levomefolate
Approved
Jul 1, 1955
Levomefolic acid (INN, also known as L-5-MTHF, L-methylfolate and L-5-methyltetrahydrofolate and (6S)-5-methyltetrahydrofolate, and (6S)-5-MTHF) is the primary biologically active form of folate used at the cellular level for DNA reproduction, the cysteine cycle and the regulation of homocysteine. It is also the form found in circulation and transported across membranes into tissues and across the blood–brain barrier. In the cell, L-methylfolate is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon unit for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. The un-methylated form, folic acid (vitamin B9), is a synthetic form of folate, and must undergo enzymatic reduction by dihydrofolate reductase (DHFR) to become biologically active. Systematic reviews suggest that adjunctive L-methylfolate modestly improves symptoms in major depressive disorder. — Wikipedia
Clinical trial activity
6 trials · 1 clinical orgs · 4 marketing orgs
Earliest trial started Aug 1, 2006 (NCT01253174)
Timeline
1950s
- Jul 1, 1955
Earliest FDA Approval
2010s
- Sep 24, 2010
Bayer — First NDA Organization
- Sep 24, 2010
Bayer — NDA Secondary Org
- Sep 24, 2010
Bayer — NDA Organization
- Jan 1, 2013
- Oct 11, 2016
Watson Pharmaceuticals — Marketing Organization
- Oct 11, 2016
Allergan PLC (2015) — Marketing Organization
- Dec 12, 2017
Lupin — Marketing Organization
Indications
Approved for
Mechanism of action
- UnclearUnclear
Unclear unclear
Combination products
beyaz
with ethinyl estradiol, drospirenone
Also known as safyral, tydemy
Approval history
- withdrawnJul 1, 1955
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaLevomefolic acid ↗
Also known as
- bay 86-7660
- bay 86-7660
- levomefolate
- levomefolate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01902264 | Phase 3 | Aug 1, 2013 | Bayer |
| NCT01331655 | Phase 3 | Apr 1, 2013 | Bayer |
| NCT01031355 | Phase 1 | Dec 1, 2009 | Bayer |
| NCT00941057 | Phase 1 | Sep 1, 2009 | Bayer |
| NCT01253187 | Phase 1 | Oct 1, 2006 | Bayer |
| NCT01253174 | Phase 1 | Aug 1, 2006 | Bayer |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 6 | 6 | 2 | 2006 |
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Allergan PLC (2015) | For profit | MKTG | Oct 11, 2016 |
| Bayer | For profit | NDA2 | Sep 24, 2010 |
| Bayer | For profit | NDA | Sep 24, 2010 |
| Lupin | For profit | MKTG | Dec 12, 2017 |
| Lupin | For profit | SYN | Dec 12, 2017 |
| Watson Pharmaceuticals | For profit | MKTG | Oct 11, 2016 |