Drugs / 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
| 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 · 1 met primary · 2 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT02029274 | Aug 2013 → Feb 2016 | dermatomyositis | Novartis Pharmaceuticals | Terminated | Missed primary |
| 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 Stop: Enrollment |
| Phase 2 | NCT00879658 | Mar 2009 → May 2011 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2020-09-11 | Novartis Pharmaceuticals | Results 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 ↗
Post hoc EXPAND analysis showed improvements in cognitive processing speed in patients with active and non-active SPMS treated with Mayzent |
| 2020-09-08 | Novartis Pharmaceuticals | Results Novartis data at ACTRIMS-ECTRIMS highlight the strength of leading multiple sclerosis (MS) portfolio with life-changing therapies for people across the MS spectrum novartis.com ↗
Subgroup analyses of the EXPAND trial showed sustained benefits on disability, cognitive processing speed and relapse outcomes for up to five years |
| 2020-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options novartis.com ↗ |
| 2020-05-28 | Novartis Pharmaceuticals | Results Novartis data highlight benefit of early treatment initiation in patients with secondary progressive multiple sclerosis (SPMS) novartis.com ↗
These data also show that for every 2 years of treatment with Mayzent patients can achieve 1 year of delay of progression and cognitive decline |
| 2020-04-21 | Novartis Pharmaceuticals | Results 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 ↗
Patients in the Mayzent group were significantly less likely to experience both three- and six-month confirmed disability progression (CDP) (p=0.0064 and p=0.0048, respectively) compared with the placebo switch group, which underscores advantages of early treatment |
| 2020-01-20 | Novartis Pharmaceuticals | Regulatory Novartis announces EU approval of Mayzent® (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease novartis.com ↗
Basel, January 20, 2020 — Novartis today announced the European Commission (EC) has approved Mayzent ® (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. |
| 2019-11-15 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Mayzent® (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis (SPMS) novartis.com ↗ |
| 2019-09-13 | Novartis Pharmaceuticals | Results New Novartis data show that neuronal and glial filaments, biomarkers of disease activity, have the potential to support decision making in the management of multiple sclerosis (MS) patient novartis.com ↗
New post hoc data from EXPAND show glial fibrillary acidic protein (GFAP) concentrations were reduced from baseline with Mayzent ® (siponimod) compared with placebo |
| 2019-09-12 | Novartis Pharmaceuticals | Results New Novartis data show Mayzent® can help preserve mobility for longer in patients with secondary progressive multiple sclerosis (SPMS) novartis.com ↗
Further EXPAND analyses demonstrate Mayzent also significantly reduced grey matter volume loss at one and two years, a key driver of disability progression and cognitive decline in patients with SPMS [2],[3] |
| 2019-09-10 | Novartis Pharmaceuticals | Results Novartis data at ECTRIMS to highlight innovative approach to reimagining care for people living with multiple sclerosis (MS) novartis.com ↗
Additional EXPAND data support that patients benefit from Mayzent treatment, which has a positive impact on cognition and prolonged mobility[2-4] |
| 2019-07-18 | Novartis Pharmaceuticals | Results Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased novartis.com ↗
Mayzent (siponimod) data from EXPAND study, presented at AAN, demonstrated that treatment had a clinically meaningful positive impact on cognitive processing speed in patients with secondary progressive MS, an important element in cognitive function. |
| 2019-07-02 | Novartis Pharmaceuticals | Results Novartis highlights cognition data in secondary progressive multiple sclerosis (SPMS) novartis.com ↗
EXPAND data previously presented demonstrated Mayzent® (siponimod) has a meaningful benefit on cognitive processing speed with a 22.6% relative risk reduction versus placebo in SPMS patients with cognitive impairment[2] |
| 2019-05-08 | Novartis Pharmaceuticals | Results Novartis data at AAN show Mayzent's® positive impact on cognitive processing speed, a core element of cognitive function, in people living with secondary progressive MS novartis.com ↗
Novartis today announced a new analysis of the Phase III EXPAND study, demonstrating that treatment with Mayzent ® (siponimod) had a clinically meaningful positive impact on cognitive processing speed (CPS) in patients with SPMS, an important element in cognitive function. |
| 2019-04-30 | Novartis Pharmaceuticals | Results New data at AAN reinforce Novartis commitment to transforming the lives of people of all ages who live with neurological conditions novartis.com ↗
New analyses from the Phase III EXPAND study show Mayzent ® (siponimod) had a sustained benefit on cognition in secondary progressive MS (SPMS) patients. |
| 2019-03-27 | Novartis Pharmaceuticals | Regulatory Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease novartis.com ↗
Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent ® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS)*. |
| 2018-10-08 | Novartis Pharmaceuticals | Regulatory 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 ↗
Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company's New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively |
| 2018-04-20 | Novartis Pharmaceuticals | Results New Novartis analyses at AAN show siponimod's efficacy on disability and cognition in secondary progressive MS patients novartis.com ↗
In pre-specified statistical analyses, treatment with siponimod consistently reduced the risk of confirmed disability progression in SPMS patients, with and without relapses[1]. |
| 2018-03-23 | Novartis Pharmaceuticals | Results Phase III data in The Lancet show Novartis siponimod significantly improves outcomes in patients with secondary progressive MS novartis.com ↗
These pivotal results show significant reductions in the risk of three- (primary endpoint) and six-month confirmed disability progression with siponimod versus placebo[1] and favorable outcomes in other relevant measures of MS disease activity[1]. |
| 2017-10-25 | Novartis Pharmaceuticals | Results Novartis confirms leadership in multiple sclerosis (MS) with scientific advancements and new data presented at ECTRIMS novartis.com ↗
New data from the Phase III EXPAND study of siponimod demonstrating its effect on magnetic resonance imaging (MRI) lesions and brain shrinkage in SPMS[2]. |
| 2016-09-17 | Novartis Pharmaceuticals | Results Novartis BAF312 reduces the risk of disability progression in pivotal phase III study in secondary progressive MS patients novartis.com ↗
Novartis today announced positive results of the Phase III EXPAND study showing that oral once-daily BAF312 (siponimod) significantly reduced the risk of disability progression compared with placebo in people with secondary progressive multiple sclerosis (SPMS). |
| 2016-08-25 | Novartis Pharmaceuticals | Results Novartis announces positive phase III results showing efficacy of BAF312 in patients with secondary progressive MS novartis.com ↗
Novartis today announced the Phase III EXPAND study, evaluating the efficacy and safety of oral, once-daily, BAF312 (siponimod) in secondary progressive multiple sclerosis (SPMS), met its primary endpoint of a reduction in the risk of disability progression, compared with placebo. |
All press releases naming this drug 21 releases
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 ↗ |