A Look at Lynkuet® (Elinzanetant) for the Treatment of Moderate to Severe Vasomotor Symptoms

Introduction

Elinzanetant is a novel, dual neurokinin (NK)1,3 receptor agonist that has recently been approved for the treatment of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.¹ VMS are extremely common during menopause, affecting up to 80% of women (of these, approximately one-third have highly frequent or severe symptoms), and often persist for 7 to 10 years after the last menstrual period.^2,3 VMS can contribute to sleep disturbances (reported in up to 60% of individuals undergoing menopause) and negatively affect daily activities, work productivity, and quality of life.^2,4 They may also be linked with cardiovascular events, symptoms of depression, and cognitive decline.^2,4 VMS are distressing to patients and are the top reason for pursuing medical attention during the menopausal transition.⁴

Menopausal hormone therapy (MHT), which is composed of estrogen or estrogen-progestin combinations, is the most commonly used treatment for moderate to severe VMS.⁵ However, these may be linked with an increased risk for venous thromboembolism, major coronary artery disease, stroke, and breast, endometrial, and ovarian cancers.⁵ Although the magnitude of these risk increases are modest and likely related to individual patient factors and type and duration of hormone therapy, potential candidates may opt out of MHT due to concerns about these adverse events.⁵ MHT is also contraindicated for patients at high risk for breast cancer, heart disease, and venous thromboembolism, as well as those with a history of stroke, myocardial infarction, or pulmonary embolism.⁵ Given these concerns, women with VMS may prefer to seek nonhormonal options for treatment.⁵ Furthermore, improvement in symptoms with MHT may take several months, and the effectiveness of MHT for nighttime awakening may be limited.⁴ Thus, there has been an unmet need for safe and effective alternatives to MHT to manage menopause-associated VMS.³ The recent launch of elinzanetant for moderate to severe VMS associated with menopause could provide a dual NK-targeted option for many women, including those who are unable to or choose not to use MHT.² This article provides an overview of elinzanetant, including mechanism of action, pharmacokinetics and pharmacodynamics information, efficacy and safety data, and dosage and administration.

Mechanism of Action

Elinzanetant is a selective antagonist of NK1 and NK3 receptors, with a 10-fold greater affinity for NK1 than for NK3, and has been shown to bind to the human NK1 brain receptor in single and repeated-dose receptor occupancy studies.⁶ NK receptor systems are involved in menopause-related VMS via hypothalamic mechanisms.⁴ Postmenopausal women have hypertrophy of kisspeptin, neurokinin B, and dynorphin (KNDy) neurons in the hypothalamus and increased gene expression of kisspeptin, NKB (endogenous ligand for NK3 receptors), and substance P (endogenous ligand for NK1 receptors).⁴ In particular, the NK3 receptor and NKB ligand are associated with the pathophysiology of hot flashes through the thermal regulatory center, and NK3 receptor blockade has been shown to reduce the number and severity of hot flashes.^4,7 NK1 and substance P are also involved in VMS, as the immunoreactivity of substance P is often colocalized with kisspeptin and NKB in the infundibular area of the hypothalamus.⁴ Peripherally, desensitization of the NK1 receptor reduces dilation of blood vessels in the skin, and infusion of substance P increases vasodilation and facial flushing, which are symptoms associated with hot flashes.⁴ Overactivation of KNDy neurons has been associated with abnormalities in thermoregulation.⁶ Based on this knowledge about the pathophysiology of menopause-related VMS, targeting NK receptors has been proposed as a promising approach for managing VMS.⁶

Pharmacokinetics and Pharmacodynamics

Elinzanetant is orally administered and rapidly absorbed, with an oral bioavailability estimated to be 36.7%.⁶ The elimination half-life of elinzanetant is approximately 35 hours, with an estimated clearance of 7.26 L/hour.⁶ The central and peripheral distribution volumes were approximately 23.7 L and 168 L, respectively.⁶

When elinzanetant is dosed once per day, a steady state is typically reached within 5 to 7 days.⁶ Accumulation of elinzanetant is less than 2-fold with multiple daily doses.⁶ Metabolism of elinzanetant primarily occurs via the cytochrome P450 enzyme 3A4 (CYP3A4; 81%), with CYP3A5 (7%) and uridine 5’-diphospho-glucuronosyltransferase (5%-12%) also involved.^1,6 In a population pharmacokinetic/pharmacodynamic model, predicted receptor occupancies at steady state had mild fluctuations during the day and were greater than 99% for NK1 and greater than 94.8% for NK3 during the daytime and nighttime with continuous once-daily 120-mg doses, demonstrating sustained and nearly complete inhibition of the targeted receptors.⁶ Although circadian fluctuations were observed with elinzanetant clearance in a simulated population pharmacokinetic model, the effects of circadian modulation on elinzanetant pharmacodynamics are unlikely to be clinically relevant because these changes were mostly seen in the elimination phase.⁶

Elinzanetant is primarily excreted through the feces (90.4%), with a negligible amount found in urine (0.4%).¹ In analyses of the effects of food intake and formulation on drug absorption, just a high-fat breakfast was shown to affect absorption, with decreases in first-order absorption rate (91%), increases in absorption lag time (55%), and decreases in absolute oral bioavailability (23%).⁶ A 55% increase in absorption lag time and 26% decrease in absorption rate constant were observed with the hard gel capsule compared with the soft gel capsule (the formulation used in clinical trials), but the extent of absorption was similar between the formulations.⁶

Effects of intrinsic patient factors on elinzanetant exposure were evaluated, with height taller than the population median, Black race, and bilirubin levels above the median associated with lower exposure on univariate analysis.⁶ However, the study authors noted that the median height was slightly greater for Black women than for White women in the study, and which covariate is contributing to the observed exposure discrepancies is unclear and should be evaluated further.⁶

Efficacy Data

The approval of elinzanetant for VMS related to menopause was based on data from the OASIS phase 3 clinical trial program, which assessed the efficacy and safety of elinzanetant 120 mg in 4 phase 3 clinical trials: OASIS-1 (NCT05042362), OASIS-2 (NCT05099159), OASIS-3 (NCT05030584), and OASIS-4 (NCT05587296).

OASIS-1 and OASIS-2

The phase 3 OASIS-1 and OASIS-2 trials were pivotal, multinational, double-blind, randomized, placebo-controlled trials conducted over a 26-week period.² OASIS-1 (N = 396) and OASIS-2 (N = 400) were conducted simultaneously, with similar designs and identical primary and secondary end points to guarantee reliability and reproducibility, and conducted in different study locations primarily in the United States and Europe.² Study participants were 40 to 65 years of age, postmenopausal either due to natural or surgical (bilateral oophorectomy with or without hysterectomy) causes, and experiencing 50 or more moderate to severe VMS over 7 days during trial screening.² Patients were excluded if they had abnormal liver measurements (eg, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] more than 2 times the upper limit of normal [ULN]), disordered proliferative endometrium, endometrial hyperplasia or polyps, or current or prior malignancy within the previous 5 years (except for basal or squamous cell skin carcinomas).² During the first 12 weeks, participants were randomized 1:1 to receive oral elinzanetant 120 mg or identical-appearing placebo once per day.² After this 12-week period, all participants received elinzanetant 120 mg for an additional 14 weeks, which was followed by posttreatment follow-up for 4 weeks.² The prespecified primary efficacy end points in both trials were mean change in frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12.² Key secondary end points included mean changes in moderate to severe VMS frequency from baseline to week 1, the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) 8b total T score, and the Menopause-Specific Quality of Life (MENQOL) questionnaire total score from baseline to week 12.² The PROMIS SD SF 8b evaluated aspects of sleep disturbance over the prior 7 days, including restless sleep, satisfaction with sleep, refreshing sleep, difficulties falling asleep, staying asleep, initiating sleep, quantity of sleep, and quality of sleep.² T scores of 55 to 59, 60 to 69, and 70 or greater indicated mild, moderate, or severe sleep disturbance, respectively.² The MENQOL is a 29-item questionnaire that evaluated the presence and perceived severity of menopausal symptoms over the past week, including VMS, psychosocial, physical, and sexual domains.² These symptoms were measured by their “degree of bother” (ie, perceived severity) on a scale from 0 to 6, with higher numbers corresponding with greater “bother.”² Both the PROMISE SD SF 8b and MENQOL have been validated for use in VMS clinical trials.²

Participants tracked the frequency and severity of VMS once in the morning and once in the evening using an electronic hot flash daily diary recorded in a handheld device.² This device had been researched previously and is considered suitable to use for measuring the efficacy end points studied in phase 3 trials of VMS treatments.²

Across both trials, elinzanetant was associated with significantly greater least squares (LS) mean decrease in daily VMS frequency compared with placebo at week 4 (OASIS-1: ‒3.3 [95% confidence interval (CI) ‒4.5 to ‒2.1], P < .001; OASIS-2: ‒3.0 [95% CI, ‒4.4 to ‒1.7], P < .001) and week 12 (OASIS-1: ‒3.2 [95% CI, ‒4.8 to ‒1.6]; P < .001; OASIS-2: ‒3.2 [95% CI, ‒4.6 to ‒1.9; P < .001).² These differences between elinzanetant and placebo were considered to be clinically meaningful on a group level (the Food and Drug Administration considers a difference of at least 2 VMS per day to be clinically meaningful).² Significantly greater LS mean changes in daily VMS severity were also observed with elinzanetant compared with placebo at week 4 (OASIS-1: ‒0.3 [95% CI, ‒0.4 to ‒0.2], P < .001; OASIS-2: ‒0.2 [95% CI, ‒0.3 to ‒0.1]; P < .001) and week 12 (OASIS-1: 0.4 [95% CI, −0.5 to −0.3], P < .001; OASIS-2: −0.3 [95% CI, −0.4 to −0.1], P < .001).² The elinzanetant group also had significantly greater improvement in sleep disturbances, as measured by greater LS mean changes in PROMIS SD SF 8b total T score (OASIS-1: ‒5.6 [95% CI, ‒7.2 to ‒4.0], P < .001; OASIS-2: ‒4.3 [95% CI, ‒5.8 to ‒2.9]; P < .001) and menopause-related quality of life, as measured by greater LS mean changes in MENQOL total score (OASIS-1: ‒0.4 [95% CI, ‒0.6 to ‒0.2], P < .001; OASIS-2: ‒0.3 [95% CI, ‒0.5 to ‒0.1]; P = .0059).² The reductions in frequency and severity of VMS, PROMIS SD SF 8b total T score, and MENQOL total score observed in the elinzanetant group persisted through 26 weeks.² These measures also improved further in the group that received placebo during the first 12 weeks and switched to elinzanetant from 13 to 26 weeks.² Additionally, a 50% or greater reduction in VMS frequency, which is identified in the literature as a clinically relevant improvement on an individual level, was achieved by more than 80% of participants at 26 weeks, including in the group that started with placebo and switched to elinzanetant at 12 weeks.² The authors concluded that, with significant and clinically relevant improvements in VMS frequency observed as early as 1 week, elinzanetant represents a promising option for dual NK-targeted treatment of VMS that has a rapid onset of action and yields meaningful improvements in symptoms and quality of life.²

OASIS-3

The OASIS-3 trial assessed the long-term efficacy and safety of elinzanetant 120 mg given to naturally or surgically postmenopausal women 40 to 65 years of age with moderate to severe VMS over a 52-week period.⁸ Participants were randomized 1:1 to receive elinzanetant (n = 313) or placebo (n = 315) for 52 weeks.⁸ The primary end point was mean change in the frequency of moderate to severe VMS from baseline to week 12.⁸ Secondary end points included the mean change from baseline in PROMIS SD SF 8b total T score and MENQOL total score.⁸

Elinzanetant was associated with a significantly greater reduction in VMS frequency from baseline to 12 weeks compared with placebo (LS mean difference of ‒1.6 [95% CI, ‒2.0 to ‒1.1]; P < .0001) that persisted through week 50.⁸ Mean changes from baseline to week 52 in the elinzanetant and placebo groups were ‒9.4 (8.4) and ‒5.7 (7.9), respectively, for the PROMIS SD SF 8b total T score and were ‒1.3 (1.3) and ‒1.1 (1.4), respectively, for the MENQOL total score.⁸ These findings support those from the OASIS-1 and OASIS-2 trials and highlight the durable effects of elinzanetant for improving VMS frequency and severity, as well as menopause-related sleep disturbances and quality of life.

OASIS-4

VMS are common in patients taking endocrine therapy (tamoxifen or aromatase inhibitors) for hormone receptor (HR)-positive breast cancer and can be severe, particularly for younger women who frequently take gonadotropin-releasing hormone (GnRH) analogues at the same time.⁹ This may negatively affect health-related quality of life and reduce adherence to endocrine therapy.⁹ Therefore, the OASIS-4 trial studied the efficacy of elinzanetant for management of VMS in patients 18 to 70 years of age who reported moderate to severe VMS associated with endocrine therapy (tamoxifen or aromatase inhibitors, with or without GnRH analogues) taken to treat or prevent HR-positive breast cancer.⁹ Patients were excluded if they had an initial diagnosis of metastatic HR-positive breast cancer or recurrence of HR-positive breast cancer while taking endocrine therapy, treatments other than endocrine therapy within 3 months of giving informed consent or that were scheduled to take place during the trial period, or were taking medications that could affect VMS or the pharmacokinetics of elinzanetant.⁹

Participants were randomized 2:1 to receive elinzanetant 120 mg once daily for 52 weeks or placebo once daily for 12 weeks, followed by 40 weeks of elinzanetant 120 mg once daily for both groups.⁹ The primary end points were the change in mean daily frequency of moderate to severe VMS from baseline to week 4 and to week 12.⁹ Key secondary end points included mean change in PROMIS SD SF 8b total T score and MENQOL total score from baseline to week 12.⁹

Compared with the placebo group (n = 158), the elinzanetant group (n = 316) had a significantly greater decrease in daily frequency of moderate to severe VMS at week 4 (LS mean difference, ‒3.5 [95% CI, ‒3.9 to ‒2.2]; P < .001) and at week 12 (LS mean difference, ‒3.4 [95% CI, ‒4.2 to ‒2.5]; P < .001).⁹ The elinzanetant group also had significantly greater improvement in sleep disturbances (LS mean difference in PROMIS SD SF 8b total T score, ‒6.1 points [95% CI, ‒7.5 to 4.8]; P < .001) and menstrual-related quality of life (LS mean difference in MENQOL total score, ‒0.7 points [95% CI, ‒0.9 to ‒0.5; P < .001).⁹ Exploratory analyses revealed that greater than 70% of participants who received elinzanetant had a 50% or greater reduction of symptoms at 12 weeks, and more than 90% of patients who received the treatment for 52 weeks opted to take elinzanetant for an additional 2-year extension, suggesting satisfaction with the treatment.⁹ Having an effective therapy such as elinzanetant for reducing VMS in women undergoing endocrine therapy may be particularly helpful, as these patients are generally not eligible for MHT and often have limited improvement in symptoms with complementary medicine and lifestyle interventions.⁹ Because VMS and sleep disturbances could potentially reduce long-term adherence to endocrine therapy and thus negatively impact breast cancer-related outcomes, finding an effective nonhormonal strategy to treat these adverse events could address an important unmet need in these patients.⁹

Safety and Tolerability

The safety profile of elinzanetant was found to be favorable in the OASIS-1 and OASIS-2 trials and was maintained through 52 weeks in the OASIS-3 trial.^2,8 During the initial placebo-controlled 12 weeks, treatment-emergent adverse events (TEAEs) occurred in 51.3% and 48.5% of the elinzanetant and placebo groups, respectively, in the OASIS-1 trial, and in 44.3% and 38.2% of the elinzanetant and placebo groups, respectively, in OASIS-2.² Most of these TEAEs were of mild to moderate severity, with headache and fatigue more commonly experienced in the elinzanetant group than in the placebo group.² The majority of patients in the OASIS-3 trial reported one or more TEAEs (70% and 61.1% of the elinzanetant and placebo groups, respectively) throughout the 52-week period, with headache, fatigue, and somnolence more frequent in the elinzanetant group than in the placebo group.⁸ Serious TEAEs were infrequent, occurring in 4.9% and 1.9% of participants in the elinzanetant and placebo groups, respectively, and deemed to be unrelated to treatment by the investigators.⁸ Body weight did not change significantly, and changes in bone mineral density at the femoral neck, hip, and lumbar spine aligned with expected age-related decreases over the 52-week trial period.⁸ No cases of endometrial hyperplasia, malignant neoplasms, or drug-induced liver injury determined to be related to elinzanetant by an independent liver safety monitoring board were observed in the OASIS-1, OASIS-2, and OASIS-3 trials.^2,8

The adverse event profile of elinzanetant was similar among participants in the OASIS-4 trial, with more frequent reports of somnolence, fatigue, and diarrhea in the elinzanetant group.⁹ All participants (33in the elinzanetant group and 14in the placebo group) who underwent endometrial biopsies for symptoms such as vaginal bleeding and had an evaluable sample had benign findings.⁹ Endometrial hyperplasia, an adverse event that has been observed with some MHT (particularly unopposed estrogen), was identified in just 2 participants in OASIS-4.^9,10

Because of the potential for liver enzyme elevations with NK3 targeted compounds and possible effects of endocrine therapy (eg, tamoxifen) on liver health, a blinded independent external liver safety monitoring board was employed to evaluate cases for potential drug-induced liver injury.^9,11,12 Elevations in liver enzymes were reported in 5 women while taking elinzanetant, but none of these cases were thought to be caused by this drug.⁹ Furthermore, concomitant use of elinzanetant and endocrine therapy did not have apparent effects on the pharmacokinetics of any of the agents or their metabolites, further supporting its suitability in patients on endocrine therapy.⁹

Administration and Storage

Elinzanetant was administered orally once per day at a dose of 120 mg based on findings from the phase 2b SWITCH-1 trial (NCT03596762) that showed clinically relevant efficacy with the 120-mg dose (but not with lower doses) and no further benefit of the 160-mg dose.^3,13 Elinzanetant comes in 60-mg soft gel capsules stored in blister cards, with 2 capsules per blister taken daily at bedtime.³ Capsules should be swallowed whole without cutting, crushing, or chewing.¹³ The medication should be ideally be stored at 20°C to 25°C (a range of 15°C-30°C is acceptable).¹³ Patients taking a modified dose (one 60-mg capsule per day) should peel back the foil covering of the blister cell such that only one capsule is exposed.¹³

Precautions

The elevations in liver enzymes in the OASIS trials were infrequent and thought to be unrelated to elinzanetant treatment.^5,12,13 However, liver function tests, including serum ALT, AST, alkaline phosphatase, and bilirubin (total and direct), should be performed at baseline and 3 months after starting elinzanetant or if signs and symptoms of liver injury (eg, nausea, vomiting, jaundice) appear.¹³ Elinzanetant should not be initiated if ALT, AST, or total bilirubin are 2 or more times greater than the ULN based on the reference standards for the evaluating laboratory.¹³ Elinzanetant should be discontinued if the patient has signs or symptoms of liver injury (eg, new-onset fatigue, reduced appetite, nausea, vomiting, pruritis, jaundice, pale feces, dark urine, or abdominal pain), transaminase levels are more than 5 times the ULN, or transaminases are more than 3 times the ULN and total bilirubin is greater than 2 times the ULN, after excluding other causes of liver function test abnormalities.¹³

No data are available in pregnant women to determine risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with the use of elinzanetant.¹³ However, data from animal reproduction studies suggest an association between use of elinzanetant and pregnancy loss or stillbirth; thus, the drug is contraindicated in pregnancy.¹³ Pregnancy should be excluded before initiating elinzanetant and if pregnancy occurs during treatment, elinzanetant should be discontinued.¹³ To prevent pregnancy, effective contraception should be used during and for 2 weeks after discontinuing treatment.¹³ No data are available on whether elinzanetant or its metabolites are present in human milk, have effects on breastfed children, or affect milk production.¹³ Because elinzanetant is present in animal milk, it is assumed that it would also be present in human milk.¹³

No dose adjustments are needed for patients with mild to severe renal impairment (estimated glomerular filtration rate 15 to 90 mL/min/1.73m²) or mild hepatic impairment (Child-Pugh A).¹³ Elinzanetant is not recommended for patients with moderate to severe hepatic impairment because moderate hepatic impairment increased elinzanetant exposure, and its pharmacokinetics have not been studied in patients with end-stage renal disease.¹³

Metabolism of elinzanetant primarily occurs through the cytochrome P450 3A4 (CYP3A4) enzyme.¹³ Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase likelihood of treatment-related adverse events.¹³ Concomitant use of elinzanetant with strong CYP3A4 inhibitors and grapefruit/grapefruit juice should be avoided.¹³ The dose of elinzanetant should be decreased when used with moderate CYP3A4 inhibitors.¹³ Concomitant use of elinzanetant with strong and moderate CYP3A4 inducers is not recommended because it may decrease the effectiveness of elinzanetant (via decreased exposure).¹³

