Lapatinib (GW572016) Clinical Trials

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25mg	USD 147
100mg	USD 270

Clinical Trials

Lapatinib has been extensively evaluated in numerous clinical trials across several oncology indications, prominently including breast, metastatic triple-negative breast, ovarian, head and neck, and renal cell carcinomas. Ranging from early phase through Phase 3 studies of monotherapy and combination regimens, these protocols encompass diverse recruitment statuses, including active, completed, terminated, and withdrawn trials. Research sponsors include academic medical centers such as the University of Kentucky, collaborative networks like UNICANCER and the EORTC, and industry partners including Novartis and GlaxoSmithKline.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02029001	RECRUITING	Malignant Solid Neoplasms	Centre Leon Berard	2014-03	PHASE2
NCT01947023	ACTIVE_NOT_RECRUITING	Metastatic Thyroid Gland Carcinoma; Unresectable Thyroid Gland Carcinoma	National Cancer Institute (NCI)	2013-09-27	PHASE1
NCT06313983	RECRUITING	Breast Cancer	Tianjin Hemay Pharmaceutical Co., Ltd	2022-01-08	PHASE3
NCT04591431	UNKNOWN	Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer	Fondazione per la Medicina Personalizzata	2020-10-07	PHASE2
NCT03500380	UNKNOWN	Breast Neoplasms; Breast Diseases; Capecitabine; HER2-positive Breast Cancer; HER2 Positive Breast Carcinoma; HER2-positive Advanced Breast With Liver Metastases	RemeGen Co., Ltd.	2018-04-24	PHASE2; PHASE3
NCT04608409	COMPLETED	Ovarian Cancer	Frederick R. Ueland, M.D.	2021-03-17	PHASE1
NCT01591577	COMPLETED	Newly Diagnosed Glioblastoma Multiforme	Jonsson Comprehensive Cancer Center	2012-12-07	PHASE2
NCT03784014	COMPLETED	Soft Tissue Sarcoma	Institut National de la Santé Et de la Recherche Médicale, France	2019-10-19	PHASE3
NCT00455039	Withdrawn	Breast Cancer	University of New Mexico	2023-07-31	Phase 1\|Phase 2
NCT03523585	COMPLETED	Breast Cancer	Daiichi Sankyo	2018-08-01	PHASE3
NCT01619111	COMPLETED	HER2-negative Metastatic Breast Cancer; HER2-positive Circulating Tumor Cells	Prof. Wolfgang Janni	2012-02	PHASE3
NCT02101905	COMPLETED	Anaplastic Astrocytoma; Anaplastic Ependymoma; Anaplastic Oligodendroglioma; Gliosarcoma; Mixed Glioma; Recurrent Adult Brain Neoplasm; Recurrent Glioblastoma	National Cancer Institute (NCI)	2016-11-07	PHASE1
NCT02158507	COMPLETED	Metastatic Triple Negative Breast Cancer	University of Alabama at Birmingham	2014-09-04
NCT01873833	TERMINATED	HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer	University of Southern California	2013-07-29	PHASE2
NCT04608409	Active not recruiting	Ovarian Cancer	Frederick R. Ueland M.D.\|National Cancer Institute (NCI)\|University of Kentucky	2021-03-17	Phase 1
NCT02650752	COMPLETED	Metastatic Breast Cancer; Central Nervous System (CNS) Metastases	Memorial Sloan Kettering Cancer Center	2016-01-06	PHASE1
NCT01711658	COMPLETED	Non-HPV Locally Advanced Head and Neck Cancer	Radiation Therapy Oncology Group	2013-03-15	PHASE2
NCT04185649	UNKNOWN	HER2-positive Advanced Breast Cancer	Bio-Thera Solutions	2018-07-01	PHASE3
NCT02213042	TERMINATED	Neoplasms, Breast	Novartis Pharmaceuticals	2014-10-24	PHASE2
NCT02362958	COMPLETED	HER2 Positive Breast Cancer	Sun Yat-sen University	2015-01-09	PHASE2
NCT00543504	COMPLETED	Advanced Cancer	M.D. Anderson Cancer Center	2007-10-10	PHASE1
NCT01622868	COMPLETED	HER2-Positive Breast Carcinoma; Invasive Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7	National Cancer Institute (NCI)	2012-12-06	PHASE2
NCT02836847	UNKNOWN	Cholangiocarcinoma of the Extrahepatic Bile Duct; Gallbladder Cancer	Shanghai Jiao Tong University School of Medicine	2016-07	PHASE2
NCT02230553	COMPLETED	Colorectal Cancer	The Netherlands Cancer Institute	2014-10-07	PHASE1; PHASE2
NCT03273595	UNKNOWN	Neoplasms, Breast	Xijing Hospital	2016-07	PHASE2
NCT03418558	UNKNOWN	Metastatic Colorectal Cancer	Fondazione del Piemonte per l'Oncologia	2015-07-08	PHASE2
NCT01783756	COMPLETED	Central Nervous System Metastases; HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer	Jonsson Comprehensive Cancer Center	2013-06-26	PHASE1; PHASE2
NCT03080805	UNKNOWN	HER2 Positive Metastatic Breast Cancer	Jiangsu HengRui Medicine Co., Ltd.	2017-05-03	PHASE3
NCT02073487	COMPLETED	Breast Cancer	The Methodist Hospital Research Institute	2014-02	PHASE2
NCT01827163	COMPLETED	HER2-Positive Early Stage Breast Cancer	Memorial Sloan Kettering Cancer Center	2013-04	PHASE2
NCT00939523	COMPLETED	Pituitary Adenomas; Prolactinomas	Cedars-Sinai Medical Center	2009-07	PHASE2
NCT02073916	COMPLETED	Metastatic Breast Cancer	Jenny C. Chang, MD	2013-10	PHASE1
NCT03225937	UNKNOWN	Metastatic Colorectal Cancer	Fondazione del Piemonte per l'Oncologia	2012-08	PHASE2
NCT03084939	COMPLETED	Breast Cancer	Hoffmann-La Roche	2017-04-24	PHASE3
NCT01808573	COMPLETED	HER2+ Metastatic Breast Cancer (MBC)	Puma Biotechnology, Inc.	2013-03-29	PHASE3
NCT00826241	COMPLETED	Brain Tumors; Spinal Cord Tumors	National Institutes of Health Clinical Center (CC)	2009-01	PHASE2
NCT03085368	UNKNOWN	HER2-positive Breast Cancer	Peking Union Medical College Hospital	2017-03-01	PHASE2; PHASE3
NCT03075995	UNKNOWN	Breast Cancer	Sun Yat-sen University	2017-04-12
NCT01273610	ACTIVE_NOT_RECRUITING	Breast Neoplasms; HER2/Neu Positive; Geriatric Health Services	City of Hope Medical Center	2011-04-20	PHASE2
NCT01636908	COMPLETED	Cancer; Advanced Solid Tumors	Amsterdam UMC, location VUmc	2011-08
NCT00450203	UNKNOWN	Oesophagogastric Cancer	Professor David Cunningham	2007-10	PHASE2; PHASE3
NCT01730677	UNKNOWN	Metastatic Breast Cancer	National Cancer Center, Korea	2012-07	PHASE2
NCT01190241	TERMINATED	Advanced Solid Tumors; Inoperable; Metastasis	Amsterdam UMC, location VUmc	2010-08
NCT02294786	TERMINATED	Cancer	Novartis Pharmaceuticals	2014-12-17	PHASE2
NCT01589861	TERMINATED	Breast Cancer	Institut Paoli-Calmettes	2011-12	PHASE1; PHASE2
NCT02238509	UNKNOWN	Metastatic Breast Cancer	Consorzio Oncotech	2014-11	PHASE2
NCT01104571	UNKNOWN	Breast Cancer	Institute of Cancer Research, United Kingdom	2010-04	PHASE3
NCT02015169	COMPLETED	HER2-positive Gastric Cancer Patients With Liver Metastasis	Samsung Medical Center	2012-07-09	PHASE2
NCT03075995	Unknown status	Breast Cancer	Sun Yat-sen University	2017-04-12	Not Applicable
NCT01300962	COMPLETED	Metastatic Breast Cancer	UNC Lineberger Comprehensive Cancer Center	2011-08	PHASE1
NCT01700010	WITHDRAWN	Urothelial Cancer; Bladder Cancer	University of Michigan Rogel Cancer Center	2012-11	PHASE2
NCT01875666	COMPLETED	Breast Neoplasms	UNC Lineberger Comprehensive Cancer Center	2013-08-05	EARLY_PHASE1
NCT01137994	WITHDRAWN	Neoplasms, Breast	GlaxoSmithKline	2011-10	PHASE2
NCT02394496	UNKNOWN	Metastatic Breast Cancer	Consorzio Oncotech	2007-11	PHASE3
NCT01891357	TERMINATED	Carcinoma, Ductal, Breast	Women's Cancer Study Group GmbH	2013-09-30	PHASE2
NCT01612351	COMPLETED	Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck	UNC Lineberger Comprehensive Cancer Center	2012-06	PHASE2
NCT01847599	TERMINATED	Metastatic Breast Cancer; Colorectal Cancer	Centre Jean Perrin	2011-09-06
NCT01771458	COMPLETED	Reccurent/Metastatic Solid Tumor Disease	Institut Curie	2012-10	PHASE2
NCT02422199	UNKNOWN	HER2 Positive Metastatic Breast Cancer	Jiangsu HengRui Medicine Co., Ltd.	2015-05	PHASE1; PHASE2
NCT00790816	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2008-10	PHASE1
NCT00721630	COMPLETED	Breast Cancer	Memorial Sloan Kettering Cancer Center	2008-07	PHASE2
NCT01973660	COMPLETED	Breast Cancer	SOLTI Breast Cancer Research Group	2013-10	PHASE2
NCT02338245	COMPLETED	Metastatic Breast Cancer	ASLAN Pharmaceuticals	2014-12-29	PHASE2
NCT02581124	COMPLETED	Anemia of Chronic Kidney Disease	Akros Pharma Inc.	2015-10	PHASE1
NCT01283789	UNKNOWN	Metastatic Breast Cancer	University of Kansas Medical Center	2011-02	PHASE2
NCT01160211	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2011-05-05	PHASE3
NCT01557764	WITHDRAWN	Breast Neoplasms	Washington University School of Medicine	2012-09	PHASE2
NCT01434303	COMPLETED	HER2/Neu Positive; Invasive Breast Carcinoma; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7	National Cancer Institute (NCI)	2012-01-10	PHASE1
NCT01934894	TERMINATED	Metastatic Breast Cancer With Intracranial Metastases	SCRI Development Innovations, LLC	2014-05	PHASE2
NCT02342587	COMPLETED	HER2-positive Refractory Advanced Cancer	Samsung Medical Center	2014-12-03	PHASE2
NCT02131506	TERMINATED	HER-2 Positive Breast Cancer; Malignant Neoplasm of Breast	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS	2009-12	PHASE1
NCT00508274	TERMINATED	Neoplasms, Breast	Novartis Pharmaceuticals	2007-07-18	PHASE3
NCT01497626	TERMINATED	Advanced Solid Tumors	Georgetown University	2011-09	PHASE1
NCT00759642	TERMINATED	Metastatic Breast Cancer	University of Kansas Medical Center	2009-03	PHASE2
NCT01526369	COMPLETED	Metastatic Breast Cancer	Cancer Trials Ireland	2012-02-13	PHASE3
NCT01479179	WITHDRAWN	Breast Cancer	M.D. Anderson Cancer Center	2012-11	PHASE1; PHASE2
NCT01044433	COMPLETED	Head and Neck Cancer; Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage IV Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity	Abramson Cancer Center at Penn Medicine	2009-10	PHASE2
NCT01087983	COMPLETED	Advanced Cancers	M.D. Anderson Cancer Center	2010-03	PHASE1
NCT00949455	UNKNOWN	Bladder Cancer	Queen Mary University of London	2009-03	PHASE2; PHASE3
NCT00883688	COMPLETED	Brain Cancer; Pediatric Cancers	M.D. Anderson Cancer Center	2009-07	PHASE2
NCT00912275	COMPLETED	Metastatic Breast Cancer	National Taiwan University Hospital	2008-11-24	PHASE1; PHASE2
NCT01454804	COMPLETED	Advanced Cancers	M.D. Anderson Cancer Center	2011-10	PHASE1
NCT01534455	TERMINATED	Metastatic Breast Cancer	GBG Forschungs GmbH	2012-02	PHASE2
NCT01985893	WITHDRAWN	Metastatic Breast Cancer	Berufsverband Niedergelassener Gynäkologischer Onkologen in Deutschland e.V.	2013-09	PHASE2
NCT01328054	COMPLETED	Cancer	GlaxoSmithKline	2011-12	PHASE4
NCT00662636	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Mayo Clinic	2008-08	PHASE1
NCT01868503	TERMINATED	Male Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer	Stanford University	2013-07	PHASE2
NCT02338245	Completed	Metastatic Breast Cancer	ASLAN Pharmaceuticals	2014-12-29	Phase 2
NCT02294786	Terminated	Cancer	Novartis Pharmaceuticals\|Novartis	2014-12-17	Phase 2
NCT01427322	TERMINATED	Epithelial Cancer	Virginia Commonwealth University	2011-09	EARLY_PHASE1
NCT01309607	UNKNOWN	ErbB2-Positive Stage I-III Breast Cancer	National University Hospital, Singapore	2011-04	PHASE2
NCT01395537	TERMINATED	Adenocarcinoma of the Esophagus; Adenocarcinoma of the Gastroesophageal Junction	Case Comprehensive Cancer Center	2011-08	PHASE1; PHASE2
NCT01499160	TERMINATED	Breast Neoplasms; Endocrine Breast Diseases; Neoplasm Metastasis	University of Maryland, Baltimore	2012-05	PHASE2
NCT00999804	ACTIVE_NOT_RECRUITING	Breast Cancer	Baylor Breast Care Center	2011-10	PHASE2
NCT01495884	TERMINATED	Her2 Positive Metastatic Breast Cancer	Cancer Trials Ireland	2011-03	PHASE1; PHASE2
NCT02158507	Active not recruiting	Metastatic Triple Negative Breast Cancer	University of Alabama at Birmingham\|Breast Cancer Research Foundation of Alabama\|GlaxoSmithKline\|AbbVie	2014-09	Not Applicable
NCT01658358	TERMINATED	Metastatic Breast Cancer	China Medical University Hospital	2012-07	PHASE1; PHASE2
NCT01485926	COMPLETED	Breast Cancer	Cancer Trials Ireland	2010-10	PHASE2
NCT00555152	COMPLETED	Ductal Breast Carcinoma In Situ; HER2/Neu Positive	National Cancer Institute (NCI)	2009-08-19
NCT01245205	COMPLETED	HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2010-11	PHASE1
NCT01218529	COMPLETED	Brain Metastases; Lung Tumors; Breast Tumors	Hellenic Cooperative Oncology Group	2010-10	PHASE2
NCT00863122	COMPLETED	Vestibular Schwannoma; NF2; Neurofibromatosis 2; Acoustic Neuroma; Auditory Tumor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2009-06	EARLY_PHASE1
NCT00390455	COMPLETED	Estrogen Receptor Positive; HER2 Positive Breast Carcinoma; HER2/Neu Negative; Progesterone Receptor Positive; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7	National Cancer Institute (NCI)	2006-09-15	PHASE3
NCT01238029	TERMINATED	Metastatic Breast Cancer; HER2 Positive; First or Second Line Therapy; Failure or Contraindication of Trastuzumab Therapy	Sponsor GmbH	2010-10	PHASE1
NCT01138384	COMPLETED	Breast Cancer	NCIC Clinical Trials Group	2010-10-27	PHASE1; PHASE2
NCT01161368	TERMINATED	Metastatic Breast Cancer	Central European Cooperative Oncology Group	2010-09	PHASE2
NCT01275859	COMPLETED	Breast Cancer	Asan Medical Center	2010-09	PHASE2
NCT01304784	COMPLETED	HER-2 Gene Amplification	Merrimack Pharmaceuticals	2011-01	PHASE1
NCT00807859	COMPLETED	Breast Cancer; Breast Neoplasms; Breast Tumors; Cancer; Locally Recurrent and Metastatic Breast Cancer; Metastases; Metastatic Cancer; Oncology; Solid Tumors; Tumors	Amgen	2009-03-09	PHASE1
NCT00968968	TERMINATED	Cancer	Novartis Pharmaceuticals	2010-01-20	PHASE3
NCT01306045	COMPLETED	Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell Lung; Carcinoma, Thymic	National Cancer Institute (NCI)	2011-02-08	PHASE2
NCT01769508	TERMINATED	HER2 Positive Esophagogastric Cancer	SCRI Development Innovations, LLC	2013-02	PHASE2
NCT01441596	COMPLETED	Breast Neoplasms; Neoplasm Metastasis	Boehringer Ingelheim	2011-10	PHASE2
NCT00770809	COMPLETED	Male Breast Carcinoma; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7	National Cancer Institute (NCI)	2009-02-24	PHASE3
NCT00684983	COMPLETED	HER2 Positive Breast Carcinoma; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7	National Cancer Institute (NCI)	2008-07-30	PHASE2
NCT01138046	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2010-04	PHASE2
NCT00490139	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2007-05-16	PHASE3
NCT00313599	COMPLETED	Bladder Cancer; Brain and Central Nervous System Tumors; Breast Cancer; Esophageal Cancer; Extragonadal Germ Cell Tumor; Gastric Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer	University of California, San Francisco	2006-02	PHASE1
NCT01477060	TERMINATED	Metastatic Breast Cancer	Fondazione Michelangelo	2011-11	PHASE2
NCT01281163	TERMINATED	Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Positive; Progesterone Receptor Negative; Progesterone Receptor Positive; Recurrent Breast Carcinoma; Stage IV Breast Cancer	National Cancer Institute (NCI)	2011-01	PHASE1
NCT01688609	COMPLETED	HER2-positive Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer	National Cancer Institute (NCI)	2012-07	PHASE2
NCT00470704	COMPLETED	Breast Cancer	Nancy Lin, MD	2007-05-14	PHASE2
NCT01264081	TERMINATED	Malignant Melanoma	National Cancer Institute (NCI)	2011-05-20	PHASE2
NCT01666431	TERMINATED	Squamous Cell Carcinoma	University of Zurich	2012-06	PHASE2
NCT00769470	COMPLETED	Breast Cancer	Translational Oncology Research International	2009-04	PHASE2
NCT00756470	TERMINATED	Breast Cancer	M.D. Anderson Cancer Center	2008-10	PHASE2
NCT01123473	TERMINATED	Adenocarcinoma of the Gastroesophageal Junction; Gastric Cancer	European Organisation for Research and Treatment of Cancer - EORTC	2010-12	PHASE2
NCT01382706	TERMINATED	Recurrent Bladder Cancer; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder	University of Southern California	2011-06-13	PHASE2
NCT00450892	COMPLETED	Breast Cancer	European Organisation for Research and Treatment of Cancer - EORTC	2007-02	PHASE1; PHASE2
NCT01184482	COMPLETED	Colorectal Cancer; Lung Cancer; Head and Neck Cancer	Georgetown University	2010-06	PHASE1
NCT00544804	COMPLETED	Breast Cancer; Metastatic Cancer	University of California, San Francisco	2007-08	PHASE1
NCT00103194	COMPLETED	Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer	National Cancer Institute (NCI)	2005-09	PHASE2
NCT01705340	TERMINATED	Adenocarcinoma of the Gastroesophageal Junction; HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Recurrent Esophageal Cancer; Recurrent Gastric Cancer; Stage IIIC Breast Cancer; Stage IIIC Esophageal Cancer; Stage IIIC Gastric Cancer; Stage IV Breast Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer	National Cancer Institute (NCI)	2012-09	PHASE1
NCT00688194	UNKNOWN	Breast Cancer	Gruppo Italiano Mammella (GIM)	2008-05	PHASE3
NCT00953576	TERMINATED	Prostate Cancer	Dana-Farber Cancer Institute	2009-09-29	PHASE1; PHASE2
NCT01454479	UNKNOWN	Recurrent Endometrial Cancer	Hung-Hsueh Chou	2011-03	PHASE1
NCT01290354	COMPLETED	Cancer	GlaxoSmithKline	2011-09-12	PHASE1
NCT00424255	COMPLETED	Neoplasms, Head and Neck	GlaxoSmithKline	2006-12	PHASE3
NCT01145404	TERMINATED	GastroEsophageal Cancer	National Center for Tumor Diseases, Heidelberg	2010-06	PHASE2
NCT01172223	COMPLETED	Breast Cancer	Prof Dirk Elling	2007-09	PHASE1; PHASE2
NCT00490061	TERMINATED	Head and Neck Cancer; Carcinoma, Squamous Cell; Head and Neck Cancers	Quynh-Thu Le	2007-07	PHASE2
NCT01272141	TERMINATED	Breast Neoplasms; Breast Cancer; Cancer of the Breast	Emory University	2010-12	PHASE2
NCT01199367	TERMINATED	Breast Cancer	Kyowa Kirin Co., Ltd.	2010-12	PHASE1
NCT00881621	TERMINATED	Pancreas Cancer	Georgetown University	2009-08	PHASE2
NCT01118975	TERMINATED	Breast Cancer; Neoplasm Metastasis	University of Maryland, Baltimore	2010-03	PHASE1; PHASE2
NCT00495872	COMPLETED	Solid Tumors	M.D. Anderson Cancer Center	2007-06	PHASE1
NCT00973739	COMPLETED	Neurofibromatosis 2; Vestibular Schwannoma	NYU Langone Health	2009-09	PHASE2
NCT00680901	COMPLETED	Neoplasms, Gastrointestinal Tract	Novartis Pharmaceuticals	2008-06-04	PHASE3
NCT00996762	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2009-11-12	PHASE1
NCT01013740	COMPLETED	Cancer	Novartis Pharmaceuticals	2009-11-25	PHASE2
NCT00667251	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2008-10-07	PHASE3
NCT01361945	WITHDRAWN	Breast Cancer; Metastatic Breast Cancer; HER-2 Positive Breast Cancer; ER Positive Breast Cancer	Texas Tech University Health Sciences Center, El Paso	2011-07	PHASE1; PHASE2
NCT00984425	COMPLETED	Solid Tumors	Istituto Clinico Humanitas	2009-09	PHASE1
NCT00246753	COMPLETED	Prostate Cancer	UNC Lineberger Comprehensive Cancer Center	2005-10	PHASE2
NCT00829166	COMPLETED	Breast Cancer	Hoffmann-La Roche	2009-02	PHASE3
NCT00820222	COMPLETED	Metastases, Brain	Novartis Pharmaceuticals	2009-04-14	PHASE3
NCT00623064	COMPLETED	Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter	European Organisation for Research and Treatment of Cancer - EORTC	2007-11	PHASE1
NCT00486668	UNKNOWN	Invasive Breast Cancer	NSABP Foundation Inc	2007-07	PHASE3
NCT01471847	COMPLETED	Locally Advance Breast Cancer (LABC); Metastatic Breast Cancer (MBC)	Novartis Pharmaceuticals	2012-02	PHASE1
NCT00429299	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2006-08	PHASE2
NCT00709618	TERMINATED	Neoplasms, Breast	GlaxoSmithKline	2008-06	PHASE2
NCT00903656	TERMINATED	Metastatic Breast Cancer	Arbeitsgemeinschaft medikamentoese Tumortherapie	2009-05	PHASE2
NCT01128543	COMPLETED	Cancer	GlaxoSmithKline	2009-04	PHASE2
NCT00967031	COMPLETED	Breast Cancer; Metastatic Cancer	UNICANCER	2009-04	PHASE2
NCT00486954	COMPLETED	Neoplasms, Gastrointestinal Tract	GlaxoSmithKline	2007-07	PHASE3
NCT00842998	UNKNOWN	Metastatic Breast Cancer	Azienda Ospedaliera Ordine Mauriziano di Torino	2009-02	PHASE2
NCT01262469	COMPLETED	Metastatic Breast Cancer; 70 Years Old Patients and Over; After One Line of Chemotherapy With Trastuzumab	UNICANCER	2009-12	PHASE2
NCT00841828	COMPLETED	Breast Cancer	Spanish Breast Cancer Research Group	2009-02	PHASE2
NCT00694252	COMPLETED	Metastatic Breast Cancer	University Hospital of Crete	2008-07	PHASE2
NCT01044485	COMPLETED	Metastatic Breast Cancer	Centre Georges Francois Leclerc	2008-11	PHASE1; PHASE2
NCT01005641	WITHDRAWN	Breast Cancer	National Cancer Institute, Naples	2009-12	PHASE2
NCT01245660	TERMINATED	Bladder Carcinoma; Infiltrative Bladder Carcinoma; Cystectomy	University Hospital, Bordeaux	2011-01	EARLY_PHASE1
NCT00225758	TERMINATED	Metastatic Breast Cancer	Gary Schwartz	2006-01	PHASE2
NCT00374322	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2006-08	PHASE3
NCT00963547	TERMINATED	Advanced Solid Tumors; Breast Cancer	Merck Sharp & Dohme LLC	2009-09-15	PHASE1
NCT00567554	COMPLETED	Breast Cancer	GBG Forschungs GmbH	2007-10	PHASE3
NCT00804310	TERMINATED	Unspecified Adult Solid Tumor, Protocol Specific	University of California, Davis	2009-08	PHASE1
NCT00316875	COMPLETED	Breast Cancer	Northwestern University	2006-05	PHASE1
NCT00826267	COMPLETED	Breast Neoplasms	Boehringer Ingelheim	2009-01	PHASE2
NCT00299286	COMPLETED	Breast Cancer	Institute of Cancer Research, United Kingdom	2007-06	PHASE2
NCT00820924	TERMINATED	Neoplasms, Breast	GlaxoSmithKline	2008-06	PHASE2
NCT00952692	COMPLETED	Metastatic Breast Cancer	Michael Morse, MD	2009-07	PHASE1; PHASE2
NCT00482391	COMPLETED	Breast Cancer	Memorial Sloan Kettering Cancer Center	2007-03	PHASE2
NCT00118157	COMPLETED	Estrogen Receptor Positive; Male Breast Carcinoma; Progesterone Receptor Positive; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer	National Cancer Institute (NCI)	2005-05	PHASE2
NCT00614978	COMPLETED	Metastatic Breast Cancer; Brain Metastases; HER2 Positive	Jules Bordet Institute	2008-01	PHASE1
NCT00206427	COMPLETED	Breast Cancer	Baylor Breast Care Center	2004-08	PHASE2
NCT00558103	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2007-12	PHASE2
NCT00526669	COMPLETED	Neoplasms, Gastrointestinal Tract	GlaxoSmithKline	2008-03	PHASE2
NCT00422903	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2007-04	PHASE2
NCT00821054	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2009-03-06	PHASE1
NCT00754702	TERMINATED	Breast Cancer	University Hospital of Crete	2008-10	PHASE2
NCT00096447	COMPLETED	Recurrent Endometrial Carcinoma	National Cancer Institute (NCI)	2004-11	PHASE2
NCT00682279	WITHDRAWN	Advanced Solid Tumors	GlaxoSmithKline	2008-09	PHASE1
NCT00113373	COMPLETED	Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer	National Cancer Institute (NCI)	2005-05	PHASE2
NCT00777101	COMPLETED	Advanced Breast Cancer; Breast Cancer	Puma Biotechnology, Inc.	2009-02-04	PHASE2
NCT00709761	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2008-07-02	PHASE2
NCT00548184	COMPLETED	Breast Cancer	Baylor Breast Care Center	2008-05	PHASE2
NCT00367471	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2006-12-07	PHASE1
NCT00404066	COMPLETED	Breast Cancer; Metastatic Breast Cancer	George Albert Fisher	2006-10	PHASE2
NCT01205217	WITHDRAWN	Neoplasms, Breast	GlaxoSmithKline	2010-12	PHASE2
NCT01050322	COMPLETED	BRMS1; Performance Status Zero to Two for Beginning the Study; Patient With a Maximum of One Chemotherapy; Patient With Progression After Taxanes	Latin American Cooperative Oncology Group	2009-11	PHASE2
NCT01068704	COMPLETED	Breast Cancer	Bristol-Myers Squibb	2010-06	PHASE2
NCT00962312	COMPLETED	Pancreatic Cancer	Cancer Trials Ireland	2009-01	PHASE2
NCT00820872	COMPLETED	Breast Cancer	Alliance for Clinical Trials in Oncology	2009-02	PHASE2
NCT00477464	COMPLETED	Metastatic Breast Cancer; Neoplasms, Breast	GlaxoSmithKline	2007-06	PHASE2
NCT00524303	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2007-08	PHASE2
NCT00516672	COMPLETED	Carcinoma, Renal Cell	GlaxoSmithKline	2007-09-10	PHASE1
NCT00857714	TERMINATED	Ductal Carcinoma in Situ	Indiana University	2009-04
NCT00095940	COMPLETED	Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Ependymoma; Recurrent Childhood Giant Cell Glioblastoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Gliosarcoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Oligodendroglioma	National Cancer Institute (NCI)	2004-10	PHASE1; PHASE2
NCT00281658	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2006-01-02	PHASE3
NCT00251433	TERMINATED	Neoplasms, Breast	Novartis Pharmaceuticals	2005-09-26	PHASE1
NCT00379509	COMPLETED	Breast Cancer	UNC Lineberger Comprehensive Cancer Center	2006-04	PHASE1
NCT00634088	TERMINATED	Locally Advanced or Metastatic Breast Cancer	R-Pharm	2008-06	PHASE1
NCT01133912	COMPLETED	Breast Cancer	Jungsil Ro	2009-03	PHASE1
NCT00553358	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2008-01-05	PHASE3
NCT00513058	COMPLETED	Breast Cancer	UNICANCER	2007-06	PHASE1
NCT00496366	TERMINATED	Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; HER2/Neu-positive Breast Cancer	Rutgers, The State University of New Jersey	2007-07-23	PHASE2
NCT00470847	COMPLETED	Breast Cancer; Brain Metastases	Nancy Lin, MD	2007-04	PHASE1
NCT00350727	COMPLETED	Glioma	GlaxoSmithKline	2006-12	PHASE2
NCT00849329	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2009-03-10	PHASE1
NCT00316407	COMPLETED	Ovarian Epithelial Cancer Stage III; Stage IV Ovarian Cancer; Stage IV Breast Cancer	Swedish Medical Center	2005-08	PHASE1; PHASE2
NCT00499681	TERMINATED	Breast Cancer	Vanderbilt-Ingram Cancer Center	2007-07	PHASE2
NCT00657137	TERMINATED	Breast Cancer	Tragara Pharmaceuticals, Inc.	2008-04	PHASE2
NCT00479856	TERMINATED	Relapsed Breast Cancer; Neoplasms, Breast	GlaxoSmithKline	2007-11	PHASE2
NCT00574171	COMPLETED	Metastatic Colorectal Cancer	University of Wisconsin, Madison	2007-09	PHASE2
NCT00272987	TERMINATED	Neoplasms, Breast	Novartis Pharmaceuticals	2005-12-13	PHASE3
NCT00388076	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2006-04-28	PHASE1
NCT00650910	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2008-04-23	PHASE1
NCT00424164	COMPLETED	Breast Cancer	European Organisation for Research and Treatment of Cancer - EORTC	2006-11	PHASE1
NCT00387127	COMPLETED	Neoplasms, Head and Neck	GlaxoSmithKline	2006-11	PHASE2
NCT00528281	COMPLETED	Lung Cancer, Non-Small Cell	GlaxoSmithKline	2007-09-20	PHASE1
NCT00169533	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2004-08-19	PHASE1
NCT00447226	TERMINATED	Cancer	GlaxoSmithKline	2007-05	PHASE2
NCT00107536	COMPLETED	Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer	National Cancer Institute (NCI)	2005-10	PHASE2
NCT00343759	WITHDRAWN	Breast Cancer	University of Pennsylvania	2006-06	PHASE2
NCT00320411	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2005-11-28	PHASE2
NCT00389922	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	University of California, Davis	2005-12	PHASE1
NCT00436566	COMPLETED	Breast Cancer; Cardiac Toxicity	Mayo Clinic	2007-03-16	PHASE2
NCT00436644	COMPLETED	Ovarian Cancer; Peritoneal Cavity Cancer	Mayo Clinic	2007-03	PHASE2
NCT00095563	COMPLETED	High-grade Salivary Gland Carcinoma; High-grade Salivary Gland Mucoepidermoid Carcinoma; Low-grade Salivary Gland Carcinoma; Low-grade Salivary Gland Mucoepidermoid Carcinoma; Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Recurrent Salivary Gland Cancer; Salivary Gland Acinic Cell Tumor; Salivary Gland Adenocarcinoma; Salivary Gland Adenoid Cystic Carcinoma; Salivary Gland Malignant Mixed Cell Type Tumor	National Cancer Institute (NCI)	2004-09	PHASE2
NCT00437073	TERMINATED	Neoplasms, Breast	GlaxoSmithKline	2007-05	PHASE2
NCT00101036	COMPLETED	Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer	National Cancer Institute (NCI)	2004-11	PHASE2
NCT00632489	COMPLETED	Breast Cancer	SCRI Development Innovations, LLC	2008-05	PHASE1
NCT00498953	COMPLETED	Head and Neck Cancer	European Organisation for Research and Treatment of Cancer - EORTC	2007-05	PHASE1; PHASE2
NCT00753207	COMPLETED	Breast Cancer	Cancer Trials Ireland	2007-10	PHASE1
NCT00536809	COMPLETED	Neoplasms, Colorectal	GlaxoSmithKline	2007-09-26	PHASE1
NCT00347919	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2006-07	PHASE2
NCT00447122	TERMINATED	Metastatic Pancreatic Cancer	Brown University	2007-03	PHASE1
NCT00444535	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2007-02-27	PHASE2
