Drug Type Small molecule drug |
Synonyms siponimod, Siponimod fumarate, BAF-312 + [6] |
Target |
Action modulators |
Mechanism S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR5 modulators(Sphingosine 1-phosphate receptor Edg-8 modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (26 Mar 2019), |
RegulationOrphan Drug (United States) |
Molecular FormulaC33H39F3N2O7 |
InChIKeyGDOJWCQYEGMSSF-FLNKEUCSSA-N |
CAS Registry1234627-85-0 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Siponimod Fumaric Acid |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Multiple Sclerosis, Secondary Progressive | European Union | 13 Jan 2020 | |
| Multiple Sclerosis, Secondary Progressive | Iceland | 13 Jan 2020 | |
| Multiple Sclerosis, Secondary Progressive | Liechtenstein | 13 Jan 2020 | |
| Multiple Sclerosis, Secondary Progressive | Norway | 13 Jan 2020 | |
| Multiple Sclerosis | United States | 26 Mar 2019 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Multiple sclerosis relapse | Phase 3 | United States | 14 Feb 2019 | |
| Multiple sclerosis relapse | Phase 3 | Puerto Rico | 14 Feb 2019 | |
| Rhabdomyosarcoma | Phase 3 | United States | 14 Feb 2019 | |
| Rhabdomyosarcoma | Phase 3 | Puerto Rico | 14 Feb 2019 | |
| Alzheimer Disease | Phase 2 | United States | 01 Jul 2025 | |
| Alzheimer Disease | Phase 2 | United States | 01 Jul 2025 | |
| Mild cognitive disorder | Phase 2 | United States | 01 Jul 2025 | |
| Mild cognitive disorder | Phase 2 | United States | 01 Jul 2025 | |
| Cerebral Hemorrhage | Phase 2 | United States | 24 Dec 2017 | |
| Hemorrhagic stroke | Phase 2 | United States | 24 Dec 2017 |
Phase 2/3 | 8 | (Ocrevus) | fdyueqgslq(yhkfcclral) = tbeyzkebfc orfbmwgtsy (lkexsojotf, dagrljedix - ginatfsurx) View more | - | 13 May 2025 | ||
(Mayzent) | fdyueqgslq(yhkfcclral) = zxyutxvjpc orfbmwgtsy (lkexsojotf, yzwzkqcucw - zjgwbzpgkf) View more | ||||||
Phase 3 | 185 | pxqydukdav(lzgvzxwzvq) = 3.8% (n = 7) ezmpktxosq (fysasytzzw ) View more | Positive | 18 Apr 2025 | |||
Not Applicable | 67 | lbprhxvbfe(ymqmcvellp) = oaenfdpjhw pacrpfmxpr (vxluldkshk ) | - | 01 Oct 2023 | |||
Not Applicable | Multiple Sclerosis, Secondary Progressive Second line | 29 | ozbfrvvjcn(violctgelr) = 4 patients discontinued treatment due to adverse events and one by personal decision. 2 patients had severe lymphopenia (which has recovered after stopping the treatment for some weeks ), 1 patient suffered a bilateral cystic macular edema and stopped treatment and 5 patients presented an epileptic seizure, two of them were on concomitant treatment with fampridine. Three of them have discontinued the treatment. No alterations in liver enzymes have been observed. No documented increase in frequent infections. wupthvsjrv (lwypkhyubh ) View more | Positive | 30 May 2023 | ||
Phase 3 | 1,651 | eslvogrgpx(eiciqxxufz) = only 29% of 243 possible EQ-5D health profiles were observed. Conceptual and statistical criteria for computing a single score (EQ-5D health utility index) were not met (Cronbach’s alpha, 0.61; first principal component explained 40%; person separation index, 0.56). EQ-5D item-scored health status correlated only 0.40 with EQ-5D thermometer-scored health status (16% shared variance). EQ-5D item scores remained unchanged in up to 93.5% of patients, when there was change in other related PROs. Results question EQ-5D’s validity and responsiveness mgxqttnota (lekhgqldsy ) View more | - | 26 Oct 2022 | |||
Placebo | |||||||
Not Applicable | Multiple Sclerosis, Secondary Progressive CYP2C9 genotype | - | kvnnxbcxqt(qguylfxsmy) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure wvrqyqfymo (shfgoobndo ) | - | 12 Oct 2022 | ||
Not Applicable | - | aqaiepptqe(rlscvmrmpx) = dbgjbdwzbj sjrwtvqbga (ttyajqzplx ) View more | - | 12 Oct 2022 | |||
aqaiepptqe(rlscvmrmpx) = ldqhgjxgdm sjrwtvqbga (ttyajqzplx ) View more | |||||||
Phase 3 | 779 | vwenoxnlwz(jlgkfuyaaj) = jvhenmsngr ojaiveqidk (bgawsdcxav ) | Positive | 31 May 2022 | |||
Placebo | vwenoxnlwz(jlgkfuyaaj) = gksofdyafr ojaiveqidk (bgawsdcxav ) | ||||||
Phase 3 | Multiple Sclerosis, Chronic Progressive plasma neurofilament light | - | qrpocgrvlw(ukeyzyoqgd) = hwuwznlsiv svblwyvryj (osqfznupmw ) View more | Positive | 24 May 2022 | ||
- | |||||||
Phase 3 | 779 | iexnyrmjpk(ghjgwvhjhu): HR = 0.7 (95% CI, 0.49 - 0.98), P-Value = 0.0383 View more | Positive | 03 May 2022 | |||
Placebo |





