Drugs / Pyrotinib
Trials 179 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT06770296 | Nov 2024 → Nov 2026 expected | breast cancer | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 1 | NCT05252546 | Mar → Aug 2022 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04850651 | Apr → May 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04680091 | Nov 2020 → Jan 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04367090 | May 2020 → Aug 2022 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04315116 | Apr 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04315493 | Mar 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04479891 | Sep → Oct 2019 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03480256 | Jul 2018 → Nov 2019 | gastric cancer | Peking University | Unknown | No outcome recorded |
| Phase 1 | NCT02500199 | Jun 2015 → May 2021 | breast cancer, gastric cancer, non-small cell lung carcinoma | Hengrui Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT02378389 | Sep 2014 → Aug 2016 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02361112 | Aug 2014 → Aug 2016 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01937689 | Jan 2013 → Jul 2016 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1/213 trials | ||||||
| Phase 1/2 | NCT05745740 | Dec 2027 expected | non-small cell lung carcinoma | RemeGen Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07189884 | Sep 2025 → Jun 2026 overdue | breast cancer | The First Affiliated Hospital of Xiamen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07708194 | Jun 2025 → Feb 2027 expected | HER2 positive breast carcinoma, hormone receptor-positive breast cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06718933 | Jan 2025 → Aug 2026 overdue | breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06208410 | Jan 2024 → Feb 2027 expected | neoplasm | Risen (Suzhou) Pharma Tech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05575804 | Oct 2022 → Jan 2025 | HER2 positive breast carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05482568 | Sep 2022 → Dec 2026 expected | non-small cell lung carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05016544 | Jul 2021 → Aug 2023 | non-small cell lung carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04227041 | Jan 2020 → Jan 2021 | carcinoma | Qingdao Zhixin Health Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04152057 | Nov 2019 → Apr 2020 | HER2 positive breast carcinoma | West China Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03772353 | May 2019 → Jun 2023 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03805399 | Oct 2018 → Dec 2022 | triple-negative breast carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02422199 | May 2015 → Oct 2016 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 2117 trials · 5 met primary | ||||||
| Phase 2 | NCT07836257 | Oct 2026 → Oct 2028 expected | breast cancer | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07610720 | Jun 2026 → Nov 2028 expected | HER2 positive breast carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07417241 | Mar 2026 → Jan 2029 expected | HER2 positive breast carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07393425 | Feb 2026 → Sep 2027 expected | HER2 positive breast carcinoma | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07290166 | Dec 2025 → Oct 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07340398 | Dec 2025 → Dec 2028 expected | HER2 positive breast carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT07307287 | Dec 2025 → Dec 2027 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07179939 | Sep 2025 → Dec 2030 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07132242 | Aug 2025 → Aug 2028 expected | HER2 positive breast carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07180082 | Aug 2025 → Sep 2028 expected | breast cancer | Wenjin Yin | Recruiting | No outcome recorded |
| Show all 117 trials opens the full record — a long page | ||||||
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07653451 | Jul 2026 → Dec 2027 expected | esophageal squamous cell carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05426486 | May 2022 → Dec 2025 overdue | HER2 positive breast carcinoma | Caigang Liu | Active not recruiting | No outcome recorded |
| Phase 318 trials · 3 met primary | ||||||
| Phase 3 | NCT07797218 | Jul 2026 → Jun 2028 expected | breast cancer | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT07528716 | May 2026 → Dec 2027 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT07239271 | Nov 2025 → Dec 2027 expected | HER2 positive breast carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07615751 | Feb 2025 → Dec 2028 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT06144944 | Jan 2024 → Jun 2026 overdue | female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06278870 | Sep 2023 → Jun 2031 expected | HER2 positive breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05910398 | Jun 2023 → Apr 2030 expected | invasive breast carcinoma | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05841381 | May 2023 → May 2028 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05346861 | Sep 2021 → Oct 2023 | HER2 positive breast carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 3 | NCT04973319 | Aug 2021 → Aug 2027 expected | breast cancer | Shengjing Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05429684 | Jan 2021 → Feb 2024 | HER2 positive breast carcinoma | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 3 | NCT04447118 | Sep 2020 → Jun 2023 | non-small cell lung carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04254263 | Dec 2019 → Aug 2026 overdue | female breast carcinoma | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT03980054 | Jul 2019 → Jul 2022 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT03863223 | Apr 2019 → Dec 2022 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03588091 | Jul 2018 → Jan 2024 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03080805 | May 2017 → Mar 2019 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT02973737 | Jul 2016 → Jun 2023 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07600164 | Jul 2026 → Dec 2031 expected | HER2 positive breast carcinoma | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06641544 | Oct 2024 → Dec 2027 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT06245824 | Jan 2024 → Mar 2026 overdue | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06217185 | Jan 2024 → Dec 2025 overdue | HER2 positive breast carcinoma | Hebei Medical University Fourth Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04929548 | Jan 2022 overdue | breast cancer | Wuhan University | Not yet recruiting | No outcome recorded |
| Phase not applicable11 trials · 1 met primary | ||||||
| — | NCT06495541 | Apr → Jul 2026 overdue | breast cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06718335 | Dec 2024 → Dec 2027 expected | HER2 positive breast carcinoma | Nie Jianyun | Not yet recruiting | No outcome recorded |
| — | NCT06015113 | Sep 2023 → Apr 2026 overdue | breast cancer | Xi'an International Medical Center Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06035679 | Aug 2023 → Nov 2026 expected | female breast carcinoma | Youzhi Zhu | Recruiting | No outcome recorded |
| — | NCT05560308 | Sep 2022 → Aug 2024 | breast carcinoma by gene expression profile | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| — | NCT06234137 | Nov 2021 → Jul 2025 overdue | breast cancer | Wang Ouchen | Recruiting | No outcome recorded |
| — | NCT06015100 | Feb 2021 → Aug 2023 | breast cancer | Yan Xue | Unknown | No outcome recorded |
| — | NCT03756064 | Aug 2019 → Jul 2020 | breast cancer | Zhejiang Cancer Hospital | Unknown | Met primary |
| — | NCT03843749 | Jul 2019 | colorectal cancer | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| — | NCT03947242 | Jun 2019 → Jun 2020 | HER2 positive breast carcinoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| — | NCT03847818 | Mar 2019 → Mar 2020 | HER2 positive breast carcinoma | Shandong University | Unknown | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1/2 | NCT06015048 Background | Aug 2023 → Nov 2026 expected | — | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06973525 Comparator | Sep 2025 → May 2027 expected | HER2 positive breast carcinoma | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04236310 Background | Jan 2020 → Dec 2022 | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT06958627 Background | Apr 2024 → Apr 2025 overdue | HER2 positive breast carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04290793 Comparator | Mar 2020 → Dec 2026 expected | breast cancer | Hebei Medical University Fourth Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05424835 Comparator | Aug 2022 → Dec 2026 expected | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT04736589 Comparator | Feb 2021 → Feb 2024 overdue | breast cancer | Peking Union Medical College | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04646759 Comparator | Oct 2020 → Dec 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-02-16 | RemeGen Co., Ltd. | Regulatory RemeGen Disitamab Vedotin in Combination with Pyrotinib Maleate Tablets in the Treatment of Non-Small Cell Lung Cancer Approved for Clinical Trials remegen.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-02-16 | RemeGen Co., Ltd. | RemeGen Disitamab Vedotin in Combination with Pyrotinib Maleate Tablets in the Treatment of Non-Small Cell Lung Cancer Approved for Clinical Trials remegen.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 189 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pyrotinib | “In patients with ER-positive and HER2-positive breast cancer, the therapeutic potential of combining trastuzumab, pertuzumab, and pyrotinib-representing a triple-targeted...” NCT07290166 ↗182“Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic gastric cancer” NCT03480256 ↗ “Pyrotinib combined with docetaxel, carboplatin and trastuzumab (TCbHPy) for neoadjuvant therapy of HR+/HER2+ breast cancer” NCT05430347 ↗ “This study investigated the antitumor effect of an irreversible pan-HER receptor tyrosine kinase inhibitor, pyrotinib.” PMID 30596880 ↗ Mar 2019 “Group A received Inetetamab+Pertuzumab+TPC, while Group B received Inetetamab+Pyrotinib+TPC.” NCT06641544 ↗ “they receive the PyroHT regimen (pyrotinib plus trastuzumab and docetaxel) for two cycles.” NCT07239271 ↗ “Pyrotinib: 400mg po within 30 minutes after a meal, QD, every 3 weeks” NCT04760431 ↗ “Pyrotinib 400mg PO daily will be administrated at the same time.” NCT05318339 ↗ “Each eligible subject will receive pyrotinib, 320 mg once a day” NCT04983121 ↗ “Pyrotinib” NCT05429684 ↗ |
| Known as | Pyrotinib maleate | “Pyrotinib maleate tablets: 320 mg each time, Qd, orally administered within 30 minutes after breakfast, 21 days as a cycle.” NCT05350917 ↗4“Pyrotinib Maleate tablets, 320mg, oral administration once daily on days 1 to 28, every 4 weeks” NCT06684600 ↗ “Pyrotinib maleate” NCT05621434 ↗ |
| Known as | Pyrotinib Maleate Tablets | “Pyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses...” NCT07189884 ↗2“Pyrotinib Maleate Tablets: Continuously administered from the first day of the first course of treatment, 400 Mg/day, orally administered within 30 minutes after breakfast” NCT06483386 ↗ “Pyrotinib Maleate Tablets: 400 mg, taken orally once daily, within 30 minutes after a meal” NCT06015113 ↗ |
| Known as | SHR1258 | “The discovery and development of a novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor SHR1258 (pyrotinib) for the treatment of HER2-postive breast cancer is presented.” PMID 28115222 ↗ Jan 2017 |
| Action | Inhibit | “Pyrotinib, a novel irreversible tyrosine kinase inhibitor (TKI)” PMID 36803645 ↗ Feb 2023 |
| Modality | Small molecule | “Pyrotinib is an oral tyrosine kinase inhibitor” NCT01937689 ↗ |
| Route | Oral | “Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.” NCT01937689 ↗ |
| Target | EGFR | “Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors.” NCT02378389 ↗ |