Drugs / Tebipenem
Tebipenem
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pyeloureteritis cystica | 2025-12-19 | “GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr” sperotx.com ↗ “In December 2025, GSK resubmitted the tebipenem HBr NDA to the FDA.” sperotx.com ↗ |
| Filed | US (FDA) | — | pyeloureteritis cystica | 2022-01-03 | “The NDA, which is currently under FDA regulatory review, seeks approval for tebipenem pivoxil oral tablets (tebipenem HBr) for the treatment of cUTI, including pyelonephritis” sperotx.com ↗ “On January 3, 2022, Spero announced that the FDA has accepted its NDA for tebipenem HBr tablets.” sperotx.com ↗ |
| Filed | US (FDA) | — | pyeloureteritis cystica | 2021-10-28 | “regarding a previously filed New Drug Application (NDA), seeking approval for treatment in adult patients with certain bacterial microorganisms that cause complicated urinary...” sperotx.com ↗ “today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeking approval for tebipenem HBr tablets” sperotx.com ↗ |
| Rejected (CRL) | US (FDA) | — | pyeloureteritis cystica | — | “As previously reported, Spero received a Complete Response Letter (CRL) from the FDA in June 2022” sperotx.com ↗ “In late June 2022, the FDA issued a Complete Response Letter for the NDA” sperotx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05296382 | Apr → Jun 2022 | — | Hartford Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04919954 | Jul 2021 → Aug 2022 | bacterial infectious disease, diabetes mellitus, skin infection | Hartford Hospital | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| 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. |
| 2025-12-19 | Sperotx | Regulatory Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis sperotx.com ↗
today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. |
| 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). |
| 2025-05-28 | 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. |
| 2023-11-13 | Sperotx | Regulatory Spero Therapeutics Announces Third Quarter 2023 Operating Results and Provides a Business Update sperotx.com ↗
Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO trial of tebipenem HBr; Trial expected to begin with First Patient, First Visit in 4Q 2023 |
| 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 ↗ |
| 2022-09-06 | Sperotx | Regulatory Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting with the U.S. Food and Drug Administration sperotx.com ↗
During the Type A meeting, the FDA indicated that positive results from a single additional Phase 3 clinical trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support the approval of tebipenem HBr for the treatment of cUTI, including pyelonephritis for a limited use indication. |
| 2022-06-27 | Sperotx | Regulatory Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application sperotx.com ↗
In the CRL, the FDA communicated that it had completed its review of the NDA and determined that the NDA could not be approved in its present form. |
| 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. |
| 2018-07-09 | Sperotx | Results Spero Announces Positive Interim Phase 1 SAD/MAD Results for SPR994 sperotx.com ↗
The data also show that the mean free drug plasma concentrations of tebipenem, the active metabolite of SPR994, remained above the MIC90 for the relevant bacterial pathogens for >50% of an 8-hour dosing interval (three-times daily administration), consistent with the targeted therapeutic range observed in Spero's hollow fiber experiments. |
All press releases naming this drug 33 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tebipenem | “and 4) tebipenem (if approved by the EMA).” NCT07236944 ↗ |
| Known as | SPR994 | “This study will determine the tissue penetration of a broad-spectrum orally bioavailable carbapenem, tebipenem pivoxil hydrobromide (SPR994) (Spero Therapeutics, Inc.), into...” NCT04919954 ↗1“The purpose of this study is to measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube...” NCT05296382 ↗ |
| Known as | tebipenem pivoxil hydrobromide | “This study will determine the tissue penetration of a broad-spectrum orally bioavailable carbapenem, tebipenem pivoxil hydrobromide (SPR994) (Spero Therapeutics, Inc.), into...” NCT04919954 ↗ |
| Modality | Small molecule | “a broad-spectrum orally bioavailable carbapenem” NCT04919954 ↗ |
| Route | Oral | “administered orally” NCT04919954 ↗ |