Patients should be advised to review the FDA-approved patient labeling and counseled on potential for somnolence, symptoms of hepatic transaminase elevation that warrant discontinuation of elinzanetant and need for bloodwork to monitor hepatic function, need for effective contraception during and 2 weeks after treatment, and the need to report history of seizures or conditions that lower seizure threshold as well as other medications (prescription or nonprescription) or dietary supplements used.¹³

Conclusions

Elinzanetant is a novel, selective antagonist of NK1 and NK3 receptors, which play a role in VMS associated with menopause, and may fulfill the unmet need for a safe, effective dual NK-targeted treatment for moderate to severe VMS associated with menopause or endocrine therapy for breast cancer.^2,8,9 The phase 3 OASIS clinical trials show that elinzanetant led to clinically meaningful decreases in frequency and severity of VMS episodes, sleep disturbances associated with menopause, and menopause-related quality of life measures.^2,8,9 Although elinzanetant has not been directly compared with the limited treatment options available for menopause-associated VMS, meta-analyses suggest that elinzanetant may have a faster onset of effect, yield greater improvements in menopause-specific quality of life and sleep disturbances, and have a favorable adverse event profile compared with other nonhormonal treatment options commonly used for moderate to severe VMS associated with menopause.^14,15 Additional research will be important for directly comparing efficacy and safety of elinzanetant with other treatment options and evaluating long-term efficacy and safety of elinzanetant across multiple patient populations.^2,15

References

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2. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618
3. Simon JA, Anderson RA, Ballantyne E, et al. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023;30(3):239-246. doi:10.1097/GME.0000000000002138
4. Trower M, Anderson RA, Ballantyne E, Joffe H, Kerr M, Pawsey S. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause. 2020;27(5):498-505. doi:10.1097/GME.0000000000001500
5. Hager M, Goldstein T, Fitz V, Ott J. Elinzanetant, a new combined neurokinin-1/-3 receptor antagonist for the treatment of postmenopausal vasomotor symptoms. Expert Opin Pharmacother. 2024;25(7):783-789. doi:10.1080/14656566.2024.2358131
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7. Prague JK, Roberts RE, Comninos AN, et al. Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389(10081):1809-1820. doi:10.1016/S0140-6736(17)30823-1
8. Panay N, Joffe H, Maki P, et al. Efficacy and long-term safety of elinzanetant for the treatment of VMS associated with menopause: a phase 3 randomized trial (OASIS 3). P-121. Presented at: The Menopause Society’s 2024 Annual Meeting; Chicago, IL; September 10-14, 2024.
9. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for vasomotor symptoms from endocrine therapy for breast cancer. N Engl J Med. Published online ahead of print. June 2, 2025. doi:10.1056/NEJMoa2415566
10. Furness S, Roberts H, Marjoribanks J, Lethaby A. Hormone therapy in postmenopausal women and risk of endometrial hyperplasia. Cochrane Database Syst Rev. 2012;2012(8):CD000402. doi:10.1002/14651858.CD000402.pub4
11. Soltamox. Prescribing information. Midatech Pharma US Inc. Updated September 2018. Accessed July 6, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf
12. Veozah. Prescribing information. Astellas Pharma US, Inc. Updated May 2023. Accessed July 6, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216578s000lbl.pdf.
13. LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2025
14. Sassarini J, Shulman LP, Giannopoulou A, et al. Comparative efficacy of elinzanetant versus other non-hormonal therapies for the treatment of moderate to severe vasomotor symptoms associated with menopause—a network meta-analysis. Presented at: Academy of Managed Care Pharmacy 2025 Annual Meeting; Houston, TX; March 31-April 3, 2025.
15. de Oliveira HM, Diaz CAV, Barbosa LM, Flávio-Reis VHP, Zamora FV, Gonçalves Barbosa Júnior O. Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: a systematic review and meta-analysis. Maturitas. 2025;195:108220. doi:10.1016/j.maturitas.2025.108220

This program was made possible through the financial support of Bayer Pharmaceuticals