The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 8 July, become the first regulator in the world to
approve elinzanetant (Lynkuet) for the treatment of moderate to
severe vasomotor symptoms (hot flushes) associated with the
menopause.
When oestrogen levels drop during menopause, certain brain cells
become overactive and interrupt the body's ability to control
temperature, which leads to hot flushes and night sweats.
Elinzanetant is a new non-hormonal medication which
works by calming these signals in the brain, helping bring the
body's temperature control back into balance.
It may also help improve sleep problems that often come with
menopause. This medicine is administered in tablet
form, to be taken orally.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
“Hot flushes and night sweats associated with menopause can have
a significant negative impact on quality of life.
“We are therefore pleased to announce our approval of
elinzanetant, which has met the MHRA's standards for safety,
quality and effectiveness.
“Elinzanetant offers a non-hormonal alternative for those
who may not be able to, or prefer not to, take hormone-based
therapies. As with all licensed medicines, we will continue to
monitor its safety closely as it becomes more widely used.”
Elinzanetant's approval is based on results from the OASIS
clinical trials, which involved over 1,400 women aged 40 to 65
across several countries. These studies showed that taking a
daily 120 mg tablet of elinzanetant significantly reduced the
number and intensity of hot flushes and night sweats over 26 to
52 weeks, compared to a placebo.
Like all medicines, this medicine can cause side effects in some
people. A full list of side effects can be found in the Patient
Information Leaflet (PIL) or the Summary of Product
Characteristics (SmPC), available on the MHRA website within 7
days of approval.
Anyone who suspects they are having a side effect from this
medicine should talk to their doctor, pharmacist or nurse and
report it directly to the MHRA Yellow Card scheme,
either through the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
-
The new marketing authorisation was granted on 8 July 2025 to
Bayer plc.
-
This national approval was granted after an Access Consortium new
active substance work-sharing initiative (NASWSI)
procedure.
-
More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will
be published on the MHRA Products website within 7 days of
approval.
