Drugs / TBPM-PI-HBr
TBPM-PI-HBr
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | UTEBZI | — | 2026-06-17 | fda.gov ↗ |
| Filed | US (FDA) | — | complicated urinary tract infection, acute pyelonephritis | — | “In October 2021, Spero filed a new drug application for tebipenem HBr” sperotx.com ↗ “In October 2021, Spero filed an NDA for tebipenem HBr tablets” sperotx.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 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 | NCT03395249 | Oct 2017 → Aug 2018 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05121974 | Aug 2022 → Mar 2025 | shigellosis | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03788967 | Jun 2019 → May 2020 | acute pyelonephritis | Spero Therapeutics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | Sperotx | Regulatory Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs) sperotx.com ↗
This is the first and only oral carbapenem antibiotic approved for these patients. |
| 2026-06-17 | GlaxoSmithKline | Regulatory Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs) gsk.com ↗
This is the first and only oral carbapenem antibiotic approved for these patients. |
| 2025-10-21 | Sperotx | Results PIVOT-PO Phase 3 Data Show Tebipenem HBr's Potential as the First Oral Carbapenem Antibiotic for Patients with Complicated Urinary Tract Infections (cUTIs) sperotx.com ↗
Spero Therapeutics, Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK) today announced efficacy and safety results of the positive pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis (NCT06059846). |
| 2025-10-21 | GlaxoSmithKline | Results Positive PIVOT-PO phase III data show tebipenem HBr’s potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections (cUTIs) gsk.com ↗
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced full results of the positive pivotal phase III PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis (NCT06059846). |
| 2025-05-28 | Sperotx | Results Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee sperotx.com ↗
The trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. |
| 2025-05-28 | GlaxoSmithKline | Results PIVOT-PO phase III study for tebipenem HBr stopped early for efficacy following review by Independent Data Monitoring Committee gsk.com ↗
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics today announced that the pivotal phase III PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, will stop early for efficacy (NCT06059846). |
| 2023-07-31 | Sperotx | Regulatory Spero Therapeutics Announces Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr sperotx.com ↗ |
| 2022-04-06 | Sperotx | Results Spero Therapeutics Tebipenem Pivoxil Hydrobromide Phase 3 Data Published in The New England Journal of Medicine sperotx.com ↗
Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced publication in The New England Journal of Medicine (NEJM) of the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem pivoxil hydrobromide (tebipenem HBr). |
| 2022-03-31 | Sperotx | Regulatory Spero Therapeutics Announces Fourth Quarter and Full Year 2021 Operating Results and Provides Business Update sperotx.com ↗
The FDA stated that the notification does not reflect a final decision on the information under review. |
| 2022-01-03 | Sperotx | Regulatory Spero Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis sperotx.com ↗
The FDA acceptance of this NDA is a major step forward in our mission to provide patients the first and only oral carbapenem antibiotic to treat cUTI. |
| 2021-10-28 | Sperotx | Regulatory Spero Therapeutics Submits New Drug Application to U.S. FDA for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis sperotx.com ↗ |
| 2020-09-08 | Sperotx | Results Spero Therapeutics Announces Positive Topline Results from its Phase 3 ADAPT-PO Clinical Trial of Oral Tebipenem HBr in Complicated Urinary Tract Infection and Acute Pyelonephritis sperotx.com ↗
Topline data from the trial demonstrate that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP. |
| 2019-10-03 | Sperotx | Results Spero Therapeutics Announces Positive Recommendation to Continue Phase 3 Clinical Trial of SPR994 as Planned Following Independent Review Committee Analysis of SPR994 Treated Patients in Lead-in Cohort of Trial sperotx.com ↗
The Phase 3 trial will continue as planned and Spero expects to report top-line data in the third quarter of 2020. |
| 2019-02-04 | Sperotx | Regulatory Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994 sperotx.com ↗
today announced the acceptance by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for SPR994, Spero's lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI). |
| 2019-01-07 | Sperotx | Regulatory Spero Therapeutics Announces Positive Feedback from FDA Pre-Phase 3 Meeting for Oral SPR994 and Submission of IND for SPR994 in cUTI sperotx.com ↗
Based on its discussions with the FDA, Spero believes that positive results from a single pivotal Phase 3 clinical trial of SPR994 in cUTI demonstrating a 10% non-inferiority margin would support the approval of SPR994 for the treatment of cUTI. |
| 2018-09-27 | Sperotx | Results Spero Announces Positive SPR994 Phase 1 SAD/MAD Final Results sperotx.com ↗
today reported positive results from a final analysis of its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR994, its investigational oral carbapenem product candidate designed for the treatment of Gram-negative infections. |
| 2018-07-09 | Sperotx | Results Spero Announces Positive Interim Phase 1 SAD/MAD Results for SPR994 sperotx.com ↗
Interim Phase 1 results from the SAD portion of the trial demonstrate SPR994 to be well tolerated at doses ranging from 100 mg to 900 mg daily, with linear human pharmacokinetics over the dose range tested. |
| 2018-06-05 | Sperotx | Results Spero Therapeutics to Present New Preclinical Data for SPR994 at ASM Microbe 2018 sperotx.com ↗
The presentations will also include in vitro data supporting SPR994's equivalent potency to IV carbapenems, the gold standard for the treatment of ESBL infections, against the most common Gram-negative bacteria encountered in complicated urinary tract infections (cUTI). |
All press releases naming this drug 19 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 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 |
| 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 ↗ |