drugset
Drugs / SPR994
last change Apr 2022 re-read 3 minutes ago

SPR994

also known as TBPM-PI-HBr · Tebipenem pivoxil hydrobromide

Small molecule

Investigated by
CPR Pharma Services Pty Ltd, Australia · Spero Therapeutics

Trials 1

today NCT03395249 · Ph 1
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT03395249 Oct 2017 → Aug 2018 — Spero Therapeutics Completed No outcome recorded

Press releases naming this drug 11 releases

DateIssuerRelease
2022-04-06 Sperotx Spero Therapeutics Tebipenem Pivoxil Hydrobromide Phase 3 Data Published in The New England Journal of Medicine sperotx.com ↗
2019-10-03 Sperotx Spero Therapeutics Announces Positive Recommendation to Continue Phase 3 Clinical Trial of SPR994 as Planned Following Independent Review Committee Analysis of SPR994 Treated Patients in Lead-in Cohort of Trial sperotx.com ↗
2019-04-08 Sperotx Spero Therapeutics Highlights SPR994 Data at the 29th European Congress of Clinical Microbiology and Infectious Diseases sperotx.com ↗
2019-03-29 Sperotx Spero Therapeutics Receives FDA Fast Track Designation for SPR994 for the treatment of Complicated Urinary Tract infections and Acute Pyelonephritis sperotx.com ↗
2019-02-04 Sperotx Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994 sperotx.com ↗
2019-01-07 Sperