Tebipenem HBr

Oral Carbapenem in Development for Treatment of Complicated Urinary Tract Infections

Antibiotic resistance is a growing global health threat, and one especially troubling concern is the rise in resistant strains of E. coli, the bacteria that cause the majority of urinary tract infections (UTIs).

The Center for Disease Dynamics, Economics & Policy (CDDEP) reports that in 2014, the most commonly used oral class of antibiotics for UTI, fluoroquinolones, were experiencing resistance at up to 35% in E. coli. The resistance had more than doubled in the last decade. Spero Therapeutics is developing a novel oral agent to treat these resistant bacteria.

On April 6, 2022, the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem HBr, were published in the New England Journal of Medicine (NEJM).


Chemical Formula: C22H32BrN3O36S2
Molecular Weight: 578.54g/mol

Tebipenem HBr

We are developing Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) as an oral antibiotic for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) to help patients avoid hospitalizations (stay at home) and/or transition patients home after IV therapy (get home).

Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections. Carbapenems have emerged as the standard-of-care for many multidrug-resistant (MDR) Gram-negative bacterial infections, but today they are only available as intravenous therapeutics for such indications.

The Latest

On April 6, 2022, Spero Therapeutics announced publication in the New England Journal of Medicine (NEJM) the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem pivoxil hydrobromide (tebipenem HBr) in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).

In July, 2023, Spero announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO. PIVOT-PO is a global, randomized, double-blind, pivotal Phase 3 clinical trial of oral tebipenem HBr vs. IV imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary efficacy endpoint will be overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit.

On January 2, 2024, Spero announced the first patient, first visit for PIVOT-PO, commencing enrollment for the global Phase 3 trial of tebipenem HBr.

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NTM Info & Research is a 501(c)(3) non-profit organization formed for patient support, medical education and to help accelerate research.


Patients can follow the progress of SPR720 as the candidate moves through clinical trials. ClinicalTrials.gov is a database of clinical studies conducted worldwide.

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