Amphotericin B
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed invasive scopulariopsis infection 1 milestone | |||||
| Filed | US (FDA) | — | invasive scopulariopsis infection | — | “Amphotericin B liposome for injection Nanodrug Anti-infective, nonspecific drug Invasive fungal infection Application for marketing approval submitted (US)” irasia.com ↗ “In November 2023, the Abbreviated New Drug Application (ANDA) for Amphotericin B Liposome for Injection was filed successfully with the US FDA.” irasia.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 107 · started per year
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Shionogi | Results F2G and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients with Invasive Aspergillosis shionogi.com ↗
The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome® followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). |
| 2026-06-18 | F2G Ltd | Results F2G and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients with Invasive Aspergillosis f2g.com ↗
The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome® followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). |
| 2026-04-29 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - MARKETING AUTHORISATION APPLICATION FOR AMPHOTERICIN B LIPOSOMAL, POWDER FOR CONCENTRATE FOR DISPERSION FOR INFUSION (HC1507G2) APPROVED IN EUROPE irasia.com ↗ |
| 2025-03-03 | TLC Biopharmaceuticals, Inc. | Regulatory TLC BioSciences Secures Marketing Approval for Ampholipad® in China tlcbio.com ↗
Following the approval of AmBisome in China in 2023, TLC demonstrated the quality and bioequivalence of Ampholipad to AmBisome within two years, obtaining NMPA approval. |
| 2024-09-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - AMPHOTERICIN B LIPOSOME FOR INJECTION OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
Amphotericin B Liposome for Injection (the ‘‘Product ’’) developed by the Group has obtained drug registration approval granted by the Nationa l Medical Products Administration of the People ’s Republic of China. |
| 2024-07-17 | Drugs for Neglected Diseases | Results Clinical trial in Eastern Africa finds a shorter, safer, and more effective treatment for PKDL, a stigmatizing skin disease dndi.org ↗
This group had an 80% cure rate, with MF+LAmB proving to be a good treatment alternative. |
| 2024-03-22 | Matinas BioPharma Nanotechnologies, Inc. | Results Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response matinasbiopharma.com ↗
The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options. |
| 2023-08-22 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma Announces Publication of Results from the Phase 2 EnACT Clinical Trial of MAT2203 in the IDSA Journal Clinical Infectious Diseases matinasbiopharma.com ↗
With six weeks of LNC-enabled oral amphotericin B, statistically fewer lab abnormalities occurred than with one week of intravenous amphotericin B. |
| 2023-04-18 | Matinas BioPharma Nanotechnologies, Inc. | Results Compassionate Use Patient Treated with Matinas BioPharma’s MAT2203 and Showing Complete Clinical Resolution of Rare R. mucilaginosa Fungal Infection Featured in Oral Presentation at ECCMID matinasbiopharma.com ↗
Following transition, MAT2203 was well-tolerated, and led to a robust clinical response with no renal adverse effects, allowing for six continuous months of treatment with regular outpatient monitoring. |
| 2022-06-08 | Drugs for Neglected Diseases | Results New WHO treatment guidelines offer hope for people co-infected with visceral leishmaniasis and HIV dndi.org ↗
In Ethiopia, the new treatment strategy was shown to have an 88% efficacy rate at the end of therapy (after 58 days), whereas the efficacy of the current standard treatment was 55% in the trial. |
| 2021-12-15 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces US FDA Approval for Generic Amphotericin B Liposome Injection sunpharma.com ↗ |
| 2021-12-03 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - INCLUSION OF ANFULIKE IN THE NATIONAL REIMBURSEMENT DRUG LIST irasia.com ↗
The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “ Group”) is pleased to announce that Anfulike ® (“Amphotericin B Cholesteryl Sulfate Complex for Injection (50mg)”) (the “ Product”) of the Group has been included in the category B of the National Reimbursement Drug List (2021) (“ NRDL”). |
| 2021-05-27 | Halcygen Pharmaceuticals Limited | Regulatory TLC and Strides partner to launch Liposomal Amphotericin B in India strides.com ↗
TLC receives approval from Central Drugs Standard Control Organization of India to launch Amphotericin B Liposome for Injection 50mg |
| 2021-04-01 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "AMPHOTERICIN B CHOLESTERYL SULFATE COMPLEX FOR INJECTION" OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
“AMPHOTERICIN B CHOLESTERYL SULFATE COMPLEX FOR INJECTION” OBTAINS DRUG REGISTRATION APPROVAL |
| 2020-08-20 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma Announces Publication of Results from Phase 1 Portion of the EnACT Study Investigating Safety and Tolerability of MAT2203 matinasbiopharma.com ↗
They concluded that MAT2203 was well tolerated when given in 4-6 divided daily doses without the toxicities commonly seen with IV amphotericin B. |
| 2019-05-28 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma Announces Publication of MAT2203 Preclinical Cryptococcal Meningitis Data in the American Society for Microbiology Journal, mBio matinasbiopharma.com ↗
Efficacy of oral delivery of amphotericin B (MAT2203) demonstrated comparable efficacy to IV amphotericin, with similar survival of animals and reduction in fungal burden |
| 2019-01-16 | Drugs for Neglected Diseases | Results Combination therapy found to be more effective in treating patients with leishmaniasis and HIV | DNDi dndi.org ↗ |
| 2018-06-06 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma to Present Preclinical Data at ASM Microbe 2018 Further Demonstrating the Broad Utility of its LNC Platform matinasbiopharma.com ↗
