Segesterone Acetate
Small molecule targets PGR via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ANNOVERA | — | 2018-08-10 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT02994602 | Jan → Jun 2017 | — | Kimberly Myer | Completed | No outcome recorded |
| Phase 1 | NCT02432261 | Apr 2015 → Mar 2016 | — | Kimberly Myer | Completed | Met primary |
| Phase 1 | NCT02236026 | Sep 2014 → Dec 2015 | — | Population Council | Completed | No outcome recorded |
| Phase 1 | NCT02215395 | Mar 2014 → Apr 2015 | — | Population Council | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03452111 | Oct 2018 → Sep 2024 | — | Premier Research | Completed | No outcome recorded |
| Phase 2 | NCT01586000 | Mar 2012 → May 2015 | anovulation | Kimberly Myer | Completed | No outcome recorded |
| Phase 2 | NCT00213096 | Mar 2003 → Feb 2004 | — | Population Council | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT00455156 | Dec 2006 → Jan 2009 | — | Premier Research | Completed | No outcome recorded |
| Phase 3 | NCT00263341 | Dec 2005 → Aug 2014 | — | Population Council | Completed | Met primary |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT04272008 Comparator | Mar 2020 → Jun 2021 | — | TherapeuticsMD | Completed | No outcome recorded |
| Phase 1 | NCT04290390 Comparator | Feb 2020 → Jan 2021 | — | TherapeuticsMD | Completed | No outcome recorded |
| Phase 1 | NCT00891228 Comparator | May 2009 → May 2010 | — | Premier Research | Completed | No outcome recorded |
| Phase 1 | NCT00229593 Comparator | Sep 2005 → Jan 2007 | — | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00796133 Comparator | Nov 2008 → Jan 2014 | anovulation | Population Council | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-11-29 | Duchesnay Inc. | Regulatory Duchesnay Inc. is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women. duchesnay.com ↗ |
| 2018-08-10 | TherapeuticsMD | Regulatory TherapeuticsMD Announces FDA Approval of ANNOVERA™ (Segesterone Acetate/Ethinyl Estradiol Vaginal System) for Birth Control therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system), the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible. |
All press releases naming this drug 3 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | segesterone acetate | “Nestorone® (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring” PMID 29097225 ↗ Oct 20173“Nestorone® (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring” PMID 29269252 ↗ Dec 2017 |
| Known as | Elcometrine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707377 ↗ |
| Known as | NES | “The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an bolus injection on the corrected QT interval using Fridericia's formula (QTcF).” NCT02236026 ↗6“This study aims to determine the lowest effective of three Nestorone (NES)/estradiol (E2) transdermal gel doses to ensure ovulation suppression in 90-95% of cycles.” PMID 26032952 ↗ May 2015 “A contraceptive vaginal ring (CVR) containing Nestorone® (NES) and ethinyl estradiol (EE) that is reusable for 1- year (13 cycles) is under development.” PMID 26267119 ↗ Aug 2015 “Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)” NCT02215395 ↗ “Nestorone® (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring” PMID 29269252 ↗ Dec 2017 “A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally.” NCT02994602 ↗ “Nestorone® (NES) and Testosterone (T) Combination Gel” NCT03452111 ↗ |
| Known as | Nestorone | “A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in...” NCT01586000 ↗11“This study aims to determine the lowest effective of three Nestorone (NES)/estradiol (E2) transdermal gel doses to ensure ovulation suppression in 90-95% of cycles.” PMID 26032952 ↗ May 2015 “Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)” NCT02215395 ↗ “Nestorone is a potent, nonandrogenic, 19-norprogesterone derivative” NCT00263341 ↗ |
| Known as | Nestorone Gel | “Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®.” NCT00891228 ↗ |
| Known as | Segesterone acetate component of annovera | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707377 ↗ |
| Known as | ST-1435 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707377 ↗ |
| Action | Activate | “Progesterone receptor agonist” CHEMBL3707377 ↗ |
| Modality | Small molecule | “9 to 14% of the steroid (T or NES) in the gel applied” NCT03452111 ↗ |
| Route | Topical | “The steady-state delivery of a progestin and an androgen by transdermal gel application would be a user-friendly delivery method as compared to injectable or implant approaches.” NCT00229593 ↗ |
| Target | PGR | “Progesterone receptor agonist” CHEMBL3707377 ↗ |