LYNKUET

Launch

elinzanetant

NDAORALCAPSULE
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
17

Mechanism of Action

1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes. Elinzanetant has…

Clinical Trials (5)

NCT07229404Phase 1Completed

A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants

Started Nov 2025
18 enrolled
Vasomotor Symptoms
NCT06219902Phase 1Completed

A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women

Started Jan 2024
64 enrolled
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenHot Flashes
NCT06112756Phase 2Completed

A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause

Started Nov 2023
110 enrolled
Sleep Disturbances Associated With Menopause
NCT05587296Phase 3Active Not Recruiting

A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer

Started Oct 2022
474 enrolled
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerHot Flashes
NCT05481528Phase 1Completed

A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants

Started Aug 2022
51 enrolled
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenHot FlashesHealthy Volunteers

Loss of Exclusivity

LOE Date
May 14, 2045
233 months away
Patent Expiry
May 14, 2045
Exclusivity Expiry
Oct 24, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
7683056
Sep 15, 2026
SubstanceProduct
10195205
May 18, 2036
U-3622
10774091
Mar 13, 2039
Product
11787820
Mar 13, 2039
U-3622
12264164
Mar 13, 2039
U-3622