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Last update 12 Oct 2026

Estradiol

Last update 12 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryEstradiol (E2), a predominant female sex hormone and a member of the estrogen family, is responsible for regulating the menstrual and estrous cycles. It plays a pivotal role in orchestrating the development of female secondary sexual characteristics such as breast growth, widening of the hips, and a characteristic fat distribution pattern, as well as the development and sustenance of female reproductive tissues such as the mammary glands, uterus, and vagina. Apart from these crucial functions, E2 exerts significant effects on various other tissues in the body, including the liver, bone, fat, skin, and the brain. Estradiol activates both subtypes of the estrogen receptor (ERα and ERβ), is considered a potent agonist of these nuclear steroid hormone receptors. The hormone has multiple clinical applications, such as treating menopause symptoms, preventing osteoporosis in menopausal women, and treating low estrogen levels in women with ovarian failure. Moreover, it is also indicated in the treatment of certain types of breast and prostate cancer, which highlights its versatility and clinical significance. Interestingly, E2 is available in a diverse range of forms including oral tablets, topical gels or patches, vaginal creams, and injections, which provide ample options for individuals to choose from, based on their unique and specific requirements, preferences, and medical history.

Drug Type

Small molecule drug

Synonyms

17β-estradiol, 17β-Estrogen, 17β-Oestradiol

+ [74]

Target

ER x NLRP3

Action

agonists, inhibitors

Mechanism

ERs agonists(Estrogen receptors agonists), NLRP3 inhibitors(NACHT, LRR and PYD domains-containing protein 3 inhibitors)

Therapeutic Areas

Cardiovascular DiseasesEndocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases+ [2]

Active Indication

InfertilityOvarian StimulationsDyspareunia+ [12]

Inactive Indication

Advanced Prostate CarcinomaAlzheimer DiseaseBurns+ [10]

Originator Organization

Mylan NV

Active Organization

Les Laboratoires Servier SASSandoz, Inc.

Pfizer Inc.

+ [23]

Inactive Organization

Novo Nordisk A/S

Bayer AG

TherapeuticsMD, Inc.

+ [14]

License Organization

Teva Canada Ltd.

Theramex HQ UK Ltd.

Mayne Pharma Ltd.

+ [5]

Drug Highest PhaseApproved

First Approval Date

Canada (31 Dec 1976),

Vasomotor symptom

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC18H24O2

InChIKeyVOXZDWNPVJITMN-ZBRFXRBCSA-N

CAS Registry50-28-2

433

Clinical Trials associated with Estradiol

NCT07466498

/ Not yet recruitingPhase 2

Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)

This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving quality of life for patients with hormone sensitive prostate cancer that is newly diagnosed or that has come back after a period of improvement (recurrent) and has spread from where it first started (primary site) to other places in the body (metastatic). Standard prostate cancer treatment decreases hormone levels, specifically estrogen, in the body which can lead to hot flashes, fatigue, decreased bone health, and cardiovascular and metabolic dysfunction. Transdermal estrogen may help to alleviate these symptoms. Androgen receptor signaling inhibitors work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. LHRH analogues are a type of androgen deprivation therapy that blocks the use of androgen by the tumor cells. Giving estrogen with androgen receptor signaling inhibitor may improve quality of life in men with newly diagnosed or recurrent metastatic hormone sensitive prostate cancer.

Start Date01 Nov 2026

Sponsor / Collaborator

Fred Hutchinson Cancer Center

[+1]

NCT07732452

/ Not yet recruitingPhase 4IIT

HER BRAVE HEART Trial - Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition: A Randomized Feasibility Study

The goal of this clinical trial is to learn whether it is feasible to conduct a larger study comparing transdermal menopausal hormone therapy (MHT) versus no hormone therapy in menopausal women with vasomotor symptoms (hot flashes and night sweats) and at least one cardiovascular risk factor. The main questions it aims to answer are:
* What proportion of eligible women agree to be randomly assigned to either receive MHT or not?
* How many participants complete the 12-month follow-up, including repeat heart imaging?
* Does transdermal MHT affect early changes in heart muscle tissue as measured by cardiac MRI?
Researchers will compare immediate initiation of transdermal estradiol (a skin gel or patch) to a no-hormone therapy strategy to see if MHT influences early cardiovascular and brain-vascular changes over 12 months.
Participants will:
* Be randomly assigned to start transdermal MHT within 2 weeks, or to use no hormone therapy for at least the first 3 months
* Undergo a cardiac MRI and retinal eye imaging at the start of the study and again at 12 months
* Complete cognitive testing and questionnaires about symptoms, sleep, and stress at both visits
* Provide a blood sample for storage and future analysis of heart and brain health markers
* Receive follow-up phone calls at 3, 6, and 9 months to review symptoms, medications, and any health changes

Start Date01 Nov 2026

Sponsor / Collaborator

McGill University Health Centre

NCT07818278

/ Not yet recruitingPhase 4IIT

Cycle-to-cycle Variability of Progesterone in the Endometrium in Patients Undergoing an Euploid Blastocyst Transfer in a Hormone Replacement Therapy (HRT) Cycle (PROMICOFET)

This study looks at progesterone, a hormone that prepares the womb lining (endometrium) for pregnancy, in women having a frozen embryo transfer after IVF. Before an embryo is transferred, women take estrogen and progesterone medication to prepare the endometrium. Doctors currently check progesterone levels in the blood, but blood levels do not always match what is happening in the endometrium itself, and it is not yet known whether progesterone levels in the womb tissue stay the same from one treatment cycle to the next.
The study also looks at whether hormone levels relate to how the uterus contracts, to the bacteria naturally present in the vagina, cervix, uterus and gut, and to tiny particles released by cells (called extracellular vesicles) that may help the embryo and the womb "communicate" during implantation.
Participants are women who are already waiting for genetic test results on their embryos, a wait that typically lasts around 8 weeks. During this time, they go through two practice ("mock") treatment cycles using the same hormone medications as a real embryo transfer, but without an actual embryo. During these cycles, researchers collect blood and urine samples, a small tissue sample from the womb lining, swabs from the vagina, cervix and rectum, and a short ultrasound recording of womb movement. Afterwards, participants proceed with their real embryo transfer cycle, with similar (though fewer) measurements taken, and are followed to see whether they become pregnant.
The findings from this study may help doctors better understand how to personalize hormone treatment for future frozen embryo transfers, with the aim of improving pregnancy outcomes.

Start Date01 Oct 2026

Sponsor / Collaborator

Ghent University Hospital

[+1]

100 Clinical Results associated with Estradiol

100 Translational Medicine associated with Estradiol

100 Patents (Medical) associated with Estradiol

123,988

Literatures (Medical) associated with Estradiol

01 Feb 2027·TISSUE & CELL

Microbial conversion of daidzein to S-equol enhances protection against menopause-associated metabolic dysfunction by suppressing pancreatic inflammation, inhibiting DPP-4/PTP1B, activating AMPK/Akt, and enhancing energy catabolism

Article

Author: Bahrini, Insaf

Menopause-induced estrogen deficiency is associated with metabolic dysregulation, pancreatic inflammation, and oxidative stress. This study investigated the protective effects of microbial conversion of daidzein (Dzn) to S-equol (Eq), in ovariectomized (OVX) rats. The microbial biotransformation of Dzn into Eq by Slackia isoflavoniconvertens was confirmed using UV-Visible spectroscopy, HPLC, and FTIR analyses. OVX markedly reduced plasma 17β-estradiol (-84%), increased pancreatic myeloperoxidase (MPO) and elastase (ELA) activities, and elevated oxidative stress markers including hydrogen peroxide (H₂O₂), thiobarbituric acid reactive substances (TBARS), and total oxidant status, while decreasing total antioxidant status. In parallel, OVX impaired insulin signaling through increased dipeptidyl peptidase-4 (DPP-4) and protein tyrosine phosphatase 1B (PTP1B) activities and reduced AMP-activated protein kinase (AMPK) and Akt/PKB activation, leading to hyperglycemia, dyslipidemia, and increased body weight. Oral administration of Eq or Dzn (150 mg/kg) significantly restored estradiol levels (+315% and +185%, respectively) and improved pancreatic structure by reducing neutrophil infiltration and inflammatory enzyme activities. Both treatments attenuated oxidative stress by lowering H₂O₂, TBARS, and total oxidant status, while enhancing antioxidant defenses, with Eq showing greater efficacy. Moreover, Eq and Dzn improved insulin signaling by inhibiting DPP-4 and PTP1B and activating AMPK and Akt/PKB pathways, and stimulated carbohydrate and lipid catabolism via increased activities of Krebs cycle enzymes (IDH, SDH, and MDH). Collectively, these findings showed that microbial Eq as a potent phytoestrogen that mitigates menopausal metabolic and pancreatic alterations.

01 Feb 2027·TISSUE & CELL

Estrogen signaling and ferroptosis in intervertebral disc degeneration: A proposed mechanistic framework and its evidence gaps

Review

Author: Wu, Guishuai ; Chen, Chao ; Zhang, Fan ; Yang, Yangzijiu

Intervertebral disc degeneration (IVDD) is a leading contributor to low back pain and disability, characterized by progressive cell loss, extracellular matrix (ECM) degradation, and structural failure. Emerging evidence identifies ferroptosis, an iron-dependent form of regulated cell death driven by lipid peroxidation, as a critical mechanism underlying disc cell dysfunction and degeneration. In parallel, estrogen signaling has been increasingly recognized as a key modulator of disc homeostasis, particularly in the context of sex differences and postmenopausal disease acceleration. This review examines whether estrogen signaling and ferroptosis intersect in IVDD, and finds that the question has not been tested. Three separate bodies of evidence bear on the question. First, 17β-estradiol (E2) inhibits ferroptosis in other tissues, through multiple mechanisms in acute kidney injury, through G protein-coupled estrogen receptor (GPER)-dependent lipogenic signaling in tumour cells, and through dihydroorotate dehydrogenase upregulation in hippocampus. Second, ferroptosis is well characterised in disc cells, with established roles for iron dysregulation, the Nrf2/SLC7A11/GPX4 axis, and ACSL4-dependent lipid remodelling. Third, E2 is cytoprotective in nucleus pulposus and annulus fibrosus cells, reducing reactive oxygen species, suppressing NF-κB signaling, and preserving ECM. These bodies of evidence have not been joined: to our knowledge no published study has measured a ferroptosis endpoint in estrogen-treated intervertebral disc tissue, no ovariectomy study has assessed disc iron content or ferroptotic markers, and estrogen-dependent regulation of GPX4, SLC7A11, ACSL4 or iron-handling proteins has not been examined in any disc compartment. Estrogen replacement and the selective estrogen receptor modulator raloxifene preserve disc structure in ovariectomized and aging rodent models, and ferrostatin-1 and iron chelation are independently protective in disc models; no study has combined the two approaches, and receptor selection remains unsettled, since the one directly demonstrated estrogen-ferroptosis mechanism operates through GPER rather than the nuclear receptors targeted by available modulators. This review therefore presents the estrogen-ferroptosis intersection as a biologically coherent hypothesis rather than an established mechanism, specifies the minimum experiment that would test it, and identifies the evidence gaps that currently prevent its translation.

01 Feb 2027·CLINICA CHIMICA ACTA

Preliminary analytical evaluation of the fully automated Cobas i601 LC-MS/MS system for steroid hormones and vitamin D in a clinical laboratory

Article

Author: González-Casaus, María Luisa ; Serres-Gómez, Mariana ; Serrano Olmedo, María Gemma ; Iturzaeta Sánchez, José Manuel ; Fernández-Calle, Pilar ; González Almodóvar, Bernardo ; Villar Torrubiano, Daniel ; Buño Soto, Antonio

BACKGROUND:

Fully automated liquid chromatography-tandem mass spectrometry (LC-MS/MS) platforms aim to combine the analytical specificity and sensitivity of mass spectrometry with the workflow efficiency of automated routine analyzers. This study performed a preliminary analytical evaluation of the Cobas i601 LC-MS/MS system for estradiol, testosterone, aldosterone, androstenedione, 25-hydroxyvitamin D (25(OH)D) and 24,25-dihydroxyvitamin D (24,25(OH)₂D), including method comparison with routine immunoassays in a real-world clinical laboratory setting.

METHODS:

Imprecision, bias, and linearity were assessed according to Clinical and Laboratory Standards Institute (CLSI) EP10-A3 using three levels of commercial quality control material. Results were compared to analytical performance specifications (APS) based on biological variation. Method comparison and bias estimation with routine immunoassays were performed following CLSI EP09-A3 using serum samples. Predicted biases at clinical decision levels (CDL) were evaluated against allowable limits.

RESULTS:

All assays demonstrated acceptable analytical performance (maximum coefficient of variation 3.4%; maximum bias 7.8%) and fulfilled predefined APS. Linearity was confirmed across the tested ranges (p > 0.05). Testosterone showed acceptable biases at CDL (1.7% to 9.3%) according to the predefined APS, although greater variability was observed at lower concentrations. In contrast, androstenedione, estradiol, aldosterone and 25(OH)D exhibited substantial systematic bias compared with immunoassays (20%, -36.5%, -28.5% and - 16% respectively at intermediate CDL).

CONCLUSIONS:

The Cobas i601 demonstrated acceptable analytical performance in this first preliminary evaluation. However, systematic differences relative to immunoassays for several analytes highlight the need for close clinician-laboratory communication when implementing this new automated LC-MS/MS platform, and underscore the need for further analytical and clinical validation.

490

News (Medical) associated with Estradiol

09 Oct 2026

·www.businesswire.com

Seaport Therapeutics Presents Additional Pharmacokinetic Data from Phase 1 Clinical Trial of GlyphAgo™ at the 39 th European College of Neuropsychopharmacology (ECNP) Congress

BOSTON--(BUSINESS WIRE)--Seaport Therapeutics, Inc. (Nasdaq: SPTX) (“Seaport” or the “Company”), a clinical-stage therapeutics company developing novel neuropsychiatric medicines, today announced the presentation of Phase 1 clinical data for GlyphAgo™ (SPT-320 or Glyph Agomelatine) at the 39th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 10-13, 2026, in Munich, Germany. The poster represents the first scientific presentation of data from the GlyphAgo Phase 1 program and provides detailed pharmacokinetic (PK) analyses supporting previously reported topline results and reinforcing GlyphAgo's differentiated profile. GlyphAgo is a novel, “Glyphed” oral prodrug of agomelatine designed to enhance lymphatic absorption and bypass first-pass liver metabolism. In the Phase 1 program, GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability of agomelatine compared to unmodified agomelatine and showed significantly lower (10-fold) PK variability. GlyphAgo achieved therapeutically relevant exposure of agomelatine at substantially lower doses that are designed to reduce liver exposure. Seaport believes this approach has the potential to reduce the risk of liver enzyme elevations and reduce the need for routine liver function monitoring that has historically limited agomelatine’s clinical use. “The data presented at ECNP provide important clinical validation that our Glyph™ platform can meaningfully improve the pharmacokinetic profile of medicines historically limited by high first-pass liver metabolism,” said Daniel Bonner, Ph.D., Co-Founder and Senior Vice President, Platform, at Seaport Therapeutics. “The increased exposure and markedly reduced inter-individual variability observed in the Phase 1 program are particularly compelling. More predictable drug exposure may translate into more consistent clinical outcomes for patients, further supporting the development of GlyphAgo as a potential treatment for generalized anxiety disorder.” The completed multi-part Phase 1 proof-of-concept trial evaluated the safety, tolerability and pharmacokinetics of GlyphAgo in 174 healthy volunteers. The newly presented results include data from the multiple-ascending dose (MAD) portion and analyses supporting the absence of a food effect with GlyphAgo. The single- and multiple-ascending dose portions of the trial demonstrated dose-dependent increases in agomelatine exposure and showed no accumulation of exposure over seven days of dosing, supporting a consistent profile with repeat dosing. Additional analyses presented in the poster further characterize the substantially reduced PK variability observed with GlyphAgo, with variability in both AUC₀-₂₄ and Cmax substantially lower than with unmodified agomelatine. Specifically, in the SAD portion, PK variability (geometric CV%) observed in participants dosed with GlyphAgo ranged from 12.9% to 26.6% for AUC₀-₂₄ and from 17.1% to 50.5% for Cmax, compared with 200% and 217%, respectively, for unmodified agomelatine. In the crossover portion, PK variability in participants dosed with GlyphAgo ranged from 22.6% to 29.7% for AUC₀-₂₄ and from 26.5% to 44.0% for Cmax, compared with ranges of 234.6% to 350.1% and 303.7% to 500.9%, respectively, for unmodified agomelatine. As previously noted, the data showed no effect of estrogen-containing oral contraceptives on agomelatine exposure following GlyphAgo dosing, further supporting the ability of GlyphAgo to bypass first-pass hepatic metabolism and avoid drug-drug interactions that occur in the liver. Details of the presentation are as follows: Title: GlyphAgo demonstrated 6.8-fold increased bioavailability and 10-fold reduced variability versus unmodified agomelatine in healthy volunteers at doses projected to mitigate liver exposure Poster Number: PS02-2029 Presenter: Daniel Bonner, Ph.D., Co-Founder and Senior Vice President, Platform, at Seaport Therapeutics Date and Time: Sunday, October 11 th at 12:35 PM CEST Seaport has initiated a Phase 2a clinical trial evaluating GlyphAgo in adults with generalized anxiety disorder and sleep disturbance, with topline results expected in early 2028. The Company also plans to initiate a Phase 2/3 clinical trial evaluating the efficacy and safety of GlyphAgo in patients with GAD in the first half of 2027. About GlyphAgoTM (SPT-320 or Glyph Agomelatine) GlyphAgo is a novel, “Glyphed” oral prodrug of agomelatine, a clinically validated anti-anxiety and antidepressant that is approved for the treatment of GAD in Australia and Major Depressive Disorder in Australia and the European Union. Using Seaport’s proprietary GlyphTM platform, GlyphAgo is designed to enhance lymphatic absorption and avoid first-pass liver metabolism, thereby enhancing oral bioavailability and reducing side effects. By leveraging an alternative absorption pathway via the intestinal lymphatic system used by dietary fats, GlyphAgo is designed to increase systemic exposure of agomelatine, enabling exposure levels of agomelatine within the range observed to be effective in third-party placebo-controlled studies in GAD but at a lower dose that is designed to reduce liver exposure. Based on the data generated to date, Seaport believes GlyphAgo has the potential to become a leading treatment for GAD. About Seaport Therapeutics Seaport Therapeutics (Nasdaq: SPTX) is a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. Through its differentiated approach, the Company identifies clinically validated mechanisms with established efficacy and safety which had historically been limited by high first-pass metabolism, low bioavailability, and/or side effects. Seaport applies its proprietary GlyphTM platform to overcome those limitations and invent innovative oral therapies. With an experienced team of industry leaders, Seaport has a proven track record in neuropsychiatry drug discovery and development and delivering successful business outcomes. Seaport aims to develop novel, leading treatment options that will make a significant impact for patients and their families. For more information, please visit www.seaporttx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “would,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding our product candidates, including: the therapeutic potential of GlyphAgo, including its potential to achieve therapeutic exposures of agomelatine at lower doses, reduce liver exposure, and reduce or eliminate the need for liver function testing; the design and previously reported topline results of the Phase 1 trial of GlyphAgo; the design, progress, enrollment and results of the Phase 2a trial of GlyphAgo and the anticipated timing of topline data in early 2028; and the planned initiation of the Phase 2/3 trial of GlyphAgo in the first half of 2027 and the anticipated timing of topline data by the end of 2028. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect Seaport’s business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities, including with respect to the GlyphAgo Phase 2a trial and planned Phase 2/3 trial; risks that results from earlier trials, including the Phase 1 trial of GlyphAgo, or from third-party trials of agomelatine may not be predictive of future results, including with respect to liver safety; Seaport’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to Seaport’s preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Seaport’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition, including Seaport’s limited operating history and history of significant losses, its need for substantial additional funding and its ability to raise capital when needed, on acceptable terms, or at all, to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Seaport’s intellectual property protections; and risks related to the competitive landscape for Seaport’s product candidates; as well as other risks and uncertainties described in “Risk Factors,” in Seaport’s Quarterly Report on Form 10-Q for the three months ended June 30, 2026 filed with the Securities and Exchange Commission (“SEC”), as well as in subsequent filings with the SEC. Seaport expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Seaport uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts.

Clinical ResultPhase 1Phase 2Drug Approval

09 Oct 2026

·www.biospace.com

Seaport Therapeutics Presents Additional Pharmacokinetic Data from Phase 1 Clinical Trial of GlyphAgo™ at the 39th European College of Neuropsychopharmacology (ECNP) Congress

First scientific presentation of detailed PK data demonstrates dose-dependent increases in agomelatine exposure, no food effect, and no accumulation of exposure over seven days of dosing Detailed data reinforces previously reported topline results demonstrating that GlyphAgo achieved a statistically significant 6.8-fold increase in agomelatine bioavailability and substantially lower (10-fold) PK variability compared to unmodified agomelatine Agomelatine levels comparable to those seen with efficacious doses of the unmodified drug were achieved at substantially lower doses, intended to reduce hepatic exposure and the potential for liver enzyme elevations BOSTON--(BUSINESS WIRE)-- Seaport Therapeutics, Inc. (Nasdaq: SPTX) (“Seaport” or the “Company”), a clinical-stage therapeutics company developing novel neuropsychiatric medicines, today announced the presentation of Phase 1 clinical data for GlyphAgo™ (SPT-320 or Glyph Agomelatine) at the 39th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 10-13, 2026, in Munich, Germany. The poster represents the first scientific presentation of data from the GlyphAgo Phase 1 program and provides detailed pharmacokinetic (PK) analyses supporting previously reported topline results and reinforcing GlyphAgo's differentiated profile. GlyphAgo is a novel, “Glyphed” oral prodrug of agomelatine designed to enhance lymphatic absorption and bypass first-pass liver metabolism. In the Phase 1 program, GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability of agomelatine compared to unmodified agomelatine and showed significantly lower (10-fold) PK variability. GlyphAgo achieved therapeutically relevant exposure of agomelatine at substantially lower doses that are designed to reduce liver exposure. Seaport believes this approach has the potential to reduce the risk of liver enzyme elevations and reduce the need for routine liver function monitoring that has historically limited agomelatine’s clinical use. “The data presented at ECNP provide important clinical validation that our Glyph™ platform can meaningfully improve the pharmacokinetic pro medicines historically limited by high first-pass liver metabolism,” said Daniel Bonner, Ph.D., Co-Founder and Senior Vice President, Platform, at Seaport Therapeutics. “The increased exposure and markedly reduced inter-individual variability observed in the Phase 1 program are particularly compelling. More predictable drug exposure may translate into more consistent clinical outcomes for patients, further supporting the development of GlyphAgo as a potential treatment for generalized anxiety disorder.” The completed multi-part Phase 1 proof-of-concept trial evaluated the safety, tolerability and pharmacokinetics of GlyphAgo in 174 healthy volunteers. The newly presented results include data from the multiple-ascending dose (MAD) portion and analyses supporting the absence of a food effect with GlyphAgo. The single- and multiple-ascending dose portions of the trial demonstrated dose-dependent increases in agomelatine exposure and showed no accumulation of exposure over seven days of dosing, supporting a consistent pro repeat dosing. Additional analyses presented in the poster further characterize the substantially reduced PK variability observed with GlyphAgo, with variability in both AUC₀-₂₄ and Cmax substantially lower than with unmodified agomelatine. Specifically, in the SAD portion, PK variability (geometric CV%) observed in participants dosed with GlyphAgo ranged from 12.9% to 26.6% for AUC₀-₂₄ and from 17.1% to 50.5% for Cmax, compared with 200% and 217%, respectively, for unmodified agomelatine. In the crossover portion, PK variability in participants dosed with GlyphAgo ranged from 22.6% to 29.7% for AUC₀-₂₄ and from 26.5% to 44.0% for Cmax, compared with ranges of 234.6% to 350.1% and 303.7% to 500.9%, respectively, for unmodified agomelatine. As previously noted, the data showed no effect of estrogen-containing oral contraceptives on agomelatine exposure following GlyphAgo dosing, further supporting the ability of GlyphAgo to bypass first-pass hepatic metabolism and avoid drug-drug interactions that occur in the liver. Details of the presentation are as follows: Title: GlyphAgo demonstrated 6.8-fold increased bioavailability and 10-fold reduced variability versus unmodified agomelatine in healthy volunteers at doses projected to mitigate liver exposure Poster Number: PS02-2029 Presenter: Daniel Bonner, Ph.D., Co-Founder and Senior Vice President, Platform, at Seaport Therapeutics Date and Time: Sunday, October 11 th at 12:35 PM CEST Seaport has initiated a Phase 2a clinical trial evaluating GlyphAgo in adults with generalized anxiety disorder and sleep disturbance, with topline results expected in early 2028. The Company also plans to initiate a Phase 2/3 clinical trial evaluating the efficacy and safety of GlyphAgo in patients with GAD in the first half of 2027. About GlyphAgo TM (SPT-320 or Glyph Agomelatine) GlyphAgo is a novel, “Glyphed” oral prodrug of agomelatine, a clinically validated anti-anxiety and antidepressant that is approved for the treatment of GAD in Australia and Major Depressive Disorder in Australia and the European Union. Using Seaport’s proprietary Glyph TM platform, GlyphAgo is designed to enhance lymphatic absorption and avoid first-pass liver metabolism, thereby enhancing oral bioavailability and reducing side effects. By leveraging an alternative absorption pathway via the intestinal lymphatic system used by dietary fats, GlyphAgo is designed to increase systemic exposure of agomelatine, enabling exposure levels of agomelatine within the range observed to be effective in third-party placebo-controlled studies in GAD but at a lower dose that is designed to reduce liver exposure. Based on the data generated to date, Seaport believes GlyphAgo has the potential to become a leading treatment for GAD. About Seaport Therapeutics Seaport Therapeutics (Nasdaq: SPTX) is a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. Through its differentiated approach, the Company identifies clinically validated mechanisms with established efficacy and safety which had historically been limited by high first-pass metabolism, low bioavailability, and/or side effects. Seaport applies its proprietary Glyph TM platform to overcome those limitations and invent innovative oral therapies. With an experienced team of industry leaders, Seaport has a proven track record in neuropsychiatry drug discovery and development and delivering successful business outcomes. Seaport aims to develop novel, leading treatment options that will make a significant impact for patients and their families. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “would,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding our product candidates, including: the therapeutic potential of GlyphAgo, including its potential to achieve therapeutic exposures of agomelatine at lower doses, reduce liver exposure, and reduce or eliminate the need for liver function testing; the design and previously reported topline results of the Phase 1 trial of GlyphAgo; the design, progress, enrollment and results of the Phase 2a trial of GlyphAgo and the anticipated timing of topline data in early 2028; and the planned initiation of the Phase 2/3 trial of GlyphAgo in the first half of 2027 and the anticipated timing of topline data by the end of 2028. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect Seaport’s business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities, including with respect to the GlyphAgo Phase 2a trial and planned Phase 2/3 trial; risks that results from earlier trials, including the Phase 1 trial of GlyphAgo, or from third-party trials of agomelatine may not be predictive of future results, including with respect to liver safety; Seaport’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to Seaport’s preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Seaport’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition, including Seaport’s limited operating history and history of significant losses, its need for substantial additional funding and its ability to raise capital when needed, on acceptable terms, or at all, to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Seaport’s intellectual property protections; and risks related to the competitive landscape for Seaport’s product candidates; as well as other risks and uncertainties described in “Risk Factors,” in Seaport’s Quarterly Report on Form 10-Q for the three months ended June 30, 2026 filed with the Securities and Exchange Commission (“SEC”), as well as in subsequent filings with the SEC. Seaport expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Seaport uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Contacts Seaport Therapeutics Media Contact: Shannon Costello Vice President, Communications publicrelations@seaporttx.com Investor Contact: Adam Bero, Ph.D. Vice President, Head of Investor Relations ir@seaporttx.com

Phase 1Phase 2Clinical Result

06 Oct 2026

·www.prnewswire.com

Mint Pharmaceuticals Inc. and Bayer Inc. Expand Distribution Partnership in Canada

Expanded collaboration supports continued Canadian access to Bayer medicines across cardiovascular and women's health portfolios. MISSISSAUGA, ON, Oct. 6, 2026 /PRNewswire/ -- Mint Pharmaceuticals Inc. is pleased to announce the expansion of its distribution partnership with Bayer Inc. to include ANGELIQ® (drospirenone and estradiol-17β tablets), CLIMARA® 25, CLIMARA® 50 and CLIMARA® 75 (estradiol hemihydrate transdermal systems), TRIQUILAR® 21 and TRIQUILAR® 28 (levonorgestrel and ethinyl estradiol tablets), and XARELTO® (rivaroxaban granules for oral suspension) in Canada. The expanded collaboration builds on the companies' existing relationship and shared commitment to reliable access to medicines for Canadian patients and healthcare professionals. Continue Reading Olenka Crewe, VP of Business Development & Scientific Affairs, Mint Pharmaceuticals, Jaiveer Singh, CEO, Mint Pharmaceuticals, Viktoria Friedrich, President and CEO of Bayer Inc. in Canada. Jennifer Lloyd, Head of Finance, Pharmaceutical Division, Bayer Inc. (CNW Group/Mint Pharmaceuticals) The partnership was originally established to support the Canadian distribution of Bayer's ADALAT® XL® (nifedipine extended-release tablets), an antihypertensive / antianginal medicine. The addition of ANGELIQ®, CLIMARA®, TRIQUILAR®, and XARELTO® extends the collaboration across a broader range of therapeutic areas while maintaining the companies' focus on dependable supply and continuity of care. "Ensuring Canadian patients and healthcare professionals can rely on consistent access to established medicines is central to Mint's mission," said Jaiveer Singh, Chief Executive Officer of Mint Pharmaceuticals. "Expanding our work with Bayer allows us to apply Mint's resilient supply chain and nationwide distribution capabilities across a broader portfolio, while advancing our mutual focus on reliability, quality and patient care." "We are pleased to expand our partnership with Mint Pharmaceuticals Inc., building on a trusted collaboration rooted in quality, reliability and a shared commitment to patient care," said Viktoria Friedrich, President and CEO of Bayer Inc. in Canada. "By broadening this partnership across additional Bayer medicines, we can continue to leverage Mint's strong Canadian distribution network and market expertise to help ensure these treatments remain accessible to healthcare professionals and patients who rely on them." Through this expanded partnership, Mint Pharmaceuticals and Bayer Inc. aim to maintain high standards of distribution and supply continuity across the portfolio, helping ensure that healthcare professionals and patients across Canada have timely access to these medicines. About Mint Pharmaceuticals Mint Pharmaceuticals is a leading Canadian-owned and operated manufacturer of high-quality, affordable generic medicines. Mint has built one of the strongest and most resilient pharmaceutical supply chains in the country, helping safeguard patient access by averting 25 national drug shortages across 16 essential medicines in the last decade. The company has been recognized by Deloitte as one of Canada's Best Managed Companies for eight consecutive years, achieving Platinum Club status in 2025, and is a member company of the Canadian Generic Pharmaceutical Association (CGPA). About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at and at . SOURCE Mint Pharmaceuticals 21% more press release views with Request a Demo

100 Deals associated with Estradiol

External Link

KEGG	Wiki	ATC	Drug Bank
D00105	Estradiol	G03CA03	DB00783

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Infertility	Japan	Fuji Pharma Co., Ltd.	11 Mar 2022
Infertility	Japan	Bayer Yakuhin Ltd.	11 Mar 2022
Ovarian Stimulations	Japan	Bayer Yakuhin Ltd.	11 Mar 2022
Dyspareunia	United States	Mayne Pharma Ltd.	29 May 2018
Oestrogen deficiency	Brazil	Libbs Farmacêutica Ltda.	02 Oct 2002
Female Urogenital Diseases	Japan	Hisamitsu Pharmaceutical Co., Inc.	01 Oct 1999
Hot Flashes	Japan	Hisamitsu Pharmaceutical Co., Inc.	01 Oct 1999
Hypogonadism	Japan	Hisamitsu Pharmaceutical Co., Inc.	01 Oct 1999
Atrophic Vaginitis	United States	Novo Nordisk, Inc.	26 Mar 1999
Osteoporosis, Postmenopausal	United States	AbbVie, Inc.	20 Dec 1996
Urogenital Diseases	United States	Pfizer Inc.	26 Apr 1996
Hypoestrogenism	United States	Bayer Healthcare LLC	22 Dec 1994
Hypoestrogenism	United States	Bayer HealthCare Pharmaceuticals, Inc.	22 Dec 1994
Hypoestrogenism	United States	Bayer HealthCare	22 Dec 1994
Uterine Hemorrhage	United States	Bayer HealthCare	22 Dec 1994
Uterine Hemorrhage	United States	Bayer Healthcare LLC	22 Dec 1994
Uterine Hemorrhage	United States	Bayer HealthCare Pharmaceuticals, Inc.	22 Dec 1994
Vulvovaginal atrophy	United States	Bayer HealthCare	22 Dec 1994
Vulvovaginal atrophy	United States	Bayer Healthcare LLC	22 Dec 1994
Vulvovaginal atrophy	United States	Bayer HealthCare Pharmaceuticals, Inc.	22 Dec 1994

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Burns	Phase 3	Germany	Renovo Ltd.	01 Jan 2007
Burns	Phase 3	Latvia	Renovo Ltd.	01 Jan 2007
Burns	Phase 3	Russia	Renovo Ltd.	01 Jan 2007
Burns	Phase 3	United Kingdom	Renovo Ltd.	01 Jan 2007
Varicose Ulcer	Phase 3	Germany	Renovo Ltd.	01 Jan 2007
Varicose Ulcer	Phase 3	Latvia	Renovo Ltd.	01 Jan 2007
Varicose Ulcer	Phase 3	Russia	Renovo Ltd.	01 Jan 2007
Varicose Ulcer	Phase 3	United Kingdom	Renovo Ltd.	01 Jan 2007
Postmenopausal atrophic vaginitis	Phase 3	United States	Novo Nordisk A/S	01 Mar 2005
Postmenopausal atrophic vaginitis	Phase 3	Canada	Novo Nordisk A/S	01 Mar 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05617820 (CTgov)	Phase 3	Vulvovaginal atrophy \| Dyspareunia	1,050	Estradiol (Estradiol Vaginal Inserts, 4 mcg)	ctcgtisqtj = txtoypvhll emiyudgphh (woewbftphw, aoqubxhskb - ahxhdpprzi) View more	-	30 Sep 2026
				Imvexxy (IMVEXXY® (Estradiol Vaginal Inserts) 4 mcg)	ctcgtisqtj = ucanmglapp emiyudgphh (woewbftphw, ofzhthfoyt - wjcpawgpxg) View more
NCT02188745 (POLLY, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	20	letrozole+Exemestane+17B-estradiol+anastrozole	waecujdmly = dloebwodwu fczmetssun (yoyuriagll, dbdougrvil - aqgizzgkuy) View more	-	25 Sep 2026
NCT05472779 (TAPER, CTgov)	Phase 2	Urinary Tract Infections	114	Estradiol Cream (Periurethral Application of Estradiol Cream)	clelspofaa = jumuyilarg ykdnbnfvsp (jjzokcdlqv, uusfgyevia - iitnsxwrub) View more	-	24 Sep 2026
				Estradiol Cream (Intravaginal Application of Estradiol Cream)	clelspofaa = zjzsjumteo ykdnbnfvsp (jjzokcdlqv, llwmixhucb - aezjovbbrx) View more
NCT05658874 (CTgov)	Phase 3	Cystitis, Interstitial \| Blepharospasm \| Chronic pelvic pain syndrome	26	Behavioral health consultation/therapy+heparin+gentamicin+sodium bicarb+Kenalog+Vaginal estrogen+Gabapentin+Oxybutynin+Detrol+Mirabegron+lidocaine+Amitriptyline+Trospium+Methenamine (Multimodal Care Bundle)	rruafgfsec(xevvybfoon) = dmeayrcnxc rxmrjurrxb (tbjkakxogm, 7.11) View more	-	01 Apr 2026
				Usual Urogynecologic care (Usual Care)	rruafgfsec(xevvybfoon) = dthaccoayf rxmrjurrxb (tbjkakxogm, 7.34) View more
NCT05551949 (PRUVE, CTgov)	Phase 4	Urinary Tract Infections \| Cystitis	27	Vaginal estradiol tablets	bnathlnzgs(gpldtqhszm) = wiytkynnva ychqreqkqg (lzdvyqphfo, eqhayckrrd - bhxdrpvdzb) View more	-	05 Mar 2026
NCT03941730 (CTgov)	Phase 2	Breast cancer recurrent \| Metastatic breast cancer \| Metastatic Triple-Negative Breast Carcinoma ... View more	8	Computed Tomography+Therapeutic Estradiol	ihvbebzzij = netiixloyi bsvgtcrqrr (ytkoivkpnw, lqigykogci - pxpbiabghq) View more	-	05 Mar 2026
NCT04112368 (CLEAR-3, CTgov)	Phase 4	Suicidal Ideation	124	Inactive Clear Patch+Oral Micronized Progesterone 200mg+Estradiol Transdermal Patch 0.1 mg/24 hrs (Transdermal Estradiol + Oral Micronized Progesterone)	kdeeypnsvi(bnueyjlcmp) = qifowzyqvw ocapzddkoz (jbimmfussz, .05) View more	-	19 Dec 2025
				Inactive Clear Patch+Oral Micronized Progesterone 200mg+Estradiol Transdermal Patch 0.1 mg/24 hrs (Placebo Patch + Placebo Pills)	tbdbgvpmxo(xsoejdnjku) = gjpvxusecj evvybbgwyi (mmnvvaucpa, .008) View more
NCT00984399 (CTgov)	Not Applicable	Breast Cancer \| Atrophic Vaginitis	31	Letrozole (Letrozole)	uiaohnxuos(sabncsvnxv) = kyuukkodjs kqpukwocvp (jelwauaqoh, hjojkiuhiy - klzukaxjat) View more	-	09 Dec 2025
				Anastrozole (Anastrozole)	uiaohnxuos(sabncsvnxv) = wvigsyaiol kqpukwocvp (jelwauaqoh, jotvfehvcq - zwqkrhvbwd) View more
ESPE2025	Not Applicable	Turner Syndrome	16	Growth hormone	fucjqudlpv(iqlqrvhyfr) = vrtmbgiedp cccqapubzw (twykloseru ) View more	Positive	10 May 2025
				Estrogen	brjguvcfkd(hnijpbjmsx) = chflbsinfa rohwskfsjw (sfmnyiuevs )
NCT03018366 (CTgov)	Phase 2	Hypoestrogenism \| Hypothalamic amenorrhoea \| Oestrogen deficiency ... View more	29	progesterone+17beta Estradiol (17Beta Estradiol, Progesterone)	gelhafkpwp(ziggekkbvs) = oacwisbaog fxfdilmvhs (jjztqijtgr, 0.52) View more	-	24 Feb 2025
				Placebo Pill (Transdermal Placebo Patch, Placebo Pill)	gelhafkpwp(ziggekkbvs) = zlzmuouuaa fxfdilmvhs (jjztqijtgr, 0.64) View more

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