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Levomefolic acid

Generic Name
Levomefolic acid
Brand Names
Beyaz 28 Day, EnBrace HR, EnLyte, Safyral 28 Day, Tydemy 28 Day, Yaz Plus
Drug Type
Small Molecule
Chemical Formula
C20H25N7O6
CAS Number
31690-09-2
Unique Ingredient Identifier
8S95DH25XC
Background

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 Therapies
Nutritional supplementation

Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study

Phase 4
Recruiting
Conditions
Generalized Anxiety Disorder
Interventions
First Posted Date
2024-01-23
Last Posted Date
2025-04-08
Lead Sponsor
Kingston Health Sciences Centre
Target Recruit Count
10
Registration Number
NCT06218030
Locations
🇨🇦

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age

Phase 4
Conditions
Diarrhoea;Acute
Interventions
First Posted Date
2021-03-04
Last Posted Date
2022-05-19
Lead Sponsor
King Edward Medical University
Target Recruit Count
324
Registration Number
NCT04782037
Locations
🇵🇰

Mayo hospital, Lahore, Punjab, Pakistan

L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults

Phase 2
Completed
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
Drug: OROS-Methylphenidate
Drug: Placebo
First Posted Date
2013-05-14
Last Posted Date
2017-11-14
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
47
Registration Number
NCT01853280
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)

Phase 1
Completed
Conditions
Contraception
Interventions
Drug: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)
Drug: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)
First Posted Date
2010-12-03
Last Posted Date
2013-08-07
Lead Sponsor
Bayer
Target Recruit Count
48
Registration Number
NCT01253174
Locations
🇩🇪

Scope International, Hamburg, Germany

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)

Phase 1
Completed
Conditions
Contraception
Interventions
Drug: EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)
Drug: EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca)
First Posted Date
2010-12-03
Last Posted Date
2013-08-07
Lead Sponsor
Bayer
Target Recruit Count
44
Registration Number
NCT01253187
Locations
🇳🇱

Dinox B.V., Groningen, Netherlands

Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium

First Posted Date
2009-12-14
Last Posted Date
2014-02-20
Lead Sponsor
Bayer
Target Recruit Count
42
Registration Number
NCT01031355

Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis

Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2009-10-26
Last Posted Date
2013-12-19
Lead Sponsor
Pamlab, Inc.
Target Recruit Count
242
Registration Number
NCT01001559
Locations
🇺🇸

Red Oak Psychiatry Associates, PA, Houston, Texas, United States

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