Drugs / Pivmecillinam

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) PIVYA — 2024-04-24 fda.gov ↗

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT02083276 Mar 2014 → Apr 2015 chlamydia trachomatis infectious disease Oslo University Hospital Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT05224401 May 2023 → Sep 2027 expected bacterial urinary tract infection Lund University Recruiting No outcome recorded
Phase 3 NCT05545137 Sep 2022 → Feb 2024 urinary tract infection Benova (Tianjin) Innovative medicine Research Co., Ltd. Completed No outcome recorded
Phase 44 trials · 1 missed
Phase 4 NCT07236944 Dec 2025 → Mar 2029 expected bacterial urinary tract infection Uppsala University Recruiting No outcome recorded
Phase 4 NCT06709196 Jan 2025 → Jan 2027 expected urinary bladder cancer Rigshospitalet, Denmark Recruiting No outcome recorded
Phase 4 NCT03228108 Apr 2018 → Sep 2021 infectious disease, prostate cancer Radboud University Medical Center Completed Missed primary
Phase 4 NCT03282006 Sep 2017 → Apr 2020 pyelonephritis Sykehuset i Vestfold HF Completed No outcome recorded
Comparator or background therapy2 trials
Phase 2 NCT07407673 Comparator Jan 2027 → Jul 2029 expected bacterial infectious disease, disease related to solid organ transplantation Susanne Dam Nielsen, MD, DMSc Not yet recruiting No outcome recorded
Phase 4 NCT04959331 Comparator Nov 2021 → Dec 2024 urinary tract infection Jordi Gol Institute for Primary Care Research Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as Pivmecillinam ClinicalTrials.gov intervention name — accepted as the source's own label NCT03228108 ↗
8

NCT07236944 ↗

NCT07407673 ↗

NCT03282006 ↗

NCT05545137 ↗

NCT06709196 ↗

NCT05224401 ↗

NCT04959331 ↗

NCT02083276 ↗

Known as PIV “This study clarifies the efficacy and safety of pivmecillinam (PIV) used as step-down therapy for bacteremic urinary tract infection (UTI).” PMID 35590284 ↗ May 2022
Known as Pivmecilinam ChEMBL registry synonym — accepted as the source's own label CHEMBL1650818 ↗
Known as pivmecillinam hydrochloride “Treatment consisted of 400 mg of pivmecillinam hydrochloride three times a day for 7 days.” PMID 27165786 ↗ May 2016
Known as Pivya ChEMBL registry synonym — accepted as the source's own label CHEMBL1650818 ↗
Modality Small molecule “oral narrow-spectrum penicillin (pivmecillinam)” NCT07236944 ↗
Route Oral “PO 400 mg x3 for 7 days” NCT02083276 ↗