Drugs / Elinzanetant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Lynkuet | — | 2025-11-17 | europa.eu ↗ |
| Approved | US (FDA) | LYNKUET | — | 2025-10-24 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT07229404 | Nov 2025 → Jan 2026 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06219902 | Jan → Apr 2024 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05481528 | Aug 2022 → Feb 2023 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05471817 | Aug → Sep 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05381142 | May → Jul 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05351892 | May → Jun 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05071729 | Oct 2021 → Oct 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05061563 | Sep → Dec 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05028608 | Sep → Oct 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04981431 | Aug 2021 → Mar 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04903821 | Jun 2021 → Mar 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04889287 | May → Jul 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04845841 | Apr → Jun 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04654897 | Sep → Oct 2020 | — | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02865538 | Aug 2016 → Mar 2017 | — | Bayer | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06112756 | Nov 2023 → Aug 2024 | sleep disorder | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT03596762 | Nov 2018 → Nov 2019 | — | Bayer | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05587296 | Oct 2022 → Jan 2024 overdue | breast cancer | Bayer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05099159 | Oct 2021 → Jun 2023 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05042362 | Aug 2021 → Jul 2023 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05030584 | Aug 2021 → Mar 2023 | — | Bayer | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02692157 Comparator | Feb 2016 → Jul 2017 | opiate dependence | New York State Psychiatric Institute | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07077395 Comparator | Mar 2026 → Jun 2029 expected | — | Massachusetts General Hospital | Recruiting | No outcome recorded |
Press releases naming this drug 19 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-19 | Bayer | Elinzanetant recommended for approval in EU as treatment of moderate to severe vasomotor symptoms bayer.com ↗ |
| 2025-07-25 | Bayer | Bayer provides regulatory update on elinzanetant in the U.S. bayer.com ↗ |
| 2025-07-10 | Bayer | Bayer receives first approval worldwide for Lynkuet™ (elinzanetant) in the UK as treatment of moderate to severe vasomotor symptoms associated with menopause bayer.com ↗ |
| 2025-06-02 | Bayer | Elinzanetant significantly reduces frequency of moderate to severe vasomotor symptoms associated with endocrine therapy for breast cancer in Phase III OASIS-4 study bayer.com ↗ |
| 2025-03-13 | Bayer | Bayer to present research on late-stage compound elinzanetant and impact on menopause symptoms at ESG 2025 bayer.com ↗ |
| 2025-01-09 | Bayer | Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of moderate to severe vasomotor symptoms caused by breast cancer treatments bayer.com ↗ |
| 2024-10-15 | Bayer | Bayer submits EU marketing authorization application for elinzanetant to treat moderate to severe vasomotor symptoms bayer.com ↗ |
| 2024-10-09 | Bayer | U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant bayer.com ↗ |
| 2024-09-10 | Bayer | Data from Phase III study OASIS 3 support efficacy and long-term safety of investigational compound elinzanetant in the treatment of moderate to severe vasomotor symptoms associated with menopause bayer.com ↗ |
| 2024-09-04 | Bayer | Bayer to unveil new data from its Phase III OASIS 3 long-term study of elinzanetant in the treatment of vasomotor symptoms associated with menopause bayer.com ↗ |
| 2024-08-22 | Bayer | The Journal of American Medical Association (JAMA) publishes Elinzanetant Phase III data bayer.com ↗ |
| 2024-08-01 | Bayer | Bayer submits New Drug Application to U.S. FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause bayer.com ↗ |
| 2024-05-16 | Bayer | Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause bayer.com ↗ |
| 2024-05-08 | Bayer | Bayer to unveil late-breaking data from Phase III OASIS 1 and 2 for elinzanetant in the treatment of vasomotor symptoms associated with menopause bayer.com ↗ |
| 2024-03-19 | Bayer | Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant bayer.com ↗ |
| 2024-01-08 | Bayer | Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies bayer.com ↗ |
| 2024-01-08 | Bayer | Bayer starts Phase II study NIRVANA to evaluate elinzanetant in women with sleep disturbances associated with menopause bayer.com ↗ |
| 2022-10-17 | Bayer | Bayer expands development program for elinzanetant with Phase III study in breast cancer patients with vasomotor symptoms caused by endocrine therapy bayer.com ↗ |
| 2021-08-31 | Bayer | Bayer starts Phase III clinical development program OASIS with Elinzanetant bayer.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elinzanetant | “Elinzanetant (BAY 3427080), dosage 1” NCT07229404 ↗ |
| Known as | BAY3427080 | “The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause.” NCT06112756 ↗18“Elinzanetant (BAY3427080) treatment A” NCT04845841 ↗ “Elinzanetant (BAY 3427080), dosage 1” NCT07229404 ↗ “Elinzanetant (NT-814, BAY3427080)” NCT04654897 ↗ “Drug: Elinzanetant (BAY3427080)” NCT05042362 ↗ “Drug: Elinzanetant (BAY3427080)” NCT05587296 ↗ “Drug: Elinzanetant (BAY3427080)” NCT05030584 ↗ “Drug: Elinzanetant (BAY3427080)” NCT05099159 ↗ “Elinzanetant (BAY3427080)” NCT05381142 ↗ “Elinzanetant (BAY3427080)” NCT06219902 ↗ “Elinzanetant (BAY3427080)” NCT05471817 ↗ “Elinzanetant (BAY3427080)” NCT05028608 ↗ “Elinzanetant (BAY3427080)” NCT05481528 ↗ “Elinzanetant (BAY3427080)” NCT04981431 ↗ “Elinzanetant (BAY3427080)” NCT03596762 ↗ “Elinzanetant (BAY3427080)” NCT05071729 ↗ “Elinzanetant (BAY3427080)” NCT04889287 ↗ “BAY3427080” NCT04903821 ↗ |
| Known as | NT-814 | “Elinzanetant (NT-814, BAY3427080)” NCT04654897 ↗ |
| Action | Inhibit | “a neurokinin (NK) antagonist at the 1 and 3 receptor subtypes” NCT02692157 ↗2“Neurokinin 3 receptor antagonist” CHEMBL4802157 ↗ “Neurokinin 1 receptor antagonist” CHEMBL4802157 ↗ |
| Modality | Small molecule | — CHEMBL4802157 ↗ |
| Route | Oral | “50 mg NT-814 will be administered orally each evening at 8pm” NCT02692157 ↗ |
| Target | TACR1 | “Neurokinin 1 receptor antagonist” CHEMBL4802157 ↗ |
| Target | TACR3 | “Neurokinin 3 receptor antagonist” CHEMBL4802157 ↗ |