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Research Report
SP-0202 (GBP410): A 21-Valent Pneumococcal Conjugate Vaccine Candidate
1. Introduction
1.1 Overview of SP-0202 (GBP410)
SP-0202 is an investigational 21-valent pneumococcal conjugate vaccine (PCV21) candidate currently in late-stage clinical development.[1] Also identified by the development code GBP410, and sometimes referred to as "Next Gen PCV - Sanofi" or "Next-generation pneumococcal conjugate vaccine - Sanofi/SK Bioscience", this vaccine aims to prevent invasive pneumococcal disease (IPD) and other infections caused by the bacterium Streptococcus pneumoniae.[2] Pneumococcal infections, including pneumonia, meningitis, sepsis, and otitis media, represent a significant global health burden, particularly affecting young children and older adults.[4] Existing pneumococcal vaccines have substantially reduced disease incidence, but the emergence of non-vaccine serotypes and the desire for broader protection drive the development of next-generation vaccines like SP-0202/GBP410.[4] By incorporating antigens against 21 distinct pneumococcal serotypes, SP-0202/GBP410 seeks to offer expanded protection compared to currently available vaccines.[1]
1.2 Developers and Collaboration
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/20 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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