Drugs / Neratinib
Neratinib
also known as
HKI-272 · Neratinib Maleate · CDP-820 · Neratinib maleate anhydrous · Neratinib Maleate Tablets · Nerlynx · WAY-179272
Small molecule targets EGFR, ERBB2, ERBB4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | NERLYNX | — | 2019-10-01 – 2021-06-28 | fda.gov ↗ |
| Approved | EU (EMA) | Nerlynx | — | 2018-08-31 | europa.eu ↗ |
| Approved | US (FDA) | NERLYNX | — | 2017-07-17 | fda.gov ↗ |
Trials 86 · started per year
today
US approved 2017
EU approved 2018
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06008275 | Sep 2024 → Jun 2026 overdue | triple-negative breast carcinoma | Baylor Research Institute | Recruiting | No outcome recorded |
| Phase 125 trials | ||||||
| Phase 1 | NCT05372614 | Oct 2022 → Sep 2025 | metastatic malignant neoplasm | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT05274048 | Jun 2022 → Jun 2026 overdue | gastric cancer | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04502602 | Aug 2020 → Oct 2024 overdue | ovarian cancer | Virginia Commonwealth University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03065387 | Oct 2017 → Oct 2028 expected | metastatic malignant neoplasm, refractory malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02593708 | Nov 2015 → Jan 2017 | cancer | Michelle Melisko | Terminated | No outcome recorded |
| Phase 1 | NCT02334501 | Aug → Oct 2014 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00932464 | Aug 2012 | — | Puma Biotechnology, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT01423123 | May 2011 → Aug 2012 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 1 | NCT01128842 | Apr 2010 → Mar 2011 | cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00958724 | Jul 2009 → Apr 2010 | cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00838539 | Apr 2009 → Jun 2011 | carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00781430 | Apr 2009 → Feb 2010 | liver disorder | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00864487 | Apr → May 2009 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00860223 | Apr 2009 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00814060 | Jan → Mar 2009 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00757809 | Oct 2008 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00768469 | Oct 2008 → Jan 2011 | cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00708903 | May → Jul 2008 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00550212 | Mar → Apr 2008 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00498745 | Jul → Sep 2007 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00397046 | Nov 2006 → Mar 2009 | neoplasm | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00380328 | Oct → Nov 2006 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00366600 | Jul → Dec 2006 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00146172 | Nov 2003 → Jan 2007 | breast neoplasm | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/212 trials | ||||||
| Phase 1/2 | NCT05243641 | Aug 2022 → Nov 2024 | breast cancer, metastatic neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03919292 | May 2019 → Dec 2029 | cancer | Virginia Commonwealth University | Suspended | No outcome recorded |
| Phase 1/2 | NCT03101748 | Feb 2018 → May 2025 | inflammatory breast carcinoma, metastatic carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03377387 | Dec 2017 → Dec 2026 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02932280 | Oct 2016 → Oct 2026 expected | central nervous system neoplasm, leukemia, lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02236000 | Aug 2014 → Dec 2020 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT01960023 | Oct 2013 → Jul 2016 | colorectal cancer | NSABP Foundation Inc | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01111825 | Apr 2010 → Jul 2016 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00741260 | Dec 2008 → Nov 2010 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00706030 | Apr 2008 → Oct 2009 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00445458 | Sep 2007 → May 2011 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00398567 | Apr 2007 → Jul 2009 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 242 trials | ||||||
| Phase 2 | NCT07333937 | Dec 2025 → Nov 2027 expected | breast cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07152782 | Nov 2025 → Nov 2027 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT05933395 | Sep 2024 → Oct 2030 expected | breast cancer | Dartmouth-Hitchcock Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06519110 | Aug 2024 → Feb 2026 overdue | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05919108 | May 2024 → Apr 2030 expected | invasive lobular breast carcinoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06126276 | May 2024 → Feb 2027 expected | female reproductive organ cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06374888 | Apr 2024 → Sep 2026 expected | gastroesophageal adenocarcinoma | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06109467 | Jan 2024 → Mar 2028 expected | gastric cancer, gastroesophageal cancer | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06029816 | Nov 2023 → Dec 2024 | non-small cell lung carcinoma | Convalife (Shanghai) Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04901299 | Jul 2023 → Jul 2024 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, invasive breast carcinoma, progesterone-receptor positive breast cancer | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05388149 | Dec 2022 → Jul 2026 overdue | HER2 positive breast carcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT04965064 | Sep 2022 → Sep 2026 expected | breast cancer | University of Rochester | Recruiting | No outcome recorded |
| Phase 2 | NCT05512182 | Sep 2022 → Oct 2023 | — | Yonsei University | Withdrawn | No outcome recorded |
| Phase 2 | NCT05252988 | Aug 2022 → Oct 2024 overdue | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04886531 | Jul 2022 → Jun 2026 overdue | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | Ruth O'Regan | Recruiting | No outcome recorded |
| Phase 2 | NCT05154396 | Jan 2022 → Dec 2023 | HER2 positive breast carcinoma | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT04856475 | Nov 2021 | breast cancer, metastatic malignant neoplasm in the brain | Jules Bordet Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT04760431 | Oct 2021 → Sep 2024 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT06083662 | Jun 2021 → Nov 2023 | metastatic malignant neoplasm | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04781374 | May → Sep 2021 | castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma | Beth Israel Deaconess Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04460430 | Jul 2020 → Nov 2021 | breast cancer | SOLTI Breast Cancer Research Group | Terminated | No outcome recorded |
| Phase 2 | NCT04366713 | Jun 2020 → Dec 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04374305 | Jun 2020 → Dec 2029 expected | NF2-related schwannomatosis, acoustic neuroma, ependymoma, meningioma | Scott R. Plotkin, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT03812393 | Jun 2019 → Dec 2024 | HER2 positive breast carcinoma, female breast carcinoma, triple-negative breast carcinoma | West Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT03094052 | Oct 2018 → Oct 2022 | HER2 positive breast carcinoma, breast adenocarcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT03457896 | May 2018 → Sep 2021 | colorectal cancer | NSABP Foundation Inc | Unknown | No outcome recorded |
| Phase 2 | NCT03289039 | Oct 2017 → Jul 2021 | breast cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT02977780 | Feb 2017 → Feb 2028 expected | glioblastoma | Patrick Wen, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT03182634 | Dec 2016 → Nov 2022 | female breast carcinoma | Institute of Cancer Research, United Kingdom | Unknown | No outcome recorded |
| Phase 2 | NCT02673398 | Dec 2016 → Mar 2020 | HER2 positive breast carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02400476 | Feb 2015 → Apr 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01953926 | Sep 2013 → Jan 2023 | — | Puma Biotechnology, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01827267 | Jul 2013 → Sep 2016 | carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01670877 | Dec 2012 → Feb 2021 | breast neoplasm | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01008150 | Oct 2010 → Sep 2015 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2 | NCT00915018 | Aug 2009 → Aug 2013 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00777101 | Feb 2009 → Mar 2011 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00300781 | Aug 2006 → Apr 2008 | breast neoplasm | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00266877 | Dec 2005 → Jan 2009 | non-small cell lung carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05760612 | Mar 2023 → Feb 2028 expected | HER2 positive breast carcinoma, female breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT01808573 | Mar 2013 → Sep 2018 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00878709 | Jul 2009 → Aug 2014 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06015113 | Sep 2023 → Apr 2026 overdue | breast cancer | Xi'an International Medical Center Hospital | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01956253 | Jul → Sep 2013 | urinary bladder cancer | UNC Lineberger Comprehensive Cancer Center | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07153952 Comparator | Jan 2025 → Jan 2027 expected | cervical adenosquamous carcinoma | Peking Union Medical College Hospital | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01494662 Comparator | Feb 2012 → Feb 2023 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2011-10-05 | Pfizer | Pfizer Announces Licensing Agreement With Puma Biotechnology, Inc. For The Development And Commercialization Of Neratinib, An Investigational Pan-HER Inhibitor pfizer.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 90 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Neratinib | “In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab,...” NCT07153952 ↗83“Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion).” NCT03919292 ↗ “Neratinib : Week 1: 120 mg, Week 2: 160 mg, Week 3 and onwards: 240 mg/QD/Oral/Once daily” NCT05512182 ↗ “Neratinib Maleate Tablets: 240 mg, taken orally once daily with a meal” NCT06015113 ↗ “Intervention: HKI-272 (Neratinib)340 mg orally, once daily.” NCT01494662 ↗ “Neratinib: 240mg po QD, every 3 weeks” NCT04760431 ↗ “Neratinib” NCT05615818 ↗ |
| Known as | CDP-820 | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Known as | HKI-272 | “Neratinib (HKI-272), an orally administered small molecule, is an irreversible inhibitor of pan ErbB receptor tyrosine kinases” NCT01008150 ↗6“A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor” NCT01128842 ↗ “Neratinib (HKI-272)” NCT00781430 ↗ |
| Known as | Neratinib Maleate | “Drug: Neratinib Maleate” NCT06126276 ↗ |
| Known as | Neratinib maleate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Known as | Neratinib Maleate Tablets | “Neratinib Maleate Tablets: 240 mg, taken orally once daily with a meal” NCT06015113 ↗ |
| Known as | Nerlynx | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Known as | WAY-179272 | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Action | Inhibit | “pan-ErbB inhibitor that blocks signal transduction via inhibition of three epidermal growth factor receptors” PMID 22371427 ↗ Feb 2012 |
| Modality | Small molecule | “a potent, irreversible, small-molecule, orally administered, pan-ErbB inhibitor” PMID 22371427 ↗ Feb 2012 |
| Route | Oral | “Administered Orally” NCT00146172 ↗ |
| Target | ERBB2 | “ErbB1, ErbB2 (Her2) and ErbB4” PMID 22371427 ↗ Feb 2012 |
| Target | ERBB4 | “ErbB1, ErbB2 (Her2) and ErbB4” PMID 22371427 ↗ Feb 2012 |