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+ [24]

Inactive Indication

Advanced HER2-Positive Breast CarcinomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Malignant Solid Neoplasm+ [14]

Originator Organization

Pfizer Inc.

Active Organization

Puma Biotechnology, Inc.Specialised Therapeutics Asia Pte Ltd.Pierre Fabre Médicament SAS

+ [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

ITMCTR2026002158

/ SuspendedPhase 3IIT

A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial evaluating Shenling Baizhu Powder combined with standard prophylaxis for the reduction of diarrhea associated with neratinib extended adjuvant therapy in patients with early-stage HER2-positive breast cancer

Start Date01 Jan 2027

Sponsor / Collaborator-

ChiCTR2600127696

/ SuspendedPhase 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-

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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884

Literatures (Medical) associated with Neratinib maleate

01 Nov 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

Machine Learning Model Predicts Clinical Adverse Events of Small Molecule Kinase Inhibitors in Cancer Patients Using On‐/Off‐Target Engagement and Tissue Selectivity

Article

Author: Cao, Albert ; Jusko, Natalie M. ; Sun, Duxin

Adverse events (AEs) of small molecule kinase inhibitors (SMKIs) at therapeutic doses in cancer patients are largely unpredictable in phase I–III studies and clinical use, despite extensive preclinical toxicity testing under good laboratory practice conditions. To address this gap, we developed a machine learning (ML) framework to predict the occurrence and time to onset of clinical AEs caused by SMKIs using on‐/off‐target engagement and tissue/cell selectivity. The analysis included 1939 unique AEs from 3,433 patients treated with 16 SMKIs. On‐/off‐target engagement was evaluated by linking the inhibition (Ki) constants and expression of 442 kinase targets to SMKI exposure, expressed as dose‐normalized AUC across plasma and 36 tissues. For each AE, we constructed random survival forest models composed of ensembles of binary decision trees, evaluated predictive accuracy using the concordance index, and applied variable importance (VIMP) measures to identify kinase targets potentially responsible for tissue‐specific AEs. The final models successfully predict the most common AEs (rash, nausea, fatigue, headache) along with the most severe hematological AEs (neutropenia, leukopenia, lymphopenia, thrombocytopenia, anemia). VIMP analyses highlighted previously unrecognized kinases potentially involved in tissue‐specific AE profiles. External validation using data from a Phase II neratinib monotherapy trial demonstrated strong model performance, yielding Pearson correlation coefficients (PCCs) ≥ 0.87 between predicted and observed AE incidences. These findings show that integrating exposure, on‐/off‐target engagement, and tissue‐specific selectivity enables robust prediction of the likelihood of SMKI‐associated AEs for both blood‐ and organ‐related toxicities, offering a scalable approach at both the patient‐ and population‐level.

01 Oct 2026·BREAST

Patient-reported outcomes from the TBCRC 022 study of neratinib and ado-trastuzumab emtansine for HER2-positive breast cancer brain metastases

Article

Author: Mayer, Erica L ; Freedman, Rachel A ; Rocque, Gabrielle ; Brufsky, Adam M ; Nangia, Julie R ; Lin, Nancy U ; Van Poznak, Catherine ; Ruddy, Kathryn J ; DeMeo, Michelle K ; Grinda, Thomas ; Heiling, Hillary M ; Rauf, Yasmeen ; Davis, Raechel ; O'Sullivan, Ciara C ; Santa-Maria, Cesar A ; Winer, Eric P ; Moy, Beverly ; Savoie, Jennifer ; Melisko, Michelle E ; Tayob, Nabihah ; Isaacs, Claudine ; Smith, Karen L ; Burns, Robyn T ; Tolaney, Sara M ; Wolff, Antonio C ; Cotter, Christine ; Rimawi, Mothaffar F ; Krop, Ian E

PURPOSE:

In TBCRC 022 (NCT01494662), neratinib and ado-trastuzumab emtansine (T-DM1) demonstrated intracranial activity among patients with HER2-positive breast cancer brain metastases. However, gastrointestinal (GI) toxicities-particularly diarrhea-were common, potentially impacting quality of life. Clinician-reported adverse event (CTCAE) grading may underestimate the patient experience. We report GI toxicities using patient-reported outcomes (PROs) in TBCRC's neratinib-T-DM1 cohort.

METHODS:

Patients received neratinib (160 mg daily) and T-DM1 (3.6 mg/kg IV every 21 days). A pre-planned analysis assessed patient-reported GI toxicities during Cycles 1-4 using the Patient-reported Outcomes Measurement Information System (PROMIS) GI Diarrhea scale, Systemic Therapy-Induced Diarrhea Assessment Tool (STIDAT), and PRO-CTCAE. Descriptive statistics and linear mixed effects models evaluated symptom trajectories over time. We evaluated agreement for PRO and clinician-reported data.

RESULTS:

Forty-four patients enrolled; all completed ≥1 PRO. GI symptom burden increased over Cycles 1-3. PROMIS scores worsened significantly by Cycle 2, with a peak mean increase of 6.62 (95% confidence interval (CI): 2.67-10.59; p = 0.002) at Cycle 3. STIDAT scores also worsened by Cycle 3 (mean change 0.50; 95%CI: 0.11-0.90; p = 0.015). Based on maximum PRO-CTCAE scores, moderate-to-severe symptoms were reported by 20.5% (diarrhea), 24.4% (appetite loss), and 41.0% (constipation). Agreement between PRO-CTCAE and clinician-reported CTCAE was low (kappa <0.2) with clinicians reporting less toxicity. PROMIS and STIDAT scores were significantly correlated.

CONCLUSION:

This GI-focused PRO analysis highlights the value of PROs in capturing patient-experienced toxicities that impact quality of life yet are underestimated by clinicians. Incorporating PROs into clinical trials can inform supportive care and prophylactic strategies.

15 Sep 2026·ACS Omega

Electrochemical Behavior of Neratinib at a Boron-Doped Diamond Electrode: Role of Tween 20 in Interfacial Signal Enhancement

Article

Author: Meraki, Gülsüm Ece ; Uslu, Bengi ; Silah, Hülya

Abstract:

Neratinib (NER) is an irreversible tyrosine kinase inhibitor employed in the therapy of HER2-positive breast cancer. In the present research, the electrochemical oxidation of NER at a boron-doped diamond electrode (BDDE) was surveyed with particular emphasis on the act of surfactant-mediated interfacial influences. Cyclic and differential pulse voltammetry were used to characterize the oxidation behavior of NER and to establish an analytical approach for its determination. Among the explored anionic, cationic, and nonionic surfactant species, Tween 20 produced the most proper electrochemical reply, obviously augmenting the anodic peak current and improving signal stability. Electrochemical impedance spectroscopy (EIS) further represented that Tween 20 considerably revised the electrolyte/BDDE interface, increasing the charge-transfer resistance of the ferri/ferrocyanide redox probe from 510 to 1822 Ω. Importantly, this increment in interfacial resistance comprised concurrently with enhancement of the NER voltammetric response, indicating that Tween 20 does not act through a nonspecific acceleration of electron-transfer kinetics. Conversely, the monitored signal enhancement is consistent with affirmative NER–surfactant interplays and a modified interfacial microenvironment that assists the electrochemical accessibility of NER. Scan-rate and pH-dependent investigations defined that NER undergoes an irreversible, predominantly diffusion-controlled oxidation involving proton-coupled electron transfer. Under the optimized experimental conditions at pH 7.02 containing 100 μM Tween 20, the DPV signal was linear the NER concentration between 0.03–1.50 μM (16.7–836 ng mL–1). The limits of detection and quantification were 5.09 nM (2.84 ng mL–1) and 15.16 nM (8.44 ng mL–1), respectively. Overall, the outcomes demonstrate that the analytical enhancement of NER at BDDE originates from surfactant-mediated, analyte-specific interfacial impacts and ensure a mechanistic basis for its sensitive voltammetric determination.

171

News (Medical) associated with Neratinib maleate

06 Oct 2026

·www.biospace.com

Puma Biotechnology Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4) - October 5, 2026

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on October 1, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of an inducement restricted stock unit award covering 7,500 shares of Puma common stock to one new non-executive employee. The award was 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 award vests 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, October 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 award was granted as an inducement material to the new employee 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. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. 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

17 Sep 2026

·www.biospace.com

Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA ® -Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757 ) of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The ALISCA ® -Lung2 trial is a sequential dose escalation study that will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy. The primary endpoint of the trial is the safety and tolerability of alisertib when administered with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival. Puma will also evaluate clinical biomarkers to help identify which patients have the greatest benefit to guide the future development of alisertib. Taofeek K. Owonikoko, MD, PhD and Chair of the trial’s Steering Committee, said, “Treatment options for patients with small cell lung cancer that has progressed following platinum-based chemotherapy and immunotherapy remain limited, and there is an urgent need for new treatment approaches for these patients. I am pleased to see further evaluation of alisertib in these patients." Dr. Owonikoko is the Executive Director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, and the Kevin J. Cullen, MD Distinguished Professor of Oncology at the University of Maryland School of Medicine. He added, “The results from previous clinical trials of alisertib in small cell lung cancer, including those in combination with paclitaxel, suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib.” Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, “We are pleased to initiate this Phase II trial, and we hope that the study will provide important insight into the safety and clinical activity of alisertib in combination with paclitaxel in patients with small cell lung cancer. We are continuing to advance alisertib monotherapy in the ALISCA ® -Lung1 trial as well, and we view the ALISCA ® -Lung2 trial as additive to the clinical development of alisertib in small cell lung cancer. We look forward to the progress of both the ALISCA ® -Lung1 and ALISCA ® -Lung2 trials, as well as our other ongoing clinical programs, in the months ahead.” 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. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s expectations regarding the development of alisertib and clinical trials involving alisertib. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. 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

Phase 2Drug ApprovalLicense out/inImmunotherapy

09 Sep 2026

·www.biospace.com

Puma Biotechnology to Present at H.C. Wainwright’s 28th Annual Global Investment Conference

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, will provide an overview of Puma at 3:30 p.m. ET on Monday, September 14, at the H.C. Wainwright 28th Annual Global Investment Conference. The conference will be held September 14-16, 2026 at the Lotte New York Palace Hotel in New York City. A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . The presentation will be archived on the website and available for 30 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. 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

100 Deals associated with Neratinib maleate

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External Link

KEGG	Wiki	ATC	Drug Bank
D08950 D10898	Neratinib maleate	L01EH02	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	qsisrhtjao(hkllpwqixx) = 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). lgjqezxgqy (sgtcwfkbcm )	Positive	07 May 2026
NCT06029816 (AACR2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line EGFR exon 18-mutant	14	Neratinib (Hannaijia®)	rabonqfbza(fdhwikxwvd) = kccheegbyf qyvgdafzdn (remwfcogkl ) View more	Positive	21 Apr 2026
SABCS2025	Not Applicable	HER2 Positive Breast Cancer HER2-positive \| HR+	48	Neratinib	xgzhbodoxf(tnfnlwfowh) = vomiting (n=1), COVID-19 (n=1), diarrhea (n=1), nausea (n=1), fever (n=1), and duodenal ulcer (n=1) rcvupzbvnk (ygunwvomkx ) View more	Positive	11 Dec 2025
DIANER (SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2+ \| HR+	177	Neratinib + Loperamide	jqfjnsygpo(nwfedvprxw) = xlrmbutvrx gppjkmnkgc (rdcunxxwmg ) View more	Negative	11 Dec 2025
				Neratinib dose escalation + Loperamide	vxkgpmdxpc(pmdectwsrf) = styjqgtyrm mqtrphzvvn (yjmuentlds ) View more
INTUITT-NF2 (SNO2025)	Phase 2	Neurofibromatosis 2	20	Neratinib	jvfxyvuwky(epjuanhxep) = jyvigrnjyj xejnniaeza (gbbzntkzjr ) View more	Positive	19 Nov 2025
				Neratinib (target tumors)	jvfxyvuwky(epjuanhxep) = rimucusvfd xejnniaeza (gbbzntkzjr )
NCT01827267 \| NCT01953926 (PUMA-NER-4201, Pubmed \| Clin Lung Cancer)	Phase 2	Adenocarcinoma of Lung ERBB2 mutations	138	Neratinib (4201)	wsxmvwbtfv(cbeisoynaq) = sznbrfchox bkhbdjlcmf (frpzmqfjga, 0.0 - 19.5) View more	Negative	01 Oct 2025
				Neratinib plus temsirolimus (4201)	wsxmvwbtfv(cbeisoynaq) = tnjehxieke bkhbdjlcmf (frpzmqfjga, 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	yxzmumiern(bptcqtrvqf) = rgbcopfshp tztruflagx (tldddifaja ) View more	Positive	01 Sep 2025
				Neratinib + standard therapy (underwent surgery)	yxzmumiern(bptcqtrvqf) = ratptexllx tztruflagx (tldddifaja )
NCT05491057 (NER-Tree, ASCO2025)	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2+	500	Extended adjuvant neratinib treatment	bfbrsfuzkz(bbktzqjchu) = tpgctmzsbg irxgctzage (tkqanxbwum ) View more	Positive	30 May 2025
NCT05243641 (CTgov)	Phase 1/2	Inflammatory Breast Neoplasms \| Metastatic breast cancer	10	Neratinib+Capmatinib (Phase Ib)	htizjynmyu = vtzjytbkul laoisnzqtp (dbmxrrehpb, gjqbgcddxy - vsbvilddqb)	-	15 May 2025
				neratinib+capmatinib (Phase II)	szestpxjry(kibxgrrmgu) = tbdpalavtm btkcrzwkfn (rqujanbosd, bxjjdcycxw - smctjssckf) View more
NCT06029816 (SUMMIT, AACR2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma EGFR exon 18 mutations	14	Neratinib monotherapy	xvlsopjtyt(qvpsnkqhia) = rwawhzmcea hlnutsplmz (yoldygnufu ) View more	Positive	27 Apr 2025