Data demonstrate safe, effective oral delivery of antimicrobial drugs utilizing LNC technology |
| 2016-07-13 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma Announces Presentation of Cryptococcal Meningitis Preclinical Data of MAT2203 at AIDS-Associated Mycosis Meeting 2016 matinasbiopharma.com ↗
Preclinical studies demonstrate comparable survival upon treatment with combination of oral encochleated amphotericin B plus flucytosine compared to injected amphotericin B |
| 2015-09-18 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma's MAT2203 -- Encochleated Formulation of Amphotericin B -- Shows Potential to Target and Penetrate Tissue Infected With Invasive Candidiasis in Data Presented at ICAAC/ICC 2015 matinasbiopharma.com ↗
The results of the study show that in Candida- infected mice MAT2203 is taken up from the gastrointestinal (GI) tract resulting in significant concentrations of AmB in targeted tissues, but undetectable AmB levels in plasma. |
| 2014-10-14 | Drugs for Neglected Diseases | Results Study Results Support WHO Recommendations for Safe and Effective Kala-azar Treatments in Bangladesh | DNDi dndi.org ↗
The combination treatments (AmBisome® + miltefosine; AmBisome® + paromomycin; paromomycin + miltefosine) were non-inferior to AmBisome® monotherapy: the combinations of AmBisome® + paromomycin and paromomycin + miltefosine demonstrated excellent cure rates of above 98%, thus comparable with AmBisome® monotherapy. |
| 2011-01-24 | Drugs for Neglected Diseases | Results Study shows the safety and efficacy of combination treatment for visceral leishmaniasis in India | DNDi dndi.org ↗
A phase III clinical trial study published online in The Lancet shows that three short-course combination treatments for visceral leishmaniasis in India are efficacious and safe. |
| 2009-06-19 | Sumitomo Pharma America, Inc. | Regulatory Acquisition of an additional indication of AmBisome, a therapeutic agent for systemic fungal infection sumitomo-pharma.com ↗
Visceral leishmaniasis can be treated by AmBisome ® under the newly added indication, though the same has already been allowed outside of Japan. |
| 2005-12-12 | Gilead Sciences | Results Data Show Efficacy of Standard Dosing Regimen of AmBisome(R) is Similar to High Loading Dose for Patients with Invasive Fungal Infections gilead.com ↗
In this study the overall rate of response for the two dosing regimens at end of treatment were associated with similar efficacy and survival (50 percent in the standard dosing group versus 46 percent in the high loading-dose group). |
| 2000-11-17 | Gilead Sciences | Results Study Results Published in Journal of Clinical Infectious Diseases Demonstrate That Ambisome® Has an Improved Safety Profile Compared to Abelcet® gilead.com ↗
Results of the study indicate that AmBisome demonstrates an improved safety profile in a direct comparison with Abelcet with regard to nephrotoxicity and infusion-related reactions. |
| 2000-09-17 | Gilead Sciences | Results Pharmacoeconomic Study Compares Total Hospital Costs of AmBisome® to Abelcet® for Empirical Treatment of Patients with Febrile Neutropenia gilead.com ↗
In this study, AmBisome 3mg/kg/day was found to be more cost-effective than Abelcet 5mg/kg/day due to a significant reduction in treatment-related nephrotoxicity. |
| 2000-09-17 | Gilead Sciences | Results Gilead Announces Data Demonstrating that Single Dose of AmBisome® Safely and Effectively Treats Visceral Leishmaniasis in India gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced promising results from a study conducted in India examining the use of a single dose of AmBisome® (amphotericin B) liposome for injection as a treatment for visceral leishmaniasis (VL). |
| 2000-07-05 | Gilead Sciences | Regulatory FDA Approves AmBisome® for the Treatment of Cryptococcal Meningitis in AIDS Patients gilead.com ↗
Fujisawa Healthcare, Inc. and Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) approved the antifungal drug AmBisome® [(amphotericin B) liposome for injection] for the treatment of cryptococcal meningitis in HIV-infected patients. |
| 2000-03-20 | Gilead Sciences | Regulatory Canada Approves Antifungal Agent Ambisome® gilead.com ↗
March 20, 2000 Fujisawa Healthcare, Inc. (Fujisawa) and Gilead Sciences, Inc. (NASDAQ:GILD) today announced that Fujisawa Canada, Inc., a subsidiary of Fujisawa, received marketing approval from Health Canada for the anti-fungal agent AmBisome® (amphotericin B) liposome for injection. |
| 2000-02-10 | Gilead Sciences | Regulatory New AmBisome® Label Includes Claim Of Superior Safety Profile Compared To Abelcet® In Febrile Neutropenic Cancer Patients gilead.com ↗
Fujisawa Healthcare, Inc. and Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Food and Drug Administration (FDA) has approved a supplemental new drug application for AmBisome® (amphotericin B) liposome for injection. |
| 1999-09-27 | Gilead Sciences | Results AmBisome® Phase III Study For Cryptococcal Meningitis gilead.com ↗
The study results indicate that AmBisome is as effective as amphotericin B, yet appears to be significantly less toxic. |
All press releases naming this drug 75 releases
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 147 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 ↗101“'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 ↗ |
| 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 ↗26“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 ↗ |
| 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 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 | 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 | 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 | “Oral Encochleated Amphotericin B (CAMB/MAT2203)” NCT02971007 ↗2“oral encochleated Amphotericin B (CAMB/MAT2203)” NCT03187691 ↗ “Oral Encochleated Amphotericin B (CAMB)” NCT03167957 ↗ |
| 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 | LAmB | “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 ↗ |
| 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 ↗ |