Lynkuet

Pipeline

Status by Indication[3][1]

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Hot flashes3 trials

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause

Completed·Bayer·Phase 3·NCT05042362·396 enrolled

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

Completed·Bayer·Phase 3·NCT05099159·400 enrolled

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause

Completed·Bayer·Phase 3·NCT05030584·628 enrolled

Treatment3 trials

A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years

Completed·Bayer·Phase 1·NCT05381142·16 enrolled

A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants

Completed·Bayer·Phase 1·NCT05351892·18 enrolled

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

Completed·Bayer·Phase 1·NCT05481528·51 enrolled

Female2 trials

A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants

Completed·Bayer·Phase 1·NCT05471817·20 enrolled

A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults

Completed·Bayer·Phase 1·NCT04981431·62 enrolled

Menopause1 trial

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

Completed·Bayer·Phase 2·NCT06112756·110 enrolled

Drug1 trial

Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body

Completed·Bayer·Phase 1·NCT04845841·16 enrolled

7 more indications

Adult1 trial

A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults

Completed·Bayer·Phase 1·NCT05061563·14 enrolled

Vasomotor Symptoms1 trial

A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

Completed·Bayer·Phase 2·NCT03596762·199 enrolled

Function1 trial

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

Completed·Bayer·Phase 1·NCT06219902·64 enrolled

Statin1 trial

A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants

Completed·Bayer·Phase 1·NCT04889287·16 enrolled

Women1 trial

A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.

Completed·Bayer·Phase 1·NCT05028608·16 enrolled

Kidney1 trial

A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally

Completed·Bayer·Phase 1·NCT05071729·31 enrolled

Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer1 trial

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for an Additional up to 3.5 Years in Women With Hormone-receptor Positive Breast Cancer:

Active, not recruiting·Bayer·Phase 3·NCT05587296·474 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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