Overview
Multiple sclerosis, or MS, is a devastating inflammatory disease that often progresses and causes severe neurological, physical, and cognitive effects. Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of relapsing-remitting multiple sclerosis. It was developed by Novartis and initially approved by the FDA in 2010. Fingolimod was also studied for the treatment of COVID-19, the disease caused by infection with the SARS-CoV-2 virus.
Background
Multiple sclerosis, or MS, is a devastating inflammatory disease that often progresses and causes severe neurological, physical, and cognitive effects. Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of relapsing-remitting multiple sclerosis. It was developed by Novartis and initially approved by the FDA in 2010. Fingolimod was also studied for the treatment of COVID-19, the disease caused by infection with the SARS-CoV-2 virus.
Indication
Fingolimod is indicated for the treatment of patients aged 10 and above with relapsing forms of multiple sclerosis, which may include clinically isolated syndrome, relapsing-remitting disease, as well as active secondary progressive disease.
Associated Conditions
- Relapsing Multiple Sclerosis (RMS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/26 | N/A | Completed | |||
2024/05/21 | Phase 2 | Recruiting | |||
2024/05/10 | Phase 3 | Recruiting | |||
2023/10/18 | Phase 1 | Not yet recruiting | Tang-Du Hospital | ||
2023/01/18 | N/A | Recruiting | |||
2022/06/21 | N/A | Completed | |||
2022/04/01 | Phase 4 | Recruiting | General Hospital of Shenyang Military Region | ||
2022/03/18 | Phase 2 | ENROLLING_BY_INVITATION | |||
2021/12/06 | Phase 1 | Completed | |||
2021/12/02 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Solco Healthcare US, LLC | 43547-003 | ORAL | 0.5 mg in 1 1 | 10/7/2022 | |
| Zydus Lifesciences Limited | 70771-1603 | ORAL | 0.5 mg in 1 1 | 9/26/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-889 | ORAL | 0.5 mg in 1 1 | 12/27/2023 | |
| Skya Health, LLC | 73086-300 | ORAL | 0.5 mg in 1 1 | 3/14/2024 | |
| Novartis Pharmaceuticals Corporation | 0078-0607 | ORAL | 0.5 mg in 1 1 | 8/16/2019 | |
| Novartis Pharmaceuticals Corporation | 0078-0965 | ORAL | 0.25 mg in 1 1 | 8/16/2019 | |
| Biocon Pharma Inc. | 70377-019 | ORAL | 0.5 mg in 1 1 | 2/9/2024 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-166 | ORAL | 0.5 mg in 1 1 | 9/5/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-4525 | ORAL | 0.5 mg in 1 1 | 7/15/2021 | |
| Teva Pharmaceuticals, Inc. | 0480-7820 | ORAL | 0.5 mg in 1 1 | 2/15/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/17/2011 | ||
Authorised | 6/25/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FINCORD CAPSULES 0.5 MG | SIN16528P | CAPSULE, GELATIN COATED | 0.5 MG | 6/29/2022 | |
| Gilenya Capsule 0.5mg | SIN14153P | CAPSULE | 0.5mg | 5/30/2012 | |
| GILENYA CAPSULE 0.25mg | SIN15761P | CAPSULE | 0.25mg | 8/5/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fingolimod Hydrochloride Capsules | 国药准字HJ20190044 | 化学药品 | 胶囊剂 | 2/28/2024 | |
| Fingolimod Hydrochloride Capsules | 国药准字J20190024 | 化学药品 | 胶囊剂 | 9/27/2019 | |
| Fingolimod Hydrochloride Capsules | H20191019 | 化学药品 | 胶囊剂 | 8/20/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||