mafenide acetate
Trade name: sulfamylon
Approved
Jan 24, 1969
Mafenide is a sulfonamide-type medication used as an antibiotic. It is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. Mafenide is not antagonized by pABA, serum, pus or tissue exudates, and there is no correlation between bacterial sensitivities to mafenide and to the sulfonamides. A single case of bone marrow depression and a single case of an acute attack of porphyria have been reported following therapy with mafenide acetate. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate. Other adverse reactions are: pain or burning sensation, rash and pruritis, erythema, skin maceration from prolonged wet dressings, facial edema, swelling, hives, blisters, eosinophilia. — NCATS
Clinical trial activity
3 trials · 5 clinical orgs · 7 marketing orgs
Earliest trial started Jul 1, 1995 (NCT00675922)
Timeline
1960s
- Jan 24, 1969
Mylan — Earliest FDA Approval
- Jan 24, 1969
Rising Pharmaceuticals — Marketing Organization
- Jan 24, 1969
Mylan — NDA Organization
- Jan 24, 1969
Rising Pharmaceuticals — NDA Secondary Org
1990s
- Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
2010s
- Feb 12, 2013
Par Pharmaceuticals — Marketing Organization
- Feb 12, 2013
Endo Pharmaceuticals — Marketing Organization
- Feb 12, 2013
PH HEALTH — Marketing Organization
- Jul 31, 2017
Novast Labs — Marketing Organization
- Jul 31, 2017
Ingenus Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
Mechanism of action
- Bacterial dihydropteroate synthaseINHIBITOR
folP inhibitor
Broad spectrum
Approval history
- approvedPriority reviewJan 24, 1969
Chemistry & pharmacology
SMILES
NCc1ccc(S(N)(=O)=O)cc1- Mol. weight
- 186.24 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL419 ↗
- WikipediaMafenide ↗
- NCATS58447S8P4L ↗
- ChEMBLCHEMBL1201161 ↗
Also known as
- 4-(aminomethyl)benzenesulfonamide
- 4-(aminomethyl)benzenesulfonamide
- 4-(aminosulfonyl)benzylamine
- 4-homosufanilamide
- 4-homosufanilamide
- 4-homosulfanilamide
- 4-homosulfanilamide
- 4-homosulfanilamide
- 4-sulfamoylbenzylamine
- ambamide
- bensulfamide
- bensulfamide
- benzamsulfonamide
- homosulfanilamide
- mafenide
- mafenide
- mafenide
- mafenide
- mafenide
- mafenide
- mafenide
- mafenide
- mafenide acetate
- mafenide acetate
- mafenide acetate
- mafenide acetate
- mafenide acetate
- m,afenide hcl
- m,afenide hydrochloride
- malfamin
- maphenid
- maphenide
- maphenidum
- maphenidum
- p-sulfamoylbenzylamine
- sulfamylon
- sulfamylon
- sulfamylon
- sulfamylon
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00586729 | N/A | Jul 1, 2009 | Realm Therapeutics, University of Arizona |
| NCT00634166 | Phase 4 | Sep 1, 2007 | Mylan |
| NCT00675922 | Phase 2/Phase 3 (Phase 3) | Jul 1, 1995 | The University of Texas, Dallas, University of Texas, Galveston |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Mylan | For profit | 1 | 1 | 1 | 2007 |
| Realm Therapeutics | For profit | 1 | 0 | 1 | 2009 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 0 | 1 | 1995 |
| University of Arizona | Academic/Hospital | 1 | 1 | 1 | 2009 |
| University of Texas, Galveston | Academic/Hospital | 1 | 1 | 1 | 1995 |
Marketing (8)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Endo Pharmaceuticals | For profit | MKTG | Feb 12, 2013 |
| Ingenus Pharmaceuticals | For profit | MKTG | Jul 31, 2017 |
| Mylan | For profit | NDA | Jan 24, 1969 |
| Novast Labs | For profit | MKTG | Jul 31, 2017 |
| PH HEALTH | For profit | MKTG | Feb 12, 2013 |
| Par Pharmaceuticals | For profit | MKTG | Feb 12, 2013 |
| Rising Pharmaceuticals | For profit | MKTG | Jan 24, 1969 |
| Rising Pharmaceuticals | For profit | NDA2 | Jan 24, 1969 |