Vismodegib (GDC-0449) Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 370

Clinical Trials

Vismodegib has been evaluated in numerous clinical trials ranging from Early Phase 1 through Phase 4, primarily targeting locally advanced and metastatic basal cell carcinoma, as well as other oncological and fibrotic conditions including triple-negative breast carcinoma, pancreatic adenocarcinoma, ovarian cancer, glioblastoma, myelofibrosis, and idiopathic pulmonary fibrosis. Encompassing actively recruiting, completed, and terminated protocols, these studies are supported by major pharmaceutical sponsors like Genentech and Hoffmann-La Roche, academic centers, and government entities such as the National Cancer Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05538091	RECRUITING	Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; PARP Inhibitor; Hedgehog Inhibitor	Ronald Buckanovich	2023-05-15	PHASE2
NCT05561634	RECRUITING	Basal Cell Carcinoma; Radiotherapy; Complications	University Hospital, Lille	2023-06-20	PHASE2
NCT04341181	RECRUITING	Cancer; Tumors; Neoplasms; Neoplasia	Ulrik Lassen	2020-08-24	PHASE2
NCT05651828	RECRUITING	Advanced Basal Cell Carcinoma	H. Lee Moffitt Cancer Center and Research Institute	2023-03-23	EARLY_PHASE1
NCT01878617	ACTIVE_NOT_RECRUITING	Medulloblastoma	St. Jude Children's Research Hospital	2013-06-23	PHASE2
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT02523014	RECRUITING	Intracranial Meningioma; Recurrent Meningioma; NF2 Gene Mutation	Alliance for Clinical Trials in Oncology	2015-09-28	PHASE2
NCT02465060	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma	National Cancer Institute (NCI)	2015-08-17	PHASE2
NCT03297606	RECRUITING	Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors	Canadian Cancer Trials Group	2018-03-23	PHASE2
NCT06616623	RECRUITING	Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8	Dwight Owen	2024-12-31	PHASE1
NCT05159245	RECRUITING	Advanced Cancer; Solid Tumor; Haematological Malignancy	Helsinki University Central Hospital	2021-12-10	PHASE2
NCT06344052	RECRUITING	Basal Cell Carcinoma	Stamford Pharmaceuticals, Inc.	2024-04-09	PHASE2
NCT05238831	WITHDRAWN	Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8	OHSU Knight Cancer Institute	2023-01-30	EARLY_PHASE1
NCT06344052	Recruiting	Basal Cell Carcinoma	Stamford Pharmaceuticals Inc.	2024-04-09	Phase 2
NCT02091141	COMPLETED	Neoplasms; Solid Tumors; Biliary Cancer; Salivary Cancer; Bladder Cancer	Genentech, Inc.	2014-04-14	PHASE2
NCT03158389	COMPLETED	Glioblastoma, Adult	University Hospital Heidelberg	2018-05-07	PHASE1; PHASE2
NCT03498521	COMPLETED	Cancer of Unknown Primary Site	Hoffmann-La Roche	2018-07-10	PHASE2
NCT06357988	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma	National Cancer Institute (NCI)	2016-06-20	PHASE2
NCT02073838	COMPLETED	Acute Myeloid Leukemia	Sarit Assouline	2015-05	PHASE2
NCT03610022	COMPLETED	Metastatic Basal Cell Carcinoma; Locally Advanced Basal Cell Carcinoma	University Hospital, Bordeaux	2018-09-03	PHASE4
NCT03878524	TERMINATED	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma	OHSU Knight Cancer Institute	2020-04-01	PHASE1
NCT02436408	COMPLETED	Carcinoma, Basal Cell	University of Michigan Rogel Cancer Center	2015-07-15	PHASE4
NCT02667574	COMPLETED	Basal Cell Carcinoma	University Hospital, Lille	2014-11-18	PHASE2
NCT03035188	COMPLETED	Basal Cell Carcinoma	SRH Wald-Klinikum Gera GmbH	2017-01	PHASE2
NCT03052478	COMPLETED	Stomach Neoplasms	Samsung Medical Center	2017-02-10	PHASE2
NCT03767439	WITHDRAWN	Basal Cell Nevus Syndrome	Columbia University	2019-07	PHASE2
NCT01835626	COMPLETED	Locally Advanced Basal Cell Carcinoma; Skin Cancer; Cutaneous Malignancy	Sue Yom	2013-05	PHASE2
NCT02366312	COMPLETED	Keratocystic Odontogenic Tumor	NYU College of Dentistry	2015-10-27	PHASE2
NCT02956889	TERMINATED	Carcinoma, Basal Cell	Istituto Clinico Humanitas	2016-10	PHASE2
NCT03610022	Completed	Metastatic Basal Cell Carcinoma\|Locally Advanced Basal Cell Carcinoma	University Hospital Bordeaux	2018-09-03	Phase 4
NCT01267955	ACTIVE_NOT_RECRUITING	Clear Cell Chondrosarcoma; Dedifferentiated Chondrosarcoma; Locally Advanced Chondrosarcoma; Mesenchymal Chondrosarcoma; Metastatic Chondrosarcoma; Primary Central Chondrosarcoma; Unresectable Primary Central Chondrosarcoma	National Cancer Institute (NCI)	2010-12-21	PHASE2
NCT02337517	TERMINATED	Chronic Graft Versus Host Disease	National Cancer Institute (NCI)	2015-09-08	PHASE2
NCT01537107	COMPLETED	Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Mayo Clinic	2012-03-05	PHASE1
NCT01088815	COMPLETED	Metastatic Pancreatic Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2010-09-17	PHASE2
NCT02694224	UNKNOWN	Breast Cancer	Clinica Universidad de Navarra, Universidad de Navarra	2016-04	PHASE2
NCT02690948	COMPLETED	Skin Basal Cell Carcinoma	Anne Chang	2016-02-01	PHASE1; PHASE2
NCT01601184	TERMINATED	Histologically Confirmed Medulloblastoma; Activation of the Sonic Hedgehog (SHH) Pathway	Centre Leon Berard	2012-06	PHASE1; PHASE2
NCT01700049	COMPLETED	Basal Cell Carcinoma	Mayo Clinic	2013-01-14	PHASE2
NCT01367665	COMPLETED	Basal Cell Carcinoma	Hoffmann-La Roche	2011-07-01	PHASE2
NCT02593760	COMPLETED	Myelofibrosis	Hoffmann-La Roche	2016-01-25	PHASE1
NCT01893892	COMPLETED	Musculoskeletal Complications	Stanford University	2014-03
NCT03035188	Completed	Basal Cell Carcinoma	SRH Wald-Klinikum Gera GmbH	2017-01	Phase 2
NCT02168530	WITHDRAWN	Idiopathic Pulmonary Fibrosis	Hoffmann-La Roche	2014-10	PHASE2
NCT02067104	TERMINATED	Basal Cell Carcinomas	University of Arizona	2014-02-17	PHASE2
NCT02648048	COMPLETED	Idiopathic Pulmonary Fibrosis	Hoffmann-La Roche	2016-01-15	PHASE1
NCT00887159	COMPLETED	Extensive Stage Small Cell Lung Carcinoma; Recurrent Small Cell Lung Carcinoma	National Cancer Institute (NCI)	2009-07-16	PHASE2
NCT02639117	COMPLETED	Basal Cell Carcinoma	University of Arizona	2015-11-30	PHASE1
NCT02781389	Completed	Basal Cell Carcinoma	University Hospital Essen\|OnkoDataMed GmbH	2016-04-29	--
NCT02115828	COMPLETED	Prostate Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2014-04	EARLY_PHASE1
NCT01898598	TERMINATED	Basal Cell Carcinoma	Hoffmann-La Roche	2014-01-23	PHASE2
NCT02593760	Completed	Myelofibrosis	Hoffmann-La Roche	2016-01-25	Phase 1
NCT02648048	Completed	Idiopathic Pulmonary Fibrosis	Hoffmann-La Roche	2016-01-15	Phase 1
NCT01556009	COMPLETED	Basal Cell Nevus Syndrome; Gorlin's Syndrome	UCSF Benioff Children's Hospital Oakland	2012-04	PHASE2
NCT01774253	TERMINATED	Pontine Glioma	Giselle Sholler	2013-05	PHASE2
NCT01631331	COMPLETED	Basal Cell Carcinoma of the Skin; Recurrent Skin Cancer	Stanford University	2012-06	EARLY_PHASE1
NCT01815840	COMPLETED	Basal Cell Carcinoma	Hoffmann-La Roche	2013-04-30	PHASE2
NCT01154452	COMPLETED	Adult Alveolar Soft Part Sarcoma; Adult Angiosarcoma; Adult Desmoplastic Small Round Cell Tumor; Adult Epithelioid Hemangioendothelioma; Adult Epithelioid Sarcoma; Adult Extraskeletal Myxoid Chondrosarcoma; Adult Extraskeletal Osteosarcoma; Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Liposarcoma; Adult Malignant Mesenchymoma; Adult Malignant Peripheral Nerve Sheath Tumor; Adult Rhabdomyosarcoma; Adult Synovial Sarcoma; Adult Unclassified Pleomorphic Sarcoma; Chondrosarcoma; Clear Cell Sarcoma of the Kidney; Conjunctival Kaposi Sarcoma; Dermatofibrosarcoma Protuberans; Gastrointestinal Stromal Tumor; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Osteosarcoma; Ovarian Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Adult Unclassified Pleomorphic Sarcoma of Bone; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Kaposi Sarcoma; Recurrent Osteosarcoma; Recurrent Uterine Corpus Sarcoma; Small Intestine Leiomyosarcoma; Stage III Adult Soft Tissue Sarcoma; Stage III Uterine Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Stage IV Uterine Sarcoma; Unclassified Pleomorphic Sarcoma of Bone	National Cancer Institute (NCI)	2010-06	PHASE1; PHASE2
NCT01174264	COMPLETED	Malignant Neoplasm	National Cancer Institute (NCI)	2009-10	PHASE1; PHASE2
NCT01880437	TERMINATED	Myelodysplastic Syndromes, Myelogenous Leukemia, Acute	Hoffmann-La Roche	2013-09	PHASE2
NCT01330173	COMPLETED	DS Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma	National Cancer Institute (NCI)	2010-12	PHASE1
NCT01944943	TERMINATED	Diffuse Large B-cell Lymphoma; Indolent Non-hodgkin Lymphoma; Primary Central Nervous System Lymphoma; Chronic Lymphocytic Leukemia	The Lymphoma Academic Research Organisation	2013-02	PHASE2
NCT01071564	TERMINATED	Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Triple-Negative Breast Carcinoma	National Cancer Institute (NCI)	2009-11	PHASE1
NCT01713218	UNKNOWN	Pancreatic Adenocarcinoma Resectable	Jean-Luc Van Laethem	2012-12	EARLY_PHASE1
NCT01239316	COMPLETED	Recurrent Childhood Medulloblastoma	National Cancer Institute (NCI)	2010-11	PHASE2
NCT01546519	COMPLETED	Cancer	Genentech, Inc.	2012-03	PHASE1
NCT00959647	COMPLETED	Ovarian Cancer; Basal Cell Carcinoma; Metastatic Colorectal Cancer	Genentech, Inc.	2009-09-03	PHASE2
NCT00957229	COMPLETED	Basal Cell Nevus Syndrome; Gorlin Syndrome	UCSF Benioff Children's Hospital Oakland	2009-08	PHASE2
NCT00822458	COMPLETED	Recurrent Childhood Medulloblastoma	National Cancer Institute (NCI)	2009-01	PHASE1
NCT01195415	COMPLETED	Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer	National Cancer Institute (NCI)	2010-06	PHASE2
NCT01543581	COMPLETED	Basal Cell Carcinoma	Abel Torres, MD	2012-05	PHASE2
NCT01201915	COMPLETED	Basal Cell Carcinoma	Genentech, Inc.	2010-10	PHASE2
NCT00939484	COMPLETED	Adult Medulloblastoma	National Cancer Institute (NCI)	2009-06	PHASE2
NCT01772290	COMPLETED	Healthy Volunteer	Genentech, Inc.	2013-02	PHASE1
NCT00878163	ACTIVE_NOT_RECRUITING	Adult Solid Neoplasm; Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer AJCC v6 and v7	National Cancer Institute (NCI)	2009-03-31	PHASE1
NCT01064622	COMPLETED	Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer AJCC v6 and v7	National Cancer Institute (NCI)	2009-09-03	PHASE2
NCT01096732	TERMINATED	Pancreatic Ductal Adenocarcinoma	Lisa Bax	2011-02	PHASE2
NCT01163084	TERMINATED	Prostate Adenocarcinoma; Stage IIA Prostate Cancer AJCC v7; Stage IIB Prostate Cancer AJCC v7	National Cancer Institute (NCI)	2010-07-09	PHASE1; PHASE2
NCT00980343	COMPLETED	Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor	National Cancer Institute (NCI)	2010-02	PHASE2
NCT00982592	COMPLETED	Adenocarcinoma of the Gastroesophageal Junction; Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer	National Cancer Institute (NCI)	2009-09	PHASE2
NCT01209143	COMPLETED	Solid Cancers	Genentech, Inc.	2010-11	PHASE1
NCT01173536	COMPLETED	Healthy Volunteer	Genentech, Inc.	2010-08-25	PHASE1
NCT00636610	COMPLETED	Metastatic Colorectal Cancer	Genentech, Inc.	2008-05	PHASE2
NCT00833417	COMPLETED	Basal Cell Carcinoma	Genentech, Inc.	2009-02-10	PHASE2
NCT00739661	COMPLETED	Ovarian Cancer	Genentech, Inc.	2008-12	PHASE2
NCT00968981	COMPLETED	Solid Cancers	Genentech, Inc.	2009-09	PHASE1
NCT00991718	COMPLETED	Healthy	Genentech, Inc.	2009-09	PHASE1
NCT00607724	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Genentech, Inc.	2007-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-18)

Check the Vismodegib (GDC-0449) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vismodegib functions as a selective small-molecule antagonist of the Smoothened receptor, effectively blocking downstream Hedgehog pathway signal transduction and cellular proliferation. Consequently, this pathway inhibition halts aberrant cell growth, providing clinical efficacy in treating locally advanced and metastatic basal cell carcinoma.

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>).