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Methenamine and Methylthioninium chloride
Methenamine and Methylthioninium chloride is a Urinary antiseptic combination Small molecule drug developed by EMS. It is currently in Phase 3 development for Urinary tract infections (prophylaxis and treatment), Recurrent urinary tract infections.
Methenamine releases formaldehyde in acidic urine to provide antimicrobial activity, while methylthioninium chloride (methylene blue) acts as an antimicrobial agent and urinary antiseptic.
Methenamine releases formaldehyde in acidic urine to provide antimicrobial activity, while methylthioninium chloride (methylene blue) acts as an antimicrobial agent and urinary antiseptic. Used for Urinary tract infections (prophylaxis and treatment), Recurrent urinary tract infections.
At a glance
| Generic name | Methenamine and Methylthioninium chloride |
|---|---|
| Sponsor | EMS |
| Drug class | Urinary antiseptic combination |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
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 chloride (methylene blue) is an oxidizing agent with antimicrobial and antioxidant properties that enhances urinary antisepsis. Together, this combination targets urinary tract infections through dual antimicrobial mechanisms.
Approved indications
- Urinary tract infections (prophylaxis and treatment)
- Recurrent urinary tract infections
Common side effects
- Dysuria
- Urinary discoloration (blue-green)
- Nausea
- Abdominal discomfort
- Headache
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 and Methylthioninium chloride CI brief — competitive landscape report
- Methenamine and Methylthioninium chloride updates RSS · CI watch RSS
- EMS portfolio CI
Frequently asked questions about Methenamine and Methylthioninium chloride
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Related
- Drug class: All Urinary antiseptic combination drugs
- Manufacturer: EMS — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Urinary tract infections (prophylaxis and treatment)
- Indication: Drugs for Recurrent urinary tract infections
- Compare: Methenamine and Methylthioninium chloride vs similar drugs
- Pricing: Methenamine and Methylthioninium chloride cost, discount & access