Organon and Evvy Announce Collaboration to Expand Access of XACIATO® (clindamycin phosphate) vaginal gel 2%, a Treatment for Bacterial Vaginosis
June 12, 2025 9:00 am EDT
- Affecting approximately 21 million women, bacterial vaginosis (BV) symptoms are often mistaken for a yeast infection1,2
- XACIATO will be available on the Evvy platform
JERSEY CITY, N.J. & NEW YORK, N.Y. – June 12, 2025 – Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, and Evvy, a company closing the gender health gap through biomarkers in the vaginal microbiome, announced a new collaboration for women suffering from BV, the most common vaginal condition in women aged between 15 and 44 in the United States,3 affecting approximately 21 million women. On the Evvy platform, if an Evvy-affiliated provider diagnoses a patient with BV based on their test results, XACIATO, a vaginal gel prescription medicine, may be available as a BV treatment for appropriate patients, females 12 years of age or older, for same-day pharmacy pickup so women can have access to treatment quickly, without needing to schedule an in-person doctor’s appointment. XACIATO provides complete treatment for BV in one dose.
BV results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor or discharge.2,3 If left untreated, BV may lead to serious complications.4 BV has also been shown to disproportionately affect non-Hispanic Black and Mexican American women.1,5
“BV can be stigmatized, and many women prefer the privacy of home testing with quick access to treatment options,” said Elizabeth Stephens, Director, Women’s Health Strategy, Advocacy, and Partnerships at Organon. “Through this strategic partnership with Evvy, we aim to create a patient-first experience that helps women more conveniently access the treatments she needs for her health.”
The Evvy vaginal microbiome test leverages metagenomic-sequencing (mNGS) to uncover 700+ microbes with a single, at-home swab, including microbes implicated in BV, yeast infections, and recurrent UTIs. Their physician-ordered test is the first and only mNGS test to receive CLIA, CAP, and CLEP certification, as well as to publish peer-reviewed validation of the test methodology. If an Evvy-affiliated provider diagnoses a patient with BV, the patient can consult with a licensed provider through Evvy’s telehealth platform to receive a personalized and integrative prescription treatment program — which can now include XACIATO.
“We are excited to partner with Organon to expand access to XACIATO,” said Priyanka Jain, Co-Founder & CEO of Evvy. “Despite the prevalence of BV, there has been a lack of innovation in BV treatment. We’re excited to offer our patients a new option designed with their experience in mind: a single dose treatment formulated with the goal of limiting leakage. By combining comprehensive testing, personalized care programs, and now, XACIATO, Evvy continues to lead the way in empowering women with data-driven, innovative healthcare.”
About XACIATO
XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose, user-filled, disposable applicator delivers 5 g of vaginal gel containing 100 mg of clindamycin.
Selected Safety Information
XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used.
XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment.
The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.
XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug.
There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.
Please see the Prescribing Information, Patient Information, and Instructions for Use.
About Organon
Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets.
Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.
For more information, visit https://www.organon.com/ and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.
About Evvy
Evvy is closing the gender health gap through novel biomarker discovery in the vaginal microbiome. Evvy’s groundbreaking Vaginal Health Test is the world’s only certified, peer-reviewed test to uncover 700+ microbes with a single, at-home swab. Combined with precision treatment pathways and 1-1 coaching, Evvy provides over 50,000 women with data-driven, personalized healthcare for vaginal infections, fertility, menopause, and more. Evvy has built the world’s largest dataset on the vaginal microbiome, and they are pioneering novel research to transform female health outcomes.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, including, but not limited to, statements about the collaboration between Organon and Evvy and the benefits thereof, as well as expectations
regarding Organon’s and Evvy’s business plans and prospects. Forward-looking statements may be identified by words such as “mission,” “goal,” “potential,” “should,”
“continue,” “will,” “expects,” “intends,” “plans,” “believes,” “future,” “opportunity,” or words of similar meaning. These statements are based upon the current beliefs
and expectations of the management of Organon and Evvy and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or
uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, pricing pressures, including as a result of U.S. executive orders or other efforts aimed at lowering
prescription drug prices in the United States; expanded brand and class competition in the markets in which Organon operates; trade protection measures and
import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade
sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations
including the timing and amounts allocated to Organon’s customers and business partners; the failure of any supplier to provide substances, materials, or services as
agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties;
and restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the U.S. Securities and Exchange Commission (“SEC”) and other U.S. and
comparable government agencies. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future
events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the
company’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site
(www.sec.gov).
1 Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864-869. doi:10.1097/olq.0b013e318074e565
2 Understanding women’s experiences with bacterial vaginosis. American Sexual Health Association. Updated March 12, 2025. Accessed October 25, 2024. https://www.ashasexualhealth.org/understanding-womens-experiences-with-bacterial-vaginosis/
3 About Bacterial Vaginosis (BV). Centers for Disease Control and Prevention. Last reviewed December 11, 2023. Accessed October 25, 2024. https://www.cdc.gov/bacterial-vaginosis/about/index.html
4 Kairys N, Garg M. Bacterial vaginosis. NCBI Bookshelf. Updated May 6, 2024. Accessed October 25, 2024. https://www.ncbi.nlm.nih.gov/books/NBK459216/
5 Mauck C, Hillier SL, Gendreau J, et al. Single-dose bioadhesive clindamycin 2% gel for bacterial vaginosis. Obstet Gynecol. 2022;139(6):1092-1102. doi:10.1097/AOG.0000000000004805
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Source: Organon & Co.