Drugs / Pyrotinib
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Pyrotinib

Small molecule targets EGFR, ERBB2, ERBB4 via inhibition

Developed for
breast cancer · HER2 positive breast carcinoma · non-small cell lung carcinoma · female breast carcinoma · hormone receptor-positive breast cancer · metastatic malignant neoplasm in the brain · colorectal cancer · invasive breast carcinoma
+18 more · triple-negative breast carcinoma · breast carcinoma · breast neoplasm · carcinoma · digestive system neoplasm · esophageal squamous cell carcinoma · estrogen-receptor positive breast cancer · gastric cancer · neoplasm · biliary tract cancer · breast carcinoma by gene expression profile · cancer · gastric neoplasm · gastroesophageal junction adenocarcinoma · lung carcinoma · metastatic malignant neoplasm · salivary gland carcinoma · transitional cell carcinoma
Investigated by
Jiangsu HengRui Medicine Co., Ltd. · Fudan University · Sun Yat-sen University · The First Affiliated Hospital with Nanjing Medical University · Tianjin Medical University Cancer Institute and Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
+88 more · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Chinese Academy of Medical Sciences · Henan Cancer Hospital · Shengjing Hospital · Zhejiang Cancer Hospital · RenJi Hospital · Shanghai Jiao Tong University School of Medicine · First Affiliated Hospital of Zhejiang University · Hebei Medical University Fourth Hospital · Peking Union Medical College Hospital · Peking University · Peking University Cancer Hospital & Institute · Second Affiliated Hospital, School of Medicine, Zhejiang University · The Affiliated Hospital of Xuzhou Medical University · Affiliated Hospital of Jiangsu University · Affiliated Hospital of Nantong University · First Affiliated Hospital Xi'an Jiaotong University · Fujian Medical University Union Hospital · Huai'an First People's Hospital · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Peking Union Medical College · RemeGen Co., Ltd. · Shandong Cancer Hospital and Institute · Tongji Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · West China Hospital · Affiliated Hospital of Jiangnan University · Anhui Provincial Cancer Hospital · Anhui Provincial Hospital · BeiGene · Caigang Liu · Chinese PLA General Hospital · Chinese Thoracic Oncology Group · First Affiliated Hospital of Wenzhou Medical University · Fujian Medical University · Fuzhou General Hospital · GeneQuantum Healthcare (Suzhou) Co., Ltd. · Guangdong Association of Clinical Trials · Guangdong Provincial People's Hospital · Hengrui Therapeutics, Inc. · Huihua Xiong · Hunan Cancer Hospital · Innovent Biologics (Suzhou) Co. Ltd. · Jiangxi Provincial Cancer Hospital · Jingjiang People's Hospital · Jinming Yu · Nie Jianyun · Peking University Hospital of Stomatology · Peking University International Hospital · Peking University People's Hospital · Peking University Shenzhen Hospital · Qingdao Zhixin Health Technology Co., Ltd. · Risen (Suzhou) Pharma Tech Co., Ltd. · Shandong University · Shanghai Changzheng Hospital · Shanghai Chest Hospital · Shanghai Minhang Central Hospital · Shuyang County Traditional Chinese Medicine Hospital · Sir Run Run Shaw Hospital · Suzhou Municipal Hospital · Taizhou EOC Pharma Co., Ltd. · Taizhou Hospital · The Affiliated Hospital of Qingdao University · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital of Zhengzhou University · The First Hospital of Jilin University · The First People's Hospital of Xuzhou · The Second People's Hospital of Changshu · Tianjin Medical University Second Hospital · Tongji University · Wang Ouchen · Wenjin Yin · all 94 on the full record

Trials 176 · started per year

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201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 1/213 trials
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 NCT05745740 Apr 2024 → Dec 2025 non-small cell lung carcinoma RemeGen Co., Ltd. Unknown 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 2115 trials
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
Phase 2 NCT07053150 Aug 2025 → Dec 2030 expected digestive system neoplasm Tongji Hospital Not yet recruiting No outcome recorded
Show all 115 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 317 trials
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 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
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 No outcome recorded
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
Also used as a comparator or background therapy in 8 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT06015048 Background Aug 2023 → Nov 2026 expected Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 22 trials
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 2/32 trials
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 33 trials
Phase 3 NCT05424835 Comparator Aug 2022 → Dec 2026 expected HER2 positive breast carcinoma Jiangsu HengRui Medicine Co., Ltd. Active not recruiting No outcome recorded
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

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 186 sources stand behind the page.

FieldValueCited 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
179

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

PyrotinibNCT05429684

NCT05841381

NCT03980054

NCT07393425

NCT06144944

NCT04717531

NCT06035679

NCT05274191

NCT05165225

NCT07615751

NCT05577923

NCT03923179

NCT03843749

NCT05577442

NCT05800756

NCT04334330

NCT05292742

NCT06975475

NCT04680091

NCT07065435

NCT04423185

NCT06718335

NCT06254690

NCT06832904

NCT04380012

NCT03993964

NCT06563999

NCT06234137

NCT05621434

NCT07528716

NCT03947242

NCT04158856

NCT06145308

NCT06278870

NCT05111444

NCT03876587

NCT05424835

NCT07417241

NCT03080805

NCT05353361

NCT02500199

NCT04095390

NCT04681911

NCT06245824

NCT06015048

NCT04144569

NCT05880927

NCT07307287

NCT06495541

NCT03863223

NCT07189884

NCT07132242

NCT07600164

NCT05252546

NCT05070598

NCT07053150

NCT04227041

NCT02378389

NCT03735966

NCT04355858

NCT03772353

NCT03910712

NCT06217185

NCT04479891

NCT04315493

NCT04367090

NCT04126525

NCT03933982

NCT04395989

NCT04293276

NCT07610720

NCT06362096

NCT06718933

NCT04917900

NCT05228951

NCT04659499

NCT05823623

NCT07635342

NCT07708194

NCT06770296

NCT04407988

NCT07014410

NCT06015113

NCT05560308

NCT06001086

NCT04900311

NCT06000917

NCT05346861

NCT07340398

NCT04001621

NCT01937689

NCT04858516

NCT07335081

NCT06684600

NCT07179939

NCT06958627

NCT03847818

NCT05861271

NCT06483386

NCT02361112

NCT04398914

NCT05429294

NCT04246502

NCT02834936

NCT06973525

NCT05042791

NCT06692491

NCT06152822

NCT07180082

NCT04290793

NCT05834764

NCT05659056

NCT04997798

NCT04315116

NCT04963595

NCT03756064

NCT04088110

NCT05635487

NCT04706949

NCT04973319

NCT05769010

NCT02535507

NCT05745740

NCT04254263

NCT04033172

NCT06015100

NCT04255056

NCT03923166

NCT04063462

NCT04903652

NCT04236310

NCT04605575

NCT04382300

NCT04646759

NCT04152057

NCT04447118

NCT04034589

NCT05255523

NCT07653451

NCT06208410

NCT05076695

NCT05575804

NCT05328440

NCT07019337

NCT03588091

NCT03997539

NCT04736589

NCT04850651

NCT04929548

NCT05582499

NCT04066790

NCT05020964

NCT05806671

NCT05910398

NCT04481932

NCT02973737

NCT03805399

NCT04960943

NCT03691051

NCT06185400

NCT06475443

NCT03919253

NCT02422199

NCT03412383

NCT05482568

NCT04872985

NCT04639271

NCT04179656

NCT05638594

NCT05751018

NCT04486911

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 maleateNCT05621434

NCT05426486

NCT03574402

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
1

NCT04571710

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