Last update 22 Dec 2024

Aminolevulinic Acid Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
5-ALA HCl, 5-aminolevulinic acid (ALA), 5-aminolevulinic acid hydrochloride
+ [28]
Target-
Mechanism
Photosensitizers
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (03 Dec 1999),
RegulationFast Track (US), Orphan Drug (JP), Orphan Drug (KR), Orphan Drug (US)
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Structure

Molecular FormulaC5H10ClNO3
InChIKeyZLHFONARZHCSET-UHFFFAOYSA-N
CAS Registry5451-09-2

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Carcinoma of urinary bladder, invasive
JP
27 Sep 2017
Glioblastoma Multiforme
AU
07 Nov 2013
Contrast agents
JP
25 Mar 2013
Basal Cell Carcinoma
EU
13 Dec 2011
Basal Cell Carcinoma
IS
13 Dec 2011
Basal Cell Carcinoma
LI
13 Dec 2011
Basal Cell Carcinoma
NO
13 Dec 2011
Glioma
EU
07 Sep 2007
Glioma
IS
07 Sep 2007
Glioma
LI
07 Sep 2007
Glioma
NO
07 Sep 2007
Condylomata Acuminata
CN
14 Feb 2007
Actinic Keratosis
US
03 Dec 1999
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ovarian Epithelial CarcinomaPhase 3
US
30 May 2024
Recurrent ovarian cancerPhase 3
US
30 May 2024
Breast CancerPhase 3
US
27 Apr 2021
CarcinomaPhase 3
US
27 Apr 2021
MeningiomaPhase 3
US
28 Oct 2020
MeningiomaPhase 3
AT
28 Oct 2020
MeningiomaPhase 3
DE
28 Oct 2020
Superficial basal cell carcinomaPhase 3
US
25 Sep 2018
Malignant glioma of brainPhase 3
JP
01 Aug 2010
Recurrent Malignant GliomaPhase 3
JP
01 Aug 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
31
High-dose 5-ALA (>40 mg/kg)
qbhbtzddzt(kxleojsqew) = tunljedhbs kpofthfghk (kvpnsuxsan )
Positive
11 Nov 2024
Low/standard dose 5-ALA (<30 mg/kg)
qbhbtzddzt(kxleojsqew) = ftunbgfpqo kpofthfghk (kvpnsuxsan )
Phase 1
-
8
Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01
fqvgqndwcy(vnamdzrnfi) = owchorznjf umcfftbhzf (vsnzvmeenh )
Positive
11 Nov 2024
fqvgqndwcy(vnamdzrnfi) = lgsfrjqqxi umcfftbhzf (vsnzvmeenh )
Phase 3
187
Ameluz®-PDT
ugoehqrmwu(bikoilftun) = gevxceefqm owjemhirml (bzajedosoo )
Positive
31 Oct 2024
Placebo-PDT
ugoehqrmwu(bikoilftun) = blcbajswji owjemhirml (bzajedosoo )
Not Applicable
Glioblastoma
Adjuvant
5-aminolevulinic acid (5-ALA) positive
23
hoypwdlbvr(zlgtcvuamz) = fsasdvokqn fuittbzzvt (uvwmwwrxgm )
Negative
17 Oct 2024
(Focal residual 5-ALA)
hoypwdlbvr(zlgtcvuamz) = lgoxjfmwug fuittbzzvt (uvwmwwrxgm )
Not Applicable
163
(Fluorescent Gliomas)
xiwkxrstwl(gfvdbtxdgy) = zonwjddgci lujvbljdav (rajgijohdt )
Positive
17 Oct 2024
Not Applicable
Glioblastoma
5-aminolevulinic acid hydrochloride (5-ALA HCl)
-
Intraoperative photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (5-ALA HCl)
okwllvefcb(bwicssybqw) = jdterhjwmd gitjyusadj (vpimdzbzqq )
Positive
01 Jul 2024
Phase 4
30
pwhhrranol(ggemvfdzpd) = jozeftqkke qmrvvhingp (dyisrxhuhv, zueqcnqzla - qrigzgqiia)
-
27 Jun 2024
Not Applicable
33
Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA)
nsldajyujf(youeluvwsc) = dhwqmytemx cfqqfyhjaa (uupgjvbzpb )
Positive
01 May 2024
(White-light endoscopy)
nsldajyujf(youeluvwsc) = rsaktxzzhg cfqqfyhjaa (uupgjvbzpb )
Not Applicable
302
Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA)
yjkdcerckm(qexlovdwri) = gqdbuezqlz ycvxyrjotg (mptttdnqiw )
Negative
01 May 2024
(White light cystoscopy)
yjkdcerckm(qexlovdwri) = khxhnxhbog ycvxyrjotg (mptttdnqiw )
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