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+ [24]

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.

Pierre Fabre SA

+ [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)

Structure/Sequence

Molecular FormulaC34H33ClN6O7

InChIKeyVXZCUHNJXSIJIM-MEBGWEOYSA-N

CAS Registry915942-22-2

116

Clinical Trials associated with Neratinib maleate

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

NCT07333937

/ Not yet recruitingPhase 2IIT

Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+/HER2+ Advanced Breast Cancer After Trastuzumab Deruxtecan Resistance:A Single-Arm, Multicenter, Exploratory Clinical Study

This study aims to explore the efficacy and safety of neratinib combined with fulvestrant and eribulin in the treatment of HR+/HER2+ advanced breast cancer after trastuzumab deruxtecan resistance. The treatment regimen of neratinib + fulvestrant + eribulin in this study is expected to provide a new and effective therapeutic strategy for patients with triple-positive breast cancer who develop resistance to trastuzumab deruxtecan, and offer novel therapeutic insights for advanced triple-positive breast cancer.

Start Date20 Dec 2025

Sponsor / Collaborator

Xijing Hospital

NCT07152782

/ Not yet recruitingPhase 2IIT

Trastuzumab Deruxtecan With or Without Neratinib for HER2-positive Unresectable and/or Metastatic Breast Cancer With Brain Metastasis: A Multicenter, Randomized, Open Label, Phase II Trial (THUNDER Trial)

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis

Start Date01 Nov 2025

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Neratinib maleate

100 Translational Medicine associated with Neratinib maleate

100 Patents (Medical) associated with Neratinib maleate

868

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.

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.

01 May 2026·Molecular Oncology

Recurrent cancer‐associated ERBB4 mutations are transforming and confer resistance to targeted therapies

Article

Author: Farahani, Iman ; Chakroborty, Deepankar ; Dibus, Nikol ; Esparta, Olaya ; Eli, Lisa D. ; Ahonen, Sini ; Suominen, Peppi ; Kurppa, Kari J. ; Boettcher, Steffen ; Tuohisto‐Kokko, Aura ; Elenius, Klaus ; Peltola, Sara ; Ojala, Veera K. ; Johnson, Mark S. ; Airenne, Tomi T. ; Jokilammi, Anne

Receptor tyrosine kinase ERBB4 (HER4) is frequently mutated in human cancer, and ERBB4 mutations have been identified in patients relapsing on targeted therapy. Here, we addressed the functional consequences of recurrent cancer‐associated ERBB4 mutations that are located at regions important for receptor activation and/or are paralogous to known oncogenic hotspot mutations in other ERBB genes. Eleven out of 18 analyzed mutations were transforming in cell models, thus suggesting oncogenic potential for more than half of the recurrent ERBB4 mutations. More detailed analyses of the most potent mutations, S303F, E452K, and L798R, showed that they are activating, can co‐operate with other ERBB receptors and are sensitive to clinically available second‐generation pan‐ERBB inhibitors neratinib, afatinib, and dacomitinib. Furthermore, the S303F mutation, together with a previously identified activating ERBB4 mutation, E715K, promoted resistance to third‐generation EGFR inhibitor osimertinib in EGFR‐mutant lung cancer model in vitro and in vivo . Together, these results are expected to facilitate clinical interpretation of the most recurrent cancer‐associated ERBB4 mutations. The findings provide rationale for testing the efficacy of clinically used pan‐ERBB inhibitors in patients harboring driver ERBB4 mutations both in the treatment‐naïve setting, and upon development of resistance to targeted agents.

162

News (Medical) associated with Neratinib maleate

23 Jun 2026

·jaguarhealth.gcs-web.com

Jaguar Health Completes Submission of New Animal Drug Application for Full FDA Approval of Crofelemer for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs

