Drugs / Pivmecillinam
Pivmecillinam
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PIVYA | — | 2024-04-24 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 4 | NCT03282006 | Sep 2017 → Apr 2020 | pyelonephritis | Sykehuset i Vestfold HF | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| 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 41 trial | ||||||
| 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.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pivmecillinam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04959331 ↗ |
| 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 ↗ |