Last reviewed 2026-05-22 · How we verify

rDEN4delta30-4995

National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1 active Biologic ✓ Verified May 2026 Quality 0/100

rDEN4delta30-4995 is a Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 1 development.

rDEN4delta30-4995 is a small molecule vaccine candidate being studied for its safety and immune response in healthy adults with Dengue. It is being tested in a Phase 1 clinical trial, comparing the vaccine to a placebo.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	rDEN4delta30-4995
Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy 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:

rDEN4delta30-4995 CI brief — competitive landscape report
rDEN4delta30-4995 updates RSS · CI watch RSS
National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI

Frequently asked questions about rDEN4delta30-4995

What is rDEN4delta30-4995?

rDEN4delta30-4995 is a Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID).

Who makes rDEN4delta30-4995?

rDEN4delta30-4995 is developed by National Institute of Allergy and Infectious Diseases (NIAID) (see full National Institute of Allergy and Infectious Diseases (NIAID) pipeline at /company/national-institute-of-allergy-and-infectious-diseases-niaid).

What development phase is rDEN4delta30-4995 in?

rDEN4delta30-4995 is in Phase 1.

Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing