AMELUZ

Peak

aminolevulinic acid hydrochloride

NDATOPICALGEL
Approved
May 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1

Mechanism of Action

(prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are…

Clinical Trials (1)

NCT06160492Phase 3Recruiting

Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)

Started Apr 2025
144 enrolled
5-aminolevulinic AcidFluorescence-guided Resection

Loss of Exclusivity

LOE Date
Dec 8, 2043
216 months away
Patent Expiry
Dec 8, 2043
Exclusivity Expiry
Oct 4, 2027

Patent Records (3)

Patent #ExpiryTypeUse Code
11540981
Feb 7, 2028
Product
11235169
Oct 15, 2040
U-3303
12280146
Dec 8, 2043
Product