meclofenamic acid

Trade name: meclomen

Small moleculeapproved

Approved

Jun 25, 1980

Meclofenamic acid, used as Meclofenamate sodium, is a non-steroidal anti-inflammatory agent with antipyretic and antigranulation activities. Meclofenamate sodium capsules are indicated for the relief of mild to moderate pain, for the treatment of primary dysmenorrhea and for the treatment of idiopathic heavy menstrual blood loss; for relief of signs and symptoms of juvenile arthritis; so as for relief of the signs and symptoms of rheumatoid arthritis; For relief of the signs and symptoms of osteoarthritis. The mode of action, like that of other nonsteroidal anti-inflammatory agents, is not known. Therapeutic action does not result from pituitary-adrenal stimulation. In animal studies, meclofenamate sodium was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. In vitro, meclofenamate sodium was found to be an inhibitor of human leukocyte 5-lipoxygenase activity. These properties may be responsible for the anti-inflammatory action of meclofenamate sodium. There is no evidence that meclofenamate sodium alters the course of the underlying disease. — NCATS

Clinical trial activity

2 trials · 2 clinical orgs · 14 marketing orgs

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

Earliest trial started Apr 22, 2015 (NCT02429570)

Timeline

1980s

  1. Jun 25, 1980

    Parke-Davis — Earliest FDA Approval

  2. Jun 25, 1980

    Parke-Davis — NDA Secondary Org

  3. Jun 25, 1980

    Parke-Davis — NDA Organization

  4. Jun 25, 1980

    Warner Lambert — NDA Secondary Org

  5. Sep 3, 1986

    Mylan — Marketing Organization

  6. Apr 15, 1987

    Watson Pharmaceuticals — Marketing Organization

  7. Apr 15, 1987

    Teva — Marketing Organization

  8. Apr 15, 1987

    Ani Pharmaceuticals — Marketing Organization

  9. Nov 29, 1988

    Fosun — Marketing Organization

  10. Nov 29, 1988

    Chartwell Pharmaceuticals — Marketing Organization

  11. Mar 20, 1989

    Barr Laboratories — Marketing Organization

2010s

  1. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedJun 25, 1980

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ccc(Cl)c(Nc2ccccc2C(=O)[O-])c1Cl.O.[Na+]
Mol. weight
336.15 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • acide meclofenamique
  • acide meclofenamique
  • acido meclofenamico
  • acido meclofenamico
  • acidum meclofenamicum
  • acidum meclofenamicum
  • ci-583
  • ci-583
  • cl-583
  • cl-583
  • cl-583.na salt
  • cl-583.na salt
  • inf-4668
  • inf-4668
  • meclodium
  • meclodium
  • meclofenamate
  • meclofenamate
  • meclofenamate
  • meclofenamate
  • meclofenamate
  • meclofenamate
  • meclofenamate sodium
  • meclofenamate sodium
  • meclofenamate sodium
  • meclofenamate sodium
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclofenamic acid
  • meclomen
  • meclomen
  • meclomen
  • meclophenamic acid
  • n-(2,6-dichloro-3-methylphenyl)anthranilic acid
  • n-(2,6-dichloro-3-methylphenyl)anthranilic acid
  • n-(2,6-dichloro-m-tolyl)anthranilic acid
  • n-(2,6-dichloro-m-tolyl)anthranilic acid
  • n-(3-methyl-2,6-dichlorophenyl)anthranilic acid
  • n-(3-methyl-2,6-dichlorophenyl)anthranilic acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02930005Phase 2Aug 1, 2015University of Texas at Houston
NCT02429570N/AApr 22, 2015Cornell University
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cornell UniversityAcademic/Hospital1112015
University of Texas at HoustonAcademic/Hospital1112015
2 organizations
Page 1 / 1

Marketing (16)

OrganizationOrg typeRelationshipDate
Am TherapFor profitMKTG
Ani PharmaceuticalsFor profitMKTGApr 15, 1987
Ani PharmaceuticalsFor profitSYNApr 15, 1987
Barr LaboratoriesFor profitMKTGMar 20, 1989
Chartwell PharmaceuticalsFor profitMKTGNov 29, 1988
FosunFor profitMKTGNov 29, 1988
MylanFor profitMKTGSep 3, 1986
Par PharmaceuticalsFor profitMKTG
Parke-DavisFor profitNDA2Jun 25, 1980
Parke-DavisFor profitNDAJun 25, 1980
Quantum PharmaceuticalFor profitMKTG
TevaFor profitMKTGApr 15, 1987
Upsher-Smith LaboratoriesFor profitMKTG
VitarineFor profitMKTG
Warner LambertFor profitNDA2Jun 25, 1980
Watson PharmaceuticalsFor profitMKTGApr 15, 1987