Drugs / Nafarelin

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) SYNAREL 1998-12-24 fda.gov
Approved US (FDA) SYNAREL 1990-02-13 fda.gov

Trials 4 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT00034047 Sep 2002 → Aug 2006 endometriosis, pelvis syndrome National Center for Complementary and Integrative Health (NCCIH) Completed No outcome recorded
Phase 21 trial
Phase 2 NCT04850261 May 2021 → Mar 2024 infertility disorder Insel Gruppe AG, University Hospital Bern Withdrawn No outcome recorded
Phase 31 trial
Phase 3 NCT06150703 Jun 2024 → Sep 2027 expected Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase not applicable1 trial
NCT02865681 Jul 2016 → Jun 2017 infertility disorder New Hope Fertility Center Completed No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06870266 Comparator Mar 2025 → Mar 2027 expected Shaare Zedek Medical Center Not yet recruiting No outcome recorded
Phase 44 trials
Phase 4 NCT06763926 Comparator Jun 2026 → Jan 2028 expected Fundacion Dexeus Not yet recruiting No outcome recorded
Phase 4 NCT04797338 Comparator Dec 2017 → Sep 2021 ovarian hyperstimulation syndrome, pregnancy disorder with abortive outcome Assaf-Harofeh Medical Center Unknown No outcome recorded
Phase 4 NCT00843570 Comparator Nov 2009 → May 2013 infertility disorder University of Oxford Completed No outcome recorded
Phase 4 NCT00756028 Comparator Jan 2009 → Dec 2014 infertility disorder, ovarian hyperstimulation syndrome Peter Hornnes, MD, DMSc Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Nafarelin “When at least two follicles reached 18 mm or greater, Synarel (Nafarelin) will be used instead of the injectable HCG trigger.” NCT02865681
6

“Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)” NCT00756028

NCT00034047

NCT04850261

NCT06870266

NCT06763926

NCT06150703

Known as Nafarelin acetate ClinicalTrials.gov intervention name — accepted as the source's own label NCT00843570
Known as Synarel ClinicalTrials.gov intervention name — accepted as the source's own label NCT02865681
1

NCT04797338

Known as Synarela “Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)” NCT00756028
Action Activate “gonadotropin releasing hormone agonist (GnRHa)” NCT00034047
Modality Other / unclassified “GnRH agonist treatment” NCT06870266
Route Intranasal “via intranasal spray” NCT00034047