Norgestimate
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) | ORTHO CYCLEN-28 | — | 1989-12-29 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04423068 | Dec 2020 → Apr 2022 | pregnancy disorder | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 114 trials · 1 met primary | ||||||
| Phase 1 | NCT07792408 | Sep 2026 → Mar 2027 expected | autosomal dominant polycystic kidney disease | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 1 | NCT07523711 | Apr → Nov 2026 expected | obesity disorder | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07074327 | Jul 2025 → Feb 2026 | autosomal dominant polycystic kidney disease | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT06820307 | Feb → Apr 2025 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT04172987 | Feb 2020 → Feb 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03783897 | Nov 2018 → Jun 2019 | metabolic dysfunction-associated steatohepatitis | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT02792517 | Feb → Sep 2016 | migraine disorder | Amgen | Completed | Met primary |
| Phase 1 | NCT02494609 | Jul → Nov 2015 | — | Lexicon Pharmaceuticals | Unknown | No outcome recorded |
| Phase 1 | NCT02144246 | May 2014 → Jul 2015 | — | University of Pennsylvania | Terminated | No outcome recorded |
| Phase 1 | NCT02080468 | Feb → Apr 2014 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01373931 | Jun → Dec 2011 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00709982 | May → Jul 2005 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00709332 | Jan → Feb 2005 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00254865 | Aug 2002 → Mar 2003 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT00344383 | Nov 2003 → Jul 2004 | hemometra | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00320567 | ? → Apr 2004 | osteoporosis | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02922348 | Mar 2016 → Dec 2018 | primary ovarian failure | University of Pennsylvania | Withdrawn | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06067256 | Jul → Dec 2023 | — | Italfarmaco | Unknown | No outcome recorded |
| Phase 4 | NCT04828824 | Jun 2021 → Nov 2025 | — | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT01466673 | Dec 2008 → Mar 2010 | acne | Janssen-Cilag Ltd.,Thailand | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT00357604 Comparator | Jul → Nov 2006 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00439972 Comparator | Feb 2007 → Dec 2011 | — | University of Washington | Unknown | No outcome recorded |
| Phase 2/3 | NCT03357640 Comparator | May 2017 → May 2018 | ovarian cyst | Benha University | Unknown | No outcome recorded |
| Phase 3 | NCT00754065 Comparator | Sep 2008 → May 2011 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00301587 Background | ? → Dec 2004 | neural tube defect | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01475513 Comparator | Nov 2011 → May 2014 | menstrual disorder | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 4 | NCT00205504 Comparator | Jun 2005 → Jun 2009 | cardiovascular disorder, metabolic syndrome X, obesity disorder | Virginia Commonwealth University | Completed | No outcome recorded |
| — | NCT00554632 Comparator | Apr 2003 → Aug 2005 | venous thromboembolism | University of Vermont | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | norgestimate | “The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE,...” NCT07074327 ↗28“Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle.” NCT01475513 ↗ “active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD)” NCT04172987 ↗ “monophasic combined oral contraceptive containing ethinyl estradiol 0.035 mg and norgestimate 0.25 mg, 1 tablet daily” NCT02922348 ↗ “CILEST® is an oral contraceptive tablet containing 250 µg of norgestimate (NGM) and 35 µg of ethinyl estradiol (EE).” NCT00254865 ↗ “one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram)” NCT03357640 ↗ “The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet.” NCT00439972 ↗ “INTERVENTION(S): Ethinyl estradiol (35 μg) and norgestimate (0.18/0.215/0.25 mg) for 6 cycles.” PMID 21676394 ↗ Jun 2011 “35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally” NCT01373931 ↗ “Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen.” NCT00754065 ↗ “BACKGROUND: Norgestimate (NGM) is a progestin with negligible androgenic” PMID 40164172 ↗ Mar 2025 |
| Known as | Dexnorgestrel acetime | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | NGM | “The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE,...” NCT07074327 ↗8“The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate\[NGM\]/35 mcg...” NCT00709982 ↗ “active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD)” NCT04172987 ↗ “CILEST® is an oral contraceptive tablet containing 250 µg of norgestimate (NGM) and 35 µg of ethinyl estradiol (EE).” NCT00254865 ↗ “triphasic OC containing norgestimate (NGM) 180-250 microg and ethinyl estradiol (EE) 35 microg or placebo” PMID 17116511 ↗ Dec 2006 “Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen.” NCT00754065 ↗ “BACKGROUND: Norgestimate (NGM) is a progestin with negligible androgenic” PMID 40164172 ↗ Mar 2025 “Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE)” NCT06820307 ↗ “Ethinyl estradiol/Norgestimate (EE/NGM)” NCT01466673 ↗ |
| Known as | Norgestimate component of ortho tri-cyclen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimate component of prefest | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimate component of previfem | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimate component of sprintec | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimate component of tri lo sprintec | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimate component of tri-previfem | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimate component of tri-sprintec | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | Norgestimato | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | NSC-759159 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | ORF 10131 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Known as | RWJ 10131 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200934 ↗ |
| Action | Activate | “Progesterone receptor agonist” CHEMBL1200934 ↗ |
| Modality | Small molecule | — CHEMBL1200934 ↗ |
| Route | Oral | “combined hormonal oral contraceptive (OC)” PMID 21676394 ↗ Jun 2011 |
| Target | PGR | “Progesterone receptor agonist” CHEMBL1200934 ↗ |