Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR ANIDULAFUNGIN


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All Clinical Trials for anidulafungin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00037206 ↗ A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA). Completed Vicuron Pharmaceuticals Phase 2/Phase 3 2002-05-01 The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.
NCT00037206 ↗ A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA). Completed Pfizer Phase 2/Phase 3 2002-05-01 The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.
NCT00037219 ↗ The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis. Completed Vicuron Pharmaceuticals Phase 2 2001-08-01 Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.
NCT00037219 ↗ The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis. Completed Pfizer Phase 2 2001-08-01 Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.
NCT00041704 ↗ The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC) Completed Vicuron Pharmaceuticals Phase 2 2002-08-01 Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for anidulafungin

Condition Name

Condition Name for anidulafungin
Intervention Trials
Candidemia 8
Candidiasis 8
Aspergillosis 5
Fungemia 3
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Condition MeSH

Condition MeSH for anidulafungin
Intervention Trials
Candidiasis 15
Candidemia 12
Candidiasis, Invasive 10
Aspergillosis 7
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Clinical Trial Locations for anidulafungin

Trials by Country

Trials by Country for anidulafungin
Location Trials
United States 78
Brazil 13
Canada 11
Netherlands 9
Spain 6
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Trials by US State

Trials by US State for anidulafungin
Location Trials
Pennsylvania 10
North Carolina 8
Michigan 7
Texas 6
California 5
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Clinical Trial Progress for anidulafungin

Clinical Trial Phase

Clinical Trial Phase for anidulafungin
Clinical Trial Phase Trials
PHASE4 1
Phase 4 9
Phase 3 13
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Clinical Trial Status

Clinical Trial Status for anidulafungin
Clinical Trial Phase Trials
Completed 26
Terminated 6
Unknown status 2
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Clinical Trial Sponsors for anidulafungin

Sponsor Name

Sponsor Name for anidulafungin
Sponsor Trials
Pfizer 22
Vicuron Pharmaceuticals 5
Radboud University 3
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Sponsor Type

Sponsor Type for anidulafungin
Sponsor Trials
Industry 30
Other 24
NIH 3
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Anidulafungin: Clinical Trials Update, Market Analysis, and Projection

Last updated: May 6, 2026

What is anidulafungin’s current clinical-trial landscape?

Anidulafungin is an intravenous echinocandin antifungal used for invasive candidiasis and other selected Candida infections. The clinical-trial “update” for the molecule is largely driven by late-stage labeling refinements, investigator-initiated comparative studies, and post-marketing research rather than ongoing Phase 3 pivots.

What to treat as “active” in decision-making

  • Regulatory and post-approval studies: Focus on dosing, special populations, real-world outcomes, and practice variation across hospital formularies.
  • Comparative effectiveness and resistance-related analyses: Often observational or registry-based, anchored to susceptibility patterns and outcomes rather than new clinical endpoints.

Because the prompt does not provide a specific trial identifier set (NCT numbers), a complete and accurate trial-by-trial status table cannot be produced without risking misstatement. (Per operating constraints, no incomplete trial “snapshots” are included.)

Where does anidulafungin sit in the antifungal market?

Anidulafungin competes in the IV echinocandin class (with caspofungin and micafungin) for invasive candidiasis and related indications, in hospital settings where stewardship and formulary dynamics strongly influence volume.

Market structure by segment

Segment Typical buyers Key drivers Competitive set
Invasive candidiasis (hospital acute care) Tertiary hospitals, ID programs Pathogen burden, guideline adherence, ICU utilization, stewardship Echinocandins (anidulafungin, micafungin, caspofungin)
Empiric antifungal therapy in high-risk patients Hospitals with protocols Time-to-therapy, dosing convenience, formulary access Echinocandins vs amphotericin regimens
Drug procurement and substitution Pharmacy procurement WAC vs net price, contracting, rebates, tendering Same-class substitution most common

Pricing and access mechanics that move revenue

Echinocandins are largely “system-driven” products:

  • Hospital formulary position shifts with contracting cycles.
  • Net pricing depends on tendering and payer mix, not list price.
  • Switching between echinocandins happens when one product gains a contract advantage, as clinical efficacy is broadly comparable in invasive Candida management.

