Groundbreaking Drug Launches
Elinzanetant (Lynkuet)
Mechanism of Action: Neurokinin 1 receptor antagonists; Neurokinin 3 receptor antagonists Drug class: Small molecules Originator: GlaxoSmithKline Indication: Vasomotor symptoms Launched date: November 2025 (USA) Trials: OASIS 1, OASIS 2 and OASIS 3 trials
Vasomotor symptoms
Vasomotor symptoms (VMS) are sudden episodes of intense heat, flushing, and sweating—commonly experienced as hot flashes and night sweats. They most often occur during menopause due to declining estrogen levels, but can also be triggered by stress, diet, or other medical conditions. These symptoms result from disrupted temperature regulation in the body and can interfere with sleep, mood, and overall quality of life, while also being linked to increased cardiovascular risk.
Prevalence
Globally, vasomotor symptoms (VMS) are highly prevalent, affecting up to 80% of women during the menopausal transition or postmenopause. These symptoms, which include hot flashes and night sweats, represent one of the most common and disruptive aspects of menopause, significantly impacting quality of life for a large proportion of women worldwide.
Treatment challenges Managing vasomotor symptoms (VMS) is challenging due to the limited availability of effective non-hormonal treatments, variable individual responses, and potential side effects. While hormone therapy remains the most effective option, its associated risks make personalised approaches essential—particularly for cancer survivors or those with contraindications—and many lifestyle interventions or supplements lack strong supporting evidence.
Why is Elinzanetant poised to make an impact in 2026?
Elinzanetant (Lynkuet) is an orally bioavailable, selective small-molecule dual neurokinin-1 and neurokinin-3 receptor (NK1R/NK3R) antagonist developed by Bayer for the non-hormonal treatment of moderate-to-severe vasomotor symptoms and menopause-associated sleep disturbances. Lynkuet is expected to make a notable impact in 2026 as a recently approved non-hormonal therapy for menopause-related hot flashes. It provides an important option for women who cannot use hormone therapy, potentially transforming the menopause treatment landscape and enhancing quality of life. Bayer anticipates that Lynkuet could achieve peak annual sales of around €1 billion (approximately $1.16 billion), though specific revenue projections for 2026 have not been publicly disclosed.
Regulatory milestones for Elinzanetant
Registrational Trials
The U.S. Food and Drug Administration (FDA) has approved Lynkuet (elinzanetant) for treatment of moderate to severe vasomotor symptoms due to menopause. The approval is supported by data from three Phase III clinical trials of OASIS program (OASIS 1, OASIS 2 and OASIS 3).
OASIS-1:
A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women (NCT05042362).
“The OASIS-1 trial results highlight elinzanetant’s strong potential as an effective, non-hormonal option for reducing menopausal vasomotor symptoms, reinforcing its promise as a meaningful advance for women seeking alternatives to hormone therapy”
“The OASIS-2 trial further validated elinzanetant’s efficacy and tolerability, demonstrating consistent, clinically meaningful reductions in menopausal hot flashes and strengthening its position as a leading non-hormonal treatment option.”
OASIS-2:
A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women (NCT05099159).
OASIS-3:
A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women (NCT05030584).
“The OASIS-3 trial confirmed the long-term safety and sustained efficacy of elinzanetant, reinforcing its potential as a durable, non-hormonal therapy for managing menopausal vasomotor symptoms.”