Last reviewed 2026-04-19 · How we verify

CV7201 mRNA

CureVac · Phase 1 active Biologic

CV7201 mRNA is a Biologic drug developed by CureVac. It is currently in Phase 1 development. Also known as: CV7201 messenger RNA, CV7201 RNActive®.

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	CV7201 mRNA
Also known as	CV7201 messenger RNA, CV7201 RNActive®
Sponsor	CureVac
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

CV7201 mRNA CI brief — competitive landscape report
CV7201 mRNA updates RSS · CI watch RSS
CureVac portfolio CI

Frequently asked questions about CV7201 mRNA

What is CV7201 mRNA?

CV7201 mRNA is a Biologic drug developed by CureVac.

Who makes CV7201 mRNA?

CV7201 mRNA is developed by CureVac (see full CureVac pipeline at /company/curevac).

Is CV7201 mRNA also known as anything else?

CV7201 mRNA is also known as CV7201 messenger RNA, CV7201 RNActive®.

What development phase is CV7201 mRNA in?

CV7201 mRNA is in Phase 1.

Manufacturer: CureVac — full pipeline
Also known as: CV7201 messenger RNA, CV7201 RNActive®

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