Last reviewed 2026-05-22 · How we verify

CVXGA1 high dose

CyanVac LLC · Phase 1 active Biologic ✓ Verified May 2026

CVXGA1 high dose is a Biologic drug developed by CyanVac LLC. It is currently in Phase 1 development. Also known as: PIV5-SARS CoV-2 vaccine.

CVXGA1 is a small molecule, with cotinine making up 15% of its dose, being studied in a Phase 1 trial for its safety and immunogenicity in treating Covid-19. The trial involves administering either a low dose or a high dose of CVXGA1 to healthy adults and adolescents.

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	CVXGA1 high dose
Also known as	PIV5-SARS CoV-2 vaccine
Sponsor	CyanVac LLC
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents (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:

CVXGA1 high dose CI brief — competitive landscape report
CVXGA1 high dose updates RSS · CI watch RSS
CyanVac LLC portfolio CI

Frequently asked questions about CVXGA1 high dose

What is CVXGA1 high dose?

CVXGA1 high dose is a Biologic drug developed by CyanVac LLC.

Who makes CVXGA1 high dose?

CVXGA1 high dose is developed by CyanVac LLC (see full CyanVac LLC pipeline at /company/cyanvac-llc).

Is CVXGA1 high dose also known as anything else?

CVXGA1 high dose is also known as PIV5-SARS CoV-2 vaccine.

What development phase is CVXGA1 high dose in?

CVXGA1 high dose is in Phase 1.

Manufacturer: CyanVac LLC — full pipeline
Also known as: PIV5-SARS CoV-2 vaccine

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