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L-AmB standard dose
L-AmB standard dose is a Polyene antifungal Small molecule drug developed by Federal University of Health Science of Porto Alegre. It is currently in Phase 3 development for Invasive fungal infections (candidiasis, aspergillosis, cryptococcosis), Empiric therapy for suspected fungal infections in immunocompromised patients. Also known as: L-AmB conventional therapy.
L-AmB (liposomal amphotericin B) binds to ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and lead to cell death.
L-AmB (liposomal amphotericin B) binds to ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and lead to cell death. Used for Invasive fungal infections (candidiasis, aspergillosis, cryptococcosis), Empiric therapy for suspected fungal infections in immunocompromised 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 | L-AmB standard dose |
|---|---|
| Also known as | L-AmB conventional therapy |
| Sponsor | Federal University of Health Science of Porto Alegre |
| Drug class | Polyene antifungal |
| Target | Ergosterol (fungal cell membrane sterol) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Amphotericin B is a polyene antifungal that preferentially targets ergosterol, a sterol unique to fungal membranes, rather than cholesterol in human cells. The drug inserts into the fungal membrane and forms ion channels, causing leakage of intracellular contents and fungal cell lysis. The liposomal formulation reduces nephrotoxicity by preferentially delivering the drug to fungal cells and infected tissues.
Approved indications
- Invasive fungal infections (candidiasis, aspergillosis, cryptococcosis)
- Empiric therapy for suspected fungal infections in immunocompromised patients
Common side effects
- Nephrotoxicity (elevated creatinine)
- Infusion-related reactions (fever, chills, rigors)
- Hypokalemia
- Anemia
- Hypomagnesemia
Key clinical trials
- Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure (NA)
- Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease (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)
- Platform Trial For Cryptococcal Meningitis (PHASE2, PHASE3)
- Olorofim Aspergillus Infection Study (PHASE3)
- A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis (PHASE2)
- Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) (NA)
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:
- L-AmB standard dose CI brief — competitive landscape report
- L-AmB standard dose updates RSS · CI watch RSS
- Federal University of Health Science of Porto Alegre portfolio CI
Frequently asked questions about L-AmB standard dose
What is L-AmB standard dose?
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Related
- Drug class: All Polyene antifungal drugs
- Target: All drugs targeting Ergosterol (fungal cell membrane sterol)
- Manufacturer: Federal University of Health Science of Porto Alegre — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Invasive fungal infections (candidiasis, aspergillosis, cryptococcosis)
- Indication: Drugs for Empiric therapy for suspected fungal infections in immunocompromised patients
- Also known as: L-AmB conventional therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing