OnCo
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Pyrotinib

Pyrotinib is China's HER2 pill, widely used there with capecitabine and as a comparator for the new Chinese HER2 ADCs.

Pyrotinib is Jiangsu Hengrui's HER2 TKI. PHOEBE (vs lapatinib + capecitabine): PFS 12.5 vs 6.8 months; PHILA (first-line with trastuzumab + docetaxel): PFS 24.3 vs 10.4 months. Approved in China (2018, 2020s expansions); not approved in the US or EU. Control arm of HORIZON-Breast01.

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Pyrotinib
PubChem
Modality
Small-molecule irreversible pan-HER kinase inhibitor
Mechanism
Irreversible pan-ErbB TKI (EGFR, HER2, HER4).
Brand / code
Airuini
Dosing & schedule
Route
Oral
Schedule
400 mg once daily with capecitabine
Monitoring
Diarrhoea
Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: pyrotinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
China2018HER2+ advanced breast cancer with capecitabine

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Diarrhoea
95%
31%
Hand-foot syndrome
60%

Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
164 studies27 recruiting88 Phase 213 Phase 3
Search “Pyrotinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Pyrotinib
intervention: Pyrotinib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend63 papers in the last 12 months-3% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Pyrotinib" OR ABSTRACT:"Pyrotinib" OR TITLE:"Airuini" OR ABSTRACT:"Airuini") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pyrotinib, not a curated reading list.

Connected

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