How big is the market opportunity and what is the realistic unit-growth path?

A defensible projection requires current base sales, product-specific share, and forecast methodology inputs. Those base figures are not provided in the prompt. Under operating constraints, no numeric projection is generated without complete sourcing.

What can be stated with precision is the shape of the demand curve and the levers that determine whether anidulafungin grows or plateaus:

Demand levers (directional, evidence-aligned)

Lever Expected impact on anidulafungin volume
Incidence of invasive candidiasis (ageing populations, ICU utilization) Upward pressure over time
Antifungal stewardship tightening (reduction of unnecessary empiric use) Downward pressure on “catch-all” use
Contracting dynamics within echinocandins Can swing market share between products
Resistance monitoring and guideline updates Typically stabilizes class adoption rather than re-allocating away from echinocandins

What share dynamics matter most versus micafungin and caspofungin?

In IV echinocandin use, prescribers anchor on:

  • early empiric coverage for high-risk patients
  • IV-to-stepdown strategy once stable and culture data guide therapy
  • local protocols and supply continuity

Because class drugs are clinically aligned, market share often follows purchasing terms more than marginal clinical differentiation. That means projections should be modeled as:

  • Total echinocandin category volume growth (driven by patient mix and guideline adherence)
  • Relative anidulafungin share (driven by net pricing, contract coverage, and inventory continuity)

What is the investment and R&D takeaway from the clinical “update” pattern?

For anidulafungin, the actionable implication is that the primary path to value is not new blockbuster Phase 3 expansion, but execution against:

  • formulary retention and replacement risk
  • continuity of supply and contract renewal
  • comparative outcomes evidence in real-world settings used by stewardship committees

This aligns with how hospital therapeutics are managed for established IV antibiotics/antifungals: clinical differentiation exists, but buying decisions are controlled by contracting and operational fit.

What is the projection for the product over the next cycle?

A numeric forward projection (CAGR, dollar sales, or unit forecasts) cannot be produced accurately without:

  • current global and regional sales base for anidulafungin
  • time series to establish category growth assumptions
  • explicit share and pricing inputs

Per operating constraints, no numeric projection is provided.

Key Takeaways

  • Anidulafungin remains an entrenched IV echinocandin option, with “clinical trial updates” concentrated in post-approval and real-world research rather than new Phase 3 pivots.
  • Competitive outcomes are driven more by hospital contracting and formulary dynamics within the echinocandin class than by new clinical differentiation.
  • A credible market projection requires product baseline sales and share/pricing inputs; those are not available in the prompt, so no numeric forecast is issued.

FAQs

  1. Is anidulafungin still used as first-line therapy in invasive Candida infections?
    Yes, it remains an established option within guideline-driven IV echinocandin therapy for invasive candidiasis.

  2. What most strongly influences anidulafungin revenue in hospitals?
    Formulary status and contracting terms versus competing echinocandins, which drive net pricing and volume.

  3. Are there major ongoing Phase 3 programs for new anidulafungin indications?
    The practical clinical update pattern for the molecule is predominantly post-approval and observational work rather than new Phase 3 indication pivots.

  4. How does antifungal stewardship affect anidulafungin demand?
    It can reduce unnecessary empiric use, shifting demand toward better-targeted indications and culture-guided therapy.

  5. What is the main competitive risk for anidulafungin?
    Loss of formulary position or contract coverage to micafungin or caspofungin.


References

[1] FDA. Anidulafungin prescribing information (route of administration: intravenous). U.S. Food and Drug Administration.
[2] EMA. Erivedge? (not applicable) / Echinocandin product information for anidulafungin (where applicable). European Medicines Agency.
[3] IDSA. Clinical Practice Guideline for the Management of Candidiasis. Infectious Diseases Society of America.

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