Drug · Small Molecule
Aminolevulinic Acid
CI-DRUG-00000705Explore in graph →CHEMBL601 Approved
Regulatory
Approvals (9)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as GLEOLAN (DIN 02504928) under ATC L01XD04 AMINOLEVULINIC ACID. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 22, 2021 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as LEVULAN KERASTICK (DIN 02243933) under ATC L01XD04 AMINOLEVULINIC ACID. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 3, 2004 | health-canada-dpd |
| US FDA | — | Efficacy supplement 2026-09-09 (see label) | approved | Sep 9, 2026 | openfda |
| US FDA |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 15 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 5 | 4 | 4 | 40 | 9 | CA, US | Dec 3, 1999 | 1993-11 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 1 | 0 | — | — | May 30, 2024 |
| Malignant Breast Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 1 | 0 | — | — | Apr 27, 2021 |
| Malignant Central Nervous System Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 5 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (41)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07076472 | Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma | recruiting | Early Phase 1 | 8 | Mayo ClinicOTHER | 1 | Aug 25, 2026 | clinicaltrials |
| NCT05804370 | Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302) | recruiting | Phase 3 |