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Antifungal Comparator
Antifungal Comparator is a Azole antifungal Small molecule drug developed by Elion Therapeutics, Inc.. It is currently in Phase 2 development for Fungal infections.
Antifungal mechanism involves inhibiting fungal cell wall synthesis
EL219, a small molecule antifungal, is being studied in a Phase 2 clinical trial for the treatment of Invasive Mould Infection, Onychomycosis, Candida Vulvovaginitis, Atrial Fibrillation, and Ventilator Associated Pneumonia. The trial compares EL219 to IV antifungal medications, specifically liposomal amphotericin B or voriconazole.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Antifungal Comparator |
|---|---|
| Sponsor | Elion Therapeutics, Inc. |
| Drug class | Azole antifungal |
| Target | 14-alpha-demethylase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
This is achieved through the inhibition of enzymes involved in the biosynthesis of the fungal cell wall, ultimately leading to the death of the fungal cells.
Approved indications
- Fungal infections
Common side effects
- Hepatotoxicity
- Rash
- Diarrhea
Key clinical trials
- A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections. (PHASE3)
- Study of EL219 vs Standard of Care for Early Antifungal Therapy of Suspected Invasive Mould Infections (PHASE2)
- Protocol for Improvement of Therapy With Warfarin (PHASE3)
- A Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO) (PHASE3)
- A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis (PHASE2)
- Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (PHASE2)
- Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment (PHASE2)
- MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037) (PHASE2)
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:
- Antifungal Comparator CI brief — competitive landscape report
- Antifungal Comparator updates RSS · CI watch RSS
- Elion Therapeutics, Inc. portfolio CI
Frequently asked questions about Antifungal Comparator
What is Antifungal Comparator?
How does Antifungal Comparator work?
What is Antifungal Comparator used for?
Who makes Antifungal Comparator?
What drug class is Antifungal Comparator in?
What development phase is Antifungal Comparator in?
What are the side effects of Antifungal Comparator?
What does Antifungal Comparator target?
Related
- Drug class: All Azole antifungal drugs
- Target: All drugs targeting 14-alpha-demethylase
- Manufacturer: Elion Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Fungal infections
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing