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aminolevulinic acid

Generic: AMINOLEVULINIC ACID HYDROCHLORIDE·Brand: AMELUZ, Ameluz, GLEOLAN, LEVULAN

aminolevulinic acid: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

aminolevulinic acid evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect aminolevulinic acid to BFRI; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could aminolevulinic acid → BFRI affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Actinic Keratosis (Trunk & extremities)
Development Pipeline (1)
CompanyPhase
Biofrontera Inc. (BFRI)
Actinic Keratosis (Trunk & extremities)
Phase 3
Clinical Trials (1)

Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Loco-Regionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery - Phase I/II

NCT06307548·Phase 1·ENTA
Suspended

Primary endpoint: Accuracy of the fluorescence imaging (Phase I)

Interventionalopen21 targetStarted 2024-07Completion 2027-061 site · United StatesRoswell Park Cancer Institute
FDA Decisions1 records
Approval1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. AMELUZ, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is indicated for the lesion-directed and field-directed treatment of actinic ker(BFRI)FDA ↗
NDA208081Type 3 - New Dosage FormStandardTopicalGel

Frequently asked questions

Who is developing aminolevulinic acid?

aminolevulinic acid is being developed by Biofrontera Inc..

How many clinical trials involve aminolevulinic acid?

BioSniper tracks 1 clinical trial involving aminolevulinic acid.

What is aminolevulinic acid's latest FDA decision?

The most recent tracked FDA decision for aminolevulinic acid is Approval for 1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. AMELUZ, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is indicated for the lesion-directed and field-directed treatment of actinic ker, dated May 10, 2016.