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Na-GST-1
Na-GST-1 is a Biologic drug developed by Baylor College of Medicine. It is currently in Phase 1 development.
Na-GST-1 is a small molecule vaccine candidate being studied for its safety and immunogenicity in treating hookworm infection, hookworm disease, and hookworm infections. It is administered in various doses (10 μg, 30 μg, and 100 μg) combined with Alhydrogel.
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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 | Na-GST-1 |
|---|---|
| Sponsor | Baylor College of Medicine |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection (PHASE2)
- Safety and Immunogenicity Study of Na-GST-1 With or Without CpG (PHASE1)
- Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children (PHASE1)
- Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant (PHASE1)
- Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults (PHASE1)
- Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults (PHASE1)
- Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults (PHASE1)
- Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With or Without Additional Adjuvant in Brazilian Adults (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:
- Na-GST-1 CI brief — competitive landscape report
- Na-GST-1 updates RSS · CI watch RSS
- Baylor College of Medicine portfolio CI
Frequently asked questions about Na-GST-1
What is Na-GST-1?
Who makes Na-GST-1?
What development phase is Na-GST-1 in?
Related
- Manufacturer: Baylor College of Medicine — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing