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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Withdrawn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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LEVULAN KERASTICK
02243933
Powder For Solution - Topical
20 % / W/V
6/3/2004
GLEOLAN
medexus pharmaceuticals inc.
02504928
Powder For Solution - Oral
1.5 G / VIAL
2/22/2021

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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