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Avasopasem
Avasopasem is a Small molecule drug developed by The University of Texas Health Science Center at San Antonio. It is currently in Phase 1 development. Also known as: GC4419.
Avasopasem is a small molecule drug that acts as an antioxidant and superoxide dismutase mimetic. It is being studied in clinical trials for the treatment of head and neck cancer, oral mucositis, and other related conditions, including radiation-induced oral mucositis.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Avasopasem |
|---|---|
| Also known as | GC4419 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (PHASE1)
- Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer (PHASE1, PHASE2)
- ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients (PHASE3)
- Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer (PHASE2)
- Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer (PHASE2)
- Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419 (PHASE1)
- A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 (PHASE2)
- A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer (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:
- Avasopasem CI brief — competitive landscape report
- Avasopasem updates RSS · CI watch RSS
- The University of Texas Health Science Center at San Antonio portfolio CI
Frequently asked questions about Avasopasem
What is Avasopasem?
Who makes Avasopasem?
Is Avasopasem also known as anything else?
What development phase is Avasopasem in?
Related
- Manufacturer: The University of Texas Health Science Center at San Antonio — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: GC4419
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing