Duavee (conjugated estrogens / bazedoxifene) / Pfizer, Ligand - LARVOL DELTA

Prevalence and Outcomes of Hormone Therapy Use Among Menopausal Women With Inflammatory Bowel Disease (ACG 2026) - "However, patients with CD prescribed systemic HT had higher oral prednisone use, while osteoporosis/fracture outcomes were lower among patients receiving systemic HT. Figure: 1-Systemic non-transdermal HRT included oral estradiol, conjugated estrogens, esterified estrogens, synthetic conjugated estrogens A and B, oral progesterone, oral medroxyprogesterone, conjugated estrogens/bazedoxifene (Duavee), estradiol acetate vaginal ring (Femring), and norethindrone acetate/ethinyl estradiol (Femhrt). 2-Systemic transdermal HRT included estradiol/norethindrone acetate transdermal patch (CombiPatch), estradiol/levonorgestrel transdermal patch (Climara Pro), estradiol transdermal patches (Alora, Climara, Dotti, Estraderm, Lyllana, Minivelle, Vivelle-Dot), estradiol transdermal gel (EstroGel, Divigel), and estradiol transdermal spray (Evamist). 3-Local estrogen therapy included low-dose vaginal estradiol formulations (Estring, Imvexxy, Vagifem, and Yuvafem) and vaginal conjugated..."

Clinical • Cardiovascular • Coronary Artery Disease • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pulmonary Embolism • Respiratory Diseases • Ulcerative Colitis

The Promise study: A presurgical randomized clinical trial of CE/BZA vs placebo in postmenopausal women with ductal carcinoma in situ. (ASCO 2025) - P2 | "In this prospective randomized clinical trial, CE/BZA significantly reduced epithelial proliferation in ER+ DCIS with no impact on quality of life compared to placebo. These results support consideration that CE/BZA is a safe option to manage menopausal symptoms for women concerned about their risk of developing breast cancer, and provide supportive evidence that CE/BZA may reduce the risk of developing invasive breast cancer."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Rheumatology • ER

Endo2/SA3: Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (clinicaltrials.gov) - P4 | N=28 | Enrolling by invitation | Sponsor: Penn State University | Recruiting ➔ Enrolling by invitation | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment status • Trial primary completion date • Cardiovascular • Endometriosis • Gynecology • Women's Health

Proteomics Profiling of Obese Postmenopausal Women Treated with Conjugated estrogens and Bazedoxifene. (ENDO 2026) - "These findings identify new mechanistic insight into the pleiotropic effects of CE/BZA in menopausal women."

Clinical • Late-breaking abstract • Dyslipidemia • Genetic Disorders • Gynecologic Cancers • Metabolic Disorders • Obesity

The use of conjugated estrogens and bazedoxifene for the management of vasomotor symptoms in premenopausal and menopausal patients with endometriosis: a systematic review. (PubMed, Climacteric) - "Although preclinical models show reduced lesion size, human evidence remains extremely limited and biased, insufficient to assess lesion recurrence or vascular safety. CE/BZA is currently indicated only for postmenopausal vasomotor symptoms; preliminary anecdotal evidence suggests symptom improvement, but large-scale comparative trials are urgently needed to establish safety and efficacy in endometriosis."

Journal • Review • Endometriosis • Gynecology • Inflammation • Pain • Women's Health • ER

In brief: Label changes for menopausal hormone therapy products. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor

Elinzanetant (Lynkuet) for menopausal vasomotor symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

TrumpRx unveiled with up to 85% discount on four Pfizer drugs (SeekingAlpha) - "The White House on Tuesday announced the launch of a direct-to-consumer website called TrumpRx, through which Pfizer (NYSE:PFE) has agreed to sell four of its prescription medicines, including its blockbuster arthritis drug Xeljanz, at up to an 85% discount. In addition to Xeljanz, which will be available at a 40% discount, the New York-based company has agreed to offer discounts ranging from 50% to 85% for its dermatitis drug Eucrisa, osteoporosis therapy Duavee, and migraine therapy Zavzpret."

Commercial • Ankylosing Spondylitis • Atopic Dermatitis • Idiopathic Arthritis • Migraine • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

The PROMISE Study: Duavee in Women With DCIS (clinicaltrials.gov) - P2 | N=142 | Completed | Sponsor: Northwestern University | Recruiting ➔ Completed | Trial primary completion date: Aug 2023 ➔ Jun 2024

Trial completion • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • AGR2 • PTGS2 • UGT1A1

Bazedoxifene as a Potential Cancer Therapeutic Agent Targeting IL-6/GP130 Signaling. (PubMed, Curr Oncol) - "Numerous studies have highlighted the efficacy of BZA (monotherapy or combined with other chemotherapy drugs) in impeding progression across multiple cancers. In this review, we mainly focus on the anticancer activity of BZA and the underlying anticancer mechanism through inhibition of the IL-6/GP130 pathway, aiming to provide valuable insights for the design and execution of further research and the potential repositioning of BZA in oncological clinical trials."

Journal • Review • Oncology • Osteoporosis • Rheumatology • IL6

Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control. (PubMed, Contemp Clin Trials) - P2 | "Despite a late start, accrual is likely to be completed within the funding period. NCT04821141."

Journal • Breast Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Osteoporosis • Rheumatology • Solid Tumor

Drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • Osteoporosis • Rheumatology

Comparison table: Some drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Osteoporosis • Rheumatology

Navigating the Challenges of Menopause: Effective Symptom Management - PT2 (ACOG 2024) - "Select the Product Theater you would like to attend. Click continue, then "Checkout" to save it to your registration."

Women's Health

CE/BZA: Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: VA Office of Research and Development | N=40 ➔ 0 | Trial completion date: May 2026 ➔ Apr 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Sep 2025 ➔ Apr 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Genetic Disorders • Metabolic Disorders • Obesity

The Effects of Tissue Selective Estrogen Complex (TSEC) Duavee on Mood Symptoms and Resting State Functional Connectivity in Perimenopausal Depression (SOBP 2024) - "Safety considerations and side effects contribute to limitations of traditional estrogen treatment for PO-MDD. suggest that Duavee reduces mood symptoms and targets neural connectivity without the concurrent risk profile. Further research is needed to understand potential links between these effects."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Drugs for menopausal symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

CE/BZA: Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Metabolic Disorders • Obesity

CE/BZA: Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Metabolic Disorders • Obesity

Endo2/SA3: Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (clinicaltrials.gov) - P4 | N=28 | Recruiting | Sponsor: Penn State University | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Cardiovascular • Endometriosis • Gynecology • Women's Health

Endo2/SA3: Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (clinicaltrials.gov) - P4 | N=28 | Recruiting | Sponsor: Penn State University | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial primary completion date • Cardiovascular • Endometriosis • Gynecology • Women's Health

Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM) (clinicaltrials.gov) - P4 | N=17 | Completed | Sponsor: Tulane University Health Sciences Center | N=12 ➔ 17

Enrollment change • Genetic Disorders • Obesity • CRP • FGF21 • LCN2 • LEP

Fezolinetant (Veozah) for menopausal vasomotor symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

[VIRTUAL] Effect of Omalizumab for Autoimmune Progesterone Dermatitis Refractory to Bilateral Oophorectomy: A Case Report (ENDO 2021) - "Her symptoms were improved with oral prednisone use, however breakthrough episodes still occurred...Vasomotor menopausal symptoms were resolved using conjugated estrogens with bazedoxifene...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Clinical • Cardiovascular • Dermatitis • Dermatology • Endocrine Disorders • Gynecology • Immunology • Musculoskeletal Pain • Pain

Preventing estrogen receptor alpha-positive breast cancer outgrowth with the use of hormone replacement therapy (AACR 2018) - "...Follow-up sudies suggest that breast cancer cases from PremPro treatment were primarily due to the outgrowth of occult tumors, not the formation of new disease. Duavee, a more recent form of HRT that combines CE and bazedoxifene (BZA), a selective estrogen receptor modulator (SERM) and degrader (SERD), has been approved by the FDA for treatment of moderate to severe hot flashes and to reduce the risk of osteoporosis...In addition, CE+BZA was able to decrease the rate of tumor growth in an ER-positive patient-derived xenograft (PDX) mouse model. An improved understanding of the molecular mechanisms of CE+BZA action in hormone sensitive breast cancer cell and animal models should have important implications for women considering HRT."

Hormone Receptor Breast Cancer