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41 Results Found:
New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities
Sub-analysis of children with atopic dermatitis aged 2-17 in pivotal Phase 3 trials revealed early and clinically meaningful improvements in vIGA-AD ™ and EASI-75 (skin clearance and severity), POEM (patient-reported outcomes) and PP-NRS (itch), regardless of comorbidity status, at week 8 Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, on November 8, 2025. The new data demonstrate that VTAMA cream provided early and consistent response for children aged 2-17 with atopic dermatitis (AD), with or without atopic comorbidities such as asthma, allergic rhinitis and food allergies. “As many children with atopic dermatitis may also be living with potential comorbidities such as
Organon Provides Update on Phase 2 ELENA Proof-of-Concept Study Evaluating OG-6219 in Patients with Endometriosis-Related Pain
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
European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta ® (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications. The submission was based on a 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-stage, or locally advanced breast cancer as part of a complete treatment regimen. HLX11 met the primary endpoint, which was the
New Analysis of Organon’s VTAMA® (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older
Low disease activity was observed after a mean duration of 80 consecutive days off-treatment following success with VTAMA cream, with a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 at the end of the treatment-free interval Data presented as late breaker at 2025 American Academy of Dermatology (AAD) Annual Meeting JERSEY CITY, N.J.-(BUSINESS WIRE)- Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced results from an analysis of the Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA ® (tapinarof) cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema. The findings demonstrate that AD disease activity remained mild in patients who had achieved treatment success and subsequently entered a treatment-free interval lasting on average 80 days. These results were presented during a late-breaking research session today at the 2025 American
Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older
Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA ® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024. The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication. As part of its review process, the FDA requested the final datasets and clinical study report from the long-term extension study for VTAMA. After receiving the datasets, the FDA determined that the additional information requested constitutes a major amendment to the sNDA resulting in a standard three-month
OG-8276A for Dysmenorrhea Demonstrated Positive Topline Phase 3 Study Results
Organon K.K., a global healthcare company with a focus on women's health (Headquarters: Minato-ku, Tokyo; President: Ryota Sakurai) announced that the primary endpoint was achieved in a domestic Phase III clinical trial (referred here as “the trial”) evaluating the efficacy and safety of OG-8276A (referred here as “the drug”), which is being developed as a treatment for dysmenorrhea. Based on the results obtained from the trial, Organon K.K. will prepare an application for marketing approval and launch in Japan. OG-8276A is a combination of desogestrel and ethinylestradiol. It has been marketed under the brand name ‘Mercilon’ as an oral contraceptive and is currently sold by Organon in 51 countries worldwide, excluding Japan. Organon initiated development of the drug in Japan to address the unmet needs of Japanese patients with dysmenorrhea. Further analysis of the trial details will be conducted, and the findings may be published later. Dysmenorrhea is characterized by pelvic and/or
First Real-World Observational Study of the JADA®System, a Medical Device to Control Postpartum Hemorrhage (PPH), Published in ACOG’s Obstetrics & Gynecology
JADA Rapidly and Effectively Controlled Bleeding Due to PPH, 1 Reinforcing Pivotal Study Results 1 PPH is a Significant Cause of Maternal Morbidities in the U.S. 2,3,4,5 New Exploratory Post-Hoc Analysis Examined the Relationship Between Reported Severe Maternal Morbidity (SMM) Outcomes and Cumulative Blood Loss Prior to JADA Insertion 1 Organon (NYSE: OGN), a global healthcare company focused on improving women’s health, today announced that Obstetrics & Gy necology (“The Green Journal”), the peer-reviewed journal of the American College of Obstetrics and Gynecology (ACOG), published the results of the RUBY study ( NCT04995887 ) which reached its primary effectiveness outcome of successfully treating abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH) with the JADA ® System. 1 JADA is an intrauterine vacuum-induced hemorrhage control device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management
[Dermavant issued release] FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years
– EFFICACY: In the pivotal Phase 3 clinical trial program, VTAMA cream met all primary and secondary endpoints and demonstrated highly statistically significant improvement versus vehicle in Physician Global Assessment (PGA) score with 36% of patients versus 6% in vehicle in PSOARING 1 and 40% of patients versus 6% in vehicle in PSOARING 2 achieving clear or almost clear with a minimum 2-grade improvement at week 12 (p<0.0001 for both trials) – – REMITTIVE EFFECT: The median duration of clear or almost clear skin was approximately four months after cessation of treatment with VTAMA cream as measured by the time to first worsening while off-therapy during the Phase 3 Long Term Extension (LTE) study for patients who achieved clear skin (PGA 0) on VTAMA cream during PSOARING 1 or 2 – – DURABILITY: Durability of response up to 52 weeks was demonstrated with intermittent use of VTAMA cream, with no observation of tachyphylaxis (loss of response) while on therapy – – SAFE AND
Organon to Acquire Forendo Pharma
Acquisition adds pipeline of candidates targeting novel treatments in women’s health Organon (NYSE: OGN), and Forendo Pharma today announced that the companies have entered into a definitive agreement, under which Organon will acquire Forendo, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo is pioneering the science of intracrinology, addressing disease through a novel, tissue-specific approach. Its lead clinical compound is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor in early clinical development for endometriosis, being evaluated for its potential effect on endometriotic lesions. Endometriosis is a common and chronic condition that affects up to 1 in 10 women of reproductive age, causes abdominal pain and is associated with infertility. “Organon is dedicated to delivering medically significant women’s healthcare interventions, prioritizing disease areas based on her
https://www.organon.com/news/organon-to-acquire-forendo-pharma/