LDE225

Phase 2Small molecule

LDE225 is one of 299 small molecule programs targeting Nevoid Basal Cell Carcinoma Syndrome. It is currently in Phase 2.

Indications

Total Trials

Active Trials

298

Competitors

Pipeline

Status by Indication[3][1]

Indication

Nevoid Basal Cell Carcinoma SyndromeActive, not recruiting

Basal Cell CarcinomaActive, not recruiting

Pancreatic AdenocarcinomaActive, not recruiting

Breast CancerActive, not recruiting

Pancreatic CancerActive, not recruiting

Prostate CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Multiple MyelomaActive, not recruiting

MedulloblastomaActive, not recruiting

Nevoid Basal Cell Carcinoma SyndromePhase 2

Active, not recruiting

Basal Cell CarcinomaPhase 2

Active, not recruiting

Pancreatic AdenocarcinomaPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Pancreatic CancerPreclinical

Active, not recruiting

Prostate CancerPhase 1

Active, not recruiting

Ovarian CancerPhase 1

Active, not recruiting

Hepatocellular CarcinomaPhase 1

Active, not recruiting

Multiple MyelomaPhase 2

Active, not recruiting

MedulloblastomaPhase 2

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

LDE225

Novartis

Phase 2

1 2

Avastin

Voltaren

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Chirocaine

PPurdue Pharma LP

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Zoladex

Luye Pharma Group Ltd.

Preclinical

8 9

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 10

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Prostate Cancer2 trials

LDE225 + Docetaxel/Prednisone for Adv/Met Castrate Resistant Prostate Cancer w/ Disease Progression After Docetaxel

Withdrawn·MMartin Gutierrez·Phase 1·NCT02182622

A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02111187·14 enrolled

Patients With Advanced Solid Tumors2 trials

Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01576666·120 enrolled

Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT00880308·103 enrolled

Locally Advanced1 trial

Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened Inhibitors

Completed·AAnne Chang·N/A·NCT01529450·11 enrolled

Multiple Myeloma1 trial

Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT02254551·7 enrolled

Solid Tumors1 trial

LDE225 and Paclitaxel in Solid Tumors

Completed·SSwiss Cancer Institute·Phase 1·NCT01954355·30 enrolled

16 more indications

Tumors1 trial

LDE225 for Patients With PTCH1 or SMO Mutated Tumors

Terminated· Novartis logo

Novartis·Phase 2·NCT02002689·10 enrolled

Nevoid Basal Cell Carcinoma Syndrome1 trial

Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Completed· Novartis logo

Novartis·Phase 2·NCT01350115·10 enrolled

Chronic GVHD1 trial

Phase I Trial of LDE225 for Steroid-refractory Chronic GVHD After Allogeneic HSCT

Terminated·MMassachusetts General Hospital·Phase 1·NCT02086513·17 enrolled

Medulloblastoma1 trial

A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)

Completed· Novartis logo

Novartis·Phase 2·NCT01708174·22 enrolled

Hepatocellular Carcinoma1 trial

LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A/B7 Cirrhosis

Completed·—·Phase 1·NCT02151864·9 enrolled

Basal Cell Carcinoma1 trial

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Completed· Novartis logo

Novartis·Phase 2·NCT01327053·230 enrolled

Pancreatic Adenocarcinoma1 trial

Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT01431794·23 enrolled

Recurrent or Refractory1 trial

A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB

Completed· Novartis logo

Novartis·Phase 1/2·NCT01125800·76 enrolled

Breast Cancer1 trial

Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

Completed·SSpanish Breast Cancer Research Group·Phase 1·NCT02027376·12 enrolled

Ovarian Cancer1 trial

Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT02195973·15 enrolled

Hepatic Impairment1 trial

Effect of Hepatic Impairment on LDE225..

Completed· Novartis logo

Novartis·Phase 1·NCT01764776·33 enrolled

Pancreatic Cancer1 trial

A Biomarker Study to Identify Predictive Signatures of Response to LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer

Withdrawn·UUniversity of Utah·N/A·NCT01911416

Safety and Efficacy1 trial

A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

Completed· Novartis logo

Novartis·Phase 1/2·NCT01787552·50 enrolled

Acute Leukemia1 trial

Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

Completed· Novartis logo

Novartis·Phase 2·NCT01826214·70 enrolled

Tics1 trial

Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients

Completed· Novartis logo

Novartis·Phase 1·NCT01769768·114 enrolled

Unspecified1 trial

An East Asian Study of LDE225

Completed· Novartis logo

Novartis·Phase 1·NCT01208831·45 enrolled

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for LDE225. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — LDE225 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for LDE225. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Novartis

LDE225

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Prostate Cancer2 trials

Patients With Advanced Solid Tumors2 trials

Locally Advanced1 trial

Multiple Myeloma1 trial

Solid Tumors1 trial

Tumors1 trial

Nevoid Basal Cell Carcinoma Syndrome1 trial

Chronic GVHD1 trial

Medulloblastoma1 trial

Hepatocellular Carcinoma1 trial

Basal Cell Carcinoma1 trial

Pancreatic Adenocarcinoma1 trial

Recurrent or Refractory1 trial

Breast Cancer1 trial

Ovarian Cancer1 trial

Hepatic Impairment1 trial

Pancreatic Cancer1 trial

Safety and Efficacy1 trial

Acute Leukemia1 trial

Tics1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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