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Aminolevulinic Acid

Generic Name: Aminolevulinic Acid

Brand Names: Ameluz, Gliolan, Levulan

Drug Type: Small Molecule

Chemical Formula: C_₅H_₉NO_₃

CAS Number: 106-60-5

Unique Ingredient Identifier: 88755TAZ87

Overview

A compound produced from succinyl-CoA and glycine as an intermediate in heme synthesis. It is used as a photochemotherapy for actinic keratosis. [PubChem]

Background

A compound produced from succinyl-CoA and glycine as an intermediate in heme synthesis. It is used as a photochemotherapy for actinic keratosis. [PubChem]

Indication

用于皮肤癌及鲍温病、牛皮癣，男性尿道尖锐湿疣等皮肤病。可治疗消化道肿瘤、口腔癌。可诊断和治疗膀胱癌、尿路上皮肿瘤。能阻止血管成形术后在狭窄。

Associated Conditions

Actinic Cheilitis
Actinic Keratoses of the face
Actinic Keratoses of the scalp
Actinic Keratosis (AK) of the Upper Extremity
Basal Cell Carcinoma (BCC)
Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)
Glioma

Clinical Trials

A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients

Phase 2

Not yet recruiting

Posted: 2025/04/02

Sponsor:

Costas Hadjipanayis

ID:NCT06907485

Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face

Phase 4

Recruiting

Posted: 2024/12/24

Sponsor:

Psoriasis Treatment ...

ID:NCT06745999

The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours

Phase 2

Not yet recruiting

Posted: 2024/11/07

Sponsor:University College, ...

ID:NCT06678867

Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

Phase 1

Recruiting

Posted: 2024/03/13

Sponsor:Roswell Park Cancer ...

ID:NCT06307548

Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)

Phase 1

Withdrawn

Posted: 2024/02/12

Sponsor:University of Califo...

ID:NCT06252727

FDA Approved Products

GLEOLAN

Manufacturer:Medexus Pharma, Inc.

Route:ORAL

Strength:1500 mg in 1 1

Approved: 2024/01/10

NDC:59137-231

GLEOLAN

Manufacturer:NX DEVELOPMENT CORP

Route:ORAL

Strength:1500 mg in 1 1

Approved: 2019/02/15

NDC:71469-231

AMELUZ

Manufacturer:Biofrontera Inc.

Route:TOPICAL

Strength:100 mg in 1 g

Approved: 2021/11/19

NDC:70621-101

Singapore Approved Products

GLIOLAN, POWDER FOR ORAL SOLUTION, 30 MG/ML

Manufacturer:LyoContract GmBH

Form:POWDER, FOR SOLUTION

Strength:30mg/ml

Online:Yes

Approved: 2017/05/26

Approval:SIN15244P

Related News

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The FDA has granted premarket approval for Sun Pharma's next-generation BLU-U Blue Light Photodynamic Therapy Illuminator, featuring LED panels instead of fluorescent tubes for treating actinic keratosis.

Biofrontera's Ameluz Secures Patent Extension to 2043, Targets $5.7B Acne Market

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Biofrontera Inc. has secured FDA approval for a reformulated Ameluz nanoemulsion gel, extending patent protection until 2043 and allowing up to three tubes per treatment, potentially increasing revenue through larger average sales.

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Biofrontera's Ameluz-PDT Shows Promise in Phase 3 Trial for Superficial Basal Cell Carcinoma

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Biofrontera's Phase 3 trial of Ameluz-PDT for superficial basal cell carcinoma (sBCC) has reached a crucial milestone with all patients completing the 1-year follow-up.

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