Drugs / TBP-PI-HBr
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pyeloureteritis cystica | — | “On January 3, 2022, Spero announced that FDA has accepted its NDA for tebipenem HBr tablets” sperotx.com ↗ “In October 2021, Spero filed an NDA for tebipenem HBr tablets” sperotx.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06727136 | Nov 2024 → Apr 2025 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05856747 | May → Jun 2023 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06059846 | Dec 2023 → Jan 2025 | acute pyelonephritis | Spero Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| 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 ↗ |
| 2022-03-31 | 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. |
| 2019-03-29 | Sperotx | Regulatory Spero Therapeutics Receives FDA Fast Track Designation for SPR994 for the treatment of Complicated Urinary Tract infections and Acute Pyelonephritis sperotx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for SPR994, Spero's lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis. |
| 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 ↗ |
| 2018-07-09 | Sperotx | Results Spero Announces Positive Interim Phase 1 SAD/MAD Results for SPR994 sperotx.com ↗
Clinical data demonstrate SPR994 to be well tolerated at single and multiple ascending doses |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TBP-PI-HBr | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06727136 ↗ |
| Route | Oral | “single oral dose of TBP-PI-HBr 600 mg tablets” NCT05856747 ↗ |