NCT00430781	COMPLETED	Neoplasms, Uterine Cervix; Metastatic Cervical Cancer	GlaxoSmithKline	2006-11	PHASE2
NCT00073008	TERMINATED	Lung Cancer, Non-Small Cell	GlaxoSmithKline	2003-11	PHASE2
NCT00073528	COMPLETED	Breast Neoplasms	Novartis Pharmaceuticals	2003-12-09	PHASE3
NCT00513253	WITHDRAWN	Healthy Subjects	GlaxoSmithKline	2008-04	PHASE1
NCT00356811	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2006-05	PHASE2
NCT00089999	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2004-06	PHASE2
NCT00359190	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2004-06-29	PHASE1
NCT00371488	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2006-04-06	PHASE1
NCT00107003	COMPLETED	Glioma; Brain Tumor; Glioblastoma Multiforme; GBM; Gliosarcoma; GS	National Cancer Institute (NCI)	2005-03-30	PHASE2
NCT00371566	COMPLETED	Squamous Cell Carcinoma of Head and Neck	GlaxoSmithKline	2006-03	PHASE2
NCT00099060	COMPLETED	Brain and Central Nervous System Tumors	National Cancer Institute (NCI)	2004-12	PHASE1; PHASE2
NCT00095667	COMPLETED	Recurrent Prostate Cancer; Stage IV Prostate Cancer	National Cancer Institute (NCI)	2004-11	PHASE2
NCT00263588	COMPLETED	Neoplasms, Breast	Novartis Pharmaceuticals	2005-12-02	PHASE2
NCT00105950	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2005-03	PHASE2
NCT00158782	COMPLETED	Carcinoma, Renal Cell	GlaxoSmithKline	2004-09-28	PHASE1
NCT00352443	COMPLETED	Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific	SWOG Cancer Research Network	2006-09	PHASE1
NCT00320385	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2005-11	PHASE3
NCT00103324	COMPLETED	Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage III Gastric Cancer; Stage IV Gastric Cancer	National Cancer Institute (NCI)	2004-12	PHASE2
NCT00317434	TERMINATED	Ovarian Cancer	University of Alabama at Birmingham	2005-11	PHASE1
NCT00258050	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2005-11-21	PHASE1
NCT00098631	COMPLETED	Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Salivary Gland Squamous Cell Carcinoma; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Untreated Metastatic Squamous Neck Cancer With Occult Primary	National Cancer Institute (NCI)	2004-10	PHASE2
NCT00331630	COMPLETED	Breast Cancer	Northwestern University	2006-05-04	EARLY_PHASE1
NCT00111787	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2005-04-11	PHASE2
NCT00114283	COMPLETED	Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer	National Cancer Institute (NCI)	2005-03	PHASE2
NCT00075270	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2004-01	PHASE3
NCT00098605	COMPLETED	Central Nervous System Metastases; HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer; Tumors Metastatic to Brain	National Cancer Institute (NCI)	2004-10	PHASE2
NCT00239200	TERMINATED	Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus	University of Michigan Rogel Cancer Center	2005-10	PHASE2
NCT00078572	COMPLETED	Breast Cancer	GlaxoSmithKline	2004-03	PHASE3
NCT00148902	COMPLETED	Neoplasms, Breast	GlaxoSmithKline	2003-04-28	PHASE1
NCT00085020	COMPLETED	Breast Cancer	Jonsson Comprehensive Cancer Center	2004-03	PHASE1
NCT00044343	COMPLETED	Colorectal Cancer	GlaxoSmithKline	2002-09	PHASE2
NCT00259987	COMPLETED	Adenocarcinoma	GlaxoSmithKline	2005-11	PHASE2
NCT00888810	TERMINATED	Cancer; Ovarian; Relapse; Chemotherapy	Centre Francois Baclesse	2008-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-29)

Check the Lapatinib (GW572016) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lapatinib functions as a potent dual inhibitor of epidermal growth factor receptor (EGFR) and ErbB2 tyrosine kinases, effectively blocking receptor autophosphorylation and downstream signal transduction pathways. This biochemical blockade induces ferroptosis and autophagic cell death, suppressing tumor cell outgrowth and providing clinical efficacy in HER2-overexpressing malignancies such as breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).