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Pyrotinib

Small molecule

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Phase 3underway

Evidence outlook · registrational

Non-Small Cell Lung Cancer: registrational readout pending

Its supporting mid-stage evidence has not yet been graded on this platform. No registrational readout date is posted for this indication; a Phase 3 is registered in Breast Cancer (NCT04290793); see the registry list.

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Competitive landscape

62 competitors in this universe: 2 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 58 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Pyrotinib: this drugPhase 3Small moleculeEGFR/HER1, HER2, HER4
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Dacomitinib PF-00299804ApprovedSmall 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
CemiplimabApprovedMonoclonal antibodyPD-1
CeritinibApprovedSmall moleculeALK

…and 47 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

(46 total)

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

2026 (9)
November 2026 (4)
Phase 1/2HER2-expressing Advanced Solid TumorsRecruiting
Est. primary completion 2026-11 · NCT06015048 · CT.gov ↗
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Phase 1Breast CancerRecruiting
Est. primary completion 2026-11-01 · NCT06770296 · CT.gov ↗
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Phase 2Breast CancerRecruiting
Est. primary completion 2026-11-01 · NCT06254690 · CT.gov ↗
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Early phase / not applicableBreast Cancer FemaleRecruiting
Est. primary completion 2026-11-30 · NCT06035679 · CT.gov ↗
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December 2026 (5)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-12 · NCT05482568 · CT.gov ↗
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Phase 2Breast CancerActive not recruiting
Est. primary completion 2026-12-01 · NCT04486911 · CT.gov ↗
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Phase 2/3Breast CancerActive not recruiting
Est. primary completion 2026-12-01 · NCT04290793 · CT.gov ↗
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Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-12-31 · NCT05751018 · CT.gov ↗
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Phase 2HER2-positive Breast CancerRecruiting
Est. primary completion 2026-12-31 · NCT07635342 · CT.gov ↗
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2027 (16)
February 2027 (2)
Phase 1/2Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer, Metastatic Breast CancerRecruiting
Est. primary completion 2027-02 · NCT07708194 · CT.gov ↗
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Phase 1/2Advanced Solid TumorsRecruiting
Est. primary completion 2027-02-26 · NCT06208410 · CT.gov ↗
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May 2027 (1)
Phase 2HER2-positive Breast CancerNot yet recruiting
Est. primary completion 2027-05-31 · NCT06973525 · CT.gov ↗
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June 2027 (2)
Phase 3Breast CancerActive not recruiting
Est. primary completion 2027-06 · NCT03980054 · CT.gov ↗
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Phase 2Breast CancerNot yet recruiting
Est. primary completion 2027-06-01 · NCT06975475 · CT.gov ↗
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August 2027 (2)
Phase 3Breast CancerNot yet recruiting
Est. primary completion 2027-08-01 · NCT04973319 · CT.gov ↗
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Phase 2Breast NeoplasmsRecruiting
Est. primary completion 2027-08-15 · NCT04983121 · CT.gov ↗
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September 2027 (1)
Phase 2HER2 + Breast CancerRecruiting
Est. primary completion 2027-09-30 · NCT07393425 · CT.gov ↗
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November 2027 (1)
Phase 2Lung Cancer Stage III, MutationRecruiting
Est. primary completion 2027-11-01 · NCT06563999 · CT.gov ↗
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December 2027 (7)
Phase 3Breast CancerRecruiting
Est. primary completion 2027-12 · NCT07528716 · CT.gov ↗
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Phase 1/2Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2027-12-01 · NCT05745740 · CT.gov ↗
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Early phase / not applicableHER2-positive Breast CancerNot yet recruiting
Est. primary completion 2027-12-30 · NCT06718335 · CT.gov ↗
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Phase 2Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC), HER2-positive Breast Cancer …Recruiting
Est. primary completion 2027-12-31 · NCT05582499 · CT.gov ↗
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Phase 2Breast CancerRecruiting
Est. primary completion 2027-12-31 · NCT07014410 · CT.gov ↗
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Phase 2Rare TumourNot yet recruiting
Est. primary completion 2027-12-31 · NCT06692491 · CT.gov ↗
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Phase 2/3Esophageal Squamous Cell CarcinomaNot yet recruiting
Est. primary completion 2027-12-31 · NCT07653451 · CT.gov ↗
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2028 (14)
January 2028 (1)
Phase 2HER2-positive Breast Cancer, Neoadjuvant Therapy, PyrotinibRecruiting
Est. primary completion 2028-01 · NCT06832904 · CT.gov ↗
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May 2028 (1)
Phase 3Breast CancerNot yet recruiting
Est. primary completion 2028-05-06 · NCT05841381 · CT.gov ↗
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June 2028 (1)
Phase 3Breast Cancer Early Stage Breast Cancer (Stage 1-3)Recruiting
Est. primary completion 2028-06-30 · NCT07797218 · CT.gov ↗
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July 2028 (2)
Phase 2Salivary Gland Carcinoma, Precision TherapyRecruiting
Est. primary completion 2028-07-10 · NCT06145308 · CT.gov ↗
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Phase 2HER2-positive Breast Cancer, Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-07-31 · NCT07019337 · CT.gov ↗
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August 2028 (1)
Phase 2Metastatic Breast Cancer With HER2 PositiveNot yet recruiting
Est. primary completion 2028-08-30 · NCT07132242 · CT.gov ↗
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September 2028 (1)
Phase 2Advanced Breast CancerRecruiting
Est. primary completion 2028-09 · NCT07180082 · CT.gov ↗
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October 2028 (1)
Phase 2Breast CancerNot yet recruiting
Est. primary completion 2028-10-30 · NCT07836257 · CT.gov ↗
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November 2028 (1)
Phase 2Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast CancerRecruiting
Est. primary completion 2028-11-01 · NCT07610720 · CT.gov ↗
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December 2028 (5)
Phase 3Breast CancerRecruiting
Est. primary completion 2028-12-14 · NCT04646759 · CT.gov ↗
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Phase 2Metastatic Breast CancerRecruiting
Est. primary completion 2028-12-30 · NCT05769010 · CT.gov ↗
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Phase 3Breast CancerRecruiting
Est. primary completion 2028-12-30 · NCT07615751 · CT.gov ↗
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Phase 1/2Advanced/ Metastatic Her-2 Positive Breast CancerRecruiting
Est. primary completion 2028-12-31 · NCT05575804 · CT.gov ↗
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Phase 2HER2-positive Early Breast CancerRecruiting
Est. primary completion 2028-12-31 · NCT07340398 · CT.gov ↗
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2029 (1)
January 2029 (1)
Phase 2Breast Cancer, HER2-positive Breast CancerNot yet recruiting
Est. primary completion 2029-01-31 · NCT07417241 · CT.gov ↗
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2030 (3)
April 2030 (1)
Phase 3Breast Cancer InvasiveRecruiting
Est. primary completion 2030-04 · NCT05910398 · CT.gov ↗
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December 2030 (2)
Phase 2HER2-positive Breast CancerNot yet recruiting
Est. primary completion 2030-12-30 · NCT07179939 · CT.gov ↗
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Phase 2Advanced Digestive System TumorNot yet recruiting
Est. primary completion 2030-12-31 · NCT07053150 · CT.gov ↗
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2031 (3)
June 2031 (1)
Phase 3HER2-positive Metastatic Breast Cancer, First-line TreatmentRecruiting
Est. primary completion 2031-06-30 · NCT06278870 · CT.gov ↗
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December 2031 (2)
Phase 4HER2 + Breast Cancer, Advanced Breast CancerRecruiting
Est. primary completion 2031-12-30 · NCT07600164 · CT.gov ↗
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Phase 2HER2 + Breast Cancer, Advanced Breast CancerNot yet recruiting
Est. primary completion 2031-12-31 · NCT07766772 · 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 (18)
Phase 2/3 (4)
Phase 2 (118)
Phase 1/2 (14)
Phase 1 (12)
Phase 4 (4)
Early phase / not applicable (10)
Used as active comparator (2)
Appears in other studies (3)