Historically, females have been underrepresented in clinical trials, even for diseases and conditions that occur predominately in women.* Systemic changes to how we approach research are helping, such as the National Institutes of Health’s (NIH) legislation passed into law in 1993 mandating the inclusion of women and minority populations in clinical trials.** Over the four-year […]
https://www.organon.com/stories/transforming-clinical-trials-for-women/
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta ® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study ( NCT05346224 ) aimed to compare the efficacy and safety of HLX11 with reference Perjeta ® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta ® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles.
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia ® and Xgeva ® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study ( NCT05352516 ) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia ® ) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia ® ) every six months. The primary
New analysis of pooled Phase 3 data will evaluate efficacy and safety of VTAMA cream across age groups in pediatric and adult patients with atopic dermatitis (AD) Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that a new analysis of Phase 3 data evaluating VTAMA cream in AD will be presented at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting, taking place July 22 – 25, 2026, in Minneapolis, Minnesota. The presentation includes a pooled post hoc analysis of data from the pivotal Phase 3 ADORING 1 and ADORING 2 clinical trials evaluating the efficacy and safety of VTAMA cream across age subgroups of pediatric and adult patients with moderate to severe AD. Details for the presentation are as follows : Abstract Title Session/Presentation Details: Tapinarof 1% Cream in Atopic Dermatitis: Consistent Efficacy Across Age Groups From Pooled ADORING Trials Thursday, July 23,
No new safety signals identified during additional three years of extended use Organon holds exclusive global licensing rights to MIUDELLA Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that Sebela Women’s Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA ® , a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women’s Health. The prospective, single-arm Phase 3 study is being conducted by Sebela Women’s Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the
Sebela’s sNDA Seeks to Extend Approved Duration of Use from 3 to 6 Years Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the US Food and Drug Administration (FDA) has accepted for review Sebela Women’s Health’s supplemental New Drug Application (sNDA) for MIUDELLA ® (copper intrauterine system) for an extended duration of use for up to 6 years with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027. In June of 2026, Organon completed its agreement to exclusively license global rights to Sebela’s MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years and is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS), which is open for enrollment at
Healthcare Providers, Healthcare Settings, and Participating Pharmacies Can Now Begin Required Training and Certification in Preparation for MIUDELLA’s Launch Later This Year Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the MIUDELLA ® (copper intrauterine system) Risk Evaluation and Mitigation Strategy (REMS) Program is now open for enrollment at www.miudellarems.com . The website enables healthcare providers, healthcare settings, and eligible specialty pharmacies to complete the certification and enrollment activities required to support the dispensing and insertion of MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare
This transaction strengthens Organon’s contraception portfolio and expands long-acting reversible options for women Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA ®, a hormone-free, copper intrauterine device (IUD). Please see our prior announcement for a summary of the transaction terms . Approved by the US Food and Drug Administration (FDA) on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERT TM technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm. 1
Skin health is often described as a mirror of what’s happening inside the body. For women living with atopic dermatitis (AD) or psoriasis, that reflection can change repeatedly – shaped by hormones, life stages, and transitions that are still too often overlooked in care and research. Hormonal Changes and Skin Flares Across Life Stages Hormonal […]
New findings will highlight contraception affordability, biosimilar adoption, and access-focused analyses across the women’s health and general medicines portfolio Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present data across women’s health, biosimilars, dermatology, and neurology at ISPOR 2026, the leading global scientific conference hosted by the International Society for Pharmacoeconomics and Outcomes Research. The conference, focused on health economics and outcomes research, will take place May 17-20, 2026, in Philadelphia, Pennsylvania. Across 8 accepted abstracts, the data reflect Organon’s commitment to generating real-world evidence—rooted in lived experiences—that can help inform healthcare decision-making and improve health outcomes across a range of therapeutic areas. “Health economics and outcomes research is critical to ensuring the right treatments reach patients and that
https://www.organon.com/news/organon-to-present-new-research-on-access-and-value-at-ispor-2026/
