Last reviewed 2026-05-22 · How we verify

Vicineum

National Cancer Institute (NCI) · Phase 1 active Small molecule ✓ Verified May 2026

Vicineum is a Small molecule drug developed by National Cancer Institute (NCI). It is currently in Phase 1 development.

Vicineum is an antibody drug conjugate that targets the Epithelial cell adhesion molecule. It is being studied in combination with durvalumab for the treatment of urinary bladder neoplasms, specifically high-grade non-muscle-invasive bladder cancer.

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	Vicineum
Sponsor	National Cancer Institute (NCI)
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) (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:

Vicineum CI brief — competitive landscape report
Vicineum updates RSS · CI watch RSS
National Cancer Institute (NCI) portfolio CI

Frequently asked questions about Vicineum

What is Vicineum?

Vicineum is a Small molecule drug developed by National Cancer Institute (NCI).

Who makes Vicineum?

Vicineum is developed by National Cancer Institute (NCI) (see full National Cancer Institute (NCI) pipeline at /company/national-cancer-institute-nci).

What development phase is Vicineum in?

Vicineum is in Phase 1.

Manufacturer: National Cancer Institute (NCI) — full pipeline
Therapeutic area: All drugs in Other

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