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sonidegib

Trade name: odomzo

Small moleculeapproved

Approved

Jul 24, 2015

Sonidegib, also known as LDE225 and marketed as Odomzo, is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was approved by the FDA for treating basal cell carcinoma in July 2015 and is awaiting approval in the EU. The hedgehog pathway is involved in many human cancers. Sonidegib effectively inhibits the regulator called smoothened (Smo), preventing the hedgehog pathway from functioning. As a result, tumours that depend on the hedgehog pathway are unable to grow. Sonidegib is approved for use in the US and EU for treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred post surgery or radiation therapy. It is also approved for adult patients with BCC who are not eligible for surgery or radiation therapy. — NCATS

Clinical trial activity

47 trials · 33 clinical orgs · 2 marketing orgs

Phase 1
26
Phase 2
19
Phase 3
3
Phase 4
1

Earliest trial started Mar 1, 2009 (NCT00880308)

Timeline

2000s

  1. Jan 1, 2009

    Novartis — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2009

    Novartis — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jul 24, 2015

    Novartis — Earliest FDA Approval

  2. Jul 24, 2015

    Sun Pharmaceuticals — Marketing Organization

  3. Jul 24, 2015

    Novartis — NDA Organization

  4. Jul 24, 2015

    Sun Pharmaceuticals — NDA Secondary Org

  5. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJul 24, 2015

Chemistry & pharmacology

Loading structure…

SMILES

Cc1c(C(=O)Nc2ccc(N3C[C@@H](C)O[C@@H](C)C3)nc2)cccc1-c1ccc(OC(F)(F)F)cc1
Mol. weight
485.51 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • erismodegib
  • erismodegib
  • erismodegib
  • erismodegib
  • erismodegib
  • lde225
  • lde225
  • lde225
  • lde225
  • lde225
  • lde-225
  • lde225b
  • lde255
  • n-(6-((2s,6r)-2,6-dimethylmorpholino)pyridin-3-yl)-2-methyl-4'-(trifluoromethoxy)biphenyl-3-carboxamide
  • n-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridin-3-yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide
  • n-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridin-3-yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide
  • npv-lde-225
  • nvp-lde225
  • odomzo
  • odomzo
  • odomzo
  • odomzo
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib
  • sonidegib diphosphate
  • sonidegib diphosphate
  • sonidegib diphosphate
  • sonidegib diphosphate
  • sonidegib diphosphate
  • sonidegib diphosphate
  • sonidegib phosphate
  • sonidegib phosphate
  • sonidegib phosphate
  • sonidegib phosphate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06880848Phase 4Jun 21, 2023Government of China, Jemincare, Peking University, Sun Pharmaceuticals
NCT05669339Phase 1Mar 31, 2023University of Florida
NCT04806646Phase 2Jan 12, 2021Gruppo Oncologico del Nord-Ovest, University of Brescia
NCT04402073Phase 2Sep 1, 2020European Organisation for Research and Treatment of Cancer
NCT04308395Phase 3Mar 30, 2020PellePharm, Inc.
NCT04155190Phase 2Dec 30, 2019PellePharm, Inc.
NCT04007744Phase 1Jul 31, 2019Mayo Clinic, National Cancer Institute (NCI)
NCT03703310Phase 3Feb 20, 2019PellePharm, Inc.
NCT03534947Phase 2Oct 31, 2018Melanoma Institute Australia
NCT03434262Phase 1Mar 5, 2018Novartis, St. Jude Children's Hospital
NCT02323139Phase 1Feb 1, 2015Groupe Francophone des Myelodysplasies, Novartis, Paoli Calmettes institute, University of Paris
NCT02303041N/AFeb 1, 2015National Cancer Institute (NCI), Stanford University
NCT02254551Phase 2Jan 1, 2015Novartis, SCRI Development Innovations
NCT02138929Phase 1Nov 10, 2014National Cancer Institute (NCI), Novartis, University of Texas at Houston
NCT02195973Phase 1Sep 1, 2014Novartis, University of Alabama, Birmingham
NCT02182622Phase 1Jul 1, 2014Hackensack Meridian Health, Novartis, Rutgers University
NCT02151864Phase 1Jul 1, 2014Novartis, University of California, San Diego, University of California, San Francisco
NCT02027376Phase 1May 1, 2014GEICAM, Spain, Novartis, Spanish Breast Cancer Research Group
NCT02129101Phase 1May 1, 2014Mayo Clinic, National Cancer Institute (NCI)
NCT02086513Phase 1Apr 1, 2014Harvard University, Novartis
Showing 20 of 47 trials
Page 1 / 3

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit311742009
National Cancer Institute (NCI)Government6032012
Mayo ClinicAcademic/Hospital3322014
PellePharm, Inc.For profit3322019
Harvard UniversityAcademic/Hospital2212011
Johns Hopkins UniversityAcademic/Hospital2222011
Rutgers UniversityAcademic/Hospital2112012
Stanford UniversityAcademic/Hospital2212012
University of BresciaAcademic/Hospital2022013
Cornell UniversityAcademic/Hospital1112012
European Organisation for Research and Treatment of CancerAcademic/Hospital1112020
GEICAM, SpainAcademic/Hospital1012014
Government of ChinaGovernment1012023
Groupe Francophone des MyelodysplasiesAcademic/Hospital1112015
Gruppo Oncologico del Nord-OvestAcademic/Hospital1112021
Hackensack Meridian HealthAcademic/Hospital1112014
JemincareFor profit1112023
Melanoma Institute AustraliaAcademic/Hospital1112018
Paoli Calmettes instituteAcademic/Hospital1012015
Peking UniversityAcademic/Hospital1012023
33 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
NovartisFor profitNDAJul 24, 2015
Sun PharmaceuticalsFor profitMKTGJul 24, 2015
Sun PharmaceuticalsFor profitNDA2Jul 24, 2015