135293
- Jan 12, 2038method-of-use (U-3163)US 11571478
- Jan 12, 2038method-of-use (U-3163)US 11690914
- Jan 12, 2038method-of-use (U-3163)US 12296011
- Jan 17, 2037method-of-use (U-804)US 11446512
- Oct 13, 2036method-of-use (U-804)US 11179574
- Oct 13, 2036method-of-use (U-804)US 11697028
- Oct 13, 2036method-of-use (U-804)US 12290700
- Feb 7, 2028formulationUS 115409811.5y
FDA exclusivities (1)
- Oct 4, 2027D-194New Indication (3y)1.1y
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