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NVL-655 · NUV-655

Small molecule · Inhibitor of anaplastic lymphoma kinase (ALK) · developed by Nuvalent

Phase 3 Most advanced trial
NUVL Developer
2 Registered trials

What is NVL-655?

Neladalkib (NVL-655) is an orally bioavailable, brain-penetrant small molecule inhibitor of anaplastic lymphoma kinase (ALK). It targets ALK fusion proteins and activating mutations, including acquired resistance mutations such as G1202R and compound mutations. The drug is studied in ALK-positive non-small cell lung cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
NUV-655
Drug type
Small molecule
Targets
anaplastic lymphoma kinase (ALK)
Mechanism
Inhibitor of anaplastic lymphoma kinase (ALK)
Pathways
ALK-mediated signaling
Therapy area
Oncology
Developer
Nuvalent Inc. (NUVL)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 3
UNII
J32P26A6BC

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06765109 Phase 3 Non-small Cell Lung Cancer Recruiting NUVL
NCT06834074 N/A Non Small Cell Lung Cancer Available NUVL

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Anaplastic Lymphoma Kinase-positiveNon-small Cell Lung CancerALK-positive Non-small Cell Lung Cancer (NSCLC)

Other drugs acting on ALK

More from Nuvalent

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the NUVL page.

Follow NUVL, the company behind NVL-655

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.