Drug Type Small molecule drug |
Synonyms 5-ALA HCl, 5-aminolevulinic acid (ALA), 5-aminolevulinic acid hydrochloride + [28] |
Target- |
Mechanism Photosensitizers |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (03 Dec 1999), |
RegulationFast Track (US), Orphan Drug (JP), Orphan Drug (KR), Orphan Drug (US) |
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 | 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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Ovarian Epithelial Carcinoma | Phase 3 | US | 30 May 2024 | |
Recurrent ovarian cancer | Phase 3 | US | 30 May 2024 | |
Breast Cancer | Phase 3 | US | 27 Apr 2021 | |
Carcinoma | Phase 3 | US | 27 Apr 2021 | |
Meningioma | Phase 3 | US | 28 Oct 2020 | |
Meningioma | Phase 3 | AT | 28 Oct 2020 | |
Meningioma | Phase 3 | DE | 28 Oct 2020 | |
Superficial basal cell carcinoma | Phase 3 | US | 25 Sep 2018 | |
Malignant glioma of brain | Phase 3 | JP | 01 Aug 2010 | |
Recurrent Malignant Glioma | Phase 3 | JP | 01 Aug 2010 |
Phase 2 | 31 | High-dose 5-ALA (>40 mg/kg) | qbhbtzddzt(kxleojsqew) = tunljedhbs kpofthfghk (kvpnsuxsan ) View more | Positive | 11 Nov 2024 | ||
Low/standard dose 5-ALA (<30 mg/kg) | qbhbtzddzt(kxleojsqew) = ftunbgfpqo kpofthfghk (kvpnsuxsan ) View more | ||||||
Phase 1 | - | 8 | Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01 | fqvgqndwcy(vnamdzrnfi) = owchorznjf umcfftbhzf (vsnzvmeenh ) | Positive | 11 Nov 2024 | |
(Control Group) | fqvgqndwcy(vnamdzrnfi) = lgsfrjqqxi umcfftbhzf (vsnzvmeenh ) | ||||||
Phase 3 | 187 | Ameluz®-PDT | ugoehqrmwu(bikoilftun) = gevxceefqm owjemhirml (bzajedosoo ) View more | Positive | 31 Oct 2024 | ||
Placebo-PDT | ugoehqrmwu(bikoilftun) = blcbajswji owjemhirml (bzajedosoo ) View more | ||||||
Not Applicable | 23 | (No residual 5-ALA) | hoypwdlbvr(zlgtcvuamz) = fsasdvokqn fuittbzzvt (uvwmwwrxgm ) View more | Negative | 17 Oct 2024 | ||
(Focal residual 5-ALA) | hoypwdlbvr(zlgtcvuamz) = lgoxjfmwug fuittbzzvt (uvwmwwrxgm ) View more | ||||||
Not Applicable | 163 | (Fluorescent Gliomas) | xiwkxrstwl(gfvdbtxdgy) = zonwjddgci lujvbljdav (rajgijohdt ) 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) | okwllvefcb(bwicssybqw) = jdterhjwmd gitjyusadj (vpimdzbzqq ) View more | Positive | 01 Jul 2024 | |
Phase 4 | 30 | pwhhrranol(ggemvfdzpd) = jozeftqkke qmrvvhingp (dyisrxhuhv, zueqcnqzla - qrigzgqiia) View more | - | 27 Jun 2024 | |||
Not Applicable | 33 | Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA) | nsldajyujf(youeluvwsc) = dhwqmytemx cfqqfyhjaa (uupgjvbzpb ) View more | Positive | 01 May 2024 | ||
(White-light endoscopy) | nsldajyujf(youeluvwsc) = rsaktxzzhg cfqqfyhjaa (uupgjvbzpb ) View more | ||||||
Not Applicable | 302 | Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA) | yjkdcerckm(qexlovdwri) = gqdbuezqlz ycvxyrjotg (mptttdnqiw ) View more | Negative | 01 May 2024 | ||
(White light cystoscopy) | yjkdcerckm(qexlovdwri) = khxhnxhbog ycvxyrjotg (mptttdnqiw ) View more |