Rezzayo

(Rezafungin Acetate)

Phase 2Small molecule

MMundipharma (China) Pharmaceutical Co. Ltd

Rezzayo is one of 12 small molecule programs targeting Aspergillosis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AspergillosisRecruiting

AspergillosisPhase 2

Recruiting

Competition

Competitive Landscape

11 competitors in Aspergillosis

#DrugCompanyPhaseTrials

Vfend

PPrism Pharmaceuticals

Approved

13 2

Eraxis

VVicuron Pharmaceuticals

Approved

4 3

Mycamine

BBaxter Healthcare Corporation

Approved

4 4

Abelcet

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

3 5

Noxafil

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

3 6

Sporanox

SSebela Pharmaceuticals Development LLC

Approved

3 7

Cancidas

FFresenius Kabi Taiwan Ltd.

Approved

2 8

Diflucan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

—9

Versed

CConrado Roberto Hoffmann Filho

Approved

—10

Amphotericin B Deoxycholate

Merck & Co.

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Aspergillosis

NCT06794554

Clinical

Trials by Indication[1]

Age1 trial

Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age

Terminated·MMundipharma Research Limited·Phase 1·NCT05534529·32 enrolled

Aspergillosis1 trial

Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options

Recruiting·MMundipharma Research Limited·Phase 2·NCT06794554·60 enrolled

Invasive Fungal Disease1 trial

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

Active, not recruiting·MMundipharma Research Limited·Phase 3·NCT04368559·602 enrolled

Pneumonia1 trial

Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults

Recruiting·MMundipharma Research Limited·Phase 2·NCT05835479·50 enrolled

Candidiasis1 trial

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

Completed·CCidara Therapeutics Inc.·Phase 3·NCT03667690·199 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 22, 2023

REZZAYO

NDA NDA217417

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Rezafungin Acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rezafungin Acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rezafungin Acetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217417). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Mundipharma (China) Pharmaceutical Co. Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: MMundipharma (China) Pharmaceutical Co. Ltd

Rezzayo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Age1 trial

Aspergillosis1 trial

Invasive Fungal Disease1 trial

Pneumonia1 trial

Candidiasis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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