Neladalkib (NVL-655)

Phase 3Small molecule

Neladalkib (NVL-655) is one of 48 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerRecruiting

Other Solid TumorsRecruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

Other Solid TumorsPhase 2

Recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Navelbine

PPierre Fabre Medicament

Phase 3

24 2

Pyrotinib

HHengrui Therapeutics, Inc.

Phase 3

3 3

Neoadjuvant Therapy

SSun Yat-sen University

Phase 3

2 4

Neladalkib (NVL-655)

NNuvalent Inc.

Phase 3

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 1/2Recruiting

Other Solid Tumors

NCT05384626

Q4 2029

Phase 3Recruiting

Non-Small Cell Lung Cancer

NCT06765109

Clinical

Trials by Indication[1]

Other Solid Tumors1 trial

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Recruiting·NNuvalent Inc.·Phase 1/2·NCT05384626·840 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

Recruiting·NNuvalent Inc.·Phase 3·NCT06765109·450 enrolled

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Neladalkib (NVL-655). U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Neladalkib (NVL-655) compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Neladalkib (NVL-655). EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Nuvalent Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNuvalent Inc.

Neladalkib (NVL-655)

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q4 2029

Trials by Indication[1]

Other Solid Tumors1 trial

Non-Small Cell Lung Cancer1 trial

References

Drug Info

Quick Facts

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