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Methenamine + Methylthioninium
Methenamine releases formaldehyde in acidic urine to provide antimicrobial activity, while methylthioninium (methylene blue) acts as an additional antimicrobial and urinary antiseptic agent.
Methenamine releases formaldehyde in acidic urine to provide antimicrobial activity, while methylthioninium (methylene blue) acts as an additional antimicrobial and urinary antiseptic agent. Used for Urinary tract infections (prophylaxis and treatment), Cystitis.
At a glance
| Generic name | Methenamine + Methylthioninium |
|---|---|
| Also known as | methenamine + methylene blue |
| Sponsor | Fundação Educacional Serra dos Órgãos |
| Drug class | Urinary antiseptic combination |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Urology |
| Phase | FDA-approved |
Mechanism of action
Methenamine is a prodrug that hydrolyzes in acidic urine to release formaldehyde, which has broad-spectrum antimicrobial properties against bacteria and some fungi. Methylthioninium (methylene blue) is an oxidizing agent with antimicrobial and antioxidant properties that enhances urinary antisepsis. Together, they provide synergistic antimicrobial activity in the urinary tract.
Approved indications
- Urinary tract infections (prophylaxis and treatment)
- Cystitis
Common side effects
- Discoloration of urine (blue-green)
- Gastrointestinal upset
- Dysuria
- Allergic reactions
Key clinical trials
- Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis (PHASE4)
- Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria (PHASE3)
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 |
|---|---|
| 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:
- Methenamine + Methylthioninium CI brief — competitive landscape report
- Methenamine + Methylthioninium updates RSS · CI watch RSS
- Fundação Educacional Serra dos Órgãos portfolio CI