Last reviewed 2026-06-01 · How we verify

NVL-330

Nuvalent Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

NVL-330 is a Small molecule drug developed by Nuvalent Inc.. It is currently in Phase 1 development.

NVL-330 is a small molecule tyrosine kinase inhibitor being studied in a Phase 1a/1b clinical trial for patients with advanced or metastatic HER2-altered non-small cell lung cancer (NSCLC). The trial is investigating NVL-330 in patients with locally advanced solid tumors and metastatic solid tumors, including HER2-altered NSCLC.

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	NVL-330
Sponsor	Nuvalent 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 NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1) (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:

NVL-330 CI brief — competitive landscape report
NVL-330 updates RSS · CI watch RSS
Nuvalent Inc. portfolio CI

Frequently asked questions about NVL-330

What is NVL-330?

NVL-330 is a Small molecule drug developed by Nuvalent Inc..

Who makes NVL-330?

NVL-330 is developed by Nuvalent Inc. (see full Nuvalent Inc. pipeline at /company/nuvalent-inc).

What development phase is NVL-330 in?

NVL-330 is in Phase 1.

Manufacturer: Nuvalent Inc. — full pipeline

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