Are echinocandins FDA-approved, and what does the research show?

See the FDA status of every peptide, updated weekly.

What are echinocandins?

Echinocandins are antifungal drugs, medicines that kill or stop fungi, and each of the four labels calls its drug a semisynthetic lipopeptide ¹, ², ³, ⁴. A lipopeptide is a ring of amino acids with a fatty tail attached. Each is made by chemically modifying a product fermented from a fungus ¹, ², ³, ⁴.

Their target is Candida, a yeast that can invade the blood and organs of the very sick ¹, ², ³, ⁴. Candidemia is Candida in the bloodstream, and invasive candidiasis is the wider term for Candida that has reached the blood or a deep organ. The four were approved as Cancidas, Mycamine, Eraxis and Rezzayo; generic caspofungin and micafungin are approved too ⁵, ⁶, ⁷, ⁸, ⁹. These are drugs for patients whose infection can kill them, and no label names a use for weight, muscle, recovery or aging ¹, ², ³, ⁴.

Are echinocandins FDA-approved?

Yes, all four, each as a prescription medicine "for intravenous use" ¹, ², ³, ⁴. Caspofungin came first: FDA approved Merck's Cancidas, NDA 021227, on January 26, 2001 ⁵. Its label approves four uses in adults and children aged 3 months and older ¹. The first is "empirical therapy for presumed fungal infections in febrile, neutropenic patients," meaning treatment begun on suspicion in a patient with fever and too few infection-fighting white cells ¹. The second is candidemia and the Candida infections the label lists, "intra-abdominal abscesses, peritonitis, and pleural space infections" ¹.

The third is esophageal candidiasis, Candida infection of the food pipe ¹. The fourth is invasive aspergillosis, infection by the mold Aspergillus that has invaded tissue, in patients "who are refractory to or intolerant of other therapies" ¹. That means their disease did not respond to other drugs, or they could not tolerate them ¹.

Micafungin followed: FDA approved Mycamine on March 16, 2005 ⁶. Its label approves treatment of "candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses" in adults and children aged 4 months and older ². It approves the same in younger infants when the infection has not spread to the brain or eye ².

Mycamine is also approved for esophageal candidiasis at the same ages ². And it is approved for "prophylaxis of Candida infections," prevention given before any infection, in patients aged 4 months and older "undergoing hematopoietic stem cell transplantation" ². That is the transplant of blood-forming cells.

Anidulafungin was approved as Eraxis on February 17, 2006, under NDA 021632 and a second application, NDA 021948 ⁷. The label approves it for candidemia and for Candida intra-abdominal abscess and peritonitis in adults and children aged 1 month and older, and for esophageal candidiasis in adults only ³. A limitation of use says Eraxis "is associated with high relapse rates in esophageal candidiasis" ³.

Rezafungin is the newest. FDA approved Mundipharma's Rezzayo, NDA 217417, on March 22, 2023 ⁸. Its label approves it "in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis" ⁴.

The label states that "approval of this indication is based on limited clinical safety and efficacy data for REZZAYO" ⁴. The children's age band came with a supplement approved July 16, 2026 ⁸. FDA's letter describes it as an expansion "to include pediatric patients (12 to <18 years of age) who have limited or no alternative options" ¹⁰.

Mycamine's label says, "The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established" ². None of the four labels names a use outside fungal infection ¹, ², ³, ⁴.

What is sold today differs by member. Drugs@FDA, as of November 9, 2026, the date of its data, lists both Cancidas brand products as "Discontinued" ⁵. The record notes a Federal Register determination that the product was not withdrawn for safety or effectiveness reasons ⁵. Generic caspofungin is marketed under applications with "Prescription" status ⁹.

Mycamine sits under two applications, one listed "Discontinued" with the same note and one "Prescription," and generic micafungin is marketed under applications with "Prescription" status ⁶, ⁹. Both Eraxis applications and the single Rezzayo application are "Prescription" ⁷, ⁸, ⁹. The route to any of them is a clinician's prescription, and the labels' words are "for intravenous use" ¹, ², ³, ⁴.

How do echinocandins work?

A fungal cell is wrapped in a rigid wall that human cells do not have, and echinocandins attack that wall ³, ⁴. The labels say, in near-identical words, that each drug "inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls" ², ³, ⁴. Beta-1,3-D-glucan is a long chain of sugar units, "an essential component" of the wall in the label's words, and the drug blocks the enzyme that makes it ⁴. Rezzayo's label names that enzyme, "the 1,3-β-D-glucan synthase enzyme complex, which is present in fungal cell walls but not in mammalian cells" ⁴. Eraxis's label calls it glucan synthase, "an enzyme present in fungal, but not mammalian cells" ³.

Caspofungin's label says that the drug "has shown activity against Candida species and in regions of active cell growth of the hyphae of Aspergillus fumigatus," the mold's branching threads ¹. Rezzayo's label says blocking glucan synthesis "results in concentration-dependent in vitro fungicidal activity against Candida spp., however, the clinical significance of this activity is unknown" ⁴. Fungicidal means killing the fungus rather than only stopping its growth, and in vitro means in the test tube ⁴.

What does the research show?

The evidence is at the top tier: four FDA approvals for candidemia and invasive candidiasis, each resting on a randomized, double-blind trial against another antifungal ¹, ², ³, ⁴. Double-blind means neither patients nor doctors knew which drug was given. Each trial compared the new drug with an existing one ¹, ², ³, ⁴.

Studied in people, caspofungin against amphotericin B: the trial behind the candidemia use was double-blind ¹¹. It enrolled patients with "clinical evidence of infection and a positive culture for candida species from blood or another site" ¹¹. Of 239 enrolled, 224 were in the modified intention-to-treat analysis, 109 on caspofungin and 115 on amphotericin B deoxycholate ¹¹, ¹. That analysis counts everyone who met the entry criteria and received at least one dose ¹.

Successful outcomes occurred in 73.4 percent on caspofungin and 61.7 percent on amphotericin B ¹¹. The adjusted difference was 12.7 percentage points, with a 95.6 percent confidence interval of minus 0.7 to 26.0 ¹¹. A confidence interval is the range within which the true difference probably lies; one that crosses zero leaves open that the drugs are equal.

Among patients who met the trial's criteria for evaluation, the authors reported caspofungin superior ¹¹. The favorable response was 80.7 percent against 64.9 percent, a difference of 15.4 points, 95.6 percent confidence interval 1.1 to 29.7 ¹¹. In the candidemia subgroup the response was 71.7 against 62.8 percent, a difference of 10.0 points, 95.0 percent confidence interval minus 4.5 to 24.5 ¹¹. The authors reported significantly fewer drug-related adverse events on caspofungin ¹¹.

The label's own table of this trial gives favorable outcomes at the end of intravenous therapy of 81 of 109 (74.3 percent) against 78 of 115 (67.8 percent) ¹. Both figures cover the same 224 patients; the paper's abstract names no time point, and neither source explains why the counts differ ¹¹, ¹. Treatment was stopped for drug-related adverse events in 3 of 114 patients on caspofungin (2.6 percent) and 29 of 125 on amphotericin B (23.2 percent) ¹. Deaths over the study, treatment plus a follow-up of 6 to 8 weeks, were 36 of 109 (33.0 percent) and 35 of 115 (30.4 percent) ¹.

Studied in people for empirical therapy: a double-blind trial enrolled 1,111 febrile neutropenic patients and randomized them to caspofungin or liposomal amphotericin B ¹. The label's analysis held 1,095 of them, after excluding those "who did not have fever or neutropenia at study entry" ¹. An overall favorable response was a composite of five criteria ¹.

It was reached by 190 of 556 on caspofungin and 181 of 539 on the comparator, 33.9 and 33.7 percent after adjustment for strata ¹, ¹². The difference was 0.2 points, 95.2 percent confidence interval minus 5.6 to 6.0 ¹. Survival 7 days after the end of treatment was 92.6 against 89.2 percent ¹.

The aspergillosis approval rests on weaker evidence. An open-label, noncomparative study enrolled 69 patients whose invasive aspergillosis had not responded to, or who could not tolerate, other antifungals ¹. Open-label and noncomparative mean everyone knew what was given and there was no comparison drug ¹.

Of the 63 with outcome data, an independent expert panel judged 26 (41 percent) to have had a favorable response ¹. Among the 52 treated for more than 7 days it was 26 (50 percent) ¹. The label says the drug's efficacy "for initial treatment of invasive aspergillosis has not been evaluated in comparator-controlled clinical studies" ¹.

Studied in people, micafungin against caspofungin: a randomized, double-blind trial in three arms analyzed 578 patients with invasive candidiasis and candidemia ². The label reports the approved regimen's arm against caspofungin's, 191 and 188 patients ². Treatment success at the end of intravenous therapy was 135 of 191 (70.7 percent) on micafungin and 119 of 188 (63.3 percent) on caspofungin ². The difference was 7.4 points, 95 percent confidence interval minus 2.0 to 16.3 ².

Deaths over the study were 58 of 200 (29 percent) and 51 of 193 (26.4 percent) ². The Mycamine label's dosing table gives a mean of 15 days' treatment among patients treated successfully for candidemia ².

For prevention, a randomized, double-blind trial compared micafungin with fluconazole in 882 patients, 791 adults and 91 children, undergoing a stem-cell transplant ². Success meant no proven, probable or suspected fungal infection through therapy, and no proven or probable one in the four weeks after ². It was reached by 343 of 425 (80.7 percent) on micafungin and 337 of 457 (73.7 percent) on fluconazole ². The difference was 7.0 points, 95 percent confidence interval 1.5 to 12.5 ².

Studied in people, anidulafungin against fluconazole: a randomized, double-blind noninferiority trial enrolled adults with invasive candidiasis, 89 percent of them with candidemia only ¹³. Noninferiority means the trial set out to show the new drug was no worse than the old by more than a set margin ¹³. The primary analysis held 245 patients, 127 on anidulafungin and 118 on fluconazole ¹³, ³. Treatment succeeded at the end of intravenous therapy in 75.6 against 60.2 percent, a difference of 15.4 points, 95 percent confidence interval 3.9 to 27.0 ¹³.

Death from any cause was 23 percent on anidulafungin and 31 percent on fluconazole, a difference that did not reach statistical significance (P equals 0.13) ¹³. Adverse events were similar in frequency and type between the arms ¹³.

In esophageal candidiasis, a double-blind, randomized trial compared anidulafungin with oral fluconazole in 601 patients ³. Success was judged on endoscopy, a camera passed into the food pipe ³. At the end of therapy it was 225 of 231 (97.4 percent) on anidulafungin and 233 of 236 (98.7 percent) on fluconazole ³. Relapse two weeks later was 120 of 225 (53.3 percent) against 45 of 233 (19.3 percent) ³.

Studied in people, rezafungin against caspofungin: ReSTORE was a double-blind, double-dummy phase 3 trial at 66 centers in 15 countries ¹⁴. Phase 3 is the large trial stage before approval, and patients were screened from October 2018 to August 2021 ¹⁴. Double-dummy means each patient received both an active drug and a matching placebo, an inactive copy, so the different schedules stayed hidden ¹⁴. It randomized 199 adults with confirmed candidemia or invasive candidiasis, 100 to rezafungin and 99 to caspofungin, of whom 93 and 94 were in the modified intention-to-treat analysis ¹⁴.

FDA's primary endpoint, the main result the regulator asked for, was death from any cause by day 30 ¹⁴. By then 22 of 93 (24 percent) on rezafungin and 20 of 94 (21 percent) on caspofungin had died or had unknown survival ¹⁴, ⁴. The difference was 2.4 points, 95 percent confidence interval minus 9.7 to 14.4 ¹⁴, ⁴.

The European Medicines Agency's endpoint was global cure at day 14, meaning clinical cure, cure on imaging and clearance of the fungus together ¹⁴. It was reached by 55 of 93 (59 percent) against 57 of 94 (61 percent) ¹⁴. The weighted difference was minus 1.1 points, 95 percent confidence interval minus 14.9 to 12.7 ¹⁴.

The authors concluded that rezafungin was noninferior on both endpoints, and wrote that "efficacy in the initial days of treatment warrants evaluation" ¹⁴. Cidara Therapeutics and Mundipharma, the developers, funded the trial ¹⁴. The label says the use in patients aged 12 to 17 rests on the adult studies plus pharmacokinetic analyses, studies of how the body handles the drug ⁴. That is because "there have been no clinical studies conducted with REZZAYO in pediatric patients" ⁴.

What has not been studied: the labels say none has been studied, or for Mycamine adequately studied, in Candida endocarditis, osteomyelitis or meningitis ¹, ², ³, ⁴. Those are infections of the heart valves, the bone and the brain's lining. None of this page's sources studies any of the four for anything but fungal infection ¹¹, ¹, ², ³, ⁴, ¹³, ¹⁴. Long-term animal studies of cancer risk have not been conducted for caspofungin, anidulafungin or rezafungin ¹, ³, ⁴.

What are the side effects?

The labels report side effects by trial, each against its comparator, and their tables count every patient treated, so the numbers run larger than the efficacy analyses above ¹, ², ³, ⁴. In caspofungin's candidemia trial, with 114 patients on caspofungin and 125 on amphotericin B, the most frequent were laboratory findings ¹. Low blood potassium was reported in 23 percent against 32, raised alkaline phosphatase in 21 against 32, and a fall in hemoglobin in 18 against 23 ¹.

Raised ALT and AST were each reported in 16 percent on caspofungin, against 15 and 14 percent on amphotericin B ¹. Vomiting was reported in 17 percent against 16 and diarrhea in 14 against 10 ¹. Fever was reported in 13 against 33 percent, raised creatinine in 11 against 28 and chills in 9 against 30 ¹.

Micafungin's trial against caspofungin had 200 and 193 patients ². The label's selected reactions at 5 percent or more, and more frequent on micafungin, were vomiting (9 against 8 percent) and diarrhea (8 against 7) ². Low blood sugar (6 against 5), high potassium (5 against 3) and raised alkaline phosphatase (6 against 4) were also listed ². Atrial fibrillation, an irregular heart rhythm, occurred in 5 patients (3 percent) on micafungin and none on caspofungin ².

Anidulafungin's trial against fluconazole had 131 and 125 patients ³. Nausea was reported in 24 against 12 percent, vomiting in 18 against 10, low potassium in 25 against 19 and shortness of breath in 12 against 3 ³. Adverse reactions ended treatment in 11.5 percent on anidulafungin and 21.6 percent on fluconazole ³.

Rezafungin's trials had 151 patients on the approved regimen and 166 on caspofungin ⁴. The most frequent reactions at 5 percent or more were low potassium (15 against 10 percent), fever (12 against 7) and diarrhea (11 against 10) ⁴. Anemia (10 against 8), vomiting (9 against 4) and nausea (9 against 5) followed ⁴. Tremors were reported in 4 of 151 (2.6 percent) on rezafungin and none on caspofungin, all in the second or third week, and all resolved within a month ⁴. Treatment ended for an adverse reaction in 9.3 percent on rezafungin and 9.0 percent on caspofungin ⁴.

All four warn of anaphylaxis, a severe allergic reaction, and Mycamine and Eraxis add that it has included shock ¹, ², ³, ⁴. Cancidas's label reports that "cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with a fatal outcome, have been reported," two severe skin reactions ¹.

All four warn of liver effects, beginning with abnormal liver tests ¹, ², ³, ⁴. The Cancidas, Mycamine and Eraxis labels add "isolated cases" of hepatic dysfunction, hepatitis or hepatic failure, in patients with serious underlying conditions on many drugs ¹, ², ³. On cyclosporine, an immune-suppressing drug, the Cancidas label says to "only use CANCIDAS and cyclosporine in those patients for whom the potential benefit outweighs the potential risk," because of raised liver enzymes ¹.

Each member has warnings of its own. Mycamine's label reports "cases of significant hemolysis and hemolytic anemia," the breakdown of red blood cells, and "isolated cases of significant renal impairment or acute renal failure" ². It also reports rash, itching, facial swelling and vein inflammation at the injection site ².

Eraxis contains polysorbate 80, an emulsifier, and fructose ³. Its label warns of polysorbate toxicity in low-birth-weight infants, and it contraindicates the drug in hereditary fructose intolerance, where it "may precipitate a metabolic crisis" ³. Rezzayo's label warns of infusion-related reactions, "flushing, sensation of warmth, urticaria, nausea, and chest tightness" ⁴. It also says the drug "may cause photosensitivity" and that patients "should be advised to use protection from sun exposure and other sources of UV radiation" ⁴.

No label carries a boxed warning, FDA's strongest ¹, ², ³, ⁴. Each contraindicates the drug in known hypersensitivity, and Mycamine, Eraxis and Rezzayo extend that to hypersensitivity to any echinocandin ¹, ², ³, ⁴. On pregnancy, the Cancidas and Mycamine labels say the drug "may cause fetal harm" on animal findings, and the Eraxis label says it "can cause fetal harm" ¹, ², ³. The Rezzayo label reports no human data and no adverse embryofetal outcomes in rats or rabbits ⁴. Mycamine's label reports liver tumors in rats given the drug for six months, at eight times the highest recommended human exposure ².

Reports since approval add, for Cancidas, pancreatitis, hepatic necrosis and the severe skin reactions above ¹. For Mycamine they add disseminated intravascular coagulation, a clotting disorder, Stevens-Johnson syndrome, toxic epidermal necrolysis and shock ². For Eraxis they add anaphylactic shock and bronchospasm, and for Rezzayo drug hypersensitivity and anaphylactic reaction ³, ⁴.

In sport

No echinocandin is named on WADA's 2026 Prohibited List, and the list has no class for antifungals ¹⁵. WADA, the World Anti-Doping Agency, publishes the list that tested athletes are held to. The four hold FDA approval ⁵, ⁶, ⁷, ⁸. One listed method does bear on a drug given into a vein ¹⁵, ¹. M2.2 prohibits "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹⁵.

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JumpstartMD does not prescribe echinocandins. Our peptide library covers them so you have the facts on their FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.