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Klaron (SULFACETAMIDE)
Klaron (SULFACETAMIDE) is a sulfonamide antibacterial small molecule drug originally developed by ORTHO MCNEIL PHARM and currently owned by Schering. It targets dihydrofolate reductase and has been FDA-approved since 1945 for various indications including acne vulgaris, amebic infection, and blepharoconjunctivitis. Klaron is off-patent with 15 generic manufacturers available. Key safety considerations include its antibacterial properties which may contribute to antibiotic resistance. As a sulfonamide, it may also cause hypersensitivity reactions in some individuals.
At a glance
| Generic name | SULFACETAMIDE |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Sulfonamide Antibacterial |
| Target | Dihydrofolate reductase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1945 |
Approved indications
- Acne vulgaris
- Amebic infection
- Blepharoconjunctivitis
- Chlamydial conjunctivitis
- Gardnerella Vaginalis Bacterial Vaginosis
- Infective blepharitis
- Iridocyclitis
- Pityriasis simplex
- Seborrheic dermatitis
- Superficial Ocular Infection
- Trachoma
- Uveitis
- Vulvovaginitis
Common side effects
- Stevens-Johnson syndrome
- Local hypersensitivity
- Syndrome resembling systemic lupus erythematosus
Key clinical trials
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- Intraductal Meibomian Gland Probing Trial (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Klaron CI brief — competitive landscape report
- Klaron updates RSS · CI watch RSS
- Merck & Co. portfolio CI