Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

FDA approval
An FDA-approved product contains this peptide
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

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Status as of

Key takeaway

The echinocandins (caspofungin, micafungin, and anidulafungin; sold as Cancidas, Mycamine, and Eraxis) are antifungal lipopeptides that attack the fungal cell wall, a structure human cells lack. They are a preferred option for invasive Candida infections and are generally well tolerated. All three have been FDA-approved in the U.S. since the 2000s, a fourth (rezafungin, sold as Rezzayo) was approved in 2023, and all are given intravenously.

At a glance

What they are
Echinocandin antifungal lipopeptides that block fungal cell-wall synthesis
Approved for
Invasive candidiasis and candidemia, esophageal candidiasis, and (caspofungin) some aspergillosis and febrile neutropenia
Key fact
Caspofungin was at least as effective as amphotericin B for invasive candidiasis, with fewer side effects
Route
Intravenous
Evidence strength
FDA approved

Summary

Echinocandins are FDA-approved antifungal lipopeptides that block the fungal cell wall. Learn how caspofungin, micafungin, and anidulafungin work and are used.

What are the echinocandins?

The echinocandins are a class of antifungal drugs, semi-synthetic cyclic lipopeptides, that includes caspofungin (Cancidas), micafungin (Mycamine), and anidulafungin (Eraxis). They are used mainly for serious Candida infections and have become a preferred option because they combine strong activity with a clean safety profile. Caspofungin, the first in the class, was approved in the United States in 2001, followed by micafungin in 2005 and anidulafungin in 2006. A newer member of the class, rezafungin (Rezzayo), was approved in 2023 and is given once a week.

How do they work?

Echinocandins target the fungal cell wall, specifically the enzyme 1,3-beta-D-glucan synthase. This enzyme builds 1,3-beta-D-glucan, a structural sugar polymer that gives the fungal wall its integrity. By blocking it, echinocandins weaken the wall until the fungal cell can no longer withstand internal pressure and ruptures. They are fungicidal against most Candida species and fungistatic against Aspergillus.

A key advantage is selectivity: human cells have no cell wall and no equivalent of this enzyme, so echinocandins cause relatively little direct toxicity to the patient. Caspofungin, micafungin, and anidulafungin are given intravenously once daily, and rezafungin once weekly. In its pivotal trial, caspofungin was at least as effective as amphotericin B for invasive candidiasis while causing fewer adverse effects, and anidulafungin outperformed fluconazole on the primary measure in its own trial.

Is it FDA-approved?

Editor’s note

Status: Yes. Caspofungin, micafungin, and anidulafungin are all FDA-approved, as is rezafungin; the table shows each one's approval year and approved uses. Drug | FDA approval | Approved uses include Caspofungin | 2001 | Candidemia, invasive candidiasis, and esophageal candidiasis; additionally, empiric therapy in febrile neutropenia and invasive aspergillosis refractory to or intolerant of other therapy Micafungin | 2005 | Candidemia, invasive candidiasis, and esophageal candidiasis; additionally, Candida prophylaxis in stem-cell transplant recipients Anidulafungin | 2006 | Candidemia, invasive candidiasis, and esophageal candidiasis Rezafungin | 2023 | Candidemia and invasive candidiasis in adults with limited or no other treatment options None carry a boxed warning.

Category: FDA-approved · Primary body area: Heart & blood

Yes. Caspofungin, micafungin, and anidulafungin are all FDA-approved, as is rezafungin; the table shows each one's approval year and approved uses.

Study findings for Echinocandins
Drug FDA approval Approved uses include
Caspofungin2001Candidemia, invasive candidiasis, and esophageal candidiasis; additionally, empiric therapy in febrile neutropenia and invasive aspergillosis refractory to or intolerant of other therapy
Micafungin2005Candidemia, invasive candidiasis, and esophageal candidiasis; additionally, Candida prophylaxis in stem-cell transplant recipients
Anidulafungin2006Candidemia, invasive candidiasis, and esophageal candidiasis
Rezafungin2023Candidemia and invasive candidiasis in adults with limited or no other treatment options

None carry a boxed warning.

What are they prescribed for?

Echinocandins are prescribed for invasive Candida infections, including candidemia, and for esophageal candidiasis. Caspofungin is also used for suspected fungal infection in neutropenic fever and for certain Aspergillus infections, and micafungin for preventing Candida infection during stem-cell transplantation.

What are the side effects?

Common side effects include:

  • Fever
  • Infusion-related reactions such as flushing, rash, or itching
  • Nausea and headache
  • Low potassium and raised liver enzymes

More serious considerations include:

  • Liver effects and, rarely, more significant liver dysfunction
  • Rare severe allergic reactions
  • Dose adjustment for caspofungin in liver impairment and some drug interactions

Sources: FDA prescribing information for Cancidas, Mycamine, Eraxis, and Rezzayo; the caspofungin trial (Mora-Duarte et al., The New England Journal of Medicine, 2002, DOI: 10.1056/NEJMoa021585) and the anidulafungin trial (Reboli et al., The New England Journal of Medicine, 2007, DOI: 10.1056/NEJMoa066906), both indexed on PubMed. This document is educational and does not constitute medical advice.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

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