NERLYNX (neratinib maleate)
Nerlynx is a kinase inhibitor indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer to follow adjuvant trastuzumab-based therapy. It is also indicated in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
How NERLYNX Works
Neratinib is an intracellular kinase inhibitor that irreversibly binds to the epidermal growth factor receptor (EGFR), HER2, and HER4. This binding reduces receptor autophosphorylation and inhibits downstream MAPK and AKT signaling pathways. This mechanism suppresses the proliferation and survival of cancer cells and demonstrates antitumor activity in HER2 and EGFR-expressing tumors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-07-17
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
NERLYNX Approval History
What NERLYNX Treats
1 indicationsNERLYNX is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
NERLYNX Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
NERLYNX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NERLYNX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NERLYNX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NERLYNX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06126276 | NCI-2023-09270 NCI-2023-09270, EAY191-N5 | Ph 2 | recruiting | Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial) |
| NCT05372614 | NCI-2022-04099 NCI-2022-04099, 202207020 | Ph 1 | suspended | Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT06083662 | AL20-17 | Ph 2 | completed | Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NERLYNX FDA Label Details
Indications & Usage
FDA Label (PDF)NERLYNX is indicated for the treatment of Breast Cancer.
Pro Intelligence Preview
Deep insights for NERLYNX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 20 active patents
Trial Analysis
- • 4 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment