Sonidegib
Small molecule targets SMO via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ODOMZO | — | 2017-09-18 | fda.gov ↗ |
| Approved | EU (EMA) | Odomzo | — | 2015-08-14 | europa.eu ↗ |
| Approved | US (FDA) | ODOMZO | — | 2015-07-24 | fda.gov ↗ |
Trials 40 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02111187 Comparator | Apr 2014 → Jan 2017 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01350115 Comparator | Apr 2011 → Oct 2012 | basal cell carcinoma, nevoid basal cell carcinoma syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00961896 Comparator | Jul 2009 → Aug 2010 | skin basal cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01529450 Comparator | Feb 2012 → Aug 2013 | basal cell carcinoma | Anne Chang | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-08-20 | Novartis Pharmaceuticals | Novartis drug Odomzo® gains EU approval for locally advanced basal cell carcinoma, providing new non-invasive therapy for patients novartis.com ↗ |
| 2015-07-24 | Novartis Pharmaceuticals | FDA approves Novartis drug Odomzo® (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer novartis.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sonidegib | “Sonidegib (Odomzo) is a compound that was approved by the US Food and Drug Administration in July 2015 as a treatment option for BCC.” NCT06623201 ↗16“The effect of sonidegib (LDE225) on the pharmacokinetics of bupropion and warfarin in patients with advanced solid tumours.” PMID 32736411 ↗ Aug 2020 “Safety and efficacy of the combination of sonidegib and ruxolitinib in myelofibrosis: a phase 1b/2 dose-finding study.” PMID 32634234 ↗ Jul 2020 “Phase I, multicenter, open-label, dose-escalation study of sonidegib in Asian patients with advanced solid tumors.” PMID 27467121 ↗ Sep 2016 “The Hedgehog Inhibitor used for the trial will be Sonidegib.” NCT04679480 ↗ “the smoothened (SMO) inhibitor, sonidegib (LDE225)” PMID 26546616 ↗ Nov 2015 “Sonidegib (LDE225)” NCT01708174 ↗ |
| Known as | Erismodegib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01757327 ↗ |
| Known as | Erismodegib phosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105737 ↗ |
| Known as | LDE225 | “Sonidegib (LDE225)” NCT01708174 ↗28 |
| Known as | NVP-LDE 225 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105737 ↗ |
| Known as | Odomzo | “Sonidegib (Odomzo) is a compound that was approved by the US Food and Drug Administration in July 2015 as a treatment option for BCC.” NCT06623201 ↗ |
| Known as | Sonidegib (LDE225) | “Sonidegib (LDE225)” NCT02195973 ↗ |
| Known as | Sonidegib diphosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105737 ↗ |
| Known as | SONIDEGIB PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105737 ↗ |
| Action | Inhibit | “LDE225 (a specific Smoothened inhibitor)” NCT00961896 ↗ |
| Modality | Small molecule | — CHEMBL2105737 ↗ |
| Route | Oral | “LDE225 given orally” NCT00880308 ↗ |
| Target | SMO | “smoothened (SMO) inhibitor” PMID 26546616 ↗ Nov 2015 |