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Drug

Rezafungin

Approved · FDA / EMA
Late-stage development

Also known as Rezzayo, Echinocandin B, 1-((4R,5R)-4-hydroxy-N2-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-5-(2-(trimethylammonio)ethoxy)-l-ornithine)-4-((4S)-4-hydroxy-4-(4-hydroxyphenyl)-l-allothreonine)-.

1
Active clinical trials
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2025-10-20Results expected Q4 2028 · ClinicalTrials.gov

Approval: Rezzayo (EMA)

Regulatory2023-12-22EMA

Approval: REZAFUNGIN (NDA217417)

Regulatory2023-03-22FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Rezafungin
Aliases & brands
RezzayoEchinocandin B, 1-((4R,5R)-4-hydroxy-N2-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-5-(2-(trimethylammonio)ethoxy)-l-ornithine)-4-((4S)-4-hydroxy-4-(4-hydroxyphenyl)-l-allothreonine)-
RxNorm CUI
2639155
ChEMBL ID
CHEMBL3989945
UNII
G013B5478J
Regulatory jurisdictions
emafda

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-03-222023-12-22)
Earliest approval
2023-03-22
Latest approval
2026-07-16
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-07-16Indication expansion
Indication expansion: REZAFUNGIN (NDA217417)
Evidence ↗
2025-12-10Label change
Label change: REZAFUNGIN (NDA217417)
Evidence ↗
2023-03-22ApprovalMulti-authority
Approval: REZAFUNGIN (NDA217417)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-12-22ApprovalMulti-authority
Approval: Rezzayo (EMA)

Indication: Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.  

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

3 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
3
registered trials across all phases
1
Active studies
1
Recruiting
1
Late-stage (III+)
2
Discontinued
PHASE DISTRIBUTIONn = 3
Phase 12Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Enrolling by invitationPH IIIFernanda P Silveira, MD, MSn=3852028
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.