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Gliolan
Gliolan is a Small molecule drug developed by Abramson Cancer Center at Penn Medicine. It is currently in Phase 2 development for Actinic keratosis, Fluorescent stain, Non-Hyperkeratotic Actinic Keratoses. Also known as: ALA, 5-Aminolevulinic Acid Hydrochloride (5-ALA), 5-Aminolevulinic acid, 5-ALA.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Gliolan |
|---|---|
| Also known as | ALA, 5-Aminolevulinic Acid Hydrochloride (5-ALA), 5-Aminolevulinic acid, 5-ALA |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
- Actinic keratosis
- Fluorescent stain
- Non-Hyperkeratotic Actinic Keratoses
Common side effects
Key clinical trials
- Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401) (PHASE1)
- Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma (EARLY_PHASE1)
- INtraoperative photoDYnamic Therapy of GliOblastoma (NA)
- Fluorescence Spectroscopy Guided Surgery (PHASE1)
- Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Brain Tumors (PHASE2)
- Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (PHASE2)
- The IMmunotherapy Pleural 5-ALA PDT (PHASE2)
- Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gliolan CI brief — competitive landscape report
- Gliolan updates RSS · CI watch RSS
- Abramson Cancer Center at Penn Medicine portfolio CI
Frequently asked questions about Gliolan
What is Gliolan?
What is Gliolan used for?
Who makes Gliolan?
Is Gliolan also known as anything else?
What development phase is Gliolan in?
Related
- Manufacturer: Abramson Cancer Center at Penn Medicine — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Actinic keratosis
- Indication: Drugs for Fluorescent stain
- Indication: Drugs for Non-Hyperkeratotic Actinic Keratoses
- Also known as: ALA, 5-Aminolevulinic Acid Hydrochloride (5-ALA), 5-Aminolevulinic acid, 5-ALA