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Conventional amphotericin B
Conventional amphotericin B is a Polyene antifungal Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Systemic fungal infections (invasive aspergillosis, candidiasis, cryptococcosis), Empiric antifungal therapy in febrile neutropenic patients, Leishmaniasis.
Amphotericin B binds to ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and lead to cell death.
Amphotericin B binds to ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and lead to cell death. Used for Systemic fungal infections (invasive aspergillosis, candidiasis, cryptococcosis), Empiric antifungal therapy in febrile neutropenic patients, Leishmaniasis.
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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. -
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 | 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 | Conventional amphotericin B |
|---|---|
| Sponsor | Pfizer |
| Drug class | Polyene antifungal |
| Target | Ergosterol |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Amphotericin B is a polyene antibiotic that selectively targets ergosterol, a sterol unique to fungal cell membranes. By binding to ergosterol, it forms ion channels in the membrane, causing leakage of intracellular contents and ultimately fungal cell lysis. The conventional formulation has higher nephrotoxicity compared to lipid-based formulations due to its interaction with mammalian cholesterol.
Approved indications
- Systemic fungal infections (invasive aspergillosis, candidiasis, cryptococcosis)
- Empiric antifungal therapy in febrile neutropenic patients
- Leishmaniasis
Common side effects
- Nephrotoxicity (acute kidney injury)
- Infusion-related reactions (fever, chills, rigors)
- Hypokalemia
- Hypomagnesemia
- Anemia
- Phlebitis at infusion site
Key clinical trials
- Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS (PHASE3)
- Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis (PHASE2)
- Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011) (PHASE2)
- Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis (PHASE3)
- A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood. (PHASE3)
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:
- Conventional amphotericin B CI brief — competitive landscape report
- Conventional amphotericin B updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Conventional amphotericin B
What is Conventional amphotericin B?
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Related
- Drug class: All Polyene antifungal drugs
- Target: All drugs targeting Ergosterol
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Systemic fungal infections (invasive aspergillosis, candidiasis, cryptococcosis)
- Indication: Drugs for Empiric antifungal therapy in febrile neutropenic patients
- Indication: Drugs for Leishmaniasis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing