Sonidegib (NVP-LDE225, Erismodegib) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 470

Clinical Trials

Numerous clinical trials have evaluated sonidegib as both monotherapy and combination therapy across Phase 1, Phase 2, combined Phase 1/2, and Phase 4 post-authorization safety studies. These investigations address oncology indications including basal cell carcinoma, pancreatic cancer, recurrent ovarian cancer, advanced solid tumors, and pediatric central nervous system malignancies such as medulloblastoma. Sponsored by pharmaceutical leaders (e.g., Novartis, Sun Pharmaceutical Industries) and academic institutions (e.g., Mayo Clinic, National Cancer Institute), these protocols encompass completed, active, recruiting, and terminated statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05669339	RECRUITING	Hepatocellular Carcinoma	University of Florida	2024-12-02	PHASE2
NCT06623201	RECRUITING	Basal Cell Carcinoma (BCC)	Nathalie Zeitouni	2024-10-07	PHASE1
NCT06880848	COMPLETED	Carcinoma, Basal Cell (BCC)	Jemincare	2023-06-21	PHASE4
NCT04402073	TERMINATED	Medulloblastoma	European Organisation for Research and Treatment of Cancer - EORTC	2022-11-11	PHASE2
NCT04007744	ACTIVE_NOT_RECRUITING	Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Gastric Adenocarcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Locally Advanced Urothelial Carcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Metastatic Urothelial Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Refractory Lung Non-Small Cell Carcinoma; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Lung Cancer AJCC v8; Unresectable Malignant Solid Neoplasm; Unresectable Melanoma	Mayo Clinic	2020-02-13	PHASE1
NCT03534947	COMPLETED	Basal Cell Carcinoma; Basal Cell Carcinoma of Skin, Site Unspecified; Skin Cancer; Invasive Carcinoma	Melanoma Institute Australia	2019-07-23	PHASE2
NCT04806646	ACTIVE_NOT_RECRUITING	Locally Advanced Basal Cell Carcinoma	Gruppo Oncologico del Nord-Ovest	2021-01-12	PHASE2
NCT03434262	COMPLETED	Anaplastic Astrocytoma; Anaplastic Ependymoma; Anaplastic Ganglioglioma; Anaplastic Meningioma; Anaplastic Oligodendroglioma; Pleomorphic Xanthoastrocytoma, Anaplastic; Atypical Teratoid/Rhabdoid Tumor; Brain Cancer; Brain Tumor; Central Nervous System Neoplasms; Choroid Plexus Carcinoma; CNS Embryonal Tumor With Rhabdoid Features; Ganglioneuroblastoma of Central Nervous System; CNS Tumor; Embryonal Tumor of CNS; Ependymoma; Glioblastoma; Glioma; Glioma, Malignant; Medulloblastoma; Medulloblastoma; Unspecified Site; Medulloepithelioma; Neuroepithelial Tumor; Neoplasms; Neoplasms, Neuroepithelial; Papillary Tumor of the Pineal Region (High-grade Only); Pediatric Brain Tumor; Pineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only); Pineoblastoma; Primitive Neuroectodermal Tumor; Recurrent Medulloblastoma; Refractory Brain Tumor; Neuroblastoma. CNS; Glioblastoma, IDH-mutant; Glioblastoma, IDH-wildtype; Medulloblastoma, Group 3; Medulloblastoma, Group 4; Glioma, High Grade; Neuroepithelial Tumor, High Grade; Medulloblastoma, SHH-activated and TP53 Mutant; Medulloblastoma, SHH-activated and TP53 Wildtype; Medulloblastoma, Chromosome 9q Loss; Medulloblastoma, Non-WNT Non-SHH, NOS; Medulloblastoma, Non-WNT/Non-SHH; Medulloblastoma, PTCH1 Mutation; Medulloblastoma, WNT-activated; Ependymoma, Recurrent; Glioma, Recurrent High Grade; Glioma, Recurrent Malignant; Embryonal Tumor, NOS; Glioma, Diffuse Midline, H3K27M-mutant; Embryonal Tumor With Multilayered Rosettes (ETMR); Ependymoma, NOS, WHO Grade III; Ependymoma, NOS, WHO Grade II; Medulloblastoma, G3/G4; Ependymoma, RELA Fusion Positive	St. Jude Children's Research Hospital	2018-03-05	PHASE1
NCT02086552	COMPLETED	Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma	Mayo Clinic	2014-01-17	PHASE2
NCT02303041	TERMINATED	Carcinoma, Basal Cell; Recurrent Skin Cancer; Skin Neoplasms; Basal Cell Nevus Syndrome	Anne Chang	2015-02	PHASE2
NCT02129101	COMPLETED	Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndrome; Essential Thrombocythemia; Myelodysplastic Syndrome; Myelodysplastic/Myeloproliferative Neoplasm; Polycythemia Vera; Previously Treated Myelodysplastic Syndrome; Primary Myelofibrosis; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia	Mayo Clinic	2014-05	PHASE1
NCT02027376	COMPLETED	Advanced Breast Cancer	Spanish Breast Cancer Research Group	2014-05	PHASE1
NCT02254551	TERMINATED	Multiple Myeloma	SCRI Development Innovations, LLC	2015-01	PHASE2
NCT02358161	Completed	Pancreatic Cancer	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)\|Novartis\|Celgene Corporation	2015-09	Phase 1\|Phase 2
NCT02254551	Terminated	Multiple Myeloma	SCRI Development Innovations LLC\|Novartis	2015-01	Phase 2
NCT02138929	Completed	Esophageal Cancer	M.D. Anderson Cancer Center\|Novartis\|National Cancer Institute (NCI)	2014-11-10	Phase 1
NCT02195973	Completed	Recurrent Ovarian Cancer	University of Alabama at Birmingham\|Novartis Pharmaceuticals	2014-09	Phase 1
NCT02027376	Completed	Advanced Breast Cancer	Spanish Breast Cancer Research Group\|Novartis	2014-05	Phase 1
NCT02111187	Completed	Prostate Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2014-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-14)

Check the Sonidegib (NVP-LDE225, Erismodegib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sonidegib selectively binds to and inhibits the Transmembrane Smoothened (Smo) receptor, thereby suppressing downstream Hedgehog signaling pathway activation and reducing the expression of key target genes such as Gli1 and Gli2 to halt cell proliferation. This targeted blockade of Hedgehog signal transduction provides the biological basis for its therapeutic efficacy in Hedgehog-driven cancers, particularly basal cell carcinoma and medulloblastoma.

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>).