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Mycoster (R)
Mycoster (R) is a Small molecule drug developed by University Hospital, Rouen. It is currently in Phase 3 development for Fungal infections (specific indication not publicly detailed). Also known as: Ciclopirox olamine.
Mycoster is an antifungal agent that disrupts fungal cell wall synthesis or membrane integrity.
Mycoster (R) is an intervention studied in a clinical trial for the treatment of Severe Seborrheic Dermatitis. The trial, NCT02004860, also compared Mycoster (R) to Protopic (R) in the maintenance treatment of Severe Seborrheic Dermatitis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Mycoster (R) |
|---|---|
| Also known as | Ciclopirox olamine |
| Sponsor | University Hospital, Rouen |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
While specific mechanistic details for this investigational formulation are limited in public literature, Mycoster appears to be designed as an antifungal therapeutic, likely targeting ergosterol synthesis or cell wall components critical to fungal pathogens. The drug is in phase 3 development, suggesting it has demonstrated sufficient preclinical and early clinical activity to warrant advanced testing.
Approved indications
- Fungal infections (specific indication not publicly detailed)
Common side effects
Key clinical trials
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:
- Mycoster (R) CI brief — competitive landscape report
- Mycoster (R) updates RSS · CI watch RSS
- University Hospital, Rouen portfolio CI
Frequently asked questions about Mycoster (R)
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Related
- Manufacturer: University Hospital, Rouen — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Fungal infections (specific indication not publicly detailed)
- Also known as: Ciclopirox olamine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing