Organon Provides Update on Phase 2 ELENA Proof-of-Concept Study Evaluating OG-6219 in Patients with Endometriosis-Related Pain

July 2, 2025 7:30 am EDT JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition of Forendo Pharma in 2021. In the study, OG-6219 did not demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo. Based on these results, the company plans to discontinue the OG-6219 clinical development program. “While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women including those living with endometriosis,” said Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon. “We are grateful to all the patients, caregivers, and investigators for their participation in and support of this study.” The randomized, double-blind, placebo-controlled, parallel-group, global multi-center Phase 2a/b study (NCT05560646) aimed to evaluate the efficacy, safety, and tolerability of three dose levels of OG-6219 in pre-menopausal women 18 to 49 years of age who have been surgically diagnosed with endometriosis with moderate-to-severe endometriosis-related pain. Eligible patients were randomized to receive one of three doses of OG-6219 or placebo orally twice a day. The primary efficacy endpoint was the change from the baseline cycle (placebo run-in cycle) to the last planned treatment cycle (third month of treatment exposure), in the mean endometriosis-related overall pelvic pain score (measured using an eleven-point numerical rating scale). About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. 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 Organon’s future business efforts and prospects. Forward-looking statements may be identified by words such as “plans”, “mission,” “vision,” “future,” “may,” “can,” “will,” “expects,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management 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. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’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). Media Contacts: Karissa Peer (614) 314-8094 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129 Source: Organon & Co. let btnSave2PDF = document.getElementById('btnSave2PDF'); btnSave2PDF.addEventListener('click', function () { save2PDF(); }); function addScript(url) { var script = document.createElement('script'); script.type = 'application/javascript'; script.src = url; document.head.appendChild(script); } function deferSave2PDF(method) { if (typeof html2pdf === "function") { method(); } else { setTimeout(function() { deferSave2PDF(method) }, 50); } } function disableSave2PDFButton() { btnSave2PDF.innerText = "Creating PDF..."; btnSave2PDF.setAttribute('disabled', true); } function enableSave2PDFButton() { btnSave2PDF.innerHTML = '<svg xmlns="http://www.w3.org/2000/svg" width="16" height="16" viewBox="0 0 16 16"><path fill="#e20177" d="M2.556 3.894v9.326h10.888V3.894H15v9.326c0 .863-.7 1.555-1.556 1.555H2.556A1.555 1.555 0 0 1 1 13.22V3.894h1.556zM8.924.775v8.59L10.9 7.391l1.1 1.1-3.85 3.85-3.85-3.85 1.1-1.1 1.974 1.974V.775h1.551z"></path></svg> Save'; btnSave2PDF.removeAttribute('disabled'); } function save2PDF() { try { disableSave2PDFButton(); addScript('https://raw.githack.com/eKoopmans/html2pdf/master/dist/html2pdf.bundle.js'); deferSave2PDF(function() { var element = document.getElementsByClassName('content-area')[0]; var opt = { filename: 'organon-provides-update-on-phase-2-elena.pdf' }; html2pdf().set(opt).from(element).save().then(enableSave2PDFButton()); }); } catch(ex) { console.log(ex); } } Connect with us on social Opens a new window Opens a new window Opens a new window Opens a new window Opens a new window Company About us Our Leaders Environmental, social & governance Policies & positions Resources Patient resources Investor relations Media Organon Pro for healthcare professionals Contact us Contact information Global locations Forward-Looking Statement Cookie policy Privacy Policy Consumer Health Data Policy Terms of Use Sitemap © 2026 Organon group of companies. All rights reserved. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. This site is intended for residents of the United States. Opens a new window Opens a new window You are leaving Organon.com Cancel Continue Opens a new window Forward-looking statement of Organon Any statements set forth on this website that are not historical facts are considered “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. By their nature, forward-looking statements involve risks and uncertainties because they depend on circumstances that may or may not occur in the future. Although these statements are based on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and you should not place undue reliance on them. 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 other filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov). Decline Accept

The release as fetched from its publisher. organon.com ↗