siponimod
Trade name: Mayzent
Approved
Mar 26, 2019
Siponimod (BAF312) is a dual agonist at the sphingosine-1 phosphate receptors, S1PR1 and S1PR5. The S1P receptor is commonly found on the surface of specific cells residing in the central nervous system (CNS), that are responsible for causing CNS damage that drives loss of function in secondary progressive multiple sclerosis (SPMS). Siponimod (BAF312) enters the brain and by binding to these specific receptors, may prevent the activation of these harmful cells, helping to reduce the loss of physical and cognitive function associated with SPMS. — NCATS
Clinical trial activity
16 trials · 8 clinical orgs · 5 marketing orgs
Earliest trial started Oct 1, 2006 (NCT00422175)
Timeline
2000s
2010s
2020s
- Jan 10, 2025
Cipla — Marketing Organization
- Apr 22, 2025
RiconPharma — Marketing Organization
- Jun 5, 2025
Dr. Reddy's Laboratories — Marketing Organization
- Mar 6, 2026
Aurobindo Pharma — Marketing Organization
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 2
- Cognitive Dysfunction · Phase 2
- Dermatology · Phase 2
- Dermatomyositis · Phase 2
- Healthy Volunteers · Phase 1
- Hemorrhage · Phase 2
- Hemorrhagic Stroke · Phase 2
- Kidney Failure, Chronic · Phase 1
- Liver Diseases · Phase 1
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Multiple Sclerosis · Phase 3
- Multiple Sclerosis, Chronic Progressive · Phase 3
- Multiple Sclerosis, Relapsing-Remitting · Phase 2
- Polymyositis · Phase 2
Mechanism of action
S1PR5 agonist
S1PR1 agonist
Approval history
- approvedPriority reviewMar 26, 2019
Chemistry & pharmacology
SMILES
CCC1=C(CN2CC(C2)C(O)=O)C=CC(=C1)C(\C)=N\OCC3=CC(=C(C=C3)C4CCCCC4)C(F)(F)F- Mol. weight
- 516.595 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaSiponimod ↗
- NCATSRR6P8L282I ↗
- ChEMBLCHEMBL4298150 ↗
- ChEMBLCHEMBL2336071 ↗
Also known as
- 1-(4-(1-((e)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid
- baf312
- baf312
- baf312
- baf-312
- baf-312
- siponimod
- siponimod
- siponimod
- siponimod
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06639282 | Phase 2 | Nov 30, 2024 | Arizona State University, LabCorp, National Institute on Aging (NIA), Novartis, Texas Tech University, University of Arizona |
| NCT04926818 | Phase 3 | Oct 5, 2021 | Novartis |
| NCT04925557 | Phase 4 | Sep 27, 2021 | State University of New York, Buffalo |
| NCT04792567 | Phase 4 | Apr 19, 2021 | Novartis |
| NCT03623243 | Phase 3 | Sep 17, 2018 | Novartis |
| NCT03338998 | Phase 2 | Dec 24, 2017 | Novartis, Yale University |
| NCT02029274 | Phase 2 | Nov 1, 2013 | Novartis |
| NCT01904214 | Phase 1 | Jul 1, 2013 | Novartis |
| NCT01801917 | Phase 2 | Apr 1, 2013 | Novartis |
| NCT01665144 | Phase 3 | Dec 20, 2012 | Novartis |
| NCT01565902 | Phase 1 | Oct 1, 2012 | Novartis |
| NCT01185821 | Phase 2 | Aug 1, 2010 | Novartis |
| NCT01148810 | Phase 2 | Jun 1, 2010 | Novartis |
| NCT00879658 | Phase 2 | Mar 1, 2009 | Novartis |
| NCT00422175 | Phase 1 | Oct 1, 2006 | Novartis |
| NCT04540861 | N/A | — | Novartis |
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novartis | For profit | 15 | 14 | 5 | 2006 |
| Arizona State University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| LabCorp | For profit | 1 | 0 | 1 | 2024 |
| National Institute on Aging (NIA) | Government | 1 | 0 | 1 | 2024 |
| State University of New York, Buffalo | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Texas Tech University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Arizona | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Yale University | Academic/Hospital | 1 | 0 | 1 | 2017 |
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aurobindo Pharma | For profit | MKTG | Mar 6, 2026 |
| Cipla | For profit | MKTG | Jan 10, 2025 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jun 5, 2025 |
| Novartis | For profit | MKTG | Mar 26, 2019 |
| Novartis | For profit | NDA | Mar 26, 2019 |
| RiconPharma | For profit | MKTG | Apr 22, 2025 |