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Anidulafungin, VER002
Anidulafungin, VER002 is a Echinocandin antifungal Small molecule drug developed by Pfizer. It is currently in Phase 2 development for Invasive candidiasis (Phase 2 development).
Anidulafungin inhibits fungal cell wall synthesis by targeting β-1,3-glucan synthase, leading to fungal cell death.
Anidulafungin is a small molecule inhibitor of 1,3-beta-glucan synthase, classified as an INHIBITOR drug class. It is used as an antifungal treatment for conditions such as candidemia, candidiasis, and infection, typically administered for a standard 14-day period.
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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. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Anidulafungin, VER002 |
|---|---|
| Sponsor | Pfizer |
| Drug class | Echinocandin antifungal |
| Target | β-1,3-glucan synthase (FKS1) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Anidulafungin is an echinocandin antifungal that binds to and inhibits the enzyme β-1,3-glucan synthase in the fungal cell wall. This prevents the synthesis of β-1,3-glucan, a critical structural component of the fungal cell wall, causing cell wall integrity to fail and resulting in fungal cell lysis and death. It is fungicidal against Candida species and other susceptible fungi.
Approved indications
- Invasive candidiasis (Phase 2 development)
Common side effects
- Elevated liver enzymes
- Infusion-related reactions
- Hypokalemia
- Headache
Key clinical trials
- A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (PHASE3)
- Translational PKPD Modeling of Anti-infective Drugs Used in Pediatric Units.
- A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
- Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
- Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
- Azole-echinocandin Combination Therapy for Invasive Aspergillosis (PHASE3)
- Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment (PHASE2)
- Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease (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:
- Anidulafungin, VER002 CI brief — competitive landscape report
- Anidulafungin, VER002 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Anidulafungin, VER002
What is Anidulafungin, VER002?
How does Anidulafungin, VER002 work?
What is Anidulafungin, VER002 used for?
Who makes Anidulafungin, VER002?
What drug class is Anidulafungin, VER002 in?
What development phase is Anidulafungin, VER002 in?
What are the side effects of Anidulafungin, VER002?
What does Anidulafungin, VER002 target?
Related
- Drug class: All Echinocandin antifungal drugs
- Target: All drugs targeting β-1,3-glucan synthase (FKS1)
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Invasive candidiasis (Phase 2 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing