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Sonidegib (LDE225)
N/A, Phase 2, Phase 1, Phase 1/Phase 2, , Phase 0
SMO receptor inhibitor
Hemat
LDE225

Compound Description Selective Smo inhibitor

Area of Research Medulloblastoma (MB), basal cell carcinoma (BCC), pancreatic cancer, small cell lung cancer (SCLC), chronic myeloid leukemia, myelofibrosis, and other solid tumors

Preclinical Data Sonidegib has demonstrated activity against Hh-dependent and Smo-dependent cellular proliferation in vivo.[3]

Clinical Status There is an ongoing Phase III study in patients with Hh-pathway activated relapsed medulloblastoma and a pediatric Phase I study in MB.[4,5] Other ongoing studies include combination and monotherapy for basel cell carcinoma, myelofibrosis, and pancreatic cancer.[7,8,9]

LDE225 is investigational. Efficacy and safety have not been established.
There is no guarantee that LDE225 will become commercially available.
References 1. Pasca di Magliano M, Hebrok M. Hedgehog signaling in cancer formation and maintenance. Nature Rev. 2003;3:903-911. 2. Mahindroo N, Punchihewa C, Fujii N. Hedgehog-Gli signaling pathway inhibitors as anticancer agents. J Med Chem. 2009;52:3829-3845. 3. Dorsch M, Buonamici S, Williams J, et al. The discovery of mechanisms of resistance to SMO antagonists and the therapeutic implications. In: Proceedings from the 101st Annual Meeting of the American Association for Cancer Research (AACR); April 17-21, 2010; Washington, DC. Abstract 1976. 4. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrials.gov/ct2/show/NCT01708174. Updated September 16, 2013. Accessed January 10, 2014. 5. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrials.gov/ct2/show/NCT01125800. Updated September 11, 2013. Accessed January 10, 2014. 6. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrials.gov/ct2/show/NCT01826214. Updated July 10, 2013. Accessed January 10, 2014. 7. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrials.gov/ct2/show/NCT01431794. Updated August 16, 2013. Accessed January 10, 2014. 8. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrials.gov/ct2/show/NCT01787552. Updated November 19, 2013. Accessed January 10, 2014. 9. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrial.gov/ct2/show/NCT01327053. Updated June 3, 2013. Accessed January 16, 2014 10.National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrial.gov/ct2/show/NCT02002689. Updated January 22, 2014. Accessed January 28, 2014. 11. National Institutes of Health (NIH). ClinicalTrials.gov. www.clinicaltrial.gov/ct2/show/NCT01576666. Updated September 10, 2013. Accessed January 28, 2014.

Last updated on April 12, 2013.

All Compounds are either investigational or studied in new indications. Efficacy and safety have not been established. There is no guarantee that they will become commercially available.

The search results, details, and descriptions of clinical trials viewed herein are supplied by ClinicalTrials.gov and EUtrialregistry.com. This information is maintained by a third party over whom Novartis Pharmaceuticals Corporation has no control. As such, Novartis Pharmaceuticals Corporation does not guarantee the accuracy, completeness, adequacy, or any other aspect of the information contained on this site.