Last reviewed 2026-05-29 · How we verify

ZW251

Zymeworks BC Inc. · Phase 1 active Small molecule ✓ Verified May 2026

ZW251 is a Small molecule drug developed by Zymeworks BC Inc.. It is currently in Phase 1 development.

ZW251 is a novel glypican-3 targeting antibody-drug conjugate being studied in a Phase 1 clinical trial for the treatment of advanced solid tumors, including Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer, and Germ Cell Tumor. The study, NCT07164313, is being conducted by Zymeworks BC Inc. to evaluate the safety and efficacy of ZW251 in participants with these conditions.

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	ZW251
Sponsor	Zymeworks BC Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of ZW251 in Participants With Advanced Solid Tumors (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:

ZW251 CI brief — competitive landscape report
ZW251 updates RSS · CI watch RSS
Zymeworks BC Inc. portfolio CI

Frequently asked questions about ZW251

What is ZW251?

ZW251 is a Small molecule drug developed by Zymeworks BC Inc..

Who makes ZW251?

ZW251 is developed by Zymeworks BC Inc. (see full Zymeworks BC Inc. pipeline at /company/zymeworks-bc-inc).

What development phase is ZW251 in?

ZW251 is in Phase 1.

Manufacturer: Zymeworks BC Inc. — full pipeline

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