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Qdenga
Qdenga is a Small molecule drug developed by IRCCS Sacro Cuore Don Calabria di Negrar. It is currently in Phase 2 development.
Qdenga is a vaccine used to prevent dengue fever in humans. It is a biological vaccine that induces an immune response by containing a live attenuated dengue virus.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Qdenga |
|---|---|
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers (EARLY_PHASE1)
- A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers (PHASE3)
- A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia
- Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
- Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.
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:
- Qdenga CI brief — competitive landscape report
- Qdenga updates RSS · CI watch RSS
- IRCCS Sacro Cuore Don Calabria di Negrar portfolio CI
Frequently asked questions about Qdenga
What is Qdenga?
Who makes Qdenga?
What development phase is Qdenga in?
Related
- Manufacturer: IRCCS Sacro Cuore Don Calabria di Negrar — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing