Last reviewed 2026-05-13 · How we verify

Neladalkib (NVL-655)

Neladalkib is a selective ALK (anaplastic lymphoma kinase) inhibitor that blocks ALK-driven signaling in cancer cells.

Neladalkib is a selective ALK (anaplastic lymphoma kinase) inhibitor that blocks ALK-driven signaling in cancer cells. Used for ALK-positive non-small cell lung cancer, ALK-positive solid tumors.

At a glance

Mechanism of action

Neladalkib targets anaplastic lymphoma kinase (ALK), a receptor tyrosine kinase that is aberrantly activated in certain cancers through chromosomal translocations or mutations. By inhibiting ALK phosphorylation and downstream signaling, the drug suppresses proliferation of ALK-dependent tumor cells. It is being developed for ALK-positive malignancies, particularly non-small cell lung cancer and other solid tumors.

Approved indications

• ALK-positive non-small cell lung cancer
• ALK-positive solid tumors

Common side effects

• Nausea
• Fatigue
• Diarrhea
• Elevated transaminases

Key clinical trials

• Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC (PHASE3)
• Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
• A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) (PHASE1, PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Neladalkib (NVL-655) CI brief — competitive landscape report
• Neladalkib (NVL-655) updates RSS · CI watch RSS
• Nuvalent Inc. portfolio CI