Asset profile

Zongertinib

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Non-Small Cell Lung Cancer

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

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Competitive landscape

73 competitors in this universe: 12 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Zongertinib: this drugApprovedSmall moleculeHER2 Mutant-selective, HER2
Trastuzumab DeruxtecanApprovedAntibody–drug conjugateHER2
ZanidatamabApprovedMultispecific antibodyHER2
BL-M07D1Phase 3Antibody–drug conjugateHER2
Disitamab VedotinPhase 3Antibody–drug conjugateHER2
Trastuzumab RezetecanPhase 3Antibody–drug conjugateHER2
TucatinibPhase 3Small moleculeHER2
HRS-4508Phase 2Small moleculeHER2
177Lu-DWJ155Phase 1RadiopharmaceuticalHER2
BL-M17D1Phase 1Antibody–drug conjugateHER2
KJ015Phase 1Monoclonal antibodyHER2
MT-304Phase 1Cell therapyHER2
NVL-330Phase 1Small moleculeHER2
DB-1303Phase 3Monoclonal antibodyHER2
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK

…and 58 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

(7 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 3Lung Cancer, Non-squamous, Non-small CellActive not recruiting
Est. primary completion 2026-12-10 · NCT06151574 · CT.gov ↗
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Phase 1Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2026-12-30 · NCT04886804 · CT.gov ↗
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2027 (1)
August 2027 (1)
Phase 2Lung Cancer, Non-squamous, Non-small CellRecruiting
Est. primary completion 2027-08-12 · NCT07486817 · CT.gov ↗
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2028 (2)
September 2028 (1)
Phase 2Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 MutationNot yet recruiting
Est. primary completion 2028-09-28 · NCT07619066 · CT.gov ↗
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November 2028 (1)
Phase 2Solid TumoursRecruiting
Est. primary completion 2028-11-30 · NCT06581432 · CT.gov ↗
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2029 (1)
January 2029 (1)
Phase 1/2Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma …Recruiting
Est. primary completion 2029-01-08 · NCT06324357 · CT.gov ↗
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2032 (1)
February 2032 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2032-02-26 · NCT07195695 · 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 (2)
Phase 2 (3)
Phase 1/2 (1)
Phase 1 (11)