Last reviewed 2026-04-19 · How we verify

UV1 synthetic peptide vaccine and GM-CSF

Ultimovacs ASA · Phase 1 active Biologic

UV1 synthetic peptide vaccine and GM-CSF is a Biologic drug developed by Ultimovacs ASA. It is currently in Phase 1 development. Also known as: UV1, Leukine.

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	UV1 synthetic peptide vaccine and GM-CSF
Also known as	UV1, Leukine
Sponsor	Ultimovacs ASA
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (PHASE1, PHASE2)
A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (PHASE1, PHASE2)

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:

UV1 synthetic peptide vaccine and GM-CSF CI brief — competitive landscape report
UV1 synthetic peptide vaccine and GM-CSF updates RSS · CI watch RSS
Ultimovacs ASA portfolio CI

Frequently asked questions about UV1 synthetic peptide vaccine and GM-CSF

What is UV1 synthetic peptide vaccine and GM-CSF?

UV1 synthetic peptide vaccine and GM-CSF is a Biologic drug developed by Ultimovacs ASA.

Who makes UV1 synthetic peptide vaccine and GM-CSF?

UV1 synthetic peptide vaccine and GM-CSF is developed by Ultimovacs ASA (see full Ultimovacs ASA pipeline at /company/ultimovacs-asa).

Is UV1 synthetic peptide vaccine and GM-CSF also known as anything else?

UV1 synthetic peptide vaccine and GM-CSF is also known as UV1, Leukine.

What development phase is UV1 synthetic peptide vaccine and GM-CSF in?

UV1 synthetic peptide vaccine and GM-CSF is in Phase 1.

Manufacturer: Ultimovacs ASA — full pipeline
Also known as: UV1, Leukine