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Amphotericin B liposomes
Amphotericin B liposomes is a Polyene antifungal Small molecule drug developed by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. It is currently in Phase 3 development for Systemic fungal infections (invasive candidiasis, aspergillosis, cryptococcosis), Empirical antifungal therapy in febrile neutropenic patients.
Amphotericin B disrupts fungal cell membranes by binding to ergosterol, causing leakage of cellular contents and cell death.
Amphotericin B liposomes, specifically Ambisome, have been studied in clinical trials for various conditions, including liver transplantation, visceral leishmaniasis, leukemia, and hematopoietic stem cell transplantation. The pharmacokinetics of Ambisome in liver transplant patients were investigated in a clinical trial, "Blood, Bile and Tissue Pharmacokinetics of Single Dose Liposomal Amphotericin B in Liver Transplant Patients".
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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.
| 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 | Amphotericin B liposomes |
|---|---|
| Sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
| Drug class | Polyene antifungal |
| Target | Ergosterol |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Amphotericin B is a polyene antifungal that binds to ergosterol, a key sterol in fungal cell membranes, creating pores that allow intracellular potassium and other essential molecules to leak out. The liposomal formulation encapsulates the drug in lipid vesicles, which reduces its toxicity to human cells (which contain cholesterol rather than ergosterol) while maintaining antifungal efficacy. This targeted delivery improves the therapeutic index, allowing higher doses to be used against serious systemic fungal infections.
Approved indications
- Systemic fungal infections (invasive candidiasis, aspergillosis, cryptococcosis)
- Empirical antifungal therapy in febrile neutropenic patients
Common side effects
- Nephrotoxicity (elevated creatinine)
- Infusion-related reactions (fever, chills, rigors)
- Hypokalemia
- Anemia
- Hypomagnesemia
Key clinical trials
- Human Bioequivalence Study of Liposomal Amphotericin B for Injection (NA)
- Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) (PHASE3)
- Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment (PHASE2)
- Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT) (PHASE3)
- Study of EL219 vs Standard of Care for Early Antifungal Therapy of Suspected Invasive Mould Infections (PHASE2)
- A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis
- Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction (NA)
- Platform Trial For Cryptococcal Meningitis (PHASE2, 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:
- Amphotericin B liposomes CI brief — competitive landscape report
- Amphotericin B liposomes updates RSS · CI watch RSS
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. portfolio CI
Frequently asked questions about Amphotericin B liposomes
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Related
- Drug class: All Polyene antifungal drugs
- Target: All drugs targeting Ergosterol
- Manufacturer: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Systemic fungal infections (invasive candidiasis, aspergillosis, cryptococcosis)
- Indication: Drugs for Empirical antifungal therapy in febrile neutropenic patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing