levomefolate

Small moleculewithdrawn

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

Phase 1
4
Phase 2
2
Phase 3
2
Phase 4
0

Earliest trial started Aug 1, 2006 (NCT01253174)

Timeline

1950s

  1. Jul 1, 1955

    Earliest FDA Approval

2000s

  1. Jan 1, 2006

    Bayer — Earliest Phase 1 Sponsor(trial)

2010s

  1. Sep 24, 2010

    Bayer — First NDA Organization

  2. Sep 24, 2010

    Bayer — NDA Secondary Org

  3. Sep 24, 2010

    Bayer — NDA Organization

  4. Jan 1, 2013

    Bayer — Earliest Phase 3 Sponsor(trial)

  5. Oct 11, 2016

    Watson Pharmaceuticals — Marketing Organization

  6. Oct 11, 2016

    Allergan PLC (2015) — Marketing Organization

  7. Dec 12, 2017

    Lupin — Marketing Organization

Indications

Approved for

Mechanism of action

Combination products

Approval history

  • withdrawnJul 1, 1955

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • bay 86-7660
  • bay 86-7660
  • levomefolate
  • levomefolate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01902264Phase 3Aug 1, 2013Bayer
NCT01331655Phase 3Apr 1, 2013Bayer
NCT01031355Phase 1Dec 1, 2009Bayer
NCT00941057Phase 1Sep 1, 2009Bayer
NCT01253187Phase 1Oct 1, 2006Bayer
NCT01253174Phase 1Aug 1, 2006Bayer
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit6622006
1 organizations
Page 1 / 1

Marketing (6)

OrganizationOrg typeRelationshipDate
Allergan PLC (2015)For profitMKTGOct 11, 2016
BayerFor profitNDA2Sep 24, 2010
BayerFor profitNDASep 24, 2010
LupinFor profitMKTGDec 12, 2017
LupinFor profitSYNDec 12, 2017
Watson PharmaceuticalsFor profitMKTGOct 11, 2016