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Rovamycin (SPIRAMYCIN)
Rovamycin (generic name: SPIRAMYCIN) is a spiramycin Small molecule drug developed by Sanofi KK. It is currently FDA-approved for Prophylaxis of congenital toxoplasmosis.
Spiramycin (Rovamycin), marketed by Sanofi KK, is positioned in the niche but critical area of prophylaxis for congenital toxoplasmosis. Its key strength lies in its unique mechanism of action, inhibiting bacterial protein synthesis, which differentiates it from other macrolides such as erythromycin and clarithromycin. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | SPIRAMYCIN |
|---|---|
| Sponsor | Sanofi KK |
| Drug class | spiramycin |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
- Prophylaxis of congenital toxoplasmosis
Common side effects
Key clinical trials
- Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome
- Prevention of Congenital Toxoplasmosis With Pyrimethamine + Sulfadiazine Versus Spiramycine During Pregnancy (PHASE3)
- Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis (PHASE4)
- Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients (NA)
- A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea (PHASE1)
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:
- Rovamycin CI brief — competitive landscape report
- Rovamycin updates RSS · CI watch RSS
- Sanofi KK portfolio CI
Frequently asked questions about Rovamycin
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Related
- Drug class: All spiramycin drugs
- Manufacturer: Sanofi KK — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prophylaxis of congenital toxoplasmosis