Last reviewed 2026-04-20 · How we verify

Dengusiil

Serum Institute of India Pvt. Ltd. · Phase 1 active Biologic Quality 0/100

Dengusiil is a Biologic drug developed by Serum Institute of India Pvt. Ltd.. It is currently in Phase 1 development. Also known as: Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4).

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	Dengusiil
Also known as	Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)
Sponsor	Serum Institute of India Pvt. Ltd.
Modality	Biologic
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Dengusiil in Healthy Adults (Phase 1)

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:

Dengusiil CI brief — competitive landscape report
Dengusiil updates RSS · CI watch RSS
Serum Institute of India Pvt. Ltd. portfolio CI

Frequently asked questions about Dengusiil

What is Dengusiil?

Dengusiil is a Biologic drug developed by Serum Institute of India Pvt. Ltd..

Who makes Dengusiil?

Dengusiil is developed by Serum Institute of India Pvt. Ltd. (see full Serum Institute of India Pvt. Ltd. pipeline at /company/serum-institute-of-india-pvt-ltd).

Is Dengusiil also known as anything else?

Dengusiil is also known as Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4).

What development phase is Dengusiil in?

Dengusiil is in Phase 1.

Manufacturer: Serum Institute of India Pvt. Ltd. — full pipeline
Therapeutic area: All drugs in Other
Also known as: Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)

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