Last reviewed 2026-04-19 · How we verify

INV21 Low Dose

Inviragen Inc. · Phase 1 active Biologic

INV21 Low Dose is a Biologic drug developed by Inviragen Inc.. It is currently in Phase 1 development. Also known as: INV21.

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	INV21 Low Dose
Also known as	INV21
Sponsor	Inviragen Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71 (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:

INV21 Low Dose CI brief — competitive landscape report
INV21 Low Dose updates RSS · CI watch RSS
Inviragen Inc. portfolio CI

Frequently asked questions about INV21 Low Dose

What is INV21 Low Dose?

INV21 Low Dose is a Biologic drug developed by Inviragen Inc..

Who makes INV21 Low Dose?

INV21 Low Dose is developed by Inviragen Inc. (see full Inviragen Inc. pipeline at /company/inviragen-inc).

Is INV21 Low Dose also known as anything else?

INV21 Low Dose is also known as INV21.

What development phase is INV21 Low Dose in?

INV21 Low Dose is in Phase 1.

Manufacturer: Inviragen Inc. — full pipeline
Also known as: INV21

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