Overview
Ponesimod is a selective sphingosine 1-phosphate receptor 1 modulator indicated in the treatment of relapsing forms of multiple sclerosis in adults. Ponesimod was developed out of a need for a more selective modulator of sphingosine 1-phosphate receptor 1 than fingolimod. Fingolimod's activity at sphingosine 1-phosphate receptor 3 was suspected to be responsible for a portion of it's adverse effects, and so more selective modulators were developed. Ponesimod was granted FDA approval on 18 March 2021.
Indication
Ponesimod is indicated to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Associated Conditions
- Relapsing Multiple Sclerosis (RMS)
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Active Secondary Progressive Multiple Sclerosis (SPMS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/18 | N/A | Recruiting | |||
2022/09/23 | Phase 1 | Completed | Janssen Pharmaceutica N.V., Belgium | ||
2019/03/20 | Phase 1 | Completed | Janssen Pharmaceutica N.V., Belgium | ||
2017/07/27 | Phase 3 | Completed | Actelion | ||
2016/09/20 | Phase 3 | Terminated | Actelion | ||
2015/06/03 | Phase 2 | Terminated | Actelion | ||
2015/04/24 | Phase 3 | Completed | Actelion | ||
2014/08/22 | Phase 1 | Completed | Actelion | ||
2014/05/13 | Phase 1 | Completed | Actelion | ||
2014/04/30 | Phase 1 | Completed | Actelion |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Pharmaceuticals, Inc | 50458-720 | ORAL | 20 mg in 1 1 | 8/16/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/19/2021 | ||
Authorised | 5/19/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PONVORY ponesimod 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg film-coated tablet (Treatment initiation pack) blister composite pack | 370320 | Medicine | A | 3/11/2022 | |
| PONVORY ponesimod 20 mg film-coated tablet blister pack | 370319 | Medicine | A | 3/11/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PONVORY | 02515474 | Tablet - Oral | 3 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 2 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 6 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 10 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 7 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 5 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 4 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 8 MG | 11/1/2021 | |
| PONVORY | 02515474 | Tablet - Oral | 9 MG | 11/1/2021 | |
| PONVORY | 02515482 | Tablet - Oral | 20 MG | 11/1/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PONVORY 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratoires Juvise Pharmaceuticals | 1211550002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| PONVORY 2, 3, 4, 5, 6, 7, 8, 9 y 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratoires Juvise Pharmaceuticals | 1211550001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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