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
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2026-09-09 (see label) | approved | Sep 9, 2026 | openfda |
| US FDA | — | Efficacy supplement 2024-10-04 (see label) | approved | Oct 4, 2024 | openfda |
| US FDA | — | Efficacy supplement 2018-03-06 (see label) | approved | Mar 6, 2018 | openfda |
| US FDA | — | Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. ( 1 ) | approved |
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 |