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Tebipenem Pivoxil · Utebzi, SPR994

Small molecule · developed by Glaxosmithkline

Approved FDA, Jun 2026

7 Registered trials

What is Tebipenem Pivoxil?

Tebipenem pivoxil is an oral carbapenem antibiotic administered as tablets or granules. It is being studied in complicated urinary tract infections, acute pyelonephritis, and acute bacterial skin and soft tissue infections.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Utebzi, SPR994, L-084, LJC-11084, TBP-PI-HBr, TBPM-PI-HBr, Orapenem
Drug type: Small molecule
Therapy area: Infectious disease
Developer: Glaxosmithkline
In trials of: SPRO
FDA status: Approved as Utebzi (June 17, 2026), NDA215960
UNII: 95AK1A52I8

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06059846	Phase 3	Urinary Tract Infection	Completed	SPRO
NCT03788967	Phase 3	Complicated Urinary Tract Infection	Completed	SPRO
NCT05296382	Phase 1	Relative Bioavailability	Completed	SPRO
NCT04919954	Phase 1	Diabetes	Completed	SPRO
NCT04421885	Phase 1	Healthy Volunteers	Completed	SPRO
NCT04178577	Phase 1	Renal Impairment	Completed	SPRO
NCT03395249	Phase 1	Healthy Volunteers	Completed	SPRO

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

ABSSSIAcute PyelonephritisComplicated Urinary Tract InfectionDiabetesHealthy VolunteersRelative BioavailabilityRenal ImpairmentUrinary Tract InfectionWound Infection

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z