Overview
Levomefolic acid (INN) is the metabolite of folic acid (Vitamin B9) and it is a predominant active form of folate found in foods and in the blood circulation, accounting for 98% of folates in human plasma . It is transported across the membranes including the blood-brain barrier into various tissues where it plays an essential role in the DNA synthesis, cysteine cycle and regulation of homocysteine, where it methylates homocysteine and forms methionine and tetrahydrofolate (THF). Levomefolate is approved as a food additive and is designated a GRAS (generally regarded as safe) compound . It is available commercially as a crystalline form of the calcium salt (Metafolin(R)), which has the stability required for use as a supplement . Supplementation of levomefolic acid is desired over folic acid due to reduced potential for masking vitamin B12 deficiency symptoms.
Indication
For the treatment and prevention of folate deficiency and for use as an antidote against folic acid antagonists. Contained in oral contraceptives to reduce the risk of neural tube defects arising from folic acid deficiency for pregnant women who conceived during use or shortly after the discontinuation of the product. Being studied for use as a treatment for cardiovascular diseases and adjunct therapy for patients undergoing antidepressant pharmacotherapy .
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/23 | Phase 4 | Recruiting | |||
2021/03/04 | Phase 4 | UNKNOWN | |||
2013/05/14 | Phase 2 | Completed | |||
2010/12/03 | Phase 1 | Completed | |||
2010/12/03 | Phase 1 | Completed | |||
2009/12/14 | Phase 1 | Completed | |||
2009/10/26 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| CarWin Pharmaceutical Associates, LLC | 15370-105 | ORAL | 108 ug in 1 1 | 1/10/2024 | |
| Avion Pharmaceuticals, LLC | 75854-320 | ORAL | 750 ug in 1 1 | 1/18/2021 | |
| CarWin Pharmaceutical Associates, LLC | 15370-104 | ORAL | 108 ug in 1 1 | 1/10/2024 | |
| CarWin Pharmaceutical Associates, LLC | 15370-101 | ORAL | 81 ug in 1 mL | 8/3/2017 | |
| Avion Pharmaceuticals, LLC | 75854-321 | ORAL | 750 ug in 1 1 | 1/7/2021 | |
| Avion Pharmaceuticals, LLC | 75854-316 | ORAL | 600 ug in 1 1 | 1/7/2021 | |
| CarWin Pharmaceutical Associates, LLC | 15370-100 | ORAL | 35 ug in 1 mL | 8/3/2017 | |
| Avion Pharmaceuticals, LLC | 75854-315 | ORAL | 600 ug in 1 1 | 1/7/2021 | |
| CarWin Pharmaceutical Associates, LLC | 15370-103 | ORAL | 108 ug in 1 1 | 1/10/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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