mafenide acetate

Trade name: sulfamylon

Small moleculeapproved

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

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

Earliest trial started Jul 1, 1995 (NCT00675922)

Timeline

1960s

  1. Jan 24, 1969

    Mylan — Earliest FDA Approval

  2. Jan 24, 1969

    Rising Pharmaceuticals — Marketing Organization

  3. Jan 24, 1969

    Mylan — NDA Organization

  4. Jan 24, 1969

    Rising Pharmaceuticals — NDA Secondary Org

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Feb 12, 2013

    Par Pharmaceuticals — Marketing Organization

  2. Feb 12, 2013

    Endo Pharmaceuticals — Marketing Organization

  3. Feb 12, 2013

    PH HEALTH — Marketing Organization

  4. Jul 31, 2017

    Novast Labs — Marketing Organization

  5. Jul 31, 2017

    Ingenus Pharmaceuticals — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJan 24, 1969

Chemistry & pharmacology

Loading structure…

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

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 IDPhaseStart dateSponsor(s)
NCT00586729N/AJul 1, 2009Realm Therapeutics, University of Arizona
NCT00634166Phase 4Sep 1, 2007Mylan
NCT00675922Phase 2/Phase 3 (Phase 3)Jul 1, 1995The University of Texas, Dallas, University of Texas, Galveston
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MylanFor profit1112007
Realm TherapeuticsFor profit1012009
The University of Texas, DallasAcademic/Hospital1011995
University of ArizonaAcademic/Hospital1112009
University of Texas, GalvestonAcademic/Hospital1111995
5 organizations
Page 1 / 1

Marketing (8)

OrganizationOrg typeRelationshipDate
Endo PharmaceuticalsFor profitMKTGFeb 12, 2013
Ingenus PharmaceuticalsFor profitMKTGJul 31, 2017
MylanFor profitNDAJan 24, 1969
Novast LabsFor profitMKTGJul 31, 2017
PH HEALTHFor profitMKTGFeb 12, 2013
Par PharmaceuticalsFor profitMKTGFeb 12, 2013
Rising PharmaceuticalsFor profitMKTGJan 24, 1969
Rising PharmaceuticalsFor profitNDA2Jan 24, 1969