Last reviewed · How we verify
SA58 Nasal Spray
SA58 Nasal Spray is a Small molecule drug developed by Sinovac Life Sciences Co., Ltd.. It is currently in Phase 1 development.
SA58 Nasal Spray is a small molecule intervention being studied for its efficacy and safety in preventing COVID-19 infection in high-risk populations. It is being investigated in a clinical trial (NCT05664919) as a potential treatment for COVID-19 in medical personnel.
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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 | SA58 Nasal Spray |
|---|---|
| Sponsor | Sinovac Life Sciences Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations (NA)
- Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People (NA)
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:
- SA58 Nasal Spray CI brief — competitive landscape report
- SA58 Nasal Spray updates RSS · CI watch RSS
- Sinovac Life Sciences Co., Ltd. portfolio CI
Frequently asked questions about SA58 Nasal Spray
What is SA58 Nasal Spray?
Who makes SA58 Nasal Spray?
What development phase is SA58 Nasal Spray in?
Related
- Manufacturer: Sinovac Life Sciences Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing