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GC4419 IV
GC4419 IV is a Small molecule drug developed by Galera Therapeutics, Inc.. It is currently in Phase 1 development.
GC4419 is a small molecule being studied in a Phase 1 clinical trial to evaluate its pharmacokinetics, safety, and tolerability in individuals with renal impairment. The study is also being conducted in healthy volunteers and individuals with esophagitis, comparing the effects of different doses of GC4711.
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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 | GC4419 IV |
|---|---|
| Sponsor | Galera Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Lymphopenia
- Nausea
- Fatigue
- Constipation
- Vomiting
- Dysgeusia
- Oropharyngeal Pain
- Dry Mouth
- Radiation Skin Injury
- Weight Decreased
- Oropharyngeal pain
- Diarrhoea
Key clinical trials
- 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)
- A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers (PHASE1)
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:
- GC4419 IV CI brief — competitive landscape report
- GC4419 IV updates RSS · CI watch RSS
- Galera Therapeutics, Inc. portfolio CI
Frequently asked questions about GC4419 IV
What is GC4419 IV?
Who makes GC4419 IV?
What development phase is GC4419 IV in?
What are the side effects of GC4419 IV?
Related
- Manufacturer: Galera Therapeutics, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing