Orapenem (tebipenem pivoxil) / Spero Therap, Meiji Seika, GSK - LARVOL DELTA

Impact of acquired broad-spectrum β-lactamases on susceptibility to oral cephalosporin (ceftibuten) and oral carbapenem (tebipenem) in combination with new β-lactamase inhibitors ledaborbactam and xeruborbactam in Escherichia coli (ESCMID Global 2026) - No abstract available

Combination therapy

Oral tebipenem pivoxil tablets and intravenous imipenem-cilastatin efficacy by baseline uropathogen phenotypes and genotypes from the phase III PIVOT-PO clinical trial for complicated urinary tract infections or acute pyelonephritis (ESCMID Global 2026) - No abstract available

Clinical • P3 data • Infectious Disease • Nephrology

Comparison of in vitro antimicrobial activity of tebipenem, sulopenem, meropenem, and ertapenem against cefotaxime-resistant Enterobacterales (ESCMID Global 2026) - No abstract available

Preclinical

Activity of tebipenem against Enterobacterales, including molecularly characterised isolates causing urinary tract and bloodstream infections in the United States and United Kingdom in 2023-2024 (ESCMID Global 2026) - No abstract available

Infectious Disease

In vitro activity of tebipenem against baseline Enterobacterales phenotypes and genotypes recovered from the phase III PIVOT-PO clinical trial for complicated urinary tract infections or acute pyelonephritis (ESCMID Global 2026) - No abstract available

P3 data • Preclinical • Infectious Disease • Nephrology

Subgroup analysis of tebipenem pivoxil efficacy in patients with complicated urinary tract infection or acute pyelonephritis: results from the phase III PIVOT-PO study (ESCMID Global 2026) - No abstract available

Clinical • P3 data • Infectious Disease • Nephrology

Population Pharmacokinetic and Pharmacodynamic Prediction for Tebipenem Pivoxil Treatment of Pediatric Shigellosis. (PubMed, Clin Transl Sci) - "Three levels of ceftriaxone resistance were simulated to examine how dynamic ceftriaxone resistance may impact the trial outcome. Our findings suggest that more frequent tebipenem pivoxil dosing may increase the chance of producing treatment effects, contribute valuable insights to inform dosing strategy selection, and demonstrate a workflow that can be adapted to other drugs and diseases."

Clinical • Journal • PK/PD data • Infectious Disease • Pediatrics

Exploring the activity of a novel orally bioavailable β-lactam-β-lactamase inhibitor combination, ceftibuten-ledaborbactam, against Enterobacterales-carrying blaOXA-48. (PubMed, Microbiol Spectr) - "In this study, we compared the in vitro antimicrobial activity of ceftibuten-ledaborbactam with that of other oral antibiotics, including tebipenem, sulopenem, ceftibuten-clavulanic acid, amoxicillin-clavulanic acid, and levofloxacin, against OXA-48-producing Enterobacterales. Our results show that ceftibuten-ledaborbactam has the most potent activity, with an MIC90 of 0.5 mg/L."

Journal

Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis (GlobeNewswire) - "The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial (NCT number – NCT06059846)."

FDA filing • Infectious Disease

Carbapenem and Cephalosporin resistance in E. coli and Shigella spp. after second line treatment with Tebipenem pivoxil or Ceftriaxone for bloody diarrhoea among children in Bangladesh (ASTMH 2025) - P2 | "We enrolled 132 children, aged 24-59 months, with bloody diarrhoea after 48 hours of azithromycin therapy. Our findings suggest oral tebipenem may be a viable alternative to ceftriaxone for second-line treatment of bloody diarrhoea, particularly in the context of antimicrobial stewardship. However, further research is warranted to confirm these findings and assess long-term outcomes."

Clinical • Late-breaking abstract

Clinical efficacy of tebipenem-pivoxil versus ceftriaxone as second-line treatment for childhood shigellosis: a randomized phase IIb non-inferiority trial (ASTMH 2025) - P2 | "This single-blind, phase IIb, non-inferiority trial (NCT05121974) enrolled children aged 24-59 months with shigellosis unresponsive to azithromycin. For the primary analysis, the wide confidence interval suggests substantial uncertainty in the estimated difference, with possible values ranging from Tebipenem being slightly better than Ceftriaxone (risk difference −4.82%) to markedly worse (up to 25.68%) and the result remains inconclusive. The drug demonstrated an acceptable safety profile consistent with previous findings."

Clinical • Head-to-Head • Late-breaking abstract • P2b data

Oral β-lactam combinations are effective in vitro against Mycobacterium avium, regardless of clarithromycin susceptibility. (PubMed, Microbiol Spectr) - "Among the M. avium clinical isolates, faropenem combined with cefuroxime showed the highest synergistic effect, and amoxicillin combined with tebipenem showed the lowest minimum inhibitory concentration. In contrast, Mycobacterium intracellulare showed lower susceptibility to β-lactams. Given this difference in drug susceptibility, we emphasize the clinical need to distinguish Mycobacterium avium and Mycobacterium intracellulare to optimize treatment of Mycobacterium avium complex pulmonary disease."

Journal • Preclinical • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Sulbactam-durlobactam improves cephalosporin and carbapenem susceptibility and time-kill effect against Mycobacterium abscessus. (PubMed, Microbiol Spectr) - "The fold reduction in MICs was as follows: amoxicillin 94, ceftriaxone 103, cefuroxime 69, cefdinir 19, cefalexin 74, imipenem 23, meropenem 37, tebipenem 89, and faropenem 74. We show that sulbactam/durlobactam (Sul/Dur) can improve the kill effect of several β-lactam antibiotics that, otherwise, due to observed high minimum inhibitory concentration, deem ineffective. Based on our findings, we propose imipenem that is already included in the MAB-LD treatment recommendations and ceftriaxone that achieves very high lung concentration, to test with Sul/Dur as a double β-lactam-β-lactamase backbone regimen to advance the therapy for MAB-LD."

Journal • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

The oral penems and carbapenems. (PubMed, Clin Microbiol Rev) - "The majority of available carbapenems can only be administered parenterally, but two orally administered penems (faropenem and sulopenem) and one orally administered carbapenem (tebipenem) are in increased use due to approvals in new markets. These oral agents have a spectrum of activity similar to widely used parenteral carbapenems but are simpler to administer than intravenous agents and will likely experience rapid increases in their rates of use as they are approved in new markets. In this review, we discuss their spectra of activity, pharmacokinetics, pharmacodynamics, clinical efficacy, toxicity, antimicrobial stewardship considerations, and potential clinical applications."

Journal • Review

An evaluation of antibiotic options for the treatment of biothreat pathogens. (PubMed, Front Antibiot) - "This review includes finafloxacin, levofloxacin, delafloxacin, omadacycline, gepotidacin, tebipenem and sulopenem. The selection criteria of these antibiotics were 1) the availability of an oral formulation, 2) the regulatory status (licensed by a regulatory authority or in an advanced stage of development) and 3) the availability of publicly available information on the biodefence pathogens of concern. We hope to highlight approved or advanced clinical candidates that have significant and unique potential in the biodefense space which may be deployed to protect both the public and warfighter against these bacterial infections."

Journal • Review • Infectious Disease

In Vitro Activity of Ledaborbactam (VNRX-5236) in Combination with Amoxicillin or Tebipenem Against Mycobacterium abscessus (IDWeek 2025) - No abstract available

Combination therapy • Preclinical • Infectious Disease

In Vitro Antibacterial Spectrum and Activity of Tebipenem Against Enterobacterales Clinical Isolates Causing Urinary Tract and Bloodstream Infections in the United States and United Kingdom in 2023-2024 (IDWeek 2025) - No abstract available

Preclinical • Infectious Disease

Activity of Tebipenem Against Enterobacterales, Including Molecularly Characterized Clinical Isolates Causing Urinary Tract and Bloodstream Infections from the United States in 2023 (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Phenotypic and genotypic profiles of clinical isolates of various Nocardia species to carbapenems and fluoroquinolones. (PubMed, J Antimicrob Chemother) - "Nocardia spp. exhibited varying patterns of susceptibility to carbapenems and fluoroquinolones respectively. Importantly, different Nocardia spp. exhibited different patterns of susceptibility to carbapenems and fluoroquinolones, respectively."

Journal

Tebipenem Trial in Children With Shigellosis (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Mar 2025

Enrollment closed • Head-to-Head • Trial completion date • Trial primary completion date

SUSCEPTIBILITY OF MULTI-DRUG RESISTANT ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE TO ORAL ANTIBIOTICS IN AUSTRALIA. (PubMed, J Glob Antimicrob Resist) - "The favourable results support the use of mecillinam, tebipenem, sulopenem, faropenem, fosfomycin and omadacycline against multi-drug resistant E. coli. Mecillinam, sulopenem and fosfomycin may be useful for multi-drug resistant K. pneumoniae in Australia."

Journal • Infectious Disease • Nephrology • Pneumonia

Preclinical Study of Pharmacokinetic/Pharmacodynamic Analysis of Tebipenem Using Monte Carlo Simulation for Extended-Spectrum β-Lactamase-Producing Bacterial Urinary Tract Infections in Japanese Patients According to Renal Function. (PubMed, Antibiotics (Basel)) - "This first Japanese PK/PD analysis of TBPM in ESBL-producing UTIs provides evidence-based dosing recommendations across various renal function levels. TBPM, with appropriate renal-adjusted dosing, may offer an effective oral treatment option for patients who have traditionally required hospitalization for parenteral therapy."

Journal • PK/PD data • Preclinical • Infectious Disease • Nephrology • Pediatrics • Renal Disease

Exploring β-lactam interactions with DacB1: unraveling optimal therapies for combating drug-resistant Mycobacterium tuberculosis. (PubMed, mBio) - "Minimum inhibitory concentrations (MICs) for β-lactams and β-lactamase inhibitors against Mtb H37Ra, H37Rv, and clinical isolates showed that imipenem, meropenem, or tebipenem MICs were reduced when combined with amoxicillin or ceftriaxone or β-lactamase inhibitors such as clavulanate or durlobactam. Timed electrospray ionization mass spectrometry (ESI-MS) captured acyl-enzyme adducts between DacB1 and BLs, revealing binding interactions with carbapenems (imipenem, meropenem, and tebipenem) but not most penicillins or cephalosporins except cloxacillin and cefoxitin...Given the challenges in developing new TB drugs, repurposing β-lactams offers a cost-effective and readily implementable solution to address antimicrobial resistance. This study contributes valuable knowledge that could accelerate the development of novel TB therapies, improve treatment success rates, and ultimately reduce TB-related mortality worldwide."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

PIVOT-PO: 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) (clinicaltrials.gov) - P3 | N=1690 | Completed | Sponsor: Spero Therapeutics | Recruiting ➔ Completed | N=2648 ➔ 1690 | Trial completion date: Nov 2025 ➔ Feb 2025 | Trial primary completion date: Nov 2025 ➔ Jan 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Nephrology

A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: Spero Therapeutics | Recruiting ➔ Completed

Trial completion