AmBisome

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

2 competitors in Liposomal Amphotericin B

#DrugCompanyPhaseTrials

1

Test

RRespirent Pharmaceuticals Co Ltd.

Preclinical

12

Reference

RRespirent Pharmaceuticals Co Ltd.

Preclinical

13

AmBisome

Gilead

Preclinical

2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Visceral Leishmaniasis3 trials

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

Active, not recruiting·DDrugs for Neglected Diseases·Phase 2·NCT05593666·101 enrolled

SCH708980 With and Without AmBisome for Visceral Leishmaniasis

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT01437020

Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis

Unknown status·—·Phase 4·NCT01566552·1,300 enrolled

Infection2 trials

Antimicrobial PK in Infants With Suspected or Confirmed Infection

Completed·—··NCT00491426·450 enrolled

Olorofim Aspergillus Infection Study

Active, not recruiting·FF2G Biotech GmbH·Phase 3·NCT05101187·225 enrolled

Liposomal Amphotericin B2 trials

An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects

Completed·TTaiwan Liposome Company·Phase 1·NCT01652859·36 enrolled

Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis

Not yet recruiting·SShanghai Public Health Clinical Center·N/A·NCT06926569·116 enrolled

Lip2 trials

Bioequivalence of Amphotericin B Liposome for Injection

Completed·CCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.·Phase 1·NCT05913921·32 enrolled

A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

Completed·CCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.·Phase 1·NCT04993222·12 enrolled

Treatment2 trials

Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment

Completed·Gilead·Phase 3·NCT00158730·800 enrolled

Short Course Regimens for Treatment of PKDL (Sudan)

Unknown status·DDrugs for Neglected Diseases·Phase 2·NCT03399955·110 enrolled

8 more indications

Liver Transplant2 trials

Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00001107·500 enrolled

Ambisome in Liver Transplant Patients

Terminated·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00161356·10 enrolled

Candidiasis1 trial

CRITIC - Treatment of Candidemia and Invasive Candidiasis

Completed·Gilead·Phase 4·NCT00670657·39 enrolled

Transplantation1 trial

PROPHYSOME: Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia

Completed·Gilead·Phase 4·NCT00362544·30 enrolled

Aspergillosis1 trial

COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis

Completed·Gilead·Phase 4·NCT00334412·30 enrolled

Allogeneic Stem Cell Transplantation1 trial

PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation

Completed·Gilead·Phase 2·NCT00326157·34 enrolled

Effectiveness1 trial

Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh

Completed·MMedecins Sans Frontieres, Netherlands·Phase 4·NCT03311607·280 enrolled

Lung Transplant Recipient1 trial

Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients

Suspended·UUniversity Health Network, Toronto·Phase 2·NCT01254708·4 enrolled

Tics1 trial

Pharmacokinetics and Safety of AmBisome and DKF-5122

Completed·DDongkook Pharmaceutical Co., Ltd.·Phase 1·NCT05749380·38 enrolled

Details

Drug Info

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