Request Demo

Last update 26 May 2025

Tamoxifen Citrate

Last update 26 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(Z)-2-(4-(1,2-Diphenyl-1-butenyl)phenoxy)-N,N-dimethylethanamine, (Z)-2-(para-(1,2-Diphenyl-1-butenyl)phenoxy)-N,N-dimethylamine, 1-p-beta-Dimethylaminoethoxyphenyl-trans-1,2-diphenylbut-1-ene

+ [18]

Target

Action

antagonists

Mechanism

ERs antagonists(Estrogen receptors antagonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Estrogen receptor positive breast cancerNoninfiltrating Intraductal CarcinomaBreast Cancer

Inactive Indication

Advanced Malignant Solid NeoplasmBreast Cancer, FamilialDementia+ [10]

Originator Organization

AstraZeneca PLC

Active Organization

Mayne Pharma Commercial LLC

Suzhou First Pharmaceutical Co., Ltd.AstraZeneca KK

Inactive Organization

AstraZeneca PLCAstraZeneca Pharmaceuticals LP

Daré Bioscience, Inc.

License Organization

Midatech Pharma US, Inc.

DARA BioSciences, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (30 Dec 1977),

Breast Cancer

RegulationOrphan Drug (European Union)

Structure/Sequence

Molecular FormulaC32H37NO8

InChIKeyFQZYTYWMLGAPFJ-OQKDUQJOSA-N

CAS Registry54965-24-1

394

Clinical Trials associated with Tamoxifen Citrate

NCT06348134

/ Not yet recruitingPhase 2IIT

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT06982313

/ Not yet recruitingNot ApplicableIIT

Long-term Follow-up of the TAM-01 Study, a Phase III Trial of Low Dose Tamoxifen in Breast DCIS and Premalignant Disease

Low-dose tamoxifen (5 mg/day for three years, BabyTam) has emerged as a safer and effective alternative to the standard regimen (20 mg/day), reducing breast cancer recurrence with fewer adverse events. The TAM-01 phase III trial demonstrated a 42% reduction in breast cancer events over ten years compared to placebo in women with ductal carcinoma in situ (DCIS) or high-risk lesions (HRL, ADH, LCIS), supporting its inclusion in clinical guidelines.
The phase III TAM-01 trial enrolled 500 women, comparing low-dose tamoxifen to placebo over three years, with a median follow-up of 9.7 years (IQR, 8.3-10.9). Results showed a significant reduction in invasive breast cancer (HR = 0.58; 95% CI: 0.35-0.95; p = 0.03) and in contralateral breast cancer, CBC (HR = 0.36; 95% CI: 0.14-0.92; p = 0.025), with no increase in serious adverse events.
Exploratory analyses suggested a greater benefit in postmenopausal women (HR = 0.30; 95% CI: 0.11-0.82), compared to premenopausal women (HR = 0.73; 95% CI: 0.30-1.76), though this interaction did not reach statistical significance (p-interaction = 0.13). However, our unpublished data indicate a remarkable reduction of CBC in premenopausal women on BabyTam.
The TAM-01 long-term follow-up study aims to extend the follow-up of TAM-01 participants, evaluating long-term outcomes, including incidence of invasive breast cancer and DCIS, with a focus on tumor laterality and menopausal status as well as to assess other non-invasive events (LCIS, ADH or ALH) and adverse outcomes of special interest.
The findings are expected to strengthen the evidence supporting low-dose tamoxifen as a viable prevention strategy in high-risk populations with intraepithelial neoplasia (IEN or DCIS+HRLs).

Start Date01 Oct 2025

Sponsor / Collaborator

Ente Ospedaliero Ospedali Galliera

NCT06979596

/ Not yet recruitingPhase 2

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.
Researchers will compare MK-5684 to the standard treatments for each cancer type in this study.
The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.

