OnCo
drugsProductPhase 3

Neladalkib

A fourth-generation ALK pill that works after lorlatinib and avoids the TRK-related brain side effects; under FDA priority review with a decision due 27 November 2026.

Nuvalent's ALK-selective, TRK-sparing, brain-penetrant inhibitor covering G1202R and compound mutations. ALKOVE-1: ORR 31% in heavily TKI-pretreated patients (n=253) with intracranial activity. NDA submitted April 2026 (priority review, PDUFA 27 Nov 2026). ALKAZAR phase 3 vs alectinib first line recruiting.

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Neladalkib
PubChem
Modality
Small-molecule kinase inhibitor (ALK)
Mechanism
ALK-selective TKI designed to avoid TRK inhibition (dizziness, weight gain) and cover solvent-front and compound mutations.
Brand / code
NVL-655

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Neladalkib
intervention: Neladalkib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend4 papers in the last 12 months-20% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Neladalkib" OR ABSTRACT:"Neladalkib" OR TITLE:"NVL-655" OR ABSTRACT:"NVL-655") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Neladalkib, not a curated reading list.

Connected

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