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Rezzayo

(Rezafungin)

Small molecule

MMundipharma (China) Pharmaceutical Co. Ltd

0

Indications

3

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

7

Patents

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Withdrawn·HHartford Hospital·Phase 1·NCT06329518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 Transplant Infection1 trial

Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection

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

Regulatory

FDA Approval Timeline[3]

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]
OpenFDA — FDA approval records (NDA NDA217417). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Rezzayo. 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]
Company: MMundipharma (China) Pharmaceutical Co. Ltd

Patent Landscape[4]

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

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