Drugs / Estetrol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Lydisilka | — | 2021-05-19 | europa.eu ↗ |
| Approved | US (FDA) | NEXTSTELLIS | — | 2021-04-15 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT05677035 | Jan → Jun 2022 | — | Hyundai Pharm | Completed | No outcome recorded |
| Phase 1 | NCT04819906 | Mar → Jul 2021 | — | Estetra | Completed | No outcome recorded |
| Phase 1 | NCT03798197 | Jan → Apr 2019 | — | Donesta Bioscience | Completed | No outcome recorded |
| Phase 1 | NCT03512860 | Apr → Oct 2018 | — | Estetra | Completed | No outcome recorded |
| Phase 1 | NCT03075956 | Jan → Aug 2017 | — | Estetra | Completed | No outcome recorded |
| Phase 1 | NCT02720224 | Feb → Mar 2016 | — | Estetra | Completed | No outcome recorded |
| Phase 1 | NCT02852681 | Aug → Oct 2015 | — | Estetra | Completed | No outcome recorded |
| Phase 1 | NCT00163033 | Jun 2005 → Aug 2007 | — | Pantarhei Bioscience | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02718144 | Jun 2017 → Dec 2019 | breast cancer | Pantarhei Oncology B.V. | Completed | No outcome recorded |
| Phase 1/2 | NCT02957630 | Sep 2016 → Oct 2017 | — | Estetra | Completed | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT06308614 | Jan 2024 → Mar 2025 | physiological sexual disorder | Estetra | Completed | Missed primary |
| Phase 2 | NCT04801836 | Nov 2020 → Mar 2022 | COVID-19 | NEURALIS s.a. | Unknown | No outcome recorded |
| Phase 2 | NCT02834312 | May 2016 → Jan 2018 | flushing of ears and somnolence | Donesta Bioscience | Completed | No outcome recorded |
| Phase 2 | NCT01221831 | Sep 2010 → Sep 2011 | — | Estetra | Completed | No outcome recorded |
| Phase 2 | NCT00464516 | Apr 2007 → Feb 2009 | female breast carcinoma | Pantarhei Bioscience | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT07536763 | Jul 2026 → Jun 2029 expected | — | Dr. Hang Wun Raymond Li | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04792385 | Dec 2020 → Nov 2023 | — | Estetra | Completed | No outcome recorded |
| Phase 3 | NCT04209543 | Dec 2019 → Feb 2024 | — | Estetra | Completed | Met primary |
| Phase 3 | NCT04090957 | Sep 2019 → Aug 2022 | — | Estetra | Completed | Mixed |
| Phase 3 | NCT02817841 | Aug 2016 → Oct 2018 | — | Estetra | Completed | No outcome recorded |
| Phase 3 | NCT02817828 | Jun 2016 → Apr 2018 | — | Estetra | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05837624 | Dec 2024 → Nov 2026 expected | ovarian endometriosis | Andrew Zakhari | Recruiting | No outcome recorded |
| Phase 4 | NCT06324851 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06396221 | May → Sep 2024 | anovulation | Chulalongkorn University | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT02874248 Comparator | May → Nov 2016 | — | Estetra | Completed | No outcome recorded |
| Phase 1 | NCT02718378 Comparator | Mar 2016 → Feb 2017 | prostate neoplasm | Pantarhei Oncology B.V. | Completed | No outcome recorded |
| Phase 2 | NCT03361969 Comparator | Apr 2018 → May 2020 | prostate cancer | Pantarhei Oncology B.V. | Completed | No outcome recorded |
| Phase 2 | NCT00563472 Comparator | Nov 2007 → Aug 2008 | — | Pantarhei Bioscience | Completed | No outcome recorded |
| Phase 4 | NCT06316180 Comparator | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-05-27 | Mayne Pharma International Pty Ltd | Regulatory Nextstellis ® Receives FDA Marketing Exclusivity and Phase III Data Published maynepharma.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-05-27 | Mayne Pharma International Pty Ltd | Nextstellis ® Receives FDA Marketing Exclusivity and Phase III Data Published maynepharma.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Estetrol | “15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day...” NCT02817828 ↗28“15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day...” NCT02817841 ↗ “To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants...” NCT04792385 ↗ “Estetrol (E4) is being developed in two indications supporting women health care” NCT03075956 ↗ “Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study” NCT03512860 ↗ “15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP)” NCT02957630 ↗ “LINO-1713 (Estetrol 15mg/Drospirenone 3mg)” NCT05677035 ↗ “15 mg estetrol and 3 mg drospirenone” NCT02874248 ↗ “15 mg Estetrol/3 mg Drospirenone” NCT02852681 ↗ |
| Known as | Estetrol monohydrate | “To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants...” NCT04792385 ↗1“One Estetrol monohydrate (E4) 15 mg tablet once per day” NCT04801836 ↗ |
| Modality | Other / unclassified | “recent new research has demonstrated that E4 is a potent, orally bioavailable, natural human fetal selective estrogen receptor modulator” PMID 18464023 ↗ 2008 |
| Route | Oral | “oral administration of estetrol” NCT00163033 ↗ |