meclofenamic acid
Trade name: meclomen
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
Earliest trial started Apr 22, 2015 (NCT02429570)
Timeline
1980s
- Jun 25, 1980
Parke-Davis — Earliest FDA Approval
- Jun 25, 1980
Parke-Davis — NDA Secondary Org
- Jun 25, 1980
Parke-Davis — NDA Organization
- Jun 25, 1980
Warner Lambert — NDA Secondary Org
- Sep 3, 1986
Mylan — Marketing Organization
- Apr 15, 1987
Watson Pharmaceuticals — Marketing Organization
- Apr 15, 1987
Teva — Marketing Organization
- Apr 15, 1987
Ani Pharmaceuticals — Marketing Organization
- Nov 29, 1988
Fosun — Marketing Organization
- Nov 29, 1988
Chartwell Pharmaceuticals — Marketing Organization
- Mar 20, 1989
Barr Laboratories — Marketing Organization
2010s
- Jan 1, 2015
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Arachidonate 5-lipoxygenaseINHIBITOR
ALOX5 inhibitor
- CyclooxygenaseINHIBITOR
Cyclooxygenase inhibitor
Approval history
- approvedJun 25, 1980
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL1562610 ↗
- WikipediaMeclofenamic acid ↗
- NCATS48I5LU4ZWD ↗
- ChEMBLCHEMBL876 ↗
- ChEMBLCHEMBL509 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02930005 | Phase 2 | Aug 1, 2015 | University of Texas at Houston |
| NCT02429570 | N/A | Apr 22, 2015 | Cornell University |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2015 |
Marketing (16)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Am Therap | For profit | MKTG | — |
| Ani Pharmaceuticals | For profit | MKTG | Apr 15, 1987 |
| Ani Pharmaceuticals | For profit | SYN | Apr 15, 1987 |
| Barr Laboratories | For profit | MKTG | Mar 20, 1989 |
| Chartwell Pharmaceuticals | For profit | MKTG | Nov 29, 1988 |
| Fosun | For profit | MKTG | Nov 29, 1988 |
| Mylan | For profit | MKTG | Sep 3, 1986 |
| Par Pharmaceuticals | For profit | MKTG | — |
| Parke-Davis | For profit | NDA2 | Jun 25, 1980 |
| Parke-Davis | For profit | NDA | Jun 25, 1980 |
| Quantum Pharmaceutical | For profit | MKTG | — |
| Teva | For profit | MKTG | Apr 15, 1987 |
| Upsher-Smith Laboratories | For profit | MKTG | — |
| Vitarine | For profit | MKTG | — |
| Warner Lambert | For profit | NDA2 | Jun 25, 1980 |
| Watson Pharmaceuticals | For profit | MKTG | Apr 15, 1987 |