Rezzayo

(Rezafungin)

Phase 3Small molecule

MMundipharma (China) Pharmaceutical Co. Ltd

Rezzayo is one of 35 small molecule programs targeting Liver Transplant. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Liver TransplantActive, not recruiting

Liver TransplantPhase 3

Active, not recruiting

Competition

Competitive Landscape

353 competitors in Liver Transplant

#DrugCompanyPhaseTrials

Rezzayo

MMundipharma (China) Pharmaceutical Co. Ltd

Phase 3

1 2

Vemlidy

Gilead

Preclinical

3 3

Cysteine Hydrochloride

Novartis

Preclinical

3 4

Octreotide

Johnson & Johnson

Preclinical

2 5

Lenvima

Eisai

Preclinical

2 6

Myfortic

Novartis

Preclinical

1 7

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

4 8

Myfortic

Novartis

Preclinical

6 9

Levophed

GGeneral Hospital of Ningxia Medical University

Preclinical

1 10

Valcyte

EEngelhard Arzneimittel GmbH & Co.KG

Preclinical

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

Clinical

Trials by Indication[1]

Tics2 trials

Rezafungin Pharmacokinetics in Patients on ECMO

Withdrawn·HHartford Hospital·Phase 1·NCT06329518

Safety and Pharmacokinetics of Rezafungin

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04117607·14 enrolled

Liver Transplant1 trial

Rezafungin Prophylaxis in Liver Transplant

Enrolling by invitation·FFernanda P Silveira, MD, MS·Phase 3·NCT06774144·385 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 22, 2023

REZZAYO

NDA NDA217417

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Rezafungin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rezafungin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rezafungin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217417). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rezzayo. U.S. Food & Drug Administration.
[6]
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 3[1]
Company: MMundipharma (China) Pharmaceutical Co. Ltd

Patent Landscape[5]

Patent Cliff

Mar 2, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8722619Mar 2, 2032

11654196Mar 2, 2032

9526835Mar 14, 2033

10702573Mar 14, 2033

11712459Mar 15, 2037

2 more patents

11819533Jul 11, 2038

11197909Jul 14, 2038

Rezzayo

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Tics2 trials

Liver Transplant1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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