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Mycovia Pharmaceuticals

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uuid0008yi4

Namestring
Mycovia Pharmaceuticals
Legal namestring
Mycovia Pharmaceuticals, Inc.
Websiteurl
mycovia.com
Company typeenum
Private
Founded yearint
2018
Descriptiontext

Mycovia Pharmaceuticals is a privately held, clinical-stage-to-commercial biopharmaceutical company headquartered in Durham, North Carolina, founded in 2018. The company is focused on developing and commercializing antifungal therapies for underserved indications in women's health and infectious disease. Its sole commercial asset is VIVJOA (oteseconazole), a first-in-class oral azole antifungal that received FDA approval in 2022 for the treatment of recurrent vulvovaginal candidiasis (RVVC), a condition with historically limited therapeutic options. The clinical data package supporting VIVJOA includes the Phase 3 VIOLET studies, with 2-year extension results published in November 2025 reinforcing long-term recurrence-free efficacy.

The company's business model is a capital-light, single-product specialty pharma structure. In the US, commercialization flows through an exclusive distribution agreement with AllianceRx Walgreens Prime signed in March 2024, which concentrates revenue through a single specialty pharmacy channel. Internationally, Mycovia has licensed Greater China rights to Jiangsu Hengrui Pharmaceuticals (2019); oteseconazole received NMPA approval in June 2023 and was added to China's National Reimbursement Drug List in 2024, generating royalty revenue without local infrastructure investment. The company is also pursuing a second indication, having initiated a Phase 2 study of oteseconazole for cryptococcal meningitis in June 2025, which represents pipeline diversification beyond the RVVC franchise. Mycovia has not disclosed funding rounds or revenue, and operates with a small (11-50 employee) organization led by CEO Patrick Jordan.

Short descriptiontext

Mycovia Pharmaceuticals is a Durham, NC-based private biopharmaceutical company founded in 2018 that develops and commercializes antifungal therapies, with its sole FDA-approved product VIVJOA (oteseconazole) indicated for recurrent vulvovaginal candidiasis in women.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersDurham, United States
HQ citystring
Durham
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
antifungal therapeutics, women's health pharmaceuticals, prescription pharmaceuticals, vulvovaginal candidiasis treatment, biopharmaceutical development
Industry2 codes
1Infectious Disease & Antimicrobials Pharmaceuticals
CodeHLAIAAAGPrimaryYes
2Infectious Disease Specialty Pharmaceuticals (Non-vaccine)
CodeHLAIACAMPrimaryNo
SIC code1 code
  • Pharmaceutical Preparations2834
Product category
Antifungal Pharmaceuticals
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model2 records
1Pharmaceutical product sales (VIVJOA)
TypeSubscription Recurring
Description

Revenue generated from sales of prescription VIVJOA (oteseconazole) capsules in the US market, distributed through specialty pharmacies including AllianceRx Walgreens Pharmacy.

prnewswire.com
2Licensing royalties (Jiangsu Hengrui Pharmaceuticals)
TypeLicensing Royalties
Description

Mycovia receives licensing royalties from Jiangsu Hengrui Pharmaceuticals for the development and commercialization of oteseconazole in China (mainland China, Hong Kong, Macau, and Taiwan). Hengrui received approval from China's National Medical Products Administration in June 2023, and VIVJOA was included in China's National Reimbursement Drug List in 2024.

mycovia.com
Marketing channels5 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels2 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components4 values
Technology or R&D, Personnel, Marketing or Sales, Operations
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 record
1VIVJOA
Description

VIVJOA (oteseconazole capsules) 150 mg per capsule, for oral use - FDA-approved treatment for severe vulvovaginal candidiasis (VVC) and recurrent vulvovaginal candidiasis (RVVC).

mycovia.com
Core offering1 text field

Mycovia Pharmaceuticals develops and commercializes VIVJOA (oteseconazole capsules), a first-in-class oral antifungal medication containing 150 mg oteseconazole per capsule, approved by the FDA for the treatment of vulvovaginal candidiasis (VVC), including severe VVC and recurrent VVC. The company distributes VIVJOA through specialty pharmacies in the US and licenses it to Jiangsu Hengrui Pharmaceuticals for commercialization in China.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 2 values shown
  • 2-year efficacy results from VIOLET Phase 3 extension studies published in Journal of Women's Health (November 2025)
+1 more record
Product overview1 text field

Mycovia Pharmaceuticals is a biopharmaceutical company with a single commercial product - VIVJOA (oteseconazole capsules). The company focuses on developing novel therapies to address unmet needs in women's health and other overlooked medical conditions. VIVJOA is a first-in-class antifungal medication approved for the treatment of vulvovaginal candidiasis (VVC), including severe VVC and recurrent VVC.

Product and service1 record
1VIVJOA (oteseconazole capsules)
CategoryAntifungal pharmaceuticals (women's health)
Description

VIVJOA is a first-in-class oral antifungal medication containing 150 mg oteseconazole per capsule, approved by the FDA for the treatment of vulvovaginal candidiasis (VVC) in women, including severe VVC and recurrent VVC (RVVC). It is distributed in the US through AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies and is licensed to Jiangsu Hengrui Pharmaceuticals for the China market.

Scale indicator3 records

Each record includes

Type, Value, Description, Source

Partnership2 partners
Strategic tierCoreTypeChannel Partner/ Reseller/ DistributorAnnounced on2024-03-26
Description

Mycovia announced AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies as the exclusive distributor of VIVJOA in the US market. This partnership provides broad accessibility for patients through Walgreens' specialty pharmacy network.

Strategic tierCoreTypeChannel Partner/ Reseller/ DistributorAnnounced on2019-01-01
Description

Mycovia partnered with Jiangsu Hengrui Pharmaceuticals in an exclusive agreement to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau, and Taiwan. In June 2023, VIVJOA (Oteseconazole Capsules, 150 mg) received approval in China from the National Medical Products Administration and is indicated for the treatment of severe VVC. The drug was included in China's National Reimbursement Drug List in 2024 due to its first-in-class therapy status.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Developed Brexafemme (ibrexafungerp), a competing first-in-class antifungal also positioned for VVC/RVVC. Direct head-to-head competitor to Mycovia's oteseconazole in the same indication, patient population, and prescribing channel.

TypeDirect peer
Description

Specialty women's health biopharma commercializing Phexxi (vaginal pH modulator) for women's reproductive health. Comparable as a small specialty pharma focused on under-addressed OB-GYN conditions and operating through similar GTM motions.

TypeEmerging player
Description

Clinical-stage women's health biopharma with a pipeline focused on contraception, fertility, and vaginal health. Comparable as a small public women's-health specialty therapeutics company targeting similar OB-GYN prescribers.

TypeBroad incumbent
Description

Women's health specialty pharma (acquired by Bayer) with branded OB-GYN products. Comparable as a commercial-stage women's health therapeutics franchise with overlap in OB-GYN prescriber relationships and women's health go-to-market.

TypeBroad incumbent
Description

Global women's health-focused pharmaceutical company spun out of Merck, with an established OB-GYN commercial infrastructure and women's health product portfolio. Comparable as a scaled incumbent in women's health therapeutics distribution.

TypeBroad incumbent
Description

Large pharma with a significant antifungal franchise (Cresemba/isavuconazole and legacy amphotericin formulations). Comparable as an established innovator in invasive fungal disease treatment overlapping with Mycovia's antifungal focus.

TypeBroad incumbent
Description

Major branded pharma with Diflucan (fluconazole), the dominant legacy azole antifungal used in VVC, plus a women's health franchise. Comparable as the incumbent whose off-patent azole is the main therapeutic substitute Mycovia must displace.

TypeOthers
Description

Women's health-focused diagnostics and medical device company. Not a therapeutic competitor but adjacent — overlapping OB-GYN customer relationships and shared focus on women's health decision-makers.

TypeBroad incumbent
Description

Large pharma with established antifungal portfolio (Noxafil/posaconazole) and the originator of women's health assets now housed at Organon. Comparable as a broad incumbent in invasive fungal disease therapeutics.

TypeBroad incumbent
Description

Global pharma with an OB-GYN and women's health franchise (including acquired TherapeuticsMD assets). Comparable as a broad incumbent women'-s-health player with overlapping prescriber audience and reproductive-health commercialization muscle.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature1 record

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles1 record

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Mycovia Pharmaceuticals

Antifungal Pharmaceuticalsmycovia.com

Mycovia Pharmaceuticals is a Durham, NC-based private biopharmaceutical company founded in 2018 that develops and commercializes antifungal therapies, with its sole FDA-approved product VIVJOA (oteseconazole) indicated for recurrent vulvovaginal candidiasis in women.

What Mycovia Pharmaceuticals does

Mycovia Pharmaceuticals is a privately held, clinical-stage-to-commercial biopharmaceutical company headquartered in Durham, North Carolina, founded in 2018. The company is focused on developing and commercializing antifungal therapies for underserved indications in women's health and infectious disease. Its sole commercial asset is VIVJOA (oteseconazole), a first-in-class oral azole antifungal that received FDA approval in 2022 for the treatment of recurrent vulvovaginal candidiasis (RVVC), a condition with historically limited therapeutic options. The clinical data package supporting VIVJOA includes the Phase 3 VIOLET studies, with 2-year extension results published in November 2025 reinforcing long-term recurrence-free efficacy.

The company's business model is a capital-light, single-product specialty pharma structure. In the US, commercialization flows through an exclusive distribution agreement with AllianceRx Walgreens Prime signed in March 2024, which concentrates revenue through a single specialty pharmacy channel. Internationally, Mycovia has licensed Greater China rights to Jiangsu Hengrui Pharmaceuticals (2019); oteseconazole received NMPA approval in June 2023 and was added to China's National Reimbursement Drug List in 2024, generating royalty revenue without local infrastructure investment. The company is also pursuing a second indication, having initiated a Phase 2 study of oteseconazole for cryptococcal meningitis in June 2025, which represents pipeline diversification beyond the RVVC franchise. Mycovia has not disclosed funding rounds or revenue, and operates with a small (11-50 employee) organization led by CEO Patrick Jordan.

Mycovia Pharmaceuticals firmographics

Firmographics
Name
Mycovia Pharmaceuticals
Legal name
Mycovia Pharmaceuticals, Inc.
Website
https://mycovia.com
Company type
Private
Founded year
2018
Operating status
Operating
Headcount range
11–50 employees
Short description
Mycovia Pharmaceuticals is a Durham, NC-based private biopharmaceutical company founded in 2018 that develops and commercializes antifungal therapies, with its sole FDA-approved product VIVJOA (oteseconazole) indicated for recurrent vulvovaginal candidiasis in women.
Ownership category
akta.pro rank

Mycovia Pharmaceuticals industry classification

Industry
Product category
Antifungal Pharmaceuticals
SIC
Pharmaceutical Preparations (2834)
akta.pro primary industry
Infectious Disease & Antimicrobials Pharmaceuticals (HLAIAAAG)
akta.pro secondary industry
Infectious Disease Specialty Pharmaceuticals (Non-vaccine) (HLAIACAM)

Keywords

  • Antifungal therapeutics
  • Women's health pharmaceuticals
  • Prescription pharmaceuticals
  • Vulvovaginal candidiasis treatment
  • Biopharmaceutical development

Where Mycovia Pharmaceuticals is headquartered

Location

Headquarters

HQ city
Durham
HQ country
United States
HQ region
North America

Offices1 record

Markets served

Mycovia Pharmaceuticals business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Marketing or Sales, Operations

Revenue model

  1. Pharmaceutical product sales (VIVJOA): Revenue generated from sales of prescription VIVJOA (oteseconazole) capsules in the US market, distributed through specialty pharmacies including AllianceRx Walgreens Pharmacy.
  2. Licensing royalties (Jiangsu Hengrui Pharmaceuticals): Mycovia receives licensing royalties from Jiangsu Hengrui Pharmaceuticals for the development and commercialization of oteseconazole in China (mainland China, Hong Kong, Macau, and Taiwan). Hengrui received approval from China's National Medical Products Administration in June 2023, and VIVJOA was included in China's National Reimbursement Drug List in 2024.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Mycovia Pharmaceuticals product offering

Product offering

Core offering

Mycovia Pharmaceuticals develops and commercializes VIVJOA (oteseconazole capsules), a first-in-class oral antifungal medication containing 150 mg oteseconazole per capsule, approved by the FDA for the treatment of vulvovaginal candidiasis (VVC), including severe VVC and recurrent VVC. The company distributes VIVJOA through specialty pharmacies in the US and licenses it to Jiangsu Hengrui Pharmaceuticals for commercialization in China.

Product overview

Mycovia Pharmaceuticals is a biopharmaceutical company with a single commercial product - VIVJOA (oteseconazole capsules). The company focuses on developing novel therapies to address unmet needs in women's health and other overlooked medical conditions. VIVJOA is a first-in-class antifungal medication approved for the treatment of vulvovaginal candidiasis (VVC), including severe VVC and recurrent VVC.

Differentiator

Problem solved

Functional benefit

Brands

  • VIVJOA: VIVJOA (oteseconazole capsules) 150 mg per capsule, for oral use - FDA-approved treatment for severe vulvovaginal candidiasis (VVC) and recurrent vulvovaginal candidiasis (RVVC).

Products and services

  • VIVJOA (oteseconazole capsules) VIVJOA is a first-in-class oral antifungal medication containing 150 mg oteseconazole per capsule, approved by the FDA for the treatment of vulvovaginal candidiasis (VVC) in women, including severe VVC and recurrent VVC (RVVC). It is distributed in the US through AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies and is licensed to Jiangsu Hengrui Pharmaceuticals for the China market.

Quantifiable outcome

  • 2-year efficacy results from VIOLET Phase 3 extension studies published in Journal of Women's Health (November 2025)
  • +1 more outcomes

Companies that use Mycovia Pharmaceuticals

Customer profile

Segments2 records

Ideal customer profiles2 records

Mycovia Pharmaceuticals technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature1 record

Mycovia Pharmaceuticals partnerships and signals

Strategic signal

Partnerships

Two partnerships are on record, tiered core.

  • AllianceRx Walgreens Pharmacy and Walgreens Community-based Specialty PharmaciescoreChannel Partner/ Reseller/ Distributor · 26 March 2024Mycovia announced AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies as the exclusive distributor of VIVJOA in the US market. This partnership provides broad accessibility for patients through Walgreens' specialty pharmacy network.
  • Jiangsu Hengrui Pharmaceuticals Co., Ltd.coreChannel Partner/ Reseller/ Distributor · 1 January 2019Mycovia partnered with Jiangsu Hengrui Pharmaceuticals in an exclusive agreement to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau, and Taiwan. In June 2023, VIVJOA (Oteseconazole Capsules, 150 mg) received approval in China from the National Medical Products Administration and is indicated for the treatment of severe VVC. The drug was included in China's National Reimbursement Drug List in 2024 due to its first-in-class therapy status.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Mycovia Pharmaceuticals competitors and assessment

Company assessment

Direct peers

  • Scynexis (now part of GSK): Developed Brexafemme (ibrexafungerp), a competing first-in-class antifungal also positioned for VVC/RVVC. Direct head-to-head competitor to Mycovia's oteseconazole in the same indication, patient population, and prescribing channel.
  • Evofem Biosciences: Specialty women's health biopharma commercializing Phexxi (vaginal pH modulator) for women's reproductive health. Comparable as a small specialty pharma focused on under-addressed OB-GYN conditions and operating through similar GTM motions.

Emerging players

  • Daré Bioscience: Clinical-stage women's health biopharma with a pipeline focused on contraception, fertility, and vaginal health. Comparable as a small public women's-health specialty therapeutics company targeting similar OB-GYN prescribers.

Broad incumbents

  • TherapeuticsMD (a Bayer company): Women's health specialty pharma (acquired by Bayer) with branded OB-GYN products. Comparable as a commercial-stage women's health therapeutics franchise with overlap in OB-GYN prescriber relationships and women's health go-to-market.
  • Organon & Co. Global women's health-focused pharmaceutical company spun out of Merck, with an established OB-GYN commercial infrastructure and women's health product portfolio. Comparable as a scaled incumbent in women's health therapeutics distribution.
  • Astellas Pharma: Large pharma with a significant antifungal franchise (Cresemba/isavuconazole and legacy amphotericin formulations). Comparable as an established innovator in invasive fungal disease treatment overlapping with Mycovia's antifungal focus.
  • Pfizer: Major branded pharma with Diflucan (fluconazole), the dominant legacy azole antifungal used in VVC, plus a women's health franchise. Comparable as the incumbent whose off-patent azole is the main therapeutic substitute Mycovia must displace.
  • Merck & Co. Large pharma with established antifungal portfolio (Noxafil/posaconazole) and the originator of women's health assets now housed at Organon. Comparable as a broad incumbent in invasive fungal disease therapeutics.
  • Bayer Pharmaceuticals: Global pharma with an OB-GYN and women's health franchise (including acquired TherapeuticsMD assets). Comparable as a broad incumbent women'-s-health player with overlapping prescriber audience and reproductive-health commercialization muscle.

Others

  • Hologic: Women's health-focused diagnostics and medical device company. Not a therapeutic competitor but adjacent — overlapping OB-GYN customer relationships and shared focus on women's health decision-makers.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Mycovia Pharmaceuticals social profiles

Digital presence

Mycovia Pharmaceuticals financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Mycovia Pharmaceuticals leadership team

Management profile

Number of profiles

Profiles1 record

Mycovia Pharmaceuticals funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Mycovia Pharmaceuticals M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mycovia Pharmaceuticals

What does Mycovia Pharmaceuticals do?

Mycovia Pharmaceuticals develops and commercializes VIVJOA (oteseconazole capsules), a first-in-class oral antifungal medication containing 150 mg oteseconazole per capsule, approved by the FDA for the treatment of vulvovaginal candidiasis (VVC), including severe VVC and recurrent VVC. The company distributes VIVJOA through specialty pharmacies in the US and licenses it to Jiangsu Hengrui Pharmaceuticals for commercialization in China.

Is Mycovia Pharmaceuticals a public or private company?

Mycovia Pharmaceuticals is a private company. It is classified as unknown and is currently operating.

When was Mycovia Pharmaceuticals founded?

Mycovia Pharmaceuticals was founded in 2018. It employs 11 to 50 people.

Where is Mycovia Pharmaceuticals based?

Mycovia Pharmaceuticals is headquartered in Durham, United States, in the North America region.

How does Mycovia Pharmaceuticals make money?

Two revenue lines are on record. Pharmaceutical product sales (VIVJOA) is the primary driver. The others are licensing royalties (Jiangsu Hengrui Pharmaceuticals).

Who are Mycovia Pharmaceuticals's main competitors?

Direct peers on record are Scynexis (now part of GSK) and Evofem Biosciences. Daré Bioscience is listed as an emerging player. Broad incumbents are TherapeuticsMD (a Bayer company), Organon & Co., Astellas Pharma, Pfizer, Merck & Co. and Bayer Pharmaceuticals. Hologic is listed as an others.

Does Mycovia Pharmaceuticals have an API?

No public API is recorded for Mycovia Pharmaceuticals.

What industry is Mycovia Pharmaceuticals in?

Mycovia Pharmaceuticals's product category is Antifungal Pharmaceuticals. Its primary akta.pro industry code is HLAIAAAG, Infectious Disease & Antimicrobials Pharmaceuticals, with a secondary code of HLAIACAM, Infectious Disease Specialty Pharmaceuticals (Non-vaccine). Its SIC code is 2834.

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Live signals
pharmaphorumScientists issue call to arms over antifungal resistanceOver 50 infectious disease experts issued a call to action in Nature Medicine to combat rising antifungal resistance, proposing a five-step plan. They urge integration into the WHO's 2026 Global Action Plan on antimicrobial resistance, citing that invasive fungal diseases affect over 6.5 million people annually.PR NewswireMycovia Pharmaceuticals, Inc. Announces Publication of 2-Year VIVJOA® Efficacy Results from an Extension of the VIOLET Phase 3 Studies in Women with Recurrent Vulvovaginal Candidiasis (RVVC) in the JoMycovia Pharmaceuticals announced the publication of 2-year efficacy results from an extension of its VIOLET Phase 3 clinical program evaluating VIVJOA (oteseconazole) in women with recurrent vulvovaginal candidiasis (RVVC), published in the Journal of Women's Health. The long-term observational extension study, following 87 eligible US women for an additional 48 weeks beyond the initial 48-week study period, found that 98% of women originally randomized to receive VIVJOA for 12 weeks remained infection free versus 82% receiving placebo, demonstrating sustained protective effect for nearly two years. VIVJOA is the first and only FDA-approved therapy for RVVC, having received approval based on the VIOLET studies and the ultraVIOLET study encompassing 875 patients at 232 sites across 11 countries.PR NewswireMycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd.'s Recognition for the Inclusion of VIVJOA® (Oteseconazole) Capsules in the Chinese National Reimbursement DrugJiangsu Hengrui Pharmaceuticals held a conference in Shanghai to recognize the inclusion of VIVJOA® (oteseconazole) in China's National Reimbursement Drug List (NRDL), expanding patient accessibility to the treatment for severe vulvovaginal candidiasis. VIVJOA, developed by Mycovia Pharmaceuticals and licensed to Hengrui Pharma for China in 2019, received approval from China's National Medical Products Administration in June 2023 and was selected for the 2024 NRDL due to its first-in-class therapy status. Hengrui Pharma announced plans to explore the potential clinical utility of oteseconazole in multiple indications beyond women's health.PR NewswireMycovia Pharmaceuticals Announces Presentation of Results from Three Safety Studies Evaluating VIVJOA® (oteseconazole) in Subjects with Renal or Hepatic Impairment, and the Impact on QT Prolongation aMycovia Pharmaceuticals announced it will present topline results from three Phase 1 safety studies evaluating VIVJOA® (oteseconazole) at the 2024 IDSOG Annual Meeting in Portland, Oregon, August 1-3. The studies assessed pharmacokinetics, safety, and tolerability in women with renal or hepatic impairment, as well as cardiac repolarization effects through a thorough QT study. The findings have been incorporated into the drug's revised prescribing information, expanding VIVJOA's safety profile for use in higher-risk patient populations.PR NewswireMycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Commercial Launch of VIVJOA® (Oteseconazole) Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VJiangsu Hengrui Pharmaceuticals has commercially launched VIVJOA (oteseconazole) in China, marking the second major market entry for the drug under a five-year partnership with Mycovia Pharmaceuticals. The National Medical Products Administration approved the 2-day oral regimen, which demonstrated superior efficacy compared to fluconazole in treating severe vulvovaginal candidiasis.PR NewswireMycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Approval of Oteseconazole Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in ChinaMycovia Pharmaceuticals announced that its partner Jiangsu Hengrui Pharmaceuticals received approval in June from China's National Medical Products Administration for Oteseconazole Capsules to treat severe vulvovaginal candidiasis, with a commercial launch expected in late 2023. A Phase 3 clinical trial of 322 patients at 27 sites demonstrated statistically superior efficacy compared to fluconazole, achieving therapeutic cure rates of 66.88% versus 45.91% at Day 28. The approval triggers an important milestone under Mycovia's 2019 exclusive licensing agreement with Hengrui to develop and commercialize oteseconazole across mainland China, Hong Kong, Macau, and Taiwan.PR NewswireMycovia Pharmaceuticals Announces Presentations of its Supportive Phase 3 Clinical Study (ultraVIOLET) Evaluating the Safety and Efficacy of Oteseconazole (VT-1161) for the Treatment of Recurrent VulvMycovia Pharmaceuticals announced at IDWeek 2021 that its Phase 3 ultraVIOLET clinical trial evaluating oteseconazole (VT-1161) for recurrent vulvovaginal candidiasis met both primary and key secondary endpoints, demonstrating superiority over fluconazole/placebo (P<0.001) in preventing recurrent episodes through Week 50. The study enrolled 219 subjects at 51 U.S. sites, with oteseconazole showing safety and efficacy in treating acute VVC and preventing recurrence. The FDA has accepted Mycovia's New Drug Application for oteseconazole with a PDUFA target action date of January 27, 2022, positioning the drug to potentially become the first FDA-approved treatment for RVVC, a condition affecting 138 million women worldwide.