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Sporozoites
Sporozoites is a Biologic drug developed by Medicines for Malaria Venture. It is currently in Phase 1 development. Also known as: PfSPZ.
Sporozoites are a stage in the life cycle of apicomplexan parasites, such as those causing malaria, characterized by a distinct morphology and biochemistry. They are used in a malaria immunization trial, where radiation-attenuated sporozoites are administered via mosquito bite to assess safety and biomarkers of protection in malaria-naïve adults.
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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 | Sporozoites |
|---|---|
| Also known as | PfSPZ |
| Sponsor | Medicines for Malaria Venture |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- First-in-Human PfSPZ-LARC2 Vaccination/CHMI (PHASE1)
- Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults (PHASE1)
- Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso (PHASE1)
- Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults (PHASE2)
- Phase IIa/b Trial of PvCS/Montanide ISA-51 Malaria Vaccine in Adults in Chocó, Colombia (PHASE2)
- RTSS Vaccine and PBO Net Impact on Malaria Infection and Transmission in Malawi
- Vivax Malaria Human Infection Studies in Thailand (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:
- Sporozoites CI brief — competitive landscape report
- Sporozoites updates RSS · CI watch RSS
- Medicines for Malaria Venture portfolio CI
Frequently asked questions about Sporozoites
What is Sporozoites?
Who makes Sporozoites?
Is Sporozoites also known as anything else?
What development phase is Sporozoites in?
Related
- Manufacturer: Medicines for Malaria Venture — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: PfSPZ
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing