Amphotericin B
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | AMBISOME | — | 2000-01-28 – 2000-06-16 | fda.gov ↗ |
| Label expansion | US (FDA) | ABELCET | — | 1996-10-18 | fda.gov ↗ |
| Approved | US (FDA) | FUNGIZONE | — | 1964-11-12 | fda.gov ↗ |
Trials 108 · started per year
Also used as a comparator or background therapy in 34 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06616168 Background | Sep 2023 → Aug 2026 overdue | bacterial vaginosis | Danylo Halytsky Lviv National Medical University | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06449040 Comparator | Mar 2019 → Sep 2021 | cutaneous leishmaniasis | Hospital Universitário Professor Edgard Santos | Completed | No outcome recorded |
| Phase 1/2 | NCT00885703 Comparator | Apr 2010 → Jan 2017 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05593666 Comparator | Dec 2022 → Apr 2025 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2 | NCT03112031 Background | Oct 2017 → Jul 2018 | HIV infectious disease, meningoencephalitis, streptococcal meningitis | Oxford University Clinical Research Unit, Vietnam | Completed | No outcome recorded |
| Phase 2 | NCT00419770 Background | Oct 2007 → Dec 2009 | Zygomycosis | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00847678 Background | Aug 2006 → Nov 2007 | Cryptococcal meningitis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT00076869 Background | Jan 2003 → Sep 2004 | invasive aspergillosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00012467 Background | Jan 2000 → Jul 2001 | Cryptococcal meningitis, HIV infectious disease | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00000776 Background | ? → Sep 1996 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06666322 Comparator | May 2025 → Apr 2032 expected | Cryptococcal meningitis, HIV infectious disease | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06980493 Comparator | Apr → Jun 2025 overdue | dermatophytosis of scalp or beard | Sohag University | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT06040489 Comparator | Jun 2022 → Jun 2024 | mucocutaneous leishmaniasis | University of Brasilia | Unknown | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT07463040 Comparator | Jan 2027 → Mar 2029 expected | cutaneous leishmaniasis | Institute of Tropical Medicine, Belgium | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05541107 Comparator | Jan 2023 → Oct 2024 | Cryptococcal meningitis | Matinas BioPharma Nanotechnologies, Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT05101187 Comparator | Mar 2022 → Nov 2025 overdue | invasive aspergillosis | F2G Biotech GmbH | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01293643 Comparator | May 2010 → Jan 2011 | bacterial vaginosis, vulvovaginal candidiasis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01122771 Comparator | May 2010 → Mar 2014 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 3 | NCT01058174 Comparator | Dec 2009 → May 2012 | fungal infectious disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00889356 Comparator | Sep 2009 → Mar 2010 | bacterial vaginosis, candidiasis | Zodiac Produtos Farmaceuticos S.A. | Unknown | No outcome recorded |
| Phase 3 | NCT00876824 Comparator | Jul 2009 → Jan 2011 | visceral leishmaniasis | Bharat Serums and Vaccines Limited | Completed | No outcome recorded |
| Phase 3 | NCT00624143 Comparator | Feb 2008 → Dec 2009 | acute leukemia | All India Institute of Medical Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT00106288 Comparator | Jan 2003 → Dec 2005 | candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00003315 Background | Jul → Dec 1997 | infectious disease | Medical Research Council | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07072923 Comparator | Sep 2025 → Jul 2027 expected | osteomyelitis | University of Arizona | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06756191 Comparator | Jan → Jul 2025 overdue | fungal lung infectious disease | Bin Cao | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06178627 Comparator | Aug 2023 → Aug 2025 overdue | Cryptococcal meningitis | Huashan Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06413056 Comparator | Oct 2022 → May 2023 | candidiasis, invasive | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT03814343 Comparator | Jan 2019 → Nov 2020 | tinea unguium | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT01303549 Comparator | Nov 2011 → May 2014 | fungal infectious disease, liver disorder | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT00634166 Background | Sep 2007 → Dec 2013 | — | Mylan Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00421187 Comparator | Mar 2007 → Apr 2008 | neutropenia | Gilead Sciences | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02088970 Background | Sep 2014 → Apr 2017 | fungal keratitis | Nantes University Hospital | Terminated | No outcome recorded |
| — | NCT02136030 Comparator | Feb 2011 → Dec 2015 | Cryptococcal meningitis | TTY Biopharm | Unknown | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2005-12-12 | Gilead Sciences | Data Show Efficacy of Standard Dosing Regimen of AmBisome(R) is Similar to High Loading Dose for Patients with Invasive Fungal Infections gilead.com ↗ |
| 2000-11-17 | Gilead Sciences | Study Results Published in Journal of Clinical Infectious Diseases Demonstrate That Ambisome® Has an Improved Safety Profile Compared to Abelcet® gilead.com ↗ |
| 2000-09-17 | Gilead Sciences | Pharmacoeconomic Study Compares Total Hospital Costs of AmBisome® to Abelcet® for Empirical Treatment of Patients with Febrile Neutropenia gilead.com ↗ |
| 2000-09-17 | Gilead Sciences | Gilead Announces Data Demonstrating that Single Dose of AmBisome® Safely and Effectively Treats Visceral Leishmaniasis in India gilead.com ↗ |
| 2000-07-05 | Gilead Sciences | FDA Approves AmBisome® for the Treatment of Cryptococcal Meningitis in AIDS Patients gilead.com ↗ |
| 2000-03-20 | Gilead Sciences | Canada Approves Antifungal Agent Ambisome® gilead.com ↗ |
| 2000-02-10 | Gilead Sciences | New AmBisome® Label Includes Claim Of Superior Safety Profile Compared To Abelcet® In Febrile Neutropenic Cancer Patients gilead.com ↗ |
| 1999-09-27 | Gilead Sciences | AmBisome® Phase III Study For Cryptococcal Meningitis gilead.com ↗ |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 148 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amphotericin B | “Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin,...” NCT07072923 ↗100“'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin;...” NCT00634166 ↗ “Participants with human immunodeficiency virus (HIV) and asymptomatic cryptococcal antigenemia in Uganda were randomized to liposomal amphotericin B (10 mg/kg once) with...” PMID 39044381 ↗ Feb 2025 “A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia.” PMID 20431381 ↗ May 2010 “Preparation Prepare a 2.5% amphotericin B solution by reconstitute liposomal amphotericin B 50 mg vial in 20 ml distilled water result in a final concentration of 2.5 mg/ml.” NCT06980493 ↗ “The SDD treatment comprises two oral liquids: an oral suspension containing amphotericin B and an oral solution containing both colistin sulfate and tobramycin.” PMID 41345690 ↗ Dec 2025 “Provider choice of topical antibiotics includes Mupirocin 0.4mg/ml, Vancomycin 1mg/ml, Tobramycin 0.7mg/ml, Levofloxacin 0.4mg/ml, and Amphotericin B 20mcg/ml” NCT03935828 ↗ “Intravenous liposomal amphotericin B (beginning with 3mg/kg, up to 5 mg/kg), with or without surgery or other antifungals as clinically indicated” NCT04502381 ↗ “Amphotericin B colloidal dispersion (ABCD) is a less toxic formulation of amphotericin B for the treatment of invasive fungal infections.” PMID 34686365 ↗ Oct 2021 “Liposomal Amphotericin B (AmBisome ®) has been shown in animals to be concentrated in the liver, lungs and leukocytes.” NCT00161356 ↗ “Pharmacokinetics of Liposomal Amphotericin B (AmBisome®) Given Intravenously to Patients Undergoing Bariatric Surgery” NCT02320604 ↗ “single infusion of liposomal amphotericin B (L-AmB), followed 1 day later by short-course oral miltefosine” PMID 18781879 ↗ Oct 2008 “Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL).” NCT01857479 ↗ “Amphotericin B deoxycholate (amphotericin) (219 patients)” PMID 28614691 ↗ Jun 2017 “inhaled liposomal amphotericin B = inhaled LAmB” NCT03656081 ↗ “topical amphotericin B 0.15% alone” PMID 35044972 ↗ Jan 2022 “Amphotericin B Suspension” NCT00425620 ↗ |
| Known as | Abelcet | “Pharmacokinetic and Deposition Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet®) in Lung Transplant Recipients (Radiotagging Protocol)” NCT00235651 ↗1“Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)” NCT00177684 ↗ |
| Known as | ABLC | “Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients.” PMID 20881664 ↗ Dec 20103“three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B)” NCT00002019 ↗ |
| Known as | AMB | “To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis” NCT00000708 ↗4“Historically, amphotericin B (AMB) has been considered the "gold standard" in antifungal treatments due to its broad spectrum of activity and lack of emergence of resistance.” NCT04031833 ↗ “There are no data comparing voriconazole versus amphotericin B (AmB) as AFP in either adult/pediatric AL.” PMID 22042283 ↗ Dec 2011 “intravenous amphotericin B deoxycholate (AmB) 0.7 mg/kg (the standard therapy)” PMID 19441980 ↗ Jun 2009 “Amphotericin B (AmB) is the corner stone in CM treatment.” NCT04140461 ↗ |
| Known as | AmBD | “control group: amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg/kg/d intravenously for 14 days as the standard of care recommended by local guidelines” NCT06926569 ↗ |
| Known as | Ambisome | “The purpose of this study is to determine the steady state concentrations of inhaled liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized nebulization.” NCT00177710 ↗27“A liposomal formulation of amphotericin B, AmBisome, is also available, and is substantially less nephrotoxic than amphotericin B, but is expensive.” NCT00696969 ↗ “Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial” NCT00467883 ↗ “An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months” NCT02273661 ↗ “COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis” NCT00334412 ↗ “Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved” NCT06449040 ↗ “Liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis.” NCT00371995 ↗ “Nebulized Liposomal Amphotericin B (Ambisome) Versus Nebulized Placebo” NCT00263315 ↗ “Liposomal amphotericin B (AmBisome®) and sodium stibogluconate” NCT01067443 ↗ “Drug: Amphotericine in liposome (Ambisome®)” NCT06980493 ↗ “Amphotericine in liposome (Ambisome®)” NCT00697944 ↗ “Liposomal amphotericin B (AmBisome®)” NCT00421187 ↗ |
| Known as | AmBisome (liposomal amphotericin B) | “AmBisome® (liposomal amphotericin B)” NCT05101187 ↗ |
| Known as | Amp-B | “Amp-B deoxycholate 50 mg (Amphotret™ Bharat serums and vaccines limited)” NCT04502381 ↗ |
| Known as | amphotericin B deoxycholate | “control group: amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg/kg/d intravenously for 14 days as the standard of care recommended by local guidelines” NCT06926569 ↗2“intravenous amphotericin B deoxycholate (AmB) 0.7 mg/kg (the standard therapy)” PMID 19441980 ↗ Jun 2009 “Drug: Amphotericin B-deoxycholate” NCT01032187 ↗ |
| Known as | Amphotericin B Lipid Complex | “three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B)” NCT00002019 ↗1“Amphotericin B Lipid Complex (ABLC)” NCT00750737 ↗ |
| Known as | amphotericin B liposomal | “Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks” NCT00467883 ↗2“Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole” NCT02366884 ↗ |
| Known as | Amphotericine in liposome | “Drug: Amphotericine in liposome (Ambisome®)” NCT06980493 ↗1“Amphotericine in liposome (Ambisome®)” NCT00697944 ↗ |
| Known as | Amphotret | “Amp-B deoxycholate 50 mg (Amphotret™ Bharat serums and vaccines limited)” NCT04502381 ↗ |
| Known as | CAMB | “MAT2203 or encochleated oral amphotericin B (cAMB) is a lipid nano-crystal formulation designed for targeted oral delivery of the antifungal drug AMB for treatment of fungal...” NCT04031833 ↗3“oral encochleated Amphotericin B (CAMB/MAT2203)” NCT03187691 ↗ “Oral Encochleated Amphotericin B (CAMB/MAT2203)” NCT02971007 ↗ “Oral Encochleated Amphotericin B (CAMB)” NCT03167957 ↗ |
| Known as | Encochleated Amphotericin B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03196921 ↗ |
| Known as | Fungizone | “Amphotericin B (Fungizone®) Bottle 10% (4000mg/40ml) oral solution Dose 500mg x4 (20ml) daily orally” NCT07300553 ↗2“compared to Fungizone (Amphotericin B)” NCT00002019 ↗ “= Fortum + vancomycin + Fungizone” NCT02088970 ↗ |
| Known as | L-AmB | “This is a prospective, open-label, multicenter, single-arm exploratory clinical study designed to evaluate the safety and effectiveness of liposomal amphotericin B (L-AmB) in...” NCT07337720 ↗6“Liposomal amphotericin B (L-AmB) is the drug of choice for treatment, but access is restricted due to the high drug and hospitalization costs of the conventional long regimens.” PMID 37232940 ↗ Oct 2023 “Patients were scheduled to receive 10 mg/kg/day liposomal amphotericin B (L-AMB) monotherapy for 1 month and surgery was performed when appropriate.” PMID 26316385 ↗ Aug 2015 “Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study.” PMID 28531175 ↗ May 2017 “single infusion of liposomal amphotericin B (L-AmB), followed 1 day later by short-course oral miltefosine” PMID 18781879 ↗ Oct 2008 “Liposomal amphotericin B (L-AmB) is considered the therapy of choice for AIDS-associated histoplasmosis.” NCT04059770 ↗ “Liposomal Amphotericin B (LAmB)” NCT06525389 ↗ |
| Known as | liposomal amphotericin-B | “CRITIC: Phase II Pilot Multicenter Study on Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) at 2 mg/kg/Day in the Treatment of Candidemia and Invasive Candidiasis...” NCT00670657 ↗27“Liposomal amphotericin B (L-AmB) is the drug of choice for treatment, but access is restricted due to the high drug and hospitalization costs of the conventional long regimens.” PMID 37232940 ↗ Oct 2023 “Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study.” PMID 28531175 ↗ May 2017 “Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial” NCT00467883 ↗ “Liposomal Amphotericin B (AmBisome ®) has been shown in animals to be concentrated in the liver, lungs and leukocytes.” NCT00161356 ↗ “An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months” NCT02273661 ↗ “Liposomal amphotericin B (L-AmB) is considered the therapy of choice for AIDS-associated histoplasmosis.” NCT04059770 ↗ “Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved” NCT06449040 ↗ “Nebulized Liposomal Amphotericin B (Ambisome) Versus Nebulized Placebo” NCT00263315 ↗ “1. Liposomal Amphotericin B 10mg/kg IV given once” NCT06666322 ↗ “intravenous liposomal amphotericin B (10mg/kg)” NCT07261150 ↗ “Liposomal amphotericin B (AmBisome®)” NCT00421187 ↗ |
| Known as | MAT2203 | “MAT2203” NCT03187691 ↗ |
| Known as | Oral Encochleated Amphotericin B | “Oral Encochleated Amphotericin B (CAMB)” NCT03167957 ↗ |
| Action | Inhibit | “This causes impairing membrane barrier function. In addition, it also causes growth inhibition.” NCT03814343 ↗ |
| Route | Intravenous | “amphotericin B intravenously (in the vein)” NCT00000639 ↗ |