Drugs / TBPM-PI-HBr
TBPM-PI-HBr
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | UTEBZI | — | 2026-06-17 | fda.gov ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04710407 | Dec 2020 → Mar 2021 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04625855 | Sep → Oct 2020 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04368585 | Jul → Aug 2020 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04376554 | Feb 2020 → Apr 2021 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04238195 | Jan → Feb 2020 | short QT syndrome 7 | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04178577 | Dec 2019 → Sep 2020 | impaired renal function disease | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03395249 | Oct 2017 → Aug 2018 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05121974 | Aug 2022 → Mar 2025 overdue | shigellosis | International Centre for Diarrhoeal Disease Research, Bangladesh | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03788967 | Jun 2019 → May 2020 | acute pyelonephritis | Spero Therapeutics | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TBPM-PI-HBr | “This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide [TBPM-PI-HBr]/placebo only), placebo- and active-control, single-dose, 4-way crossover study.” NCT04238195 ↗ |
| Known as | [14C]-Tebipenem Pivoxil Hydrobromide | “A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects” NCT04625855 ↗ |
| Known as | Orapenem | “There is a single, optional, open-label control cohort that may enroll, in which all 8 subjects will receive Orapenem® (tebipenem pivoxil fine granules).” NCT03395249 ↗ |
| Known as | Tebipenem (Orapenem) | “Tebipenem (Orapenem)” NCT05121974 ↗ |
| Known as | tebipenem pivoxil | “Orapenem® (tebipenem pivoxil fine granules)” NCT03395249 ↗ |
| Known as | Tebipenem Pivoxil Hydrobromide | “BACKGROUND: Antimicrobials cause perturbations in the composition and diversity of the host microbiome. We aimed to compare gut microbiome perturbations caused by oral...” PMID 38432233 ↗ Feb 20245“Tebipenem pivoxil hydrobromide is an orally bioavailable carbapenem with activity against uropathogenic Enterobacterales, including extended-spectrum beta-lactamase-producing...” PMID 35388666 ↗ Apr 2022 “A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects” NCT04625855 ↗ “Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral carbapenem prodrug being developed for the treatment of serious bacterial infections.” PMID 35762796 ↗ Jun 2022 |
| Known as | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04178577 ↗ |
| Modality | Small molecule | “a carbapenem with activity versus multidrug-resistant (MDR) Gram-negative pathogens” PMID 31262768 ↗ Aug 2019 |
| Route | Oral | “TBPM-PI-HBr tablets administered orally.” NCT03788967 ↗ |