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ProAgio Dose Expansion
ProAgio Dose Expansion is a Small molecule drug developed by ProDa BioTech, LLC. It is currently in Phase 1 development. Also known as: ACT50, Gemcitabine.
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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 | ProAgio Dose Expansion |
|---|---|
| Also known as | ACT50, Gemcitabine |
| Sponsor | ProDa BioTech, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies (PHASE1)
- ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC) (PHASE1)
- Trial of ProAgio in Advanced/Metastatic Colorectal Cancer (PHASE1)
- ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer (PHASE1, 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:
- ProAgio Dose Expansion CI brief — competitive landscape report
- ProAgio Dose Expansion updates RSS · CI watch RSS
- ProDa BioTech, LLC portfolio CI
Frequently asked questions about ProAgio Dose Expansion
What is ProAgio Dose Expansion?
Who makes ProAgio Dose Expansion?
Is ProAgio Dose Expansion also known as anything else?
What development phase is ProAgio Dose Expansion in?
Related
- Manufacturer: ProDa BioTech, LLC — full pipeline
- Also known as: ACT50, Gemcitabine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing