Asset profile

Neratinib

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Breast Cancer

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

Also in development:Non-Small Cell Lung Cancer · Phase 2

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Competitive landscape

65 competitors in this universe: 3 direct rivals (same mechanism and indication), 0 same-class, 62 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Neratinib: this drugApprovedSmall moleculeEGFR/HER2
SevabertinibPhase 3Small moleculeEGFR/HER2
ORIC-114Phase 1/2Small moleculeEGFR/HER2
STX-721Phase 1/2Small moleculeEGFR/HER2
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor
Bevacizumab-Awwb (MVASI)ApprovedMonoclonal antibodyVEGF-A
BinimetinibApprovedSmall moleculeMEK1/2
BrigatinibApprovedSmall moleculeALK
CapmatinibApprovedSmall moleculeMET

…and 50 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(18 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (2)
December 2026 (2)
Phase 1/2Breast CancerActive not recruiting
Est. primary completion 2026-12 · NCT03377387 · CT.gov ↗
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Phase 2Breast CancerRecruiting
Est. primary completion 2026-12-22 · NCT04886531 · CT.gov ↗
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2027 (4)
February 2027 (1)
Phase 2Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm …Recruiting
Est. primary completion 2027-02-20 · NCT06126276 · CT.gov ↗
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June 2027 (2)
Phase 1Gastric Cancer, Gastrointestinal Cancer, HER2 Gene MutationRecruiting
Est. primary completion 2027-06 · NCT05274048 · CT.gov ↗
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Phase 3Biliary Tract NeoplasmsRecruiting
Est. primary completion 2027-06 · NCT05615818 · CT.gov ↗
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November 2027 (1)
Phase 2Brest CancerNot yet recruiting
Est. primary completion 2027-11-20 · NCT07333937 · CT.gov ↗
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2028 (5)
February 2028 (3)
Phase 2GlioblastomaRecruiting
Est. primary completion 2028-02-01 · NCT02977780 · CT.gov ↗
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Phase 3Breast CancerRecruiting
Est. primary completion 2028-02-16 · NCT05760612 · CT.gov ↗
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Phase 2Pancreatic Ductal Carcinoma, Advanced Cancer, Epithelial TumorRecruiting
Est. primary completion 2028-02-17 · NCT06813079 · CT.gov ↗
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March 2028 (1)
Phase 2GastroEsophageal Cancer, Gastric CancerActive not recruiting
Est. primary completion 2028-03 · NCT06109467 · CT.gov ↗
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July 2028 (1)
Phase 1Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8 …Recruiting
Est. primary completion 2028-07-17 · NCT05372614 · CT.gov ↗
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2029 (2)
August 2029 (1)
Phase 2Breast CancerRecruiting
Est. primary completion 2029-08 · NCT07152782 · CT.gov ↗
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December 2029 (1)
Phase 2Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, EpendymomaRecruiting
Est. primary completion 2029-12-01 · NCT04374305 · CT.gov ↗
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2030 (4)
April 2030 (1)
Phase 2Breast CancerRecruiting
Est. primary completion 2030-04-30 · NCT05919108 · CT.gov ↗
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July 2030 (1)
Phase 2Breast CancerRecruiting
Est. primary completion 2030-07-01 · NCT05564377 · CT.gov ↗
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October 2030 (1)
Phase 2Breast CancerRecruiting
Est. primary completion 2030-10 · NCT05933395 · CT.gov ↗
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December 2030 (1)
Phase 2Breast CancerRecruiting
Est. primary completion 2030-12 · NCT01042379 · CT.gov ↗
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2032 (1)
May 2032 (1)
Phase 2Breast CancerNot yet recruiting
Est. primary completion 2032-05 · NCT07729046 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (4)
Phase 2 (43)
Phase 1/2 (12)
Phase 1 (26)
Appears in other studies (1)