Last reviewed 2026-05-26 · How we verify

WVE-N531

Wave Life Sciences Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

WVE-N531 is a Small molecule drug developed by Wave Life Sciences Ltd.. It is currently in Phase 2 development.

WVE-N531 is an oligonucleotide being studied in an open-label extension study for Duchenne Muscular Dystrophy. The study aims to investigate the long-term safety, tolerability, pharmacokinetics, and efficacy of WVE-N531 in patients with Duchenne Muscular Dystrophy.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	WVE-N531
Sponsor	Wave Life Sciences Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

WVE-N531 CI brief — competitive landscape report
WVE-N531 updates RSS · CI watch RSS
Wave Life Sciences Ltd. portfolio CI

Frequently asked questions about WVE-N531

What is WVE-N531?

WVE-N531 is a Small molecule drug developed by Wave Life Sciences Ltd..

Who makes WVE-N531?

WVE-N531 is developed by Wave Life Sciences Ltd. (see full Wave Life Sciences Ltd. pipeline at /company/wave-life-sciences-ltd).

What development phase is WVE-N531 in?

WVE-N531 is in Phase 2.

Manufacturer: Wave Life Sciences Ltd. — full pipeline

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