Jaguar's recently completed pivotal effectiveness study of crofelemer for the treatment of CID in dogs demonstrates positive, statistically significant results SAN FRANCISCO, CA / ACCESS Newswire / June 23, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the company has completed submission of its New Animal Drug Application (NADA) to the U.S. Food and Drug Administration's Center for Veterinary Medicine for full approval of crofelemer for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Crofelemer, under the name Canalevia®-CA1, is currently conditionally approved for this indication in dogs. "We're very happy to have completed submission of this NADA," said Dr. Michael Guy , D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. "As announced, the statistically significant results of our recently completed pivotal effectiveness study of Canalevia-CA1 for the treatment of CID in dogs demonstrated that dogs suffering from CID who were treated with Canalevia-CA1 twice daily at the onset of diarrhea had, at the end of 3 days of treatment, an average daily stool that was regarded as normal. Moreover, in a survey at the end of the study, 77% of the owners of dogs participating in the study reported that they believed Canalevia-CA1 was an effective treatment for their dog's CID. Additionally, around 40% of dog owners reported that Canalevia-CA1 completely resolved their dog's CID. In comparison, only 10.5% of owners reported complete resolution in their dog's CID without the use of any CID treatments." The effectiveness study, which was undertaken at veterinary oncology clinics around the U.S ., is a core component of Jaguar's submitted NADA, along with the positive results of a study of crofelemer delayed-release tablets for treatment of cancer therapy-related diarrhea in dogs receiving neratinib - a targeted tyrosine kinase inhibitor (TKI) chemotherapy agent. Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics. Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs. About Chemotherapy-induced Diarrhea (CID) in Dogs According to the American Veterinary Medical Association , approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.1 According to the National Cancer Institute at the National Institutes of Health , roughly 6 million new cancer diagnoses are made in dogs yearly in the US. Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,2 and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their canine patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID. Important Safety Information About Canalevia®-CA1 For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. About the Jaguar Health Family of Companies Jaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for weight gain prevention and mental health indications. For more information about: Jaguar Health, visit https://jaguar.health Canalevia-CA1, visit canalevia.com Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 "Cancer in Pets." American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets 2 Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398 Contact: hello@jaguar.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

Drug ApprovalClinical ResultPhase 3

04 Jun 2026

·www.biospace.com

Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - June 3, 2026

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on June 1, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 7,000 shares of Puma common stock to two 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, June 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

20 May 2026

·allsci.com

Bayer’s Hyrnuo gains FDA Priority Review for sBLA in first-line NSCLC

Bayer announced receipt of US FDA Priority Review for a supplemental New Drug Application (sNDA) for Hyrnuo (sevabertinib), an oral reversible HER2/EGFR tyrosine kinase inhibitor (TKI). The German giant is aiming to expand Hyrnuo’s indications to include first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and who have received no prior systemic therapy. The filing is supported by preliminary data from Cohort F of the ongoing Phase I/II SOHO-01 trial (NCT05099172). Priority Review compresses the standard FDA review timeline from 10-12 months to 6 months and is reserved for therapies that, if approved, would offer a meaningful improvement in safety or effectiveness for a serious condition. Hyrnuo received US FDA accelerated approval in November 2025 for a distinct, previously treated population — adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy — based on objective response rate (ORR) and duration of response (DOR). That earlier indication remains subject to confirmatory trial requirements. The current sNDA represents a line extension into the first-line setting, where Hyrnuo is not yet approved. Sevabertinib inhibits mutated HER2, including exon 20 insertions and point mutations, as well as EGFR, with selectivity for mutant over wild-type EGFR. The molecule was developed through Bayer’s research alliance with the Broad Institute of MIT and Harvard. The clinical case for the first-line sNDA rests on Cohort F of SOHO-01, which enrolled 73 treatment-naïve patients with locally advanced or metastatic HER2-mutated NSCLC. According to data published in the New England Journal of Medicine in July 2025, with a data cutoff of June 27, 2025, the confirmed ORR by blinded independent central review per RECIST v1.1 was 71% (95% CI: 59–81%). Median duration of response was 11.0 months (95% CI: 8.1–not estimable), and median progression-free survival had not been reached at the time of analysis, with a median follow-up of 9.9 months. Among patients with brain metastases, the ORR was 78%. Grade 3 or higher drug-related adverse events occurred in 21% of patients, with any-grade drug-related adverse events reported in 97%. These figures were not disclosed in the current Priority Review announcement but were reported in the NEJM publication and concurrent ESMO 2025 presentations from the same data cut. The safety profile of sevabertinib across the broader SOHO-01 pooled population includes diarrhea in 86% of patients (Grade 3 in 15%), hepatotoxicity in 24%, and ocular toxicity in 14%. Pancreatic enzyme elevations — increased lipase in 40% and increased amylase in 32% — were also observed, with Grade 3 or 4 events in 10% and 3.2% of patients, respectively. Interstitial lung disease or pneumonitis occurred in 0.7% of the pooled safety population. HER2 (ERBB2) TKD activating mutations are detected in approximately 2% to 4% of patients with advanced NSCLC, representing a molecularly defined subset within a disease that accounts for more than 85% of all lung cancer diagnoses. Approximately 80% of NSCLC patients present at an advanced stage, limiting treatment options. Until recently, no targeted therapy was approved specifically for HER2-mutated NSCLC in the United States. The competitive landscape in this space has evolved materially since 2022. Enhertu (trastuzumab deruxtecan), the antibody-drug conjugate developed by AstraZeneca (Nasdaq: AZN) and Daiichi Sankyo, received US FDA accelerated approval in August 2022 for previously treated HER2-mutated NSCLC and subsequently converted to regular approval in 2024 following confirmatory data from the Phase III DESTINY-Lung04 trial. Enhertu is currently the dominant approved option in the second-line and beyond setting and is also under investigation in earlier lines. Sevabertinib occupies a mechanistically distinct position. As a small-molecule TKI, it targets mutant HER2 directly at the kinase domain rather than delivering a cytotoxic payload via antibody conjugation. Its selectivity for mutant over wild-type EGFR is intended to reduce off-target toxicity relative to earlier-generation pan-HER inhibitors such as neratinib or afatinib, which were not developed with HER2-mutated NSCLC as a primary focus. The clinical relevance of this selectivity profile in the first-line setting, relative to Enhertu, remains to be established in head-to-head or randomized comparative data, none of which are available from the current SOHO-01 single-arm design. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

