ERAXIS (anidulafungin) · Pfizer
Eraxis (anidulafungin) is an echinocandin antifungal indicated for the treatment of candidemia and other deep-tissue Candida infections, such as intra-abdominal abscess and peritonitis, in adults and pediatric patients aged one month and older. It is also indicated for the treatment of esophageal candidiasis in adults, though it is associated with higher relapse rates in this population. Eraxis has not been adequately studied in patients with endocarditis, osteomyelitis, or meningitis due to Candida, nor has its efficacy been established in neutropenic patients.
How ERAXIS Works
Anidulafungin is an echinocandin antifungal that works by non-competitively inhibiting 1,3-β-D-glucan synthase. This inhibition prevents the synthesis of 1,3-β-D-glucan, an essential polysaccharide component of the fungal cell wall, leading to osmotic instability and fungal cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-02-17
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
ERAXIS Approval History
What ERAXIS Treats
8 indicationsERAXIS is approved for 8 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidemia
- Candida Infections
- Intra-abdominal Abscess
- Peritonitis
- Esophageal Candidiasis
- Endocarditis
- Osteomyelitis
- Meningitis
ERAXIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04876716 IA-DUET | NL72950.078.20 2020-000627-40 | Ph 3 | terminated | Azole-echinocandin Combination Therapy for Invasive Aspergillosis |
| NCT00934934 CANTREAT results posted | CANTREAT | Ph 2 | terminated | Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment |
| NCT01734525 results posted | Early Therapy | Ph 4 | completed | Negative Beta Glucan in ICU Patients |
| NCT00761267 results posted | A8851008 2008-004150-32 | Ph 3 | completed | Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis |
| NCT01307930 results posted | A10-3616 5UL1RR024982-02 | Ph 4 | completed | Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations |
| NCT00841971 results posted | PRO08110001 | Ph 4 | completed | Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients |
| NCT01303549 AVALTRA | GESITRA 0110 2011-000804-17 | Ph 4 | completed | Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients |
| NCT00734500 results posted | Pro00000637 | Ph 1 | completed | Anidulafungin PK in Infants and Toddlers |
| NCT01188759 | A1501095 | Ph 3 | withdrawn | Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects |
| NCT00531479 results posted | A8851009 | Ph 3 | completed | Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis |
| NCT01053884 ECALTA | Anidulafungin - MG-ECALTA1 2009-014527-23 | Ph 2 | terminated | Anidulafungin in Patients With Hematologic Malignancies |
| NCT00689338 ICE results posted | A8851019 | Ph 3 | completed | Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study |
| NCT00548262 results posted | A8851015 | Ph 4 | completed | This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis |
| NCT00537329 results posted | A8851016 PF-03910960 | Ph 3 | completed | Anidulafungin In Treatment Of Candidemia In Asian Subjects |
| NCT00620074 results posted | A8851014 | Ph 4 | terminated | Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ERAXIS FDA Label Details
Indications & Usage
FDA Label (PDF)ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) • Esophageal candidiasis in adults Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. • ERAXIS...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment