Drugs / Sonidegib
Sonidegib
also known as
LDE225 · Erismodegib · Erismodegib phosphate · NVP-LDE 225 · ODOMZO · Sonidegib (LDE225) · Sonidegib diphosphate · SONIDEGIB PHOSPHATE
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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01694589 | Nov 2012 → Jun 2014 | pancreatic neoplasm | Rutgers, The State University of New Jersey | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 120 trials | ||||||
| Phase 1 | NCT06623201 | Oct 2024 → Dec 2026 expected | basal cell carcinoma | Nathalie Zeitouni | Recruiting | No outcome recorded |
| Phase 1 | NCT04007744 | Feb 2020 → May 2025 overdue | cutaneous melanoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, head and neck squamous cell carcinoma +4 | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03434262 | Mar 2018 → Sep 2022 | IDH-wildtype glioblastoma, RELA fusion-positive ependymoma, anaplastic ependymoma, anaplastic ganglioglioma +19 | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02138929 | Nov 2014 → Jun 2020 | esophageal cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02195973 | Sep 2014 → Dec 2016 | ovarian cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1 | NCT02151864 | Jul 2014 → Dec 2016 | cirrhosis of liver, hepatocellular carcinoma | Jason K. Sicklick, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT02182622 | Jul 2014 → Dec 2015 | prostate cancer | Martin Gutierrez | Withdrawn | No outcome recorded |
| Phase 1 | NCT02027376 | May 2014 → Apr 2016 | breast cancer | Spanish Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 1 | NCT02129101 | May 2014 → Dec 2016 | acquired polycythemia vera, childhood acute myeloid leukemia, chronic myelomonocytic leukemia, essential thrombocythemia +2 | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT02086513 | Apr 2014 → Dec 2016 | chronic graft versus host disease | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT01954355 | Sep 2013 → Oct 2015 | ovarian cancer | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01769768 | Apr 2013 → Aug 2016 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01764776 | Mar 2013 → Mar 2015 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01576666 | Jul 2012 → Apr 2015 | colorectal cancer, gastric cancer, gastroesophageal cancer, glioblastoma +3 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01579929 | Apr 2012 → Aug 2017 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01487785 | Mar 2012 → Jul 2014 | malignant pancreatic neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01456676 | Jan 2012 → Feb 2014 | Philadelphia-positive myelogenous leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01485744 | Dec 2011 → Nov 2019 | malignant pancreatic neoplasm | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01208831 | Oct 2010 → Oct 2013 | basal cell carcinoma, medulloblastoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00880308 | Mar 2009 → Jul 2013 | basal cell carcinoma, medulloblastoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT01787552 | May 2013 → Apr 2018 | acquired polycythemia vera, blood coagulation disease, essential thrombocythemia, hemorrhagic disease +1 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT01431794 | Dec 2011 → Nov 2018 | pancreatic ductal adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1/2 | NCT01125800 | Feb 2011 → Oct 2014 | astrocytoma (excluding glioblastoma), hepatoblastoma, medulloblastoma, neuroblastoma +1 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT05669339 | Dec 2024 → Apr 2027 expected | hepatocellular carcinoma | University of Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT04402073 | Nov 2022 → Jun 2025 | medulloblastoma | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04679480 | Feb 2021 → Dec 2024 overdue | basal cell carcinoma | Reinhard Dummer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04806646 | Jan 2021 → Dec 2024 overdue | skin basal cell carcinoma | Gruppo Oncologico del Nord-Ovest | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03534947 | Jul 2019 → Mar 2025 | invasive carcinoma, skin basal cell carcinoma | Melanoma Institute Australia | Completed | No outcome recorded |
| Phase 2 | NCT02303041 | Feb 2015 → Apr 2017 | basal cell carcinoma, nevoid basal cell carcinoma syndrome, skin cancer | Anne Chang | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02254551 | Jan → Oct 2015 | plasma cell myeloma | SCRI Development Innovations, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT01757327 | Apr 2014 → Dec 2016 | breast neoplasm | Washington University School of Medicine | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02002689 | Feb 2014 → Mar 2015 | — | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02086552 | Jan 2014 → Jan 2018 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT01708174 | May 2013 → Oct 2016 | medulloblastoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01826214 | May 2013 → May 2015 | acute leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01327053 | Jun 2011 → Jun 2013 | basal cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01033019 | Dec 2009 → Feb 2011 | skin basal cell carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06880848 | Jun 2023 → Aug 2025 | basal cell carcinoma | Jemincare | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01911416 | Jan → Oct 2014 | pancreatic ductal adenocarcinoma | University of Utah | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT02111187 Comparator | Apr 2014 → Jan 2017 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| 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 |
| — | NCT01529450 Comparator | Feb 2012 → Aug 2013 | basal cell carcinoma | Anne Chang | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2021-12-10 | Jemincare | Regulatory 济民可信成功引进“索立德吉” 国内首个基底细胞癌药物获批上市 jemincare.com ↗
2021年7月23日， 国家药品监督管理局（NMPA）正式批准由上海济煜医药科技有限公司代理申报的 磷酸索立德吉胶囊 在国内上市。 |
| 2020-06-13 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Presents ODOMZO® and LEVULAN® KERASTICK® + BLU-U® Data, Offering Clinical Insights for Treating People with or at Risk of Skin Cancer sunpharma.com ↗
Analyses of long-term data confirm that the continued and clinically meaningful results of ODOMZO (sonidegib) in people with locally advanced basal cell carcinoma (laBCC) are not impacted by concomitant medicines |
| 2017-09-20 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Odomzo® (Sonidegib) New Label Approval sunpharma.com ↗
Sun Pharma Odomzo® (Sonidegib) New Label Approval Shows Sustained Duration of Response of 26 Months in Treatment of Locally Advanced Basal Cell Carcinoma |
| 2015-08-20 | Novartis Pharmaceuticals | Regulatory Novartis drug Odomzo® gains EU approval for locally advanced basal cell carcinoma, providing new non-invasive therapy for patients novartis.com ↗
Novartis announced today that the European Commission has approved Odomzo ® (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy[1]. |
| 2015-07-24 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis drug Odomzo® (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer novartis.com ↗
The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring, |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-12-10 | Jemincare | 济民可信成功引进“索立德吉” 国内首个基底细胞癌药物获批上市 jemincare.com ↗ |
| 2020-06-13 | Sun Pharmaceutical Industries, Inc. | Sun Pharma Presents ODOMZO® and LEVULAN® KERASTICK® + BLU-U® Data, Offering Clinical Insights for Treating People with or at Risk of Skin Cancer sunpharma.com ↗ |
| 2017-09-20 | Sun Pharmaceutical Industries, Inc. | Sun Pharma Odomzo® (Sonidegib) New Label Approval sunpharma.com ↗ |
| 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 ↗ |
| 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 |