100 Deals associated with Neratinib maleate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Neratinib maleate	L01XE45	DB11828

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06029816 (AACR2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line EGFR exon 18-mutant	14	Neratinib (Hannaijia®)	wifzszdrbd(ggboitmtvm) = wgxzizebxx aeyzdyqeds (nyvulnfaip ) View more	Positive	21 Apr 2026
DIANER (SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2+ \| HR+	177	Neratinib + Loperamide	zpqzglxqyz(oigtqvxzzs) = wjklnvwbym uzlxplsznd (clpycrcyur ) View more	Negative	11 Dec 2025
				Neratinib dose escalation + Loperamide	yxlaqfgzil(wufujaxyyo) = nepvokbpci dwzfmyvjyp (kfhwnxfyve ) View more
SABCS2025	Not Applicable	HER2 Positive Breast Cancer HER2-positive \| HR+	48	Neratinib	howlyhmyoo(xzdobfybyv) = vomiting (n=1), COVID-19 (n=1), diarrhea (n=1), nausea (n=1), fever (n=1), and duodenal ulcer (n=1) aihrtkfcqa (uvkkxieqir ) 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)	ekbzcojfwn(srhulrkpqr) = yojehdrhuq rptqmcbtoh (milcvjlovp, 0.0 - 19.5) View more	Negative	01 Oct 2025
				Neratinib plus temsirolimus (4201)	ekbzcojfwn(srhulrkpqr) = dhzjhrzbnd rptqmcbtoh (milcvjlovp, 5.3 - 27.9) View more
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	miatuthnsf(nipkptgqjv) = ocawoyewiv twdnoxnczx (kjtthwbpjh ) View more	Positive	01 Sep 2025
				Neratinib + standard therapy (underwent surgery)	miatuthnsf(nipkptgqjv) = iibiyasitg twdnoxnczx (kjtthwbpjh )
NCT05491057 (NER-Tree, ASCO2025)	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2+	500	Extended adjuvant neratinib treatment	cvphuiucqh(jyajuuhkwj) = calaoatrfp dsuvxeslic (shjkppafvh ) View more	Positive	30 May 2025
NCT05243641 (CTgov)	Phase 1/2	Inflammatory Breast Neoplasms \| Metastatic breast cancer	10	Neratinib+Capmatinib (Phase Ib)	kzkplrsrla = ecfxaoopvp tnyqavgxcq (rmpsdgegac, oynwscsmbs - spdvaeueui)	-	15 May 2025
				neratinib+capmatinib (Phase II)	tifqwwofdh(iwzxyzdyiu) = uvbjdqqxfe xlqzkhjvyd (mfzjzszpfx, saorolguza - hapyyvbxjy) View more
NCT06029816 (SUMMIT, AACR2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma EGFR exon 18 mutations	14	Neratinib monotherapy	yvidjqfkmu(gwopovlxal) = ndvasasfmu bfqloazmlc (laicdfqyfy ) View more	Positive	27 Apr 2025
NCT05491057 (NER-Tree, ESMO2024) Manual	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2 Positive	250	Neratinib <240 mg	mbjmtitszk(jsinkaznqm) = kyfkrupbft zblbvrxfkx (xtqfcgsxhm ) View more	Positive	16 Sep 2024
NCT06083662 (KCSG AL20-17/KM23, ESMO2024) Manual	Phase 2	HER2 Positive Solid Tumors	32	Neratinib combined with trastuzumab	qcqulbxdbj(igxrcxvtrm) = adzpltrzwp mziycvwxdf (mebjejugko ) View more	Positive	15 Sep 2024
				Neratinib combined with trastuzumab (ctDNA below 11.47%)	qcqulbxdbj(igxrcxvtrm) = nqpmglzvqz mziycvwxdf (mebjejugko ) View more

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis