Drugs / Secnidazole

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) SOLOSEC 2021-06-30 – 2022-01-26 fda.gov
Approved US (FDA) SOLOSEC 2017-09-15 fda.gov

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT01019083 Feb 2008 → Dec 2010 cholera, typhoid fever International Centre for Diarrhoeal Disease Research, Bangladesh Completed No outcome recorded
Phase 21 trial
Phase 2 NCT02147899 May → Oct 2014 bacterial vaginosis Symbiomix Therapeutics Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05033743 Jul 2021 → Oct 2022 bacterial vaginosis Indiana University Completed No outcome recorded
Phase 35 trials
Phase 3 NCT03935217 Apr 2019 → Mar 2020 trichomoniasis Lupin Research Inc Completed No outcome recorded
Phase 3 NCT02452866 Jun → Oct 2015 bacterial vaginosis Symbiomix Therapeutics Completed No outcome recorded
Phase 3 NCT02418845 May → Oct 2015 bacterial vaginosis Symbiomix Therapeutics Completed No outcome recorded
Phase 3 NCT02111629 May 2012 → Feb 2013 vaginal discharge National University of Colombia Completed No outcome recorded
Phase 3 NCT01733966 May 2010 → Mar 2012 diverticulitis of colon Quanta Medical Terminated No outcome recorded
Phase 42 trials
Phase 4 NCT06261840 May 2025 → May 2029 expected Trichomonas vaginitis urogenital infection, bacterial vaginosis Tulane University Recruiting No outcome recorded
Phase 4 NCT03937869 Nov 2018 → Nov 2020 bacterial vaginosis Lupin Research Inc Completed No outcome recorded
Phase not applicable1 trial
NCT00607074 Jun 2003 → Apr 2004 giardiasis University of Cambridge Completed No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Secnidazole “Multi-center, Prospective, Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of...” NCT02452866
8

NCT05033743

NCT01733966

NCT00607074

NCT06261840

NCT03935217

NCT02111629

NCT03937869

NCT01019083

Known as Deprozol ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Flagentyl ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as NSC-759812 ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Ornidazole metabolite m4 ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as PM-185184 ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as RP 14539 ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Sabima ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Secnidal ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Secnidazol ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Secnidazole anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Secnol ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as Solosec ChEMBL registry synonym — accepted as the source's own label CHEMBL498847
Known as SYM-1219 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02147899
1

NCT02418845

Modality Small molecule “a next generation 5-nitroimidazole” PMID 42031495 Apr 2026
Route Oral “a single oral dose of a combined treatment with secnidazole + fluconazole” NCT02111629