Drugs / BAF312
BAF312
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MAYZENT | — | 2022-03-01 | fda.gov ↗ |
| Approved | EU (EMA) | Mayzent | — | 2020-01-13 | europa.eu ↗ |
| Approved | US (FDA) | MAYZENT | — | 2019-03-26 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01904214 | Jul 2013 → Nov 2014 | impaired renal function disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01565902 | Oct 2012 → Mar 2014 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00422175 | Oct 2006 → Nov 2007 | — | Novartis | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT06639282 | Aug 2025 → Oct 2029 expected | Alzheimer disease | St. Joseph's Hospital and Medical Center, Phoenix | Recruiting | No outcome recorded |
| Phase 2 | NCT03338998 | Dec 2017 → May 2020 | intracerebral hemorrhage | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02029274 | Aug 2013 → Feb 2016 | dermatomyositis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01801917 | Apr 2013 → Aug 2016 | polymyositis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01185821 | Aug 2010 → Oct 2016 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01148810 | Jun 2010 → Jun 2012 | dermatomyositis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT00879658 | Mar 2009 → May 2011 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04926818 | Oct 2021 → Mar 2026 overdue | multiple sclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03623243 | Feb 2019 → Jul 2022 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01665144 | Dec 2012 → Apr 2016 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04792567 | Apr → Sep 2021 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00162474 | Sep 2003 → Dec 2030 expected | — | Hadassah Medical Organization | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04540861 | — | multiple sclerosis | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-11 | Novartis Pharmaceuticals | Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS) novartis.com ↗ |
| 2020-04-21 | Novartis Pharmaceuticals | Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS) novartis.com ↗ |
| 2020-01-20 | Novartis Pharmaceuticals | Novartis announces EU approval of Mayzent® (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease novartis.com ↗ |
| 2019-11-15 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Mayzent® (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis (SPMS) novartis.com ↗ |
| 2019-03-27 | Novartis Pharmaceuticals | Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease novartis.com ↗ |
| 2018-10-08 | Novartis Pharmaceuticals | Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients novartis.com ↗ |
| 2018-04-20 | Novartis Pharmaceuticals | New Novartis analyses at AAN show siponimod's efficacy on disability and cognition in secondary progressive MS patients novartis.com ↗ |
| 2018-03-23 | Novartis Pharmaceuticals | Phase III data in The Lancet show Novartis siponimod significantly improves outcomes in patients with secondary progressive MS novartis.com ↗ |
| 2016-09-17 | Novartis Pharmaceuticals | Novartis BAF312 reduces the risk of disability progression in pivotal phase III study in secondary progressive MS patients novartis.com ↗ |
| 2016-08-25 | Novartis Pharmaceuticals | Novartis announces positive phase III results showing efficacy of BAF312 in patients with secondary progressive MS novartis.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BAF312 | “Siponimod (formerly known as BAF312 and completed trial NCT #01665144) has been FDA approved since 2019 (IND #076122) for the treatment of multiple sclerosis.” NCT06639282 ↗ |
| Known as | Mayzent (siponimod) | “Mayzent (siponimod)” NCT03535298 ↗ |
| Known as | siponimod | “Siponimod is a sphingosine 1-phosphate receptor modulator approved for active secondary progressive multiple sclerosis (aSPMS) in most countries” PMID 35639197 ↗ May 20227“Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study.” PMID 23764350 ↗ Jun 2013 “Mayzent (siponimod)” NCT03535298 ↗ |
| Route | Oral | “oral BAF312” NCT00422175 ↗ |