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

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

Conditions: Pediatric Brain Tumor

Interventions: Drug: Aminolevulinic acid hydrochloride

First Posted Date: 2025-04-02

Last Posted Date: 2025-04-23

Lead Sponsor: Costas Hadjipanayis

Target Recruit Count: 20

Registration Number: NCT06907485

Locations: 🇺🇸
MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge, Chicago, Illinois, United States
🇺🇸
UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

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

Phase 4

Recruiting

Conditions: Actinic Keratoses

Interventions: Drug: Ameluz 10% Topical Gel
Device: Red Light PDT
Procedure: Cryotherapy

First Posted Date: 2024-12-24

Last Posted Date: 2024-12-24

Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

Target Recruit Count: 40

Registration Number: NCT06745999

Locations: 🇺🇸
Psoriasis Treatment Center of New Jersey, East Windsor, New Jersey, United States

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

Phase 2

Not yet recruiting

Conditions: Brain Tumor

Interventions: Drug: 5-ALA (Gliolan)

First Posted Date: 2024-11-07

Last Posted Date: 2025-03-27

Lead Sponsor: University College, London

Target Recruit Count: 80

Registration Number: NCT06678867

Locations: 🇬🇧
Nottingham Children's Hospital, Nottingham, United Kingdom

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

Conditions: Stage III Colorectal Cancer
Locally Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma

Interventions: Drug: Aminolevulinic Acid
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Fluorescence-Guided Surgery
Procedure: Magnetic Resonance Imaging
Drug: Photodynamic Therapy
Procedure: Surgical Procedure

First Posted Date: 2024-03-13

Last Posted Date: 2024-08-05

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 21

Registration Number: NCT06307548

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

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

Phase 1

Withdrawn

Conditions: Soft Tissue Sarcoma
Soft Tissue Sarcoma Adult

Interventions: Drug: Aminolevulinic Acid

First Posted Date: 2024-02-12

Last Posted Date: 2024-08-15

Lead Sponsor: University of California, Davis

Registration Number: NCT06252727

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

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)

Phase 3

Recruiting

Conditions: Fluorescence-guided Resection
5-aminolevulinic Acid

Interventions: Drug: 5-aminolevulinic acid

First Posted Date: 2023-12-07

Last Posted Date: 2025-05-13

Lead Sponsor: Lee's Pharmaceutical Limited

Target Recruit Count: 144

Registration Number: NCT06160492

Locations: 🇨🇳
Henan Province Tumor Hospital, Zhengzhou, Henan, China
🇨🇳
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor

Phase 1

Recruiting

Conditions: Glioblastoma

Interventions: Drug: Gliolan
Radiation: Radiodynamic therapy

First Posted Date: 2022-10-21

Last Posted Date: 2024-12-16

Lead Sponsor: Universität Münster

Target Recruit Count: 34

Registration Number: NCT05590689

Locations: 🇩🇪
University Hospital Münster, Klinik für Neurochirurgie, Münster, Germany

Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Not Applicable

Conditions: Keloid
Skin Tumor
Hypertrophic Scar
Skin Diseases
Warts
Plantar Wart

Interventions: Drug: Triamcinolone acetonide(scar)/5-ALA(others)
Procedure: Piezoelectric drived microneedling
Drug: 5-ALA (a photosensitizer for photodynamic therapy).

First Posted Date: 2022-08-05

Last Posted Date: 2022-08-05

Lead Sponsor: Xiangya Hospital of Central South University

Target Recruit Count: 20

Registration Number: NCT05488860

Locations: 🇨🇳
Xiangya Hospital, Changsha, China

The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial

Phase 2

Conditions: Neoplasm
Skull Base Neoplasm

Interventions: Drug: 5-Aminolevulinic acid Hydrochloride

First Posted Date: 2021-11-01

Last Posted Date: 2024-11-19

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 7

Registration Number: NCT05101798

Locations: 🇺🇸
Mount Sinai Union Square, New York, New York, United States
🇺🇸
New York Eye and Ear Infirmary of Mount Sinai, New York, New York, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Sonodynamic Therapy with ExAblate System in Glioblastoma Patients

Phase 2

Completed

Conditions: Glioblastoma Multiforme

Interventions: Drug: 5-Aminolevulinic Acid

First Posted Date: 2021-04-15

Last Posted Date: 2024-11-11

Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Target Recruit Count: 5

Registration Number: NCT04845919

Locations: 🇮🇹
Foundation IRCCS Carlo Besta Neurological Institute, Milan, Italy

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy