Oteseconazole for Recurrent Vaginal Yeast Infections

Table of Contents

1. What Counts as a Recurrent Yeast Infection
2. Why the Infection Keeps Coming Back
3. Weekly Fluconazole and the Relapse After Stopping
4. How Oteseconazole Differs From Fluconazole
5. A Half-Life Measured in Months
6. The Trial Results
7. Side Effects and Drop-Outs in the Trials
8. What the Drug Label States
9. Ibrexafungerp and the CANDLE Trial, Compared Across Trials
10. Resistance and Non-Albicans Yeasts
11. What Is Not Known
12. Key Research Papers
13. Connections
14. Featured Videos

What Counts as a Recurrent Yeast Infection

The medical name for a vaginal yeast infection is vulvovaginal candidiasis, an overgrowth of Candida yeast that causes itching, burning, soreness and a thick discharge. When it keeps returning, it is called recurrent vulvovaginal candidiasis (RVVC). Sources do not all draw the line in the same place:

• The oteseconazole trials and the U.S. Food and Drug Administration label use three or more symptomatic episodes in a 12-month period. The phase 2 trial, the two global phase 3 trials and the label all state this definition, and so do several recent reviews and a 2024 network meta-analysis.
• The 2018 global-burden review in The Lancet Infectious Diseases counted four or more episodes a year. On that stricter definition it estimated that recurrent vulvovaginal candidiasis affects about 138 million women each year (range 103 to 172 million), with the highest prevalence, 9%, in women aged 25 to 34, and that 372 million women are affected at some point in their lives.

A 2020 immunology review gives the wider picture: up to 75% of women of childbearing age have at least one vaginal yeast infection, and up to 9% in different populations have more than three a year. The older four-episode threshold still appears in some guidance and on some pages, including the general Yeast Infections page, so the two numbers describe slightly different groups.

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Why the Infection Keeps Coming Back

Candida albicans lives harmlessly in the vagina of many healthy women. Researchers no longer see recurrent vulvovaginal candidiasis mainly as a failure of the body to fight the yeast. A 2020 review from the Radboud University Medical Center describes a newer explanation: the lining of the vagina overreacts to a yeast that is normally tolerated, and that inflammatory reaction produces the symptoms. The same review suggests that a balanced relationship between the yeast, the immune system and the vaginal bacteria may protect against repeat infections.

A 2016 review in the American Journal of Obstetrics and Gynecology adds three points. Candida albicans remains the main species behind recurrent infections. Inherited (genetic) factors help decide who is susceptible. And the at-risk years no longer end at menopause for everyone, because hormone replacement therapy extends them. The same review states that weekly fluconazole can keep the disease under control, but that a cure "remains elusive", especially now that fluconazole resistance is appearing.

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Weekly Fluconazole and the Relapse After Stopping

Before oteseconazole, there was no approved drug in the United States for recurrent vulvovaginal candidiasis, and the usual approach was weekly fluconazole. The trial behind it was published in the New England Journal of Medicine in 2004. All 387 women first took three 150 mg doses of fluconazole 72 hours apart to clear the current infection. They were then randomly assigned to 150 mg of fluconazole or a placebo once a week for six months, and followed for six more months with no treatment.

• At 6 months (end of treatment): 90.8% of the fluconazole group were free of disease, against 35.9% on placebo.
• At 9 months: 73.2% against 27.8%.
• At 12 months, six months after the last dose: 42.9% against 21.9%.
• The median time to a recurrence was 10.2 months on fluconazole and 4.0 months on placebo.
• The trial found no fluconazole resistance in the Candida albicans samples and no switch to Candida glabrata. One woman stopped fluconazole because of headache.

The authors concluded that weekly fluconazole lowers recurrences but that "a long-term cure remains difficult to achieve". Most women stayed well while taking it, and more than half of the fluconazole group had a recurrence within six months of stopping. A 2023 review lists the same two limits of long-term fluconazole: resistance developing and high recurrence rates once treatment ends.

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How Oteseconazole Differs From Fluconazole

Fluconazole and oteseconazole block the same fungal enzyme, sterol 14α-demethylase (CYP51). The yeast needs it to make ergosterol, the fungal version of cholesterol that holds its cell membrane together. When the enzyme is blocked, ergosterol runs short and abnormal sterols build up, some of which are toxic to the fungus. Humans have their own version of the enzyme, and many other related liver enzymes, so drugs aimed at it can hit human targets too.

The difference lies in the chemical "grip" that binds the drug to the iron at the centre of the enzyme:

• Fluconazole and the other standard oral azoles use a triazole ring. The 2014 chemistry paper that described oteseconazole's design states that oral azoles such as voriconazole and itraconazole strongly inhibit a broad range of human liver enzymes, which leads to drug interactions and liver toxicity.
• The designers swapped the triazole for a tetrazole ring, a group that binds the metal less avidly, and changed the rest of the molecule to recover potency. The aim was a drug more selective for the fungal 14α-demethylase than for human enzymes such as CYP3A4.

A 2014 laboratory study at Swansea University tested purified enzymes. Oteseconazole bound the Candida albicans 14α-demethylase tightly (dissociation constant 39 nanomolar or less), about as strongly as clotrimazole, fluconazole, itraconazole and voriconazole. With the human 14α-demethylase the results split: all four of those standard azoles bound the human enzyme, but oteseconazole did not, even at concentrations up to 86 micromolar. It also did not block the human enzyme at the highest concentration tested, which works out to a selectivity of more than 2,000-fold. It only weakly inhibited three human drug-handling enzymes (CYP2C9, CYP2C19 and CYP3A4). The U.S. Food and Drug Administration label summarises this by saying the tetrazole group gives oteseconazole "a lower affinity for human CYP enzymes".

Selectivity in a test tube does not mean the drug never affects human tissue. A 2024 study in human adrenal cells found that oteseconazole, two related tetrazoles, itraconazole and isavuconazole all reduced overall adrenal steroid production in cells, though not by directly blocking the steroid-making enzymes. Oteseconazole did not inhibit 11β-hydroxysteroid dehydrogenase type 2, one of the enzymes through which some triazoles cause a syndrome of high blood pressure and low potassium. The authors note that oteseconazole did not alter steroid levels in a recent clinical study, and that follow-up work is needed.

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A Half-Life Measured in Months

A drug's half-life is the time the body takes to clear half of it. According to the U.S. Food and Drug Administration label, the median terminal half-life of oteseconazole is about 138 days. The label puts the total "drug exposure window" at about 690 days, five half-lives, which is nearly two years after the last capsule. For comparison, the 2015 study of oteseconazole in mice already reported a long half-life of more than 48 hours in that species, along with 73% oral absorption and rapid entry into vaginal tissue.

The label gives further details. The drug is 99.5 to 99.7% bound to blood proteins, it is not significantly broken down by the body, and about 56% of a dose leaves in the faeces (mainly through bile) and 26% in the urine. Animal studies showed levels in vaginal tissue comparable to those in blood. Peak blood levels come 5 to 10 hours after a dose. A high-fat, high-calorie meal raised peak levels by 45% and total exposure by 36%, while a low-fat meal made no significant difference.

The long half-life has two consequences. The drug keeps working for months after the last weekly capsule, which fits the low recurrence rates seen out to 48 weeks and beyond. It also means a pregnancy started anywhere in the following two years could be exposed. The label states that this exposure window "precludes adequate mitigation of the embryo-fetal toxicity risks".

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The Trial Results

Phase 2: recurrent infection

A dose-finding trial published in 2018 enrolled 215 women with recurrent vulvovaginal candidiasis. After fluconazole cleared their current infection, they were randomly assigned to one of four oteseconazole schedules (150 mg or 300 mg daily for 7 days, then weekly for 11 or 23 weeks) or to placebo. Through week 48, between 0% and 7% of women in the oteseconazole groups had at least one culture-confirmed infection, against 52% on placebo.

Phase 2: a single acute infection

A smaller trial of 55 women with a moderate to severe acute infection compared three oteseconazole doses over 3 days with one 150 mg dose of fluconazole. At day 28, cure (no symptoms and a clear culture) was 75.0%, 85.7% and 78.6% in the oteseconazole groups against 62.5% with fluconazole. These differences were not statistically significant. During six months of follow-up, no one in the oteseconazole groups had a culture-confirmed return of yeast, against 28.5% at 3 months and 46.1% at 6 months in the fluconazole group.

Phase 3: the two VIOLET trials

The two global VIOLET trials, published together in NEJM Evidence in 2022, enrolled women with three or more episodes in the past year. Each first received three doses of fluconazole for the current infection. The 656 women whose infection cleared were randomly assigned, two to one, to 150 mg of oteseconazole daily for 7 days and then weekly for 11 weeks, or to placebo for 12 weeks, and were followed to week 48.

• The share with at least one recurrence through week 48 was 6.7% on oteseconazole against 42.8% on placebo in the first trial, and 3.9% against 39.4% in the second.
• Among women who did have a recurrence, it came on average at 45.7 and 47.2 weeks on oteseconazole, against 27.8 and 33.1 weeks on placebo. The hazard ratios were 0.11 and 0.08, roughly a 90% lower rate.
• The U.S. Food and Drug Administration label adds a wider measure: the share who had a recurrence or took any yeast-infection medicine through week 48. On that measure the gap is smaller: 27.3% against 50.8%, and 21.3% against 49.7%.

Phase 3: the ultraVIOLET trial against fluconazole

The ultraVIOLET trial, reported by Martens and colleagues in 2022, enrolled 219 women and girls aged 12 and older at 38 U.S. sites. Unlike VIOLET, it used oteseconazole for the starting infection as well: 600 mg on day 1 and 450 mg on day 2, against three 150 mg doses of fluconazole. The 185 participants whose infection cleared then took weekly oteseconazole or placebo for 11 weeks and were followed to week 50.

• The starting infection cleared by day 14 in 93.2% on oteseconazole and 95.8% on fluconazole. That met the trial's test for being "no worse" (non-inferior), not better.
• Recurrence through week 50 was 5.1% in the oteseconazole group against 42.2% in the fluconazole-then-placebo group.
• On the label's combined measure (a recurrence, a starting infection that did not clear, or use of yeast medicine) the figures were 43.5% against 59.0%.

Severe acute infection, a trial in China

A phase 3 trial in China, published in 2024, randomised 322 women with a severe acute infection to oteseconazole (600 mg then 450 mg) or fluconazole (150 mg on days 1 and 4). Cure at day 28 was 66.88% against 45.91%, a statistically significant difference. A 2026 follow-up analysis of the same trial, which its authors call exploratory, split the results by yeast species. In the 70 women with non-albicans yeasts, cure was 28.13% against 13.16%. Two authors of the trial were employees of a Chinese drug company, and that company funded the follow-up analysis.

Beyond 48 weeks

An extension study followed 70 women who had taken oteseconazole in the VIOLET trials for another 48 weeks, from week 48 to week 96, with no further treatment. One of the 70 (1.4%) had a culture-confirmed recurrence. Among 17 women who had taken placebo, 3 (17.6%) did. This was an observational follow-up of a subgroup of trial participants, and two of its authors were employees of the manufacturer.

Pooled analyses

• A 2024 network meta-analysis of 17 trials found that during treatment, weekly oteseconazole, weekly fluconazole or itraconazole, and weekly clotrimazole cream all cut recurrences by similar amounts. After treatment stopped (48 to 52 weeks), oteseconazole outperformed every other regimen tested, lowering late recurrences by more than 90%. No trial has compared oteseconazole directly with weekly fluconazole maintenance: this ranking comes from indirect comparison.
• A 2026 meta-analysis of five randomised trials found a recurrence risk ratio of 0.13 at weeks 48 to 50 for oteseconazole against comparators. Its authors judged the evidence for oteseconazole in single acute infections "remains limited".

The manufacturer funded the VIOLET trials, and staff of the developing company were among the authors of the phase 2, VIOLET and ultraVIOLET reports.

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Side Effects and Drop-Outs in the Trials

• Most common side effects. Across the three phase 3 trials (580 people treated), the label lists headache in 7.4% and nausea in 3.6%. Less common reactions (under 2%) included indigestion, hot flushes, painful urination, heavy or irregular menstrual bleeding and vulvovaginal irritation.
• Muscle enzyme rises. Creatine phosphokinase is a blood marker of muscle injury. Rises of 10 times the upper limit of normal or more occurred in 11 people (1.9%) on oteseconazole against 2 (0.7%) on comparators. The label describes them as transient.
• Stopping because of side effects. In the label's pooled data, one of 580 people (0.2%) stopped oteseconazole because of a side effect, allergic dermatitis. In the phase 2 recurrent-infection trial, no one taking oteseconazole left early because of a side effect or abnormal lab result. In the Chinese severe-infection trial, no one in either group stopped for side effects.
• Overall rates. In ultraVIOLET, 54% of the oteseconazole group had any side effect during treatment, against 64% of the fluconazole-then-placebo group. Severe events were 3.4% against 4.2%. In VIOLET, the types and rates of side effects were similar to placebo, with no drug-related serious events and no effect on liver tests or the heart's QT interval.
• Completing the trials. In the two VIOLET trials, 84% and 87% of the oteseconazole groups completed, against 83% in both placebo groups. In ultraVIOLET, 76% of each group completed.

The VIOLET report states that there were no adverse effects on pregnancy outcomes. The U.S. Food and Drug Administration label makes a stricter statement about the same body of evidence: the human pregnancy data from the trials are limited and "insufficient to exclude a potential risk of cataracts or other eye abnormalities in human infants".

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What the Drug Label States

The approval came on 26 April 2022, according to the agency's Drugs@FDA database. It was classed as a new molecular entity under priority review, and the label was revised in April 2024. The current label carries no boxed warning.

The indication is to reduce the incidence of recurrent vulvovaginal candidiasis in females with a history of it who are not of reproductive potential. The label defines that as biological females who are postmenopausal or permanently infertile for another reason, giving tubal ligation, hysterectomy and removal of the ovaries and tubes as examples.

The dose schedule: the label lists two schedules, both taken by mouth with food, with capsules swallowed whole.

• Oteseconazole only: 600 mg on day 1 and 450 mg on day 2, then 150 mg once a week for 11 weeks starting on day 14 (weeks 2 to 12).
• Fluconazole first: fluconazole 150 mg on days 1, 4 and 7, then oteseconazole 150 mg daily on days 14 to 20, then 150 mg once a week for 11 weeks starting on day 28 (weeks 4 to 14).

The label's main warning is harm to an unborn baby, based on animal studies. In rats given the drug from mid-pregnancy through nursing, at about 3.5 times the human exposure, the offspring had eye abnormalities: cataracts, clouding, bulging eyes, optic nerve and retinal wasting, lens degeneration and bleeding. At higher doses given only during organ formation, rats showed no malformations. Rabbits had miscarriages at doses that also made the mothers ill, but no malformations.

The label lists three contraindications:

• Females of reproductive potential.
• Pregnant and breastfeeding women. There are no data on whether the drug passes into human or animal milk. Infants of mothers in the trials had no reported problems, but the label states that follow-up was too short to draw conclusions.
• Known hypersensitivity to oteseconazole.

The label notes that "although females of reproductive potential were included in the clinical efficacy data", the drug is contraindicated in them. In the clinical trial population, 84% were aged 18 to 44.

On drug interactions, oteseconazole blocks a drug-export pump called breast cancer resistance protein. Taken with the cholesterol drug rosuvastatin, which this pump handles, it raised rosuvastatin's peak level by 118% and total exposure by 114%. The label directs prescribers to start such drugs at the lowest possible dose and to watch for side effects. It found no clinically significant change in midazolam, ethinyl estradiol, norethindrone or digoxin levels. A 2024 analysis of U.S. Food and Drug Administration application data likewise lists oteseconazole among the 2022 approvals that inhibit drug-transport pumps.

For kidneys and liver, the label does not recommend the drug for severe kidney impairment or end-stage kidney disease, or for moderate or severe liver impairment, because too few such patients were studied.

Among the other animal findings: in a lifetime study in rats at doses similar to or above human exposure, thyroid tumours and testicular (Leydig cell) tumours increased, and male rats at about 5 times human exposure had bleeding in many organs. The label calls these of uncertain or unclear relevance to humans. At 5 times the maximum exposure, the drug did not lengthen the QT interval to any clinically relevant extent.

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Ibrexafungerp and the CANDLE Trial, Compared Across Trials

The other newer oral option is ibrexafungerp. It is not an azole: it is a first-in-class triterpenoid, a different drug family. It is approved in the United States for acute vaginal yeast infections and for reducing recurrences. Its recurrence trial, CANDLE, was published in 2025. After fluconazole cleared the starting infection, 260 participants took ibrexafungerp (300 mg twice on one day) or placebo once every 4 weeks for six treatments.

• By the week-24 test-of-cure visit, 70.8% on ibrexafungerp and 58.5% on placebo had no culture-proven recurrence.
• Four months after the last dose, the figures were 65.4% against 53.8%.
• Treatment-related side effects occurred in 14.6% against 6.9%, and no one stopped because of a side effect.

This is a cross-trial comparison, not a head-to-head one. Set beside VIOLET, where roughly 4 to 7% on oteseconazole and about 40% on placebo had a recurrence by week 48, the oteseconazole gap looks far larger. But the trials differ in design and in how they counted. CANDLE reported the share free of recurrence at week 24 and 4 months later, VIOLET the share with a recurrence through week 48. The populations, schedules and follow-up also differed, and no trial has tested the two drugs against each other. A 2023 commentary in Clinical Infectious Diseases notes that both newer drugs have only been compared with placebo, and that without allergy, intolerance or resistance it is unclear whether either will replace fluconazole.

There was also a recall in September 2023. A company announcement posted on the U.S. Food and Drug Administration's recalls page, dated 27 September 2023, states that the manufacturer of ibrexafungerp tablets voluntarily recalled 2 lots nationwide, down to the consumer level. The reason was potential cross-contamination of the ibrexafungerp ingredient with a "non-antibacterial beta-lactam drug substance", found during a review of a supplier's equipment and cleaning. According to the notice, that contamination "could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction", and the company "has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination". The recalled lots had been distributed across the United States from December 2022. The U.S. Food and Drug Administration's enforcement record classes it as a Class I recall.

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Resistance and Non-Albicans Yeasts

Some vaginal yeast infections are caused by species other than Candida albicans, most often Candida glabrata, and these "non-albicans" yeasts respond less reliably to standard azoles, as the Yeast Infections page describes. Laboratory and animal studies have looked at oteseconazole against them and against fluconazole-resistant Candida albicans:

• In the laboratory, a 2017 Duke University study tested 34 Candida glabrata and 50 Candida krusei isolates. Every one was resistant to at least one standard antifungal. For all of them, the concentration of oteseconazole needed to stop growth was at least 5-fold below the blood levels people reach.
• In the laboratory and in mice, a 2015 study found that oteseconazole kept its potency in the test tube against 10 fluconazole-resistant Candida albicans isolates from women with vaginal infections. In mice with vaginal infections caused by a highly fluconazole-resistant strain, it significantly reduced the amount of yeast. Against one strain that was less sensitive to both drugs, neither oteseconazole nor fluconazole worked in mice.
• Shared resistance routes also appear in laboratory work. A 2019 New Zealand study found that yeast drug-export pumps, extra production of the target enzyme, and changes in the drug's binding pocket all reduced susceptibility to oteseconazole. A 2019 study of Candida glabrata found its activity comparable to the triazoles, with resistance driven by "many of the same known resistance mechanisms". The U.S. Food and Drug Administration label likewise reports that rising resistance levels in the laboratory were linked to export pumps and extra target enzyme. It also states that oteseconazole kept meaningful activity in the laboratory against certain fluconazole-resistant Candida isolates, and that the clinical significance of the laboratory data is unknown.

Resistance to the older drugs is reported to be rising in some places. A 2024 study from a hospital in Chongqing, China, found Candida glabrata behind 24.46% of recurrent infections, and only 35.84% of Candida albicans isolates from women with recurrent infection were sensitive to fluconazole. A 2023 review warns that resistance to oteseconazole could also develop and cause treatment failure.

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What Is Not Known

• How it compares with weekly fluconazole. No published trial has compared oteseconazole maintenance directly with six months of weekly fluconazole. A 2024 drug review states that the research "lacks comparison with established maintenance regimens".
• Results in the approved group. The approved group is people who cannot become pregnant, mainly postmenopausal women. The trials mostly enrolled women aged 18 to 44, so separate results for older women are not given in the abstracts or label summarised here.
• Eye safety in infants. The label states that the human data cannot rule out eye abnormalities in babies exposed before birth.
• Long-term durability and resistance. Follow-up beyond 96 weeks has not been published, and how often resistance emerges in everyday use is unknown.
• Adrenal effects. The adrenal finding in cells has not been followed up in people at risk.
• Cost and access. No source read for this page gave a price. A 2023 review notes only that "the availability and cost may, like for most novel drugs, affect the widespread clinical implementation" of oteseconazole. In 2022 the review behind the 2021 U.S. Centers for Disease Control and Prevention (CDC) sexually transmitted infection guidelines described oteseconazole as "not yet commercially available".

Decisions about prescription antifungals belong with the prescriber, who can check the label's restrictions against a person's history.

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Key Research Papers

1. Martens MG, Maximos B, Degenhardt T, Person K, Curelop S, Ghannoum M, et al. Phase 3 study evaluating the safety and efficacy of oteseconazole in the treatment of recurrent vulvovaginal candidiasis and acute vulvovaginal candidiasis infections. American Journal of Obstetrics and Gynecology. 2022;227(6):880.e1-880.e11. PubMed PMID: 35863457
2. Sobel JD, Donders G, Degenhardt T, Person K, Curelop S, Ghannoum M, et al. Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis. NEJM Evidence. 2022;1(8):EVIDoa2100055. PubMed PMID: 38319878
3. Brand SR, Degenhardt TP, Person K, Sobel JD, Nyirjesy P, Schotzinger RJ, et al. A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of orally administered VT-1161 in the treatment of recurrent vulvovaginal candidiasis. American Journal of Obstetrics and Gynecology. 2018;218(6):624.e1-624.e9. PubMed PMID: 29534874
4. Brand SR, Sobel JD, Nyirjesy P, Ghannoum MA, Schotzinger RJ, Degenhardt TP. A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis. Clinical Infectious Diseases. 2021;73(7):e1518-e1524. PubMed PMID: 32818963
5. Wang X, Chen L, Ruan H, Xiong Z, Wang W, Qiu J, et al. Oteseconazole versus fluconazole for the treatment of severe vulvovaginal candidiasis: a multicenter, randomized, double-blinded, phase 3 trial. Antimicrobial Agents and Chemotherapy. 2024;68(1):e0077823. PubMed PMID: 38095426
6. Wang X, Xue F, Zhang C, An R, Ruan H, Zhu L, et al. Efficacy and Safety of Oteseconazole in Severe Vulvovaginal Candidiasis Categorized by Candida Species and Previous Genital Tract Infection: A Post Hoc Analysis of a Phase 3 Trial. Drug Design, Development and Therapy. 2026;20:599356. PubMed PMID: 42266513
7. Lederman SN, Sobel R, Sobel JD, Curelop SB, Brand SR. Sustained Efficacy of Oteseconazole in Women with Recurrent Vulvovaginal Candidiasis. Journal of Women's Health. 2026;35(3):334-339. PubMed PMID: 41204724
8. Gardella B, Cassani C, Dominoni M, Pasquali MF, Spinillo A. Maintenance pharmacological therapy of recurrent vulvovaginal candidiasis. A Bayesian network meta-analysis of randomized studies. European Journal of Obstetrics, Gynecology, and Reproductive Biology. 2024;302:310-316. PubMed PMID: 39362128
9. Samadi Y, Ajmal Z, Ishaque R, Mohammed AA, Irshad K, Ahmer M, et al. Oteseconazole for acute and recurrent vulvovaginal candidiasis: A systematic review, meta-analysis, and trial sequential analysis of randomized trials. The Journal of International Medical Research. 2026;54(9):3000605261476919. PubMed PMID: 42731055
10. Sobel JD, Wiesenfeld HC, Martens M, Danna P, Hooton TM, Rompalo A, et al. Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. The New England Journal of Medicine. 2004;351(9):876-83. PubMed PMID: 15329425
11. Goje O, Azie NE, Angulo DA, Sobel R, Nyirjesy P, Sobel JD. A phase 3, multicenter, randomized, placebo-controlled trial of monthly oral ibrexafungerp to reduce the incidence of recurrent vulvovaginal candidiasis. American Journal of Obstetrics and Gynecology. 2025;233(6):617.e1-617.e18. PubMed PMID: 40752754
12. Sobel JD. New Antifungals for Vulvovaginal Candidiasis: What Is Their Role? Clinical Infectious Diseases. 2023;76(5):783-785. PubMed PMID: 36610791
13. Hoy SM. Oteseconazole: First Approval. Drugs. 2022;82(9):1017-1023. PubMed PMID: 35713845
14. Lanier C, Melton TC. Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis: A Drug Review. Annals of Pharmacotherapy. 2024;58(6):636-644. PubMed PMID: 37650387
15. Vandecruys P, Baldewijns S, Sillen M, Van Genechten W, Van Dijck P. Oteseconazole: a long-awaited diversification of the antifungal arsenal to manage recurrent vulvovaginal candidiasis (RVVC). Expert Review of Anti-Infective Therapy. 2023;21(8):799-812. PubMed PMID: 37449774
16. Warrilow AG, Hull CM, Parker JE, Garvey EP, Hoekstra WJ, Moore WR, et al. The clinical candidate VT-1161 is a highly potent inhibitor of Candida albicans CYP51 but fails to bind the human enzyme. Antimicrobial Agents and Chemotherapy. 2014;58(12):7121-7. PubMed PMID: 25224009
17. Hoekstra WJ, Garvey EP, Moore WR, Rafferty SW, Yates CM, Schotzinger RJ. Design and optimization of highly-selective fungal CYP51 inhibitors. Bioorganic & Medicinal Chemistry Letters. 2014;24(15):3455-8. PubMed PMID: 24948565
18. Jäger MC, González-Ruiz V, Joos FL, Winter DV, Boccard J, Degenhardt T, et al. Assessment of the potential risk of oteseconazole and two other tetrazole antifungals to inhibit adrenal steroidogenesis and peripheral metabolism of corticosteroids. Frontiers in Pharmacology. 2024;15:1394846. PubMed PMID: 39175536
19. Yu J, Wang Y, Ragueneau-Majlessi I. Risk of Enzyme- and Transporter-mediated Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2022: A Detailed Analysis of In Vitro and Clinical Data Available in New Drug Application Reviews. Clinical Therapeutics. 2024;46(6):499-508. PubMed PMID: 38734524
20. Garvey EP, Hoekstra WJ, Schotzinger RJ, Sobel JD, Lilly EA, Fidel PL Jr. Efficacy of the clinical agent VT-1161 against fluconazole-sensitive and -resistant Candida albicans in a murine model of vaginal candidiasis. Antimicrobial Agents and Chemotherapy. 2015;59(9):5567-73. PubMed PMID: 26124165
21. Schell WA, Jones AM, Garvey EP, Hoekstra WJ, Schotzinger RJ, Alexander BD. Fungal CYP51 Inhibitors VT-1161 and VT-1129 Exhibit Strong In Vitro Activity against Candida glabrata and C. krusei Isolates Clinically Resistant to Azole and Echinocandin Antifungal Compounds. Antimicrobial Agents and Chemotherapy. 2017;61(3):e01817-16. PubMed PMID: 27956419
22. Monk BC, Keniya MV, Sabherwal M, Wilson RK, Graham DO, Hassan HF, et al. Azole Resistance Reduces Susceptibility to the Tetrazole Antifungal VT-1161. Antimicrobial Agents and Chemotherapy. 2019;63(1):e02114-18. PubMed PMID: 30397057
23. Nishimoto AT, Whaley SG, Wiederhold NP, Zhang Q, Yates CM, Hoekstra WJ, et al. Impact of the Major Candida glabrata Triazole Resistance Determinants on the Activity of the Novel Investigational Tetrazoles VT-1598 and VT-1161. Antimicrobial Agents and Chemotherapy. 2019;63(10):e01304-19. PubMed PMID: 31383660
24. Li L, Zhang X, Li Q, Zhong W, Zou H. The Increasing Trend of Triazole-Resistant Candida from Vulvovaginal Candidiasis. Infection and Drug Resistance. 2024;17:4301-4310. PubMed PMID: 39385847
25. Denning DW, Kneale M, Sobel JD, Rautemaa-Richardson R. Global burden of recurrent vulvovaginal candidiasis: a systematic review. The Lancet Infectious Diseases. 2018;18(11):e339-e347. PubMed PMID: 30078662
26. Rosati D, Bruno M, Jaeger M, Ten Oever J, Netea MG. Recurrent Vulvovaginal Candidiasis: An Immunological Perspective. Microorganisms. 2020;8(2):144. PubMed PMID: 31972980
27. Sobel JD. Recurrent vulvovaginal candidiasis. American Journal of Obstetrics and Gynecology. 2016;214(1):15-21. PubMed PMID: 26164695
28. Nyirjesy P, Brookhart C, Lazenby G, Schwebke J, Sobel JD. Vulvovaginal Candidiasis: A Review of the Evidence for the 2021 Centers for Disease Control and Prevention of Sexually Transmitted Infections Treatment Guidelines. Clinical Infectious Diseases. 2022;74(Suppl_2):S162-S168. PubMed PMID: 35416967

PubMed Topic Searches

1. PubMed: oteseconazole
2. PubMed: oteseconazole trials in recurrent vulvovaginal candidiasis
3. PubMed: VT-1161 and fungal CYP51 selectivity
4. PubMed: fluconazole maintenance for recurrent vulvovaginal candidiasis
5. PubMed: fluconazole-resistant vulvovaginal candidiasis
6. PubMed: ibrexafungerp for recurrent vulvovaginal candidiasis

Regulatory Documents

• Drugs@FDA: oteseconazole application 215888 (approval history and labels)
• DailyMed: current oteseconazole prescribing information
• U.S. Food and Drug Administration recalls page: September 2023 ibrexafungerp tablet recall announcement

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Connections

• Drugs — every drug page on the site
• Yeast Infections — symptoms, diagnosis and the standard treatments
• Bacterial Vaginosis — the most common look-alike
• Menopause — the group the drug's approval is limited to
• Fungal Infections — the wider family of Candida and other fungal disease
• Oral Thrush — Candida infection of the mouth
• Diabetes — high blood sugar and repeat yeast infections
• Reproductive Medicine — the section index

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