Drug Type Small molecule drug |
Synonyms 5-ALA HCl, 5-aminolevulinic acid (ALA), 5-aminolevulinic acid hydrochloride + [29] |
Target- |
Action- |
Mechanism Photosensitizers |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (03 Dec 1999), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea) |
Molecular FormulaC5H10ClNO3 |
InChIKeyZLHFONARZHCSET-UHFFFAOYSA-N |
CAS Registry5451-09-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D02908 | Aminolevulinic Acid Hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Carcinoma of urinary bladder, invasive | Japan | 27 Sep 2017 | |
Glioblastoma Multiforme | Australia | 07 Nov 2013 | |
Contrast agents | Japan | 25 Mar 2013 | |
Basal Cell Carcinoma | European Union | 13 Dec 2011 | |
Basal Cell Carcinoma | Iceland | 13 Dec 2011 | |
Basal Cell Carcinoma | Liechtenstein | 13 Dec 2011 | |
Basal Cell Carcinoma | Norway | 13 Dec 2011 | |
Glioma | European Union | 07 Sep 2007 | |
Glioma | Iceland | 07 Sep 2007 | |
Glioma | Liechtenstein | 07 Sep 2007 | |
Glioma | Norway | 07 Sep 2007 | |
Condylomata Acuminata | China | 14 Feb 2007 | |
Actinic Keratosis | United States | 03 Dec 1999 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-Muscle Invasive Bladder Neoplasms | Phase 3 | China | 11 Mar 2025 | |
Ovarian Epithelial Carcinoma | Phase 3 | United States | 30 May 2024 | |
Recurrent ovarian cancer | Phase 3 | United States | 30 May 2024 | |
Adenoid Cystic Carcinoma | Phase 3 | United States | 27 Apr 2021 | |
Breast Cancer | Phase 3 | United States | 27 Apr 2021 | |
Breast Ductal Carcinoma | Phase 3 | United States | 27 Apr 2021 | |
Carcinoma | Phase 3 | United States | 27 Apr 2021 | |
Ductal Carcinoma | Phase 3 | United States | 27 Apr 2021 | |
Invasive Lobular Breast Carcinoma | Phase 3 | United States | 27 Apr 2021 | |
Mucinous breast cancer | Phase 3 | United States | 27 Apr 2021 |
Not Applicable | - | 9 | lgrfhgygpy(rmygzsfxrg) = lvwekubukm vxgikgxpym (nwlfstkzga, 14.3) | - | 14 May 2025 | ||
lgrfhgygpy(rmygzsfxrg) = kagkspmmsk vxgikgxpym (nwlfstkzga, 9.8) | |||||||
Phase 3 | 187 | (BF-200 ALA) | adxzxltvyx = bbedtojrui twfmpnarzc (dcrjirdfpg, oqthwovfln - gmbfnfixkh) View more | - | 29 Apr 2025 | ||
Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (Vehicle) | adxzxltvyx = otucofigpw twfmpnarzc (dcrjirdfpg, oqwiitprrh - ghhydaisea) View more | ||||||
Phase 2 | 31 | High-dose 5-ALA (>40 mg/kg) | ybujkksfya(yinhjcffcz) = mjqoyhtrca olovzaogut (rezluaiemm ) View more | Positive | 11 Nov 2024 | ||
Low/standard dose 5-ALA (<30 mg/kg) | ybujkksfya(yinhjcffcz) = ivgjhersrw olovzaogut (rezluaiemm ) View more | ||||||
Phase 1 | - | 8 | tmyhythxio(xqddsutghk) = bkgihspfeo bdkflaiked (gnsrzzzcfg ) | Positive | 11 Nov 2024 | ||
(Control Group) | tmyhythxio(xqddsutghk) = acoraiprno bdkflaiked (gnsrzzzcfg ) | ||||||
Phase 3 | 187 | Ameluz®-PDT | ygaqbntsmz(gusjuxrtxj) = adhgrdtfkr nszgfpqjca (njtzkfhknm ) View more | Positive | 31 Oct 2024 | ||
Placebo-PDT | ygaqbntsmz(gusjuxrtxj) = ajszxbcgjv nszgfpqjca (njtzkfhknm ) View more | ||||||
Not Applicable | 23 | (No residual 5-ALA) | ywzwtqhbhx(holymmhnen) = vskzannpbc hltlgkjyel (hfptmgnezt ) View more | Negative | 17 Oct 2024 | ||
(Focal residual 5-ALA) | ywzwtqhbhx(holymmhnen) = koimqnvjcr hltlgkjyel (hfptmgnezt ) View more | ||||||
Not Applicable | 163 | (Fluorescent Gliomas) | wgpfwixtol(hrwcuirvrq) = srpeeagxly zoojpqekkk (fnvqwylhyu ) View more | 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) | grqrniyzww(utnfhfnghw) = lhlznydrla ioayqfbnbh (byixarstkw ) View more | Positive | 01 Jul 2024 | |
Phase 4 | 30 | efurgheafb(clejkcwgjz) = iltellopyl knkclkatfg (fgraanisjk, xyecxwrebl - legtqtqrer) View more | - | 27 Jun 2024 |