Start Date17 Jul 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Tamoxifen Citrate

100 Translational Medicine associated with Tamoxifen Citrate

100 Patents (Medical) associated with Tamoxifen Citrate

20,885

Literatures (Medical) associated with Tamoxifen Citrate

01 Sep 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Surface-enhanced Raman spectroscopy facilitates the detection of multiple metabolic modulators

Article

Author: Li, Yuanyuan ; Yang, Tao ; Ma, Yueyue ; Xia, Zhichao ; Zhou, Na ; Luo, Xiaojun ; Shen, Yushi

Metabolic regulators can improve the athletic ability of athletes by regulating body metabolism, but it is not conducive to fair competition, so it is listed as a prohibited substance. At the same time, the State General Administration of Sport ordered major event organizers to test food for food-borne stimulants. Surface-enhanced Raman scattering (SERS) spectroscopy has been widely used because of its excellent sensitivity and strong spectral characteristics. Based on the available information, SERS spectrum data of metabolic regulators in food-related fields were lacking. In this study, we used gold dodecahedron nanoparticles as SERS active substrate and successfully captured the characteristic peaks of 6 metabolic regulatory factors. A low cost and stable SERS detection technique for detecting trimetazidine in milk samples with good recovery rate was proposed. Therefore, this method can not only protect the food safety of large-scale sports events, but also have broad application prospects in the food field.

01 Jun 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Estrogenic and androgenic activity of tert-butyl phenolic antioxidants assessed by in vitro receptor transcriptional activation and their association with in silico molecular docking analysis

Article

Author: Park, Kwangsik ; Hoang, Ngoc Minh-Hong

Tert-butyl phenolic antioxidants (TBP-AOs) are utilized in a variety of consumer products, including food packaging, daily use items, and industrial applications. Their widespread use raises significant concerns regarding potential health risks, particularly endocrine disruption. However, our understanding of many TBP-AOs concerning endocrine systems remains limited, underscoring the need for screening of their hormonal activities and better insight into their adverse outcome pathways (AOPs). Transcriptional activation (TA) assays are crucial experimental tools in the early stages of risk assessment. This study evaluated the estrogenic and androgenic characteristics of 30 TBP-AOs through TA assays in hERα-HeLa-9903 and 22Rv1/MMTV_GR-KO cell lines, respectively, augmented by docking simulation using CB-Dock2. Our findings identified 21 estrogen receptor (ER) agonists, one ER antagonist, and eight androgen receptor (AR) antagonists, with significant correlations between biological activity and docking scores for specific proteins: 1GWR_C4 and 7KBS_C2 for ERα, and 2AM9_C1 for AR. These results enhance our understanding of TBP-AOs' toxicity on the endocrine system and confirm that TA assays and docking are effective methods for evaluating their endocrine activities. This research lays the foundation for future studies on endocrine disruptors, aiming to elucidate the mechanisms underlying molecular initiating events and key events within AOPs for TBP-AOs and other chemicals.

01 Jun 2025·LIFE SCIENCES

Metabolic reprogramming and synergistic cytotoxicity of genistein and chemotherapy in human breast cancer cells

Article

Author: Vargas-Castillo, Ariana ; Torres, Nimbe ; Tobón-Cornejo, Sandra ; Schcolnik-Cabrera, Alejandro ; Noriega, Lilia G ; Morales-Bárcenas, Rocío ; Acevedo-Carabantes, Joshua Ayork ; Granados-Portillo, Omar ; Tovar, Armando R ; Chávez-Blanco, Alma ; Juarez, Mandy

Breast cancer (BCa) is a heterogeneous disease, initially responsive to hormone therapy but often developing resistance to both hormonal and chemotherapy treatments. Novel therapeutic strategies are needed for drug-resistant BCa. Genistein, a phytoestrogen structurally similar to estrogen, competes with estrogen for receptor binding and exhibits anti-cancer effects. In this study, we investigated the cellular and metabolic impacts of genistein, alone or in combination with chemotherapy, in two human BCa cell lines-one estrogen receptor-positive (ER+) and one estrogen receptor-negative (ER-). We observed a strong synergistic effect on cell viability at low concentrations of genistein and chemotherapy, resulting in reduced clonogenic capacity and impaired cell migration. Genistein alone modulated cellular energy metabolism, notably reducing ATP production in MCF7 (ER+) cells. This metabolic shift was linked to a decreased dependence on fatty acids for energy, coupled with a decrease in the rate-limiting mitochondrial translocase CPT1 required for fatty acid oxidation, alongside with an increase in intracellular fatty acid levels. While the most significant changes occurred in ER+ cells, ER- cells also showed responses to genistein treatment. Collectively, our findings suggest that low genistein concentrations, in combination with conventional chemotherapy, induces synergistic anti-cancer effects, promoting cellular senescence.

101

News (Medical) associated with Tamoxifen Citrate

13 May 2025

·www.prnewswire.com

Atossa Therapeutics Announces First Quarter 2025 Financial Results and Provides a Corporate Update

Announced strategic plan to advance (Z)-endoxifen for metastatic breast cancer indication Enhanced (Z)-endoxifen intellectual property portfolio with three new U.S. patents, expanding IP portfolio to more than 200 patent claims related to (Z)-endoxifen Ended first quarter 2025 with $65.1 million in cash and cash equivalents and no debt SEATTLE, May 13, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the first quarter ended March 31, 2025 and provided an update on recent company developments. First Quarter 2025 Highlights: Announced Strategic Decision to Pursue Metastatic Breast Cancer Indication: Atossa announced plans to target metastatic breast cancer as its lead program for (Z)-endoxifen. The decision reflects its commitment to addressing the persistent unmet medical need in metastatic breast cancer and the potential for a more streamlined regulatory pathway to deliver (Z)-endoxifen to these patients. Current treatment options for metastatic breast cancer often provide limited durability of response and substantial side effects. In previous clinical trials, (Z)-endoxifen has been shown to be well-tolerated as a selective estrogen receptor modulator (SERM), which Atossa believes supports its potential to fill this critical gap in treatment. Significantly Strengthened (Z)-endoxifen Patent Portfolio with Three New U.S. Patents: Atossa continued to bolster the intellectual property portfolio of (Z)-endoxifen with the grant of three new U.S. patents covering 31 claims directed at: sustained release compositions of (Z)-endoxifen (U.S. Patent No. 12,201,591); enteric oral formulations of (Z)-endoxifen and salts thereof as well as their use in treating hormone-dependent breast and reproductive tract disorders (U.S. Patent No. 12,275,684); and 58 claims covering (Z)-endoxifen formulations, including various levels of purity and stability as well as methods of using those formulations (U.S. Patent No. 12,281,056). Atossa's robust patent portfolio now encompasses more than 200 patent claims related to (Z)-endoxifen formulations and their clinical applications. "Our focus remains firmly on advancing (Z)-endoxifen as a next-generation therapy for breast cancer patients across the full spectrum of care—including a strategic emphasis on metastatic breast cancer, where therapeutic innovation is urgently needed," said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. "Across multiple clinical trials involving hundreds of patients, (Z)-endoxifen has consistently demonstrated strong tolerability and therapeutic versatility, which we believe shows its potential as a therapy for breast cancer from early-stage disease to more advanced stages. We are committed to unlocking the full potential of (Z)-endoxifen for patients while delivering value to our shareholders. A cornerstone of this strategy is the robust intellectual property portfolio we are building in an effort to protect our programs globally. As we look ahead to the remainder of 2025 and beyond, we are energized by the many opportunities to position (Z)-endoxifen as a potentially safer, more effective endocrine therapy for breast cancer patients worldwide." Comparison of Three Months Ended March 31, 2025 and 2024 Revenue and Cost of Revenue. For the three months ended March 31, 2025 and 2024, we had no source of revenue and no associated cost of revenue. Operating Expenses. Total operating expenses were $7.4 million for the three months ended March 31, 2025, which was an increase of $0.4 million, from the three months ended March 31, 2024 of $7.0 million. Factors contributing to the increased operating expenses in the three months ended March 31, 2025 are explained below. Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three months ended March 31, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands): Clinical and pre-clinical trial expenses decreased $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, due to a slight decrease in spend related to our (Z)-endoxifen trials, including drug development costs. The increase in R&D compensation expenses of $0.3 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 was due to an increase in headcount. The increase in R&D professional fees and other of $0.3 million was due to an increase in spending on regulatory consulting services. General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three months ended March 31, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands): The increase in G&A compensation expenses of $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 was due to an increase in headcount quarter over quarter. Interest Income. Interest income was $0.7 million for the three months ended March 31, 2025, a decrease of $0.4 million from interest income of $1.1 million for the three months ended March 31, 2024. The decrease was due to a decrease in the balance in our money market account. About (Z)-Endoxifen (Z)-endoxifen is a highly potent SERM with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen, while exhibiting minimal or no endometrial proliferative activity—which we believe addresses key limitations of current standard-of-care therapies. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with estrogen receptor positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer, including the EVANGELINE study and an I-SPY study. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit atossatherapeutics.com. FORWARD LOOKING STATEMENTS This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. SOURCE Atossa Therapeutics Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementPhase 2

13 Mar 2025

·www.prnewswire.com

VERZENIO's Market Potential Soars as Demand for CDK4/6 Inhibitors Grows | DelveInsight

As VERZENIO gains traction in early-stage treatments and broadens its approved uses, its revenue is expected to keep growing. While the global CDK4/6 inhibitor market remains highly competitive, VERZENIO's distinct clinical advantages and ongoing studies could contribute to further market expansion. LAS VEGAS, March 13, 2025 /PRNewswire/ -- DelveInsight's " VERZENIO Market Size, Forecast, and Market Insight Report" highlights the details around VERZENIO, which is a targeted treatment known as a CDK4/6 inhibitor. The drug is a non-chemotherapy oral tablet. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of VERZENIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Eli Lilly and Company's VERZENIO (abemaciclib) Overview VERZENIO (abemaciclib) is a prescription medication used to treat adults with HR-positive, HER2-negative breast cancer that has metastasized (spread to other parts of the body). It is administered orally and is prescribed in combination with an aromatase inhibitor as an initial endocrine-based therapy. Additionally, the drug is being developed for the treatment of prostate cancer. VERZENIO is approved for the following indications: In combination with endocrine therapy for the adjuvant treatment of adults with HR+/HER2-, node-positive, early-stage breast cancer at high risk of recurrence. In combination with an aromatase inhibitor as the initial endocrine-based therapy for adults with HR+/HER2- advanced or metastatic breast cancer. In combination with fulvestrant for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed after prior endocrine therapy. As monotherapy for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed following endocrine therapy and prior chemotherapy in the metastatic setting. Learn more about VERZENIO projected market size for breast cancer @ VERZENIO Market Potential HR+/HER2- breast cancer is the most common subtype of breast cancer, defined by the presence of estrogen and progesterone hormone receptors but lacking HER2 overexpression. This form of breast cancer generally has a favorable prognosis and is primarily managed with hormone therapy to suppress hormone-driven tumor growth. According to DelveInsight's estimates, around 211,000 new cases of HR+/HER2− breast cancer were reported in the US in 2024. Over the past decade, endocrine therapy has remained the cornerstone of treatment, including for cases with visceral involvement. The current preferred approach involves combining endocrine therapy—using aromatase inhibitors or fulvestrant—with CDK4/6 inhibitors. The approval of CDK4/6 inhibitors has significantly transformed the treatment landscape for HR+/HER2− breast cancer. Currently, five selective CDK4/6 inhibitors— ENHERTU, DATROWAY, IBRANCE, KISQALI, and VERZENIO—are used in combination with endocrine therapy. In November 2023, the FDA approved TRUQAP (capivasertib) in combination with FASLODEX for patients with advanced HR+/HER2− breast cancer harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN). The NCCN Guidelines have designated KISQALI as the only Category 1 Preferred CDK4/6 inhibitor for first-line treatment in combination with an aromatase inhibitor, strengthening its position in the U.S. market. This led to KISQALI recovering its lost market share, with its U.S. revenue contribution rebounding to 50%, following declines to 46% in 2020, 36% in 2021, and 38% in 2022. In January 2025, the FDA approved DATROWAY for patients with unresectable or metastatic HR+/HER2- breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) who had previously received endocrine-based therapy and chemotherapy. Additionally, ENHERTU was approved for patients with unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that had progressed after at least one prior endocrine therapy in the metastatic setting. Also, in January 2025, Roche reported positive topline results from its Phase III INAVO120 trial, assessing ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2−, endocrine-resistant, locally advanced, or metastatic breast cancer. Among the seven major markets, the US accounted for the largest market share in HR+/HER2− breast cancer, generating USD 7.5 billion in revenue in 2023. The market is expected to experience substantial growth from 2025 to 2034, driven by the introduction of novel therapeutic options. Discover more about the breast cancer market in detail @ Metastatic HR+/HER2- Breast Cancer Market Report Emerging Competitors of VERZENIO Some of the competing emerging key players in HR+/HER2- breast cancer market are, Merck (KEYTRUDA), Arvinas (ARV-471 (vepdegestrant)), Olema Pharmaceuticals (OP1250 (palazestrant)), Celcuity (Gedatolisib), Roche (Giredestrant (RG6171, GDC-9545); Inavolisib), AstraZeneca and Daiichi Sankyo (Datopotamab Deruxtecan (Dato-DXd)), AstraZeneca (Camizestrant (AZD9833); Capivasertib), Eli Lilly (LY3484356/Imlunestrant), Sermonix Pharmaceuticals (Lasofoxifene), Veru Pharma (Enobosarm), DualityBio/BioNtech (DB-1303), Evgen Pharma (SFX-01), Carrick Therapeutics (Samuraciclib (CT-7001)), EQRx/G1 Therapeutics (Lerociclib), Immutep (Eftilagimod Alpha (LAG-3lg/IMP321)), and others. To know more about the number of competing drugs in development, visit @ VERZENIO Market Positioning Compared to Other Drugs Key Milestones of VERZENIO In 2024, Phase III trials did not meet primary endpoints or were terminated for futility. Negative Phase III CYCLONE-2 results, in which VERZENIO added to abiraterone did not meet the primary endpoint of improved radiographic progression-free survival (rPFS) in men with metastatic castration-resistant prostate cancer (mCRPC). In December 2023, Eli Lilly and Company presented results from the MONARCH 3 clinical trial at the 2023 San Antonio Breast Cancer Symposium (SABCS). Results from MONARCH 3 show a numerical improvement in overall survival (OS) of 13.1 months for women with HR+, HER2- metastatic breast cancer treated with VERZENIO plus an aromatase inhibitor in the intent-to-treat population and 14.9 months for women with visceral disease. In March 2023, the US FDA approved an expanded indication for VERZENIO in combination with endocrine therapy for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer (EBC) at a high risk of recurrence. This expanded adjuvant indication removes the Ki-67 score requirement for patient selection. In February 2022, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product VERZENIO. VERZENIO, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with HR+/HER2− negative, node-positive early breast cancer at high risk of recurrence. In October 2021, the US FDA approved VERZENIO, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. In September 2018, VERZENIO was approved in Europe for treating advanced HR+ breast cancer in women if the cancer has already spread to other parts of the body or is locally advanced. In September 2018, VERZENIO was approved for the treatment of patients with HR+/HER2− unresectable or recurrent breast cancer in combination with fulvestrant or an aromatase inhibitor (AI) in Japan. In February 2018, the US FDA approved VERZENIO in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer In September 2017, the US FDA approved VERZENIO in combination with an endocrine therapy to treat adult patients who have HR+/HER2− advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones (endocrine therapy). In October 2015, the US FDA granted Breakthrough Therapy Designation to abemaciclib for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer Discover how VERZENIO is shaping the breast cancer treatment landscape @ VERZENIO Breast Cancer VERZENIO Market Dynamics The oral administration of VERZENIO enhances patient convenience, while its expanded approval for the adjuvant treatment of adult patients with HR+/HER2- early breast cancer highlights its role as a differentiated CDK4/6 inhibitor in reducing the risk of recurrence. The rising prevalence of HR+/HER2- breast cancer is driving market demand for effective treatments like VERZENIO. Additionally, its demonstrated efficacy in combination with endocrine therapy and its ability to penetrate the central nervous system further strengthen its market position. Favorable reimbursement policies and increasing awareness among healthcare providers also contribute to its adoption. However, its adoption may be hindered by regulatory hurdles and potential side effects, including severe or life-threatening lung inflammation and serious liver problems. High treatment costs and access disparities in certain regions could also limit market penetration. Competition from other CDK4/6 inhibitors such as IBRANCE and KISQALI poses a challenge, along with concerns over long-term safety data. Additionally, the Phase III CYCLONE-2 trial failed to meet primary endpoints in mCRPC, which may impact its broader clinical prospects and investor confidence. Dive deeper to get more insight into VERZENIO's strengths & weaknesses relative to competitors @ VERZENIO Market Drug Report Table of Contents Related Reports CDK4/6 Inhibitor Market CDK4/6 Inhibitor Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies including Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, among others. Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies including Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche, Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies, including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultBreakthrough TherapyASCO

10 Jan 2025

·pmlive.com

Bayer’s non-hormonal menopause drug shows promise in phase 3 breast cancer trial

Bayer has shared positive results from a late-stage study of its investigational non-hormonal drug in patients experiencing vasomotor symptoms (VMS) as a result of breast cancer treatment. The phase 3 OASIS 4 study has been evaluating the candidate, elinzanetant, as a treatment for moderate-to-severe VMS caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in those who are at high risk of developing breast cancer. VMS, such as hot flashes, are reported by up to 80% of women at some point during the menopausal transition, and over one-third report severe symptoms. Those receiving adjuvant endocrine therapy, including tamoxifen or aromatase inhibitors, for the treatment or prevention of breast cancer may also experience VMS. There are currently no licensed treatment options for this patient population. OASIS 4 met its primary endpoint, with elinzanetant resulting in statistically significant mean reductions in the frequency of moderate-to-severe VMS from baseline to weeks four and 12 compared to placebo. All key secondary endpoints were also achieved, demonstrating a reduction in severity of VMS at weeks four and 12, a reduction in frequency of VMS at week one, as well as improvements in sleep disturbances and menopause-related quality of life at week 12 compared to placebo. Additionally, the safety profile of elinzanetant observed over 52 weeks was generally consistent with previously conducted studies and published data on the drug in postmenopausal women with VMS. Administered orally once daily, elinzanetant is a dual neurokinin-1, 3 receptor antagonist in late-stage clinical development to treat moderate-to-severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. The latest results for the drug build on positive results from the phase 3 OASIS 1, 2 and 3 trials in women with moderate-to-severe VMS associated with menopause. Fatima Cardoso, principal investigator of OASIS 4, said: “The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.” Submissions for marketing authorisations for elinzanetant are ongoing in the US, EU, UK and other markets globally, Bayer outlined.

Phase 3Clinical Result

100 Deals associated with Tamoxifen Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00966	Tamoxifen Citrate	L02BA01	DB00675

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	United States	Mayne Pharma Commercial LLC	25 Sep 2018
Noninfiltrating Intraductal Carcinoma	United States	Mayne Pharma Commercial LLC	29 Oct 2005
Breast Cancer	United States	AstraZeneca Pharmaceuticals LP	30 Dec 1977

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gynecomastia	Phase 3	Italy	AstraZeneca PLC	01 Dec 2003
Prostatic Cancer	Phase 3	Italy	AstraZeneca PLC	01 Dec 2003
Invasive Mammary Carcinoma	Phase 3	-	AstraZeneca PLC	01 Jul 1996
Hormone receptor positive breast cancer	Phase 3	Austria	AstraZeneca PLC	01 Jan 1996
Early Stage Breast Carcinoma	Phase 3	-	AstraZeneca PLC	01 Dec 1990
Vulvovaginal atrophy	Phase 2	Australia	Daré Bioscience, Inc.	22 Nov 2021
Dementia	Phase 2	United States	AstraZeneca PLC	01 Jan 2007
Dementia	Phase 2	Italy	AstraZeneca PLC	01 Jan 2007
Metastatic Neoplasm to the Bladder	Phase 2	United States	AstraZeneca PLC	01 Jan 2007
Metastatic Neoplasm to the Bladder	Phase 2	Italy	AstraZeneca PLC	01 Jan 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04079517 (Karisma-1, CTgov)	Phase 1/2	Breast Cancer	42	Tamoxifen (Tamoxifen 10mg)	zqvvinqoed(bhhjnmyaty) = rjdqmosflg hqjwaznpkx (exocyknuva, sgsxghyfpw - mtbllyadas) View more	-	06 Feb 2025
				Tamoxifen (Tamoxifen 20mg)	zqvvinqoed(bhhjnmyaty) = wnhrazsbia hqjwaznpkx (exocyknuva, nrllrgwaog - xceuzzbrix) View more
NCT03354039 (TAMDMD Group B, Pubmed \| Neuromuscul Disord)	Phase 3	Muscular Dystrophy, Duchenne	15	Tamoxifen 20 mg/day	vtrepvdyyq(uominwdzta) = bmmwghulpd tnaewlpfno (cdlpnvzxog, -26.82 to 11.22)	Negative	01 Feb 2025
NCT00412022 (HOBOE, Pubmed \| ESMO Open)	Phase 3	Hormone receptor positive breast cancer Adjuvant human epidermal growth factor receptor 2 (HER2)	-	Triptorelin + Tamoxifen	gdmjrcvbbn(kqvxycqacf): HR = 0.69 (95% CI, 0.49 - 0.97), P-Value = 0.03 View more	Positive	01 Jan 2025
				Triptorelin + Letrozole
NCT02278120 (MONALEESA-7, ESMO_ASIA2024)	Phase 3	Hormone receptor positive breast cancer	672	Ribociclib+Endocrine Therapy	eeaozbbqag(jeqamazxex) = ygacyrlvpu lfhdrewngb (rrjsnkhtmv )	Positive	07 Dec 2024
				Placebo+Endocrine Therapy	eeaozbbqag(jeqamazxex) = usygwhehsz lfhdrewngb (rrjsnkhtmv )
NCT03528902 (T3PAH, CTgov)	Phase 2	Familial Primary Pulmonary Hypertension \| Hypertension	18	Tamoxifen (Tamoxifen)	lhoduamfby(vdctxdgfdy) = ltvligprju bldlcadbzt (rvlfpanozt, 0.194) View more	-	05 Dec 2024
				Placebo Oral Tablet (Placebo)	lhoduamfby(vdctxdgfdy) = ricmjsxzts bldlcadbzt (rvlfpanozt, 0.274) View more
NCT01124695 (ECOG-ACRIN E3108, Pubmed \| Breast Cancer Res Treat) Manual	Phase 2	Metastatic breast cancer CYP2D6	85	tamoxifen (CYP2D6 poor metabolizer)	kyonpauvac(duggttwudx) = zkxlruxxnh gbzfsapbvh (tvrrbtegls )	Negative	21 Oct 2024
				tamoxifen (CYP2D6 intermediate and normal metabolizer)	kyonpauvac(duggttwudx) = eyynuzhdxp gbzfsapbvh (tvrrbtegls )
NCT05378269 (DARE-VVA1, CTgov)	Phase 1/2	Vulvovaginal atrophy	17	Placebo (Placebo)	dgodrwlqfb = peeafaimva fpomwfxlrx (dnmtzjfvot, slqgjrwcqs - ralqrpqtox) View more	-	21 Oct 2024
				Tamoxifen (DARE-VVA1 1mg)	dgodrwlqfb = mkbmvqlebz fpomwfxlrx (dnmtzjfvot, cdpkkvrxyu - blgvagxfnp) View more
NCT02913430 (CTgov)	Early Phase 1	Metastatic breast cancer	7	Fulvestrant+Palbociclib (Fulvestrant + Palbociclib)	azoohghpee(swmxfrgadr) = iewldagvzl dpdrbxboep (vmuzfzveyh, nizhcviluk - lpxfkmvivr) View more	-	23 Sep 2024
				Tamoxifen+Palbociclib (Tamoxifen + Palbociclib)	azoohghpee(swmxfrgadr) = kvrxightia dpdrbxboep (vmuzfzveyh, hxovattfqg - ruolenoari) View more
NCT00072462 (IBIS-II DCIS, CTgov)	Phase 3	Ductal Carcinoma \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma	2,980	anastrozole (Anastrozole)	wigrleofkm = cpqdphzkvg ehdyjrqwxu (zqicakosbj, lftqmjrbwt - kwdnkkpuyz) View more	-	19 Sep 2024
				tamoxifen citrate (Tamoxifen)	wigrleofkm = btvsnkmpjt ehdyjrqwxu (zqicakosbj, yzfyjtepgr - xexmxhvyhh) View more
ESMO2024	Not Applicable	Breast Cancer ER-positive \| HER2-negative \| luminal A ... View more	952	Tamoxifen therapy	sckfnavcql(eiwrqixauj): HR = 0.58 (95% CI, 0.43 - 0.79)	Positive	16 Sep 2024
				Control

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis