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Aminolevulinic Acid

Generic Name
Aminolevulinic Acid
Brand Names
Ameluz, Gliolan, Levulan
Drug Type
Small Molecule
Chemical Formula
C5H9NO3
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]

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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/08
Not Applicable
Recruiting
Sherrif Ibrahim
2025/06/26
Phase 1
Not yet recruiting
2025/04/02
Phase 2
Not yet recruiting
Costas Hadjipanayis
2024/12/24
Phase 4
Recruiting
Psoriasis Treatment Center of Central New Jersey
2024/11/07
Phase 2
Not yet recruiting
2024/03/13
Phase 1
Recruiting
2024/02/12
Phase 1
Withdrawn
2023/12/07
Phase 3
Recruiting
Lee's Pharmaceutical Limited
2022/10/21
Phase 1
Recruiting
2022/08/05
Not Applicable
UNKNOWN
Xiangya Hospital of Central South University

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Biofrontera Inc.
70621-101
TOPICAL
100 mg in 1 g
11/19/2021
NX DEVELOPMENT CORP
71469-231
ORAL
1500 mg in 1 1
2/15/2019
Medexus Pharma, Inc.
59137-231
ORAL
1500 mg in 1 1
1/10/2024

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
GLIOLAN, POWDER FOR ORAL SOLUTION, 30 MG/ML
SIN15244P
POWDER, FOR SOLUTION
30mg/ml
5/26/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
盐酸氨酮戊酸外用散
国药准字H20070027
化学药品
散剂(外用)
3/3/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
GLIOLAN POWDER FOR ORAL SOLUTION 30MG/ML
N/A
N/A
N/A
4/9/2014

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Gliolan (aminolevulinic acid HCl) powder for oral solution, 30 mg/mL, vial
202549
Medicine
A
11/7/2013
ALACARE 5-aminolevulinic acid hydrochloride 8 mg dermal patch sachet
223468
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Medicine
A
3/19/2015

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