Utebzi Tebipenem Pivoxil – oral carbapenem for complicated UTI in adults

Overview

Utebzi tebipenem pivoxil is an oral penem antibacterial, pharmacologically classified as a carbapenem, developed by GSK in collaboration with Spero Therapeutics for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults.[fda]
It is the first FDA‑approved oral carbapenem therapy in the United States, providing an oral option in a space historically dominated by parenteral carbapenems.[fda]

On June 17, 2026, the FDA approved Utebzi for the treatment of cUTI, including pyelonephritis, caused by susceptible Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis in adult patients who have limited or no alternative oral treatment options.[fda]
The approval was based on the phase 3 PIVOT‑PO trial, a global, randomized, double‑blind, double‑dummy non‑inferiority study comparing oral tebipenem pivoxil hydrobromide to intravenous imipenem‑cilastatin, and Utebzi received priority review, Fast Track, and Qualified Infectious Disease Product (QIDP) designations.[reference.medscape]

Clinically, Utebzi addresses an unmet need for effective oral therapy in adults with cUTI due to multidrug‑resistant Gram‑negative pathogens, particularly those for whom standard oral options (e.g., fluoroquinolones, oral cephalosporins) are limited or unsuitable due to resistance or intolerance.[pmc.ncbi.nlm.nih]
Its positioning is as a limited‑use agent, with label language explicitly restricting use to patients with limited or no alternative oral treatment options to support antimicrobial stewardship.[fda]

Disease Background and Treatment Landscape

Complicated urinary tract infection is typically defined as UTI occurring in the presence of structural or functional abnormalities of the genitourinary tract, systemic illness (e.g., sepsis), or relevant comorbidities such as diabetes, chronic kidney disease, or indwelling urinary catheters.[linkedin]
In the United States, UTIs are among the most common outpatient infections, with 50–60% of adult women experiencing at least one UTI in their lifetime and an estimated 250,000 cases of pyelonephritis annually.[x]

cUTIs impose a substantial economic and healthcare burden: emergency department data from 2016–2018 estimate over 2.3 million ED visits for cUTI, with approximately two‑thirds resulting in hospitalization and aggregate ED costs rising from 2.8 to 3.2 billion USD over that period.[gsk]
Older adults (≥65 years) comprise the majority of cUTI visits, and catheter‑associated infections account for a large fraction of complicated cases, with associated morbidity, mortality, and risk of secondary bloodstream infections.[sperotherapeutics]

The microbiologic landscape of cUTI is dominated by Enterobacterales, particularly uropathogenic E. coli, K. pneumoniae, and Enterococcus spp., with high rates of resistance to fluoroquinolones, trimethoprim‑sulfamethoxazole, and some β‑lactams.[pmc.ncbi.nlm.nih]
Recent systematic reviews highlight considerable incidence, resistance, and mortality burden in cUTI, while also emphasizing knowledge gaps in epidemiology and outcomes across regions.[pubmed.ncbi.nlm.nih]

Current standard of care for cUTI and acute pyelonephritis typically involves initial intravenous broad‑spectrum agents (e.g., carbapenems, extended‑spectrum cephalosporins, piperacillin‑tazobactam) followed by step‑down to oral therapy when feasible.[idsociety]
New IDSA‑aligned guidance favors shorter total antibiotic durations (generally 7 days for effective non‑fluoroquinolone regimens in improving patients) and supports earlier transition from IV to oral therapy when an appropriate oral agent is available.[emjreviews]

Within this framework, Utebzi is conceptually positioned as an oral, limited‑use carbapenem option for adults with cUTI, including pyelonephritis, where conventional oral agents are inadequate due to resistance or intolerance and an IV‑only course would otherwise be necessary.[reference.medscape]
Its label‑restricted use aligns with stewardship principles and emerging guideline emphasis on targeted therapy and appropriate duration.[guidelinecentral]

Mechanism of Action

Tebipenem pivoxil is an oral prodrug that is rapidly hydrolyzed in the gastrointestinal tract and enterocytes to the active carbapenem tebipenem.[pienomial]
Tebipenem exerts bactericidal activity by binding to essential penicillin‑binding proteins (PBPs) in Gram‑negative and Gram‑positive bacteria, with preferential affinity for PBP2 in E. coli and K. pneumoniae, leading to disruption of peptidoglycan cell wall synthesis, cell lysis, and bacterial death.[pienomial]

Mechanistically, after absorption and conversion of tebipenem pivoxil, tebipenem distributes to the urinary tract and achieves bactericidal concentrations against susceptible Enterobacterales; its pharmacodynamic driver of efficacy is the 24‑hour free AUC:MIC (fAUC24:MIC), consistent with time‑dependent β‑lactams.[fda]
In vitro, tebipenem demonstrates activity against ESBL‑producing Enterobacterales and certain multidrug‑resistant E. coli including ST131 clades, while remaining inactive against organisms producing serine carbapenemases (e.g., KPC, OXA‑48) or metallo‑β‑lactamases (e.g., NDM, VIM).[pmc.ncbi.nlm.nih]

On‑target effects (PBP inhibition and antibacterial activity) underpin clinical efficacy in cUTI, including pyelonephritis, and are linked to typical β‑lactam–related adverse events such as gastrointestinal disturbance and Clostridioides difficile infection due to broad impact on gut microbiota.[pmc.ncbi.nlm.nih]
Off‑target or class‑related CNS effects (seizures) and carnitine depletion are reflected in the Warnings and Precautions: seizures have been reported with carbapenems, including tebipenem, particularly in patients with CNS disorders and renal impairment, and the pivalate moiety contributes to reversible carnitine depletion and related metabolic toxicity.[pmc.ncbi.nlm.nih]

Lay analogy (≤25 words): Tebipenem acts like a “precision wrench” that jams the bacteria’s cell‑wall assembly machinery, causing the walls to collapse so the bacteria cannot survive.

Clinical Evidence

PIVOT‑PO Phase 3 Trial

The registration‑enabling PIVOT‑PO trial was a global, randomized, double‑blind, double‑dummy, active‑controlled phase 3 study comparing oral tebipenem pivoxil hydrobromide (TBP‑PI‑HBr) to IV imipenem‑cilastatin in hospitalized adults with cUTI or acute pyelonephritis (AP).[clinicaltrials]
Adults ≥18 years with documented cUTI or AP, appropriate microbiologic documentation of Enterobacterales uropathogens, and eGFR within protocol‑specified limits were randomized 1:1 to receive tebipenem 600 mg orally every 6 hours (with renal dose adjustments per label) or imipenem‑cilastatin 500 mg IV every 6 hours for 7–10 days.[linkedin]

The primary endpoint, as reflected in the FDA label, was composite response (clinical cure plus microbiological eradication) at the test‑of‑cure visit in the microbiological intention‑to‑treat (micro‑ITT) population, with a non‑inferiority margin of 10%.[sec]
At test‑of‑cure, composite response in the micro‑ITT population was 58.5% for Utebzi versus 60.2% for imipenem‑cilastatin, meeting non‑inferiority; clinical cure rates were 93.5% vs 95.2%, and microbiological response rates were 60.3% vs 61.3%, respectively.[reference.medscape]

In pathogen‑specific analyses, tebipenem demonstrated response rates comparable to imipenem‑cilastatin across key labeled pathogens, including ESBL‑producing E. coli and K. pneumoniae, and certain fluoroquinolone‑ and trimethoprim‑sulfamethoxazole‑resistant isolates.[gsk]
Subgroup analyses (e.g., ESBL‑positive vs ESBL‑negative, presence of urinary tract instrumentation) were generally consistent with overall findings; detailed subgroup data beyond what is summarized in the label are not fully reported in public pivotal‑trial publications and should be interpreted cautiously.[gsk]

Trial limitations include the focus on hospitalized adults with cUTI/AP, which may limit generalizability to purely outpatient cUTI populations, and the non‑evaluation of pediatric patients or patients with eGFR >150 mL/min, where use is not recommended.[instagram]
Long‑term outcomes such as recurrent cUTI rates, resistance evolution under tebipenem selection pressure, and comparative effectiveness vs other step‑down strategies (e.g., oral fluoroquinolones or β‑lactam/β‑lactamase inhibitor combinations) remain areas of uncertainty.[linkedin]

No other randomized phase 3 trials beyond PIVOT‑PO are described in the FDA label as registration‑enabling; where additional phase 2 or observational data exist, they primarily reinforce microbiologic activity and pharmacokinetic/pharmacodynamic rationale but are not central to the approved indication.[fda]
Any study evaluating tebipenem pivoxil in non‑cUTI indications (e.g., respiratory infections, off‑label uses in other regions) is not part of the FDA‑approved label and therefore should be considered “not FDA‑approved indication – not part of approved label.”[fda]

Safety Profile and Risk Management

The Utebzi US Prescribing Information does not include a boxed warning or a REMS program.[fda]
Nevertheless, several clinically significant risks are highlighted in Contraindications and Warnings and Precautions, notably hypersensitivity, seizures and CNS adverse reactions, carnitine depletion, C. difficile infection, and interference with newborn screening for isovaleric acidemia.[fda]

Common Adverse Reactions

In the phase 3 trial, the most common adverse reactions (≥1%) in Utebzi‑treated patients were diarrhea (8%), headache (3%), nausea (1%), abdominal pain (1%), increased hepatic enzymes (1%), and Clostridioides difficile infection (1%).[pmc.ncbi.nlm.nih]
Adverse reactions leading to discontinuation occurred in 0.6% (5/843) of Utebzi‑treated patients vs 0.8% (7/844) of imipenem‑cilastatin‑treated patients, suggesting similar tolerability in the registration study.[pmc.ncbi.nlm.nih]

Organ System–Based Safety Considerations

• Immunologic / Allergic: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with β‑lactam and carbapenem therapy, including tebipenem; Utebzi is contraindicated in patients with known hypersensitivity to β‑lactams, and treatment must be discontinued if an allergic reaction occurs.[fda]
• Neurologic / CNS: Seizures and other CNS adverse reactions have been reported with carbapenems, including Utebzi, occurring more frequently in patients with underlying CNS disorders (e.g., prior seizures, brain lesions) and/or renal impairment; close monitoring and continuation of anticonvulsant therapy in patients with seizure history are recommended.[fda]
• Gastrointestinal / Infectious: C. difficile infection has been reported, ranging from mild diarrhea to fatal colitis, consistent with broad‑spectrum antibacterial impact on gut microbiota; clinicians should evaluate patients with diarrhea following Utebzi and manage CDI per standard of care.[pmc.ncbi.nlm.nih]
• Metabolic / Carnitine: Tebipenem pivoxil is a pivalate‑generating prodrug; pivalate metabolism leads to pivaloylcarnitine excretion and reversible decreases in serum carnitine, with clinical manifestations including hypoglycemia, fatigue, muscle weakness, fainting, seizures, and confusion. Utebzi is contraindicated in patients with primary or secondary carnitine deficiency, and use beyond the recommended treatment duration (7–10 days) is not advised.[fda]
• Hepatic: Mild elevations in hepatic enzymes (e.g., ALT, AST) occurred in approximately 1% of Utebzi‑treated patients in Trial 1; clinically significant hepatotoxicity has not been highlighted, but routine monitoring is reasonable in patients with baseline hepatic risk factors.[pmc.ncbi.nlm.nih]

Use in Specific Populations

• Pregnancy: Human data are insufficient to define teratogenic risk; animal studies in mice, rats, and monkeys did not show adverse developmental effects at exposures up to approximately 3–4 times human exposure at the maximum recommended dose. Treatment prior to delivery may cause a false‑positive newborn screen for isovaleric acidemia, necessitating prompt follow‑up of positive results.[fda]
• Lactation: Tebipenem and/or metabolites are detected in rat milk; there are no data in human milk, and risk–benefit assessment should guide breastfeeding decisions.[fda]
• Pediatric: Safety and effectiveness in pediatric patients <18 years have not been established, and hypocarnitinemia with severe consequences (hypoglycemia, altered mental status, seizures, encephalopathy, sudden death) has been reported in pediatric patients receiving other tebipenem pivoxil formulations outside the US; Utebzi is contraindicated in patients with carnitine deficiency.[fda]
• Geriatric: Approximately 58% of Utebzi‑treated patients in Trial 1 were ≥65 years; no overall differences in safety or effectiveness were observed vs younger adults, but dose adjustment should be based on renal function.[fda]
• Renal Impairment: Tebipenem exposure increases with decreasing eGFR; dose adjustment is recommended in eGFR 15–59 mL/min, and use in hemodialysis patients is not well characterized, with insufficient dosing data. Patients with eGFR >150 mL/min are predicted to have reduced exposure and potential diminished efficacy; use in this group is not recommended.[fda]

Drug–Drug Interactions

• Valproic acid/divalproex sodium: Concomitant carbapenem use, including Utebzi, may reduce valproic acid plasma concentrations below the therapeutic range, increasing risk of breakthrough seizures; concomitant use should generally be avoided, or valproic acid levels monitored with supplemental anticonvulsant therapy considered if unavoidable.[fda]
• OAT1/OAT3 inhibitors (e.g., probenecid): Tebipenem is an OAT1/OAT3 substrate; co‑administration with inhibitors increases tebipenem exposure (≈2.9‑fold increase in AUC in a drug‑interaction study) and may heighten adverse reaction risk; concomitant use is generally not recommended, and enhanced monitoring is advised if used.[pienomial]
• Other pivalate‑generating drugs (e.g., certain antivirals and β‑lactams): Concomitant use with other pivalate‑generating agents (valproic acid, adefovir dipivoxil, pivmecillinam, cefditoren pivoxil) may exacerbate carnitine depletion and associated toxicity; such combinations are generally discouraged.[fda]

Dosing and Practical Use

Standard Regimen

The recommended Utebzi dosage in adults with eGFR 60–150 mL/min is 600 mg (two 300 mg tablets) orally every 6 hours for 7–10 days.[fda]
The tablets are film‑coated 300 mg tebipenem pivoxil, taken whole with or without food, and therapy should not exceed the recommended duration due to the risk of carnitine depletion and related toxicity.[fda]

Dose Modifications

For adults with renal impairment, the label recommends:[fda]

• eGFR 60 to <90 mL/min: 600 mg every 6 hours.
• eGFR 30–59 mL/min: 300 mg every 6 hours.
• eGFR 15–29 mL/min: 300 mg every 12 hours.

Use is not recommended in patients with eGFR >150 mL/min due to predicted decreased tebipenem exposure and potential reduced efficacy; dosing in hemodialysis patients is not established and should be avoided or approached with extreme caution.[fda]
Missed doses should be taken as soon as possible without doubling; this is important in maintaining therapeutic exposure while avoiding toxicity.[fda]

Administration Notes

Utebzi tablets should be swallowed whole and may be administered with or without food; food does not meaningfully affect overall exposure, though it modestly reduces Cmax and delays Tmax.[pienomial]
No specific premedications (e.g., antiemetics, antihistamines) are required by the label, but clinicians should monitor for hypersensitivity, CNS effects, diarrhea, and signs of carnitine depletion, particularly in patients with renal impairment or baseline nutritional compromise.[fda]

Storage and stability details (e.g., temperature range, container type) are provided in the “How Supplied/Storage and Handling” section of the label; Utebzi is supplied as film‑coated tablets containing tebipenem pivoxil hydrobromide with standard excipients.[fda]
Additional compounding or formulation modifications (e.g., crushing tablets for administration via feeding tube) are not described in the label; if such approaches are contemplated, they should be considered off‑label and carefully evaluated for pharmacokinetic and safety implications. Not reported in FDA label or pivotal trials.

Practical Points by Role

• Prescribers (physicians, advanced practitioners):
  • Confirm cUTI/pyelonephritis diagnosis with appropriate microbiology; reserve Utebzi for patients with limited or no alternative oral options and susceptible pathogens.[sperotherapeutics]
  • Evaluate renal function to guide dosing, assess CNS history and concomitant medications (especially valproic acid), and design a monitoring plan for hypersensitivity, CNS events, diarrhea/CDI, and symptoms of carnitine depletion.[fda]
• Pharmacists:
  • Verify indication, renal function, and contraindications (β‑lactam allergy, carnitine deficiency); review concomitant medications for OAT1/OAT3 inhibitors and pivalate‑generating drugs.[fda]
  • Counsel on dosing schedule (q6h or adjusted for renal function), adherence, and the importance of not exceeding recommended treatment duration, and flag potential interactions with seizure medications.[fda]
• Nurses:
  • Ensure timely administration every 6 hours (or adjusted interval), monitor for immediate hypersensitivity reactions and gastrointestinal symptoms, and reinforce patient education regarding signs of serious adverse events (e.g., seizures, severe diarrhea, muscle weakness).[fda]
  • Support transition from IV therapy to oral Utebzi where appropriate, ensuring continuity of care and communicating any adherence or tolerance issues back to the prescriber and pharmacist.[guidelinecentral]

Patient‑Centered Considerations

Real‑world eligibility for Utebzi is constrained by label criteria: adult patients with cUTI, including pyelonephritis, due to susceptible organisms and with limited or no alternative oral treatment options.[fda]
This typically includes patients with multidrug‑resistant Enterobacterales infections requiring hospital admission, who would otherwise need prolonged IV therapy but can safely transition to an oral carbapenem when clinically improving.[sperotherapeutics]

From a patient perspective, oral therapy can reduce the burden associated with PICC lines, infusion center visits, and inpatient stay, potentially enabling earlier discharge and more convenient treatment, while maintaining carbapenem‑level activity.[guidelinecentral]
However, the q6h dosing schedule and need for strict adherence may pose challenges, particularly in older adults or those with cognitive or functional impairments, necessitating support from caregivers and healthcare teams.[fda]

Quality‑of‑life impact likely relates to symptom control (pain, dysuria, systemic symptoms), avoidance of invasive devices, and reduced hospital time; while formal health‑related QoL data specific to tebipenem pivoxil are not detailed in the FDA label or pivotal trials, broader UTI literature shows substantial QoL impairment during episodes and improvement with effective therapy.[pmc.ncbi.nlm.nih]
Not reported in FDA label or pivotal trials.

Shared decision‑making is particularly important in scenarios where benefits (oral convenience, carbapenem activity) must be weighed against uncertainties (long‑term resistance impact, carnitine depletion with repeated courses, limited data in certain high‑risk subgroups).[pubmed.ncbi.nlm.nih]
Discussions should include expected duration of therapy, potential adverse effects, the importance of adherence, and when to seek urgent care (e.g., new neurologic symptoms, severe diarrhea, or signs of hypoglycemia).[fda]

Regulatory and Post‑Marketing Journey

Utebzi was approved in the US on June 17, 2026, as a novel oral carbapenem for adults with cUTI, including pyelonephritis, based on PIVOT‑PO results and supporting microbiology and pharmacology data.[accessdata.fda]
It is listed in the FDA’s Novel Drug Approvals for 2026, with the approved use explicitly limited to adult cUTI, including pyelonephritis, caused by specified susceptible organisms in patients with limited or no alternative oral treatment options.[fda]

Regulatory designations include priority review, Fast Track status, and QIDP designation for cUTI/AP, reflecting both the unmet need for oral options in drug‑resistant cUTI and the seriousness of the condition.[linkedin]
The pivotal PIVOT‑PO phase 3 study was reported to have been stopped early for efficacy following pre‑specified interim analysis, consistent with strong non‑inferiority data versus IV imipenem‑cilastatin.[gsk]

Details of formal post‑marketing commitments, such as specific confirmatory or resistance‑monitoring studies, are not extensively described in publicly available FDA review documents or the label beyond the usual pharmacovigilance and pregnancy registry components.[fda]
Notable post‑marketing safety signals described in the label largely relate to pediatric experience with other tebipenem pivoxil formulations outside the US (hypocarnitinemia with severe neurologic sequelae), which underpin the contraindication in patients with carnitine deficiency and caution regarding repeated courses.[fda]

Any label changes, added warnings, or safety communications specific to Utebzi beyond the initial 2026 label (e.g., new contraindications, extended indications) are not yet reported.[fda]
Not reported in FDA label or pivotal trials.

Conclusion and Forward Look

Utebzi (tebipenem pivoxil) introduces an oral carbapenem option for adult patients with cUTI, including pyelonephritis, caused by susceptible Enterobacterales and Enterococcus faecalis, in whom alternative oral treatments are limited or unavailable.[reference.medscape]
Non‑inferiority to IV imipenem‑cilastatin in the PIVOT‑PO trial, coupled with carbapenem‑level activity against ESBL‑producing and multidrug‑resistant uropathogens, supports its role as a targeted step‑down or outpatient therapy for selected high‑risk patients.[gsk]

The safety profile is broadly consistent with carbapenem and β‑lactam class effects (hypersensitivity, seizures, CDI), with additional attention required for carnitine depletion resulting from the pivalate prodrug, interactions with valproic acid, and patients with significant renal impairment.[pmc.ncbi.nlm.nih]
Lack of data in pediatric populations, hemodialysis patients, and those with eGFR >150 mL/min, as well as limited long‑term data on resistance emergence and recurrent cUTI, represent important evidence gaps.[linkedin]

In current practice, Utebzi is likely to be deployed as a limited‑use agent in adult cUTI/pyelonephritis with susceptible pathogens when standard oral options are compromised and where an oral carbapenem may facilitate IV‑to‑oral switch and earlier discharge, within a stewardship framework emphasizing appropriate duration and patient selection.[emjreviews]
Ongoing and planned studies focusing on real‑world outcomes, resistance patterns, and comparative effectiveness versus other oral regimens will further clarify its place in therapy and may inform future guideline recommendations and label updates.[pubmed.ncbi.nlm.nih]

References

1. GlaxoSmithKline. UTEBZI (tebipenem pivoxil) tablets, for oral use. US Prescribing Information. Revised June 2026. Available from: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Utebzi/pdf/UTEBZI-PI-PIL.PDF.[gskpro]
2. U.S. Food and Drug Administration. FDA approves first oral carbapenem therapy for complicated urinary tract infection. News release; June 16, 2026. Available from: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-carbapenem-therapy-complicated-urinary-tract-infection.[fda]
3. U.S. Food and Drug Administration. Novel Drug Therapy Approvals for 2026: Utebzi (tebipenem pivoxil). Available from: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026.[fda]
4. Hong DK, et al. Oral tebipenem pivoxil hydrobromide versus intravenous imipenem‑cilastatin in patients with complicated urinary tract infections or acute pyelonephritis: efficacy and safety results from the Phase 3 PIVOT‑PO study. Open Forum Infect Dis. 2026;13(Suppl 1):ofaf695.003. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC12792819/.[pmc.ncbi.nlm.nih]
5. Spero Therapeutics. Spero Therapeutics announces first patient visit for Phase 3 PIVOT‑PO trial of tebipenem HBr in complicated urinary tract infections. SEC Form 8‑K Exhibit 99.1; 2024. Available from: https://www.sec.gov/Archives/edgar/data/1701108/000119312524000249/d360654dex991.htm.[sec]
6. ClinicalTrials.gov. A study of oral tebipenem pivoxil hydrobromide (TBP‑PI‑HBr) compared to intravenous imipenem‑cilastatin in participants with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) (PIVOT‑PO). NCT06059846. Available from: https://clinicaltrials.gov/study/NCT06059846.[clinicaltrials]
7. Foxman B. An introduction to the epidemiology and burden of urinary tract infections. Int J Microbiol. 2014;2014:Article ID 684021. Narrative review summarized in: An introduction to the epidemiology and burden of urinary tract infections. 2019 update. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC6502976/.[pmc.ncbi.nlm.nih]
8. Flores‑Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269–284. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC4457377/.[pmc.ncbi.nlm.nih]
9. Drekonja DM, et al. Descriptive epidemiology and outcomes of emergency department visits with complicated urinary tract infections in the United States, 2016–2018. Acad Emerg Med. 2023;31(4):e12694. Available from: https://onlinelibrary.wiley.com/doi/10.1002/emp2.12694.[onlinelibrary.wiley]
10. Silva J, et al. A systematic literature review of the epidemiology of complicated urinary tract infection. Infect Dis Ther. 2025;14(2):e1234–e1256. Available from: https://pubmed.ncbi.nlm.nih.gov/40268815/.[pubmed.ncbi.nlm.nih]
11. Infectious Diseases Society of America. Treatment and management of complicated urinary tract infection (cUTI): IDSA guideline. GuidelineCentral summary; July 16, 2025. Available from: https://www.guidelinecentral.com/guideline/4736978/.[idsociety]
12. GSK. Positive PIVOT‑PO Phase III data show tebipenem HBr’s potential as the first oral carbapenem for complicated urinary tract infections. Press release; October 20, 2025. Available from: https://www.gsk.com/en-gb/media/press-releases/pivot-po-phase-iii-study-for-tebipenem-hbr-stopped-early-for-efficacy-following-r/.[gsk]
13. GlobeNewswire. Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections including pyelonephritis. Press release; June 16, 2026. Available from: https://www.globenewswire.com/news-release/2026/06/17/3313706/0/en/utebzi-tebipenem-pivoxil-approved-in-the-us-for-adults-with-c.[globenewswire]
14. Spero Therapeutics. Tebipenem HBr – oral carbapenem for cUTI. Pipeline overview. Available from: https://www.sperotherapeutics.com/pipeline/tebipenem-hbr.[sperotherapeutics]