Delving into the Latest Updates on Neratinib maleate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Neratinib, neratinib, Nerlynx

+ [17]

Target

EGFR x HER2 x HER4

Action

antagonists

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), HER4 antagonists(Receptor tyrosine-protein kinase erbB-4 antagonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesNervous System Diseases+ [3]

Active Indication

Early Stage Breast CarcinomaHormone receptor positive breast cancerBreast Cancer+ [25]

Inactive Indication

Advanced HER2-Positive Breast CarcinomaAdvanced Lung Non-Small Cell CarcinomaChronic liver disease+ [13]

Originator Organization

Pfizer Inc.

Active Organization

Pierre Fabre Médicament SAS

Puma Biotechnology, Inc.

Celcuity, Inc.

+ [10]

Inactive Organization

Wyeth Research

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

Pfizer Inc.

+ [1]

License Organization

CANbridge Life Sciences Ltd.

Puma Biotechnology, Inc.

Knight Orthodontics

+ [12]

Drug Highest PhaseApproved

First Approval Date

United States (17 Jul 2017),

HER2-negative breast cancer

RegulationFast Track (United States), Orphan Drug (United States)

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Structure/Sequence

Molecular FormulaC34H33ClN6O7

InChIKeyVXZCUHNJXSIJIM-MEBGWEOYSA-N

CAS Registry915942-22-2

The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:
1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy?
2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.
Participants will:
1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily
2. Visit the clinic every 3 months for checkups, tests and imaging studies

Start Date01 Jul 2027

Sponsor / Collaborator

University of California San Diego

ChiCTR2600127696

/ Not yet recruitingPhase 4IIT

An Open-label, Multicenter, Two-cohort, Phase II Study to Evaluate the Efficacy and Safety of Neratinib (NLX) Combined with Vinorelbine Capsules (NVB) in Patients with HER2-positive Metastatic Breast Cancer

Start Date15 Jul 2026

Sponsor / Collaborator-

ChiCTR2600124699

/ Not yet recruitingNot ApplicableIIT

Evaluation of the Efficacy and Safety of Neratinib Combined with Trastuzumab and Fulvestrant as Neoadjuvant Therapy in Chinese Patients with Stage II-III TPBC: A Prospective, Single-Arm, Multicenter Study

Start Date01 Jun 2026

Sponsor / Collaborator

Shanghai First People's Hospital

100 Clinical Results associated with Neratinib maleate

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100 Translational Medicine associated with Neratinib maleate

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100 Patents (Medical) associated with Neratinib maleate

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893

Literatures (Medical) associated with Neratinib maleate

01 Sep 2026·ARCHIVES OF GERONTOLOGY AND GERIATRICS

Identification of MMP14 and FOS as key regulators of vascular smooth muscle cell senescence in diabetic kidney disease: A combined bioinformatics and experimental study

Article

Author: Wang, Bo ; Wang, Shanshan ; Qu, Bo ; He, Yuhua ; Zhou, Li ; Mao, Bing

OBJECTIVE:

Diabetic kidney disease (DKD) is a leading microvascular complication of diabetes in which vascular smooth muscle cell (VSMC) senescence plays a pivotal pathogenic role. This study aimed to identify key genes regulating VSMC senescence in DKD through integrated bioinformatics and machine learning analysis, construct a diagnostic nomogram prediction model, screen candidate therapeutic compounds, and validate findings experimentally.

METHODS:

Transcriptomic profiles for DKD (GSE30122, GSE96804, GSE142025) and a VSMC aging dataset (GSE198983) were retrieved from the GEO repository. Genes showing differential expression were determined using limma, succeeded by weighted gene co-expression network analysis (WGCNA) and functional annotation through Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG). Feature selection employed random forest, least absolute shrinkage and selection operator (LASSO), and support vector machine-recursive feature elimination (SVM-RFE) to isolate pivotal genes and develop diagnostic frameworks. Immune cell composition was analyzed via CIBERSORT, and competing endogenous RNA (ceRNA) plus transcription factor networks were assembled. Drug candidates were forecasted using the Connectivity Map platform. Human aortic smooth muscle cells (HASMCs), employed as a surrogate macrovascular smooth muscle cell model, and human renal artery smooth muscle cells (HRASMCs), employed as a kidney-proximal vascular model for cross-validation, underwent hyperglycemic exposure to recapitulate DKD conditions, with proliferation, programmed cell death, and senescence evaluated through CCK-8 assays, flow cytometry, and senescence-associated β-galactosidase (SA-β-gal) detection. Expression of p16, p21, osteopontin (OPN), and osteocalcin (OC) was quantified by Western blotting. Cell cycle distribution was additionally assessed by propidium iodide (PI)-based flow cytometry to elucidate the mechanism of proliferative suppression.

RESULTS:

A total of 43 candidate genes demonstrated enrichment predominantly in biological aging, cellular senescence, oxidative damage, insulin signaling cascades, and MAPK transduction pathways. MMP14 and FOS emerged consistently as pivotal genes exhibiting potential diagnostic capability. Immune infiltration disclosed marked changes across multiple immune populations, with MMP14 and FOS expression demonstrating associations with various immune cell subsets. The ceRNA architecture computationally predicted MMP14, FOS, NEAT1, and hsa-miR-181a-5p as critical regulatory nodes, with SRF computationally nominated as a shared transcriptional regulator. Five therapeutic candidates (neratinib, linsitinib, amlodipine, forskolin, piceatannol) were computationally identified. linsitinib demonstrated the most favorable in silico binding affinity in molecular docking simulations. This finding has not yet been validated experimentally and requires future in vitro and in vivo confirmation. Under hyperglycemic stress, HASMCs exhibited reduced proliferation, elevated apoptosis and senescence, alongside increased expression of p16, p21, OPN, and OC. Augmentation of MMP14 expression and suppression of FOS promoted cell proliferation while mitigating hyperglycemia-induced apoptosis and senescence. Cell cycle analysis revealed that high glucose induced G0/G1 phase arrest, which was relieved by MMP14 overexpression or FOS knockdown, and further exacerbated by MMP14 knockdown or FOS overexpression. All functional findings were consistently recapitulated in HRASMCs, confirming the conserved regulatory roles of MMP14 and FOS across VSMC subtypes.

CONCLUSION:

MMP14 and FOS function as crucial modulators of VSMC senescence in DKD, presenting diagnostic and therapeutic opportunities. The characterized regulatory circuits and identified pharmaceutical agents establish a foundation for precision interventions in DKD management.

02 Jul 2026·CANCER RESEARCH

Integrated Multiomic Profiling Identifies BRD8/EP400 as a Pivotal Chromatin Module Mediating Anti-HER2 Response in HR+/HER2+ Breast Cancer

Article

Author: Wang, Yidan ; Welch Schwartz, Rene ; Ong, Irene M. ; Yang, Xingjian ; Hu, Mingshan ; Kim, Eui-Jun ; Dinh, Huy Q. ; Ma, Gui ; Burkard, Mark E. ; Donahue, Kristine ; Fernandez-Martinez, Aranzazu ; Liu, Peng ; Khatri, Parth H. ; Gao, Ang ; Chan, Ngai Ting ; Liu, Fabao ; Zhou, Jingjing ; Xu, Wei ; Perou, Charles M. ; Wisinski, Kari B.

Abstract:

Patients with hormone receptor–positive/HER2-positive (HR+/HER2+) breast cancer represent a historically underrecognized subgroup demonstrating poor response to combined endocrine and HER2-targeted therapies. In this study, using single-cell transcriptomic and epigenomic sequencing of estrogen receptor–positive (ER+)/HER2+ models, we identified BRD8, an acetyl-lysine reader in the EP400 histone acetyltransferase complex, as a critical mediator of ER/HER2 signaling cross-talk. BRD8 expression rapidly increased following anti-HER2 treatment, whereas its depletion disrupted ER–HER2 interaction and enhanced drug sensitivity. Single-nucleus assay for transposase-accessible chromatin using sequencing revealed that chromatin regions opening after anti-HER2 treatment were enriched for ER, FOX, and ETS transcription factor motifs, coinciding with BRD8-dependent gene activation through EP400-mediated acetylated H2AZ deposition. BRD8 regulated ER-dependent and ER-independent growth pathways, and depletion of BRD8 abolished neratinib-induced ER activation and restored drug sensitivity in resistant cells. A three-gene BRD8 signature successfully predicted anti-HER2 therapy response in two human clinical trials. Together, these findings establish BRD8 as both a predictive biomarker for anti-HER2 response and a therapeutic target to overcome resistance in HR+/HER2+ breast cancer.

Significance::

Multiomic single-cell profiling of breast cancer identified BRD8 as a critical mediator of resistance to HER2-targeted therapies that enables ER-HER2 cross-talk and serves as a predictive biomarker for treatment response.

01 Jul 2026·BIOORGANIC CHEMISTRY

Novel benzimidazole-based thioamide derivatives as potential anticancer agents: synthesis, biological evaluation, and in silico studies

Article

Author: Kendre, Mahadevi Vitthal ; Wakte, Pravin S ; Bhusari, Sachin S

A series of novel benzimidazole-based thioamide derivatives were designed, synthesized, and evaluated for their anticancer potential, supported by EGFR-targeted molecular docking studies. The synthetic strategy involved a base-mediated nucleophilic substitution reaction between 1-(substitutedphenyl)-2-((5-(difluoromethoxy)-1H-benzo[d]imidazol-2-yl)thio)ethan-1-one intermediate (1) and brominated nitrobenzyl derivative (2), enabling efficient CC bond formation at the C5 position of the benzimidazole ring. Reaction parameters were systematically optimized, including solvent, base, and temperature, wherein acetonitrile as solvent and potassium carbonate as base under reflux conditions afforded the best yields. Under optimized conditions, a library of ten derivatives was synthesized and fully characterized using NMR spectroscopy. The synthesized compounds were evaluated for in vitro cytotoxic activity against three human cancer cell lines: MCF7 (breast), A-549 (lung), and HEP-G2 (liver). Several derivatives exhibited promising anticancer activity, with compound 6-8b emerging as the most potent, displaying IC₅₀ values of 3.70 μM against A-549 and 5.38 μM against HEP-G2 cells. Molecular docking studies against the T790M-mutated EGFR kinase domain (PDB ID: 2JIV) revealed favorable binding interactions, superior docking scores, and binding energies compared to the reference inhibitor Neratinib. ADME predictions were made using Qikprop. These derivatives may represent a preliminary lead scaffold warranting further mechanistic validation and structural optimization; however, experimental confirmation of EGFR target engagement is required before definitive anticancer claims can be made.

165

News (Medical) associated with Neratinib maleate

24 Jul 2026

·www.biospace.com

Puma Biotechnology to Host Conference Call to Discuss Second Quarter 2026 Financial Results

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, August 6, 2026, following the release of its second quarter 2026 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com

Drug ApprovalLicense out/inPhase 2Phase 1

09 Jul 2026

·firstwordpharma.com

Biopharma bites: AstraZeneca prevails on Tagrisso, Dr Reddy's semaglutide supply hitch, and Lundbeck's Vyepti warning

US court upholds AstraZeneca Tagrisso victoryDr Reddy's delays generic semaglutide until late OctoberFDA calls out Lundbeck over marketing of Vyepti migraine drug US court upholds AstraZeneca Tagrisso victoryAn appeals court in the US on Thursday upheld a ruling in favour of AstraZeneca, confirming that its lung cancer drug Tagrisso (osimertinib) does not infringe patents asserted by Pfizer subsidiary Wyeth because the patents in question are invalid.The US Court of Appeals for the Federal Circuit agreed with a Delaware federal judge that the two patents lacked adequate written descriptions and did not sufficiently enable scientists to reproduce the claimed inventions. The decision leaves intact the lower court's 2024 ruling, which had overturned a $107.5-million verdict awarded to Wyeth in 2024.Pfizer, which acquired Wyeth in 2009, sued AstraZeneca in 2021, alleging that Tagrisso infringed patents related to the breast cancer drug Nerlynx (neratinib), marketed by Puma Biotechnology under a licence from Pfizer.Tagrisso, which generated about $7.3 billion in global sales last year, is one of AstraZeneca's top-selling drugs. Dr Reddy's delays generic semaglutide until late OctoberDr Reddy's Laboratories said supplies of its generic version of Novo Nordisk's GLP-1 drug Ozempic/Wegovy (semaglutide) will remain unavailable in India and disrupted in Canada until at least late October after an issue with the active pharmaceutical ingredient (API) forced the company to halt new production.The problem, identified during validation of a manufacturing scale-up, affects future shipments but not products already supplied to the market, according to CEO Erez Israeli. The company said the issue poses no patient safety risk and won't affect existing global regulatory filings.The setback clouds Dr Reddy's ambitions in India's newly opened semaglutide market, where it sells the drug as Obeda, following expiry of Novo's patent in March.Dr Reddy's now expects to supply 6 million to 7 million injection pens in the second half of the year; its earlier target was 12 million in the first year.The disruption also prompted Torrent Pharmaceuticals to recall selected batches of its Semalix injection pens for technical evaluation after notification from Dr Reddy's. Shares of Dr Reddy's fell nearly 6%, wiping about $678 million from its market value. FDA calls out Lundbeck over marketing of Vyepti migraine drugUS regulators are taking issue with Lundbeck's online promotional materials for migraine drug Vyepti (eptinezumab-jjmr), calling some claims "false or misleading."In a recent letter to Rebekah Snyder Logan, VP of US regulatory affairs for the company, the FDA cited the "Efficacy and 2-year patient outcomes" webpage, which includes claims and presentations based on the results of the PREVAIL trial, as well as post-hoc analyses of the PREVAIL and PROMISE trials."We note several significant limitations to the cited references that preclude the drawing of conclusory claims regarding the benefits of Vyepti," the agency said.The FDA highlighted several contentious claims, including that Vyepti provides "100% migraine freedom for a month or more," based on post-hoc analyses of the PROMISE trials. According to the agency, because these analyses lacked prespecified statistical controls for false positives, "it is not possible to ascertain whether the findings were attributable to treatment with Vyepti, or merely due to chance."The agency also criticised the "Real VYEPTI experience" webpage and the use of "attention-grabbing, colourful, bold graphics" that amplify various disputed claims.The FDA wants Lundbeck to take "immediate action" to address the violations and explain its plan for "the discontinuation of such communications, or for ceasing distribution of Vyepti."

AcquisitionPatent Infringement

02 Jul 2026

·www.biospace.com

Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - July 2, 2026

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on July 1, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 31,625 shares of Puma common stock to four new non-executive employees. The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date, July 1, 2026, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA®-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA®-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com

Drug ApprovalLicense out/inPhase 2

100 Deals associated with Neratinib maleate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Neratinib maleate	L01XE45	DB11828

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Early Stage Breast Carcinoma	Canada	Puma Biotechnology, Inc.	16 Jul 2019
Hormone receptor positive breast cancer	Canada	Puma Biotechnology, Inc.	16 Jul 2019
Breast Cancer	Australia	Specialised Therapeutics Australia Pty Ltd.	15 Mar 2019
HER2 Positive Breast Cancer	European Union	Pierre Fabre Médicament SAS	31 Aug 2018
HER2 Positive Breast Cancer	Iceland	Pierre Fabre Médicament SAS	31 Aug 2018
HER2 Positive Breast Cancer	Liechtenstein	Pierre Fabre Médicament SAS	31 Aug 2018
HER2 Positive Breast Cancer	Norway	Pierre Fabre Médicament SAS	31 Aug 2018
HER2-negative breast cancer	United States	Puma Biotechnology, Inc.	17 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	United States	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Japan	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Argentina	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Australia	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Austria	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Belgium	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Brazil	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Canada	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Czechia	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Denmark	Puma Biotechnology, Inc.	29 Mar 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07333937 (ESMO_BC2026)	Phase 2	Advanced breast cancer HR+ \| HER2+	35	Neratinib + Eribulin + Fulvestrant	mnvwumgziy(wevyesdckv) = The most common treatment-related AEs (TRAEs) were diarrhea (97.1%, all grade; 64.3% grade ≥3), fatigue (62.9%, all grade; 35.7% grade ≥3), and nausea (62.9%, all grade; 17.9% grade ≥3). aecxutvusu (nvfxvivasq )	Positive	07 May 2026
NCT06029816 (AACR2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line EGFR exon 18-mutant	14	Neratinib (Hannaijia®)	eseeztimyh(olltvdeyku) = smophzmgqu rhqawkrsds (xjckzueche ) View more	Positive	21 Apr 2026
DIANER (SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2+ \| HR+	177	Neratinib + Loperamide	exeobgkpqc(hoxvjwevgx) = bhmdvpyhmk rghwrnejmu (uxpipmrdxb ) View more	Negative	11 Dec 2025
DIANER (SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2+ \| HR+	177	Neratinib dose escalation + Loperamide	yumxaizrjm(yqxlbozqwi) = rwkcxkspvg bxbeyywrkb (vatzrxridl ) View more	Negative	11 Dec 2025
SABCS2025	Not Applicable	HER2 Positive Breast Cancer HER2-positive \| HR+	48	Neratinib	kcudqszakt(arqpcwzcev) = vomiting (n=1), COVID-19 (n=1), diarrhea (n=1), nausea (n=1), fever (n=1), and duodenal ulcer (n=1) ssrhsgouli (lbnzqmgtnz ) View more	Positive	11 Dec 2025
NCT01827267 \| NCT01953926 (PUMA-NER-4201, Pubmed \| Clin Lung Cancer)	Phase 2	Adenocarcinoma of Lung ERBB2 mutations	138	Neratinib (4201)	arwarycnxu(kmjogvixoc) = pzzcxeuhbv zxdfccpkqb (vkdxloooow, 0.0 - 19.5) View more	Negative	01 Oct 2025
	Phase 2	Adenocarcinoma of Lung ERBB2 mutations	138	Neratinib plus temsirolimus (4201)	arwarycnxu(kmjogvixoc) = lbjbisfaye zxdfccpkqb (vkdxloooow, 5.3 - 27.9) View more	Negative	01 Oct 2025
NCT03101748 (Pubmed \| Ther Adv Med Oncol)	Phase 1/2	HR Positive/HER2 Negative/Node positive breast cancer Neoadjuvant HER2-positive \| HR-positive/HER2-negative	24	Neratinib + standard therapy	lczsmlhvsp(ntzyaztpad) = gksadcxtvm lvvowthuvi (hxftwzdopa ) View more	Positive	01 Sep 2025
NCT03101748 (Pubmed \| Ther Adv Med Oncol)	Phase 1/2		24	Neratinib + standard therapy (underwent surgery)	lczsmlhvsp(ntzyaztpad) = oqvxezfyam lvvowthuvi (hxftwzdopa )	Positive	01 Sep 2025
NCT05491057 (NER-Tree, ASCO2025)	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2+	500	Extended adjuvant neratinib treatment	mzakhufktt(vtueuusdzo) = omsfgxtfwb saewjponpo (ksncipsall ) View more	Positive	30 May 2025
NCT05243641 (CTgov)	Phase 1/2	Inflammatory Breast Neoplasms \| Metastatic breast cancer	10	Neratinib+Capmatinib (Phase Ib)	kisoswitwe = xderlwxptq gkfknwbghn (kczzbsthii, wgapbhcdmo - vxrsfajapc)	-	15 May 2025
NCT05243641 (CTgov)	Phase 1/2	Inflammatory Breast Neoplasms \| Metastatic breast cancer	10	neratinib+capmatinib (Phase II)	qpwayzlmob(sghshjuigq) = tzqrsivogu eeidzufgox (hppgvdjofj, wkwfljanva - sbeqcxhjnu) View more	-	15 May 2025
NCT06029816 (SUMMIT, AACR2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma EGFR exon 18 mutations	14	Neratinib monotherapy	jiuievehpz(lljazzwymx) = xilxvwsflz jbfdrnxwnt (gkymjqlpii ) View more	Positive	27 Apr 2025
NCT05491057 (NER-Tree, ESMO2024) Manual	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2 Positive	250	Neratinib <240 mg	iwtygmrwuw(rwvnsgeebx) = hcrrebmxex nrirnvlakt (ojpzyofztp ) View more	Positive	16 Sep 2024