Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Nerlynx

(Neratinib Maleate)

Small molecule

PPuma Biotechnology, Inc.

0

Indications

4

Total Trials

3

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Female Reproductive System Neoplasm

NCT06126276

Q3 2028

Phase 1Recruiting

Metastatic Malignant Solid Neoplasm

NCT05372614

Q3 2030

Phase 2Recruiting

Advanced Malignant Solid Neoplasm

NCT05564377

Clinical

Trials by Indication[1]

Advanced Solid Cancers1 trial

Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Completed·KKorea University Guro Hospital·Phase 2·NCT06083662·42 enrolled

Advanced Malignant Solid Neoplasm1 trial

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

Female Reproductive System Neoplasm1 trial

A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06126276·70 enrolled

Metastatic Malignant Solid Neoplasm1 trial

Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination With Neratinib in Solid Tumors With HER2 Alterations

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05372614·58 enrolled

Regulatory

FDA Approval Timeline[3]

Jul 17, 2017

NERLYNX

NDA NDA208051

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Neratinib Maleate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Neratinib Maleate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208051). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Puma Biotechnology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: PPuma Biotechnology, Inc.

Related News