Oteseconazole

Oteseconazole is an antifungal drug [see Microbiology (12.4) ] .

• VIVJOA™ is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. ( 1 ) 1.1 Vulvovaginal Candidiasis VIVJOA is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) , and Clinical Studies (14) ] .ICD-10: B37.9

• VIVJOA is contraindicated in: Females of reproductive potential [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] Pregnant and lactating women [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.2) ] Patients with known hypersensitivity to oteseconazole.contraindicated

There are two recommended VIVJOA dosage regimens: a VIVJOA-only regimen and a Fluconazole/VIVJOA regimen. Use one of these two dosage regimens. ( 2.1 ) Administer VIVJOA orally with food. ( 2.1 ) For the VIVJOA-only Dosage Regimen : ( 2.2 ) On Day 1: Administer VIVJOA 600 mg (as a single dose), then On Day 2: Administer VIVJOA 450 mg (as a single dose), then Beginning on Day 14 : Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12). For the Fluconazole/VIVJOA Dosage Regimen , prescribe fluconazole and: ( 2.3 ) On Day 1 , Day 4 , and Day 7 : Administer fluconazole 150 mg orally, then On Days 14 through 20 : Administer VIVJOA 150 mg once daily for 7 days, then Beginning on Day 28 : Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14). 2.1 Dosage Overview and Important Administration Instructions There are two recommended VIVJOA dosage regimens: a VIVJOA-only regimen and a Fluconazole/ VIVJOA regimen. Use one of the following two dosage regimens: VIVJOA-only dosage regimen [see Dosage and Administration (2.2) ] Fluconazole/VIVJOA dosage regimen [see Dosage and Administration (2.3) ] . Administer VIVJOA orally with food [see Clinical Pharmacology (12.3) ]. Swallow the capsules whole. Do not chew, crush, dissolve, or open the capsules.

Embryo-Fetal Toxicity : Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant. ( 5.1 , 8.1 , 8.2 , 8.3 ) 5.1 Embryo-Fetal Toxicity VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women. Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks. Ocular abnormalities were observed in the offspring of pregnant rats dosed at 7.5-mg/kg/day during organogenesis through lactation in pre and postnatal developmental studies. The observed ocular abnormalities included cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration and hemorrhage. Ocular abnormalities occurred at doses about 3.5 times the steady state clinical exposure seen with patients being treated for RVVC. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant [see Use in Specific Populations (8.1 , 8.2 , 8.3) ].

The most frequently reported adverse reactions (incidence > 2%) were headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 580 patients were treated with VIVJOA in three clinical trials (Trial 1, Trial 2, and Trial 3) [see Clinical Studies (14) ] . Patients in the clinical trials were women with RVVC who received VIVJOA treatment for 12 weeks. The mean age of the patient population was 34 years (range:16-78 years), with 84% of patients aged 18-44 years and 16% of patients aged 45 years and older. Although females of reproductive potential were included in the clinical safety data, VIVJOA is contraindicated in females of reproductive potential due to the risk of embryo-fetal toxicity [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3 , 8.4) ] . The clinical trials population was 75% (435/580) White, 17% (96/580) Black or African American, 6% (36/580) Asian, and 2% (13/580) Other women. Fifteen percent (86/580) of all women were Hispanic/Latino.

Renal Impairment: Not recommended in severe renal impairment or ESRD (with or without dialysis). ( 8.6 ) Hepatic Impairment: Not recommended in moderate or severe hepatic impairment. ( 8.7 ) 8.1 Pregnancy Risk Summary VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA may cause fetal harm when administered to pregnant women. In addition, the drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. Ocular abnormalities were observed in a pre and postnatal animal study in the offspring of rats administered oteseconazole from Gestation Day 6 through Lactation Day 20 at doses about 3.5 times the recommended human dose based on AUC comparisons (see Data ). The observed ocular abnormalities included cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration and hemorrhage. There are limited human data in pregnant women who were exposed to VIVJOA during the clinical trials; these data are insufficient to exclude a potential risk of cataracts or other eye abnormalities in human infants. Data Animal Data Rat and rabbit embryofetal development was assessed after oral administration of oteseconazole.

Metabolism

The AUC of oteseconazole increased approximately dose proportionally while the C max increased less than dose proportionally over a dose range of 20 mg (0.13 times the lowest recommended dose) to 320 mg (0.53 times the highest recommended dose). The pharmacokinetic parameters of oteseconazole associated with the administration of the recommended dosing regimen of VIVJOA are presented in Table 1.

• Apr 26, 2022NDANDA215888Mycovia Pharms

1. 1Drug Ineffective830%
2. 2Dizziness311%
3. 3Dysuria311%
4. 4Off Label Use311%
5. 5Fungal Infection27.4%
6. 6Headache27.4%
7. 7Hot Flush27.4%
8. 8Inappropriate Schedule Of Product Administration27.4%
9. 9Product Dose Omission Issue27.4%
10. 10Pruritus27.4%
11. 11Urine Output Decreased27.4%
12. 12Vision Blurred27.4%
13. 13Abdominal Discomfort13.7%
14. 14Bladder Pain13.7%
15. 15Bladder Spasm13.7%

The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Oteseconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
  Completed · Phase 3 · Interventional · 438 enrolled · Mycovia Pharmaceuticals Inc.
  NCT03562156updated 2026-02-17
• A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
  Completed · Phase 3 · Interventional · 425 enrolled · Mycovia Pharmaceuticals Inc.
  NCT03561701updated 2026-02-17
• Platform Trial For Cryptococcal Meningitis
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,000 enrolled · University of Minnesota
  NCT06666322updated 2026-01-07
• Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC）
  Not yet recruiting · Observational · 3,000 enrolled · Beijing Tsinghua Chang Gung Hospital
  NCT07044947updated 2025-07-01
• Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
  Completed · Phase 3 · Interventional · 219 enrolled · Mycovia Pharmaceuticals Inc.
  NCT03840616updated 2022-02-04

Frequently asked questions

How does Oteseconazole work?

Oteseconazole is an antifungal drug [see Microbiology (12.4) ] .

What is Oteseconazole used for?

According to FDA labeling, Oteseconazole carries indications including: VIVJOA™ is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. ( 1 ) 1.1 Vulvovaginal Candidiasis VIVJOA is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) , and Clinical Studies (14) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oteseconazole?

Oteseconazole is classified as Triazole and tetrazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Breast Cancer Resistance Protein Inhibitors.

What are the brand names for Oteseconazole?

Oteseconazole is marketed under brand names including Vivjoa.

What are the contraindications for Oteseconazole?

Oteseconazole labeling lists contraindications including: VIVJOA is contraindicated in: Females of reproductive potential [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] Pregnant and lactating women [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.2) ] Patients with known hypersensitivity to oteseconazole.. Always consult the full prescribing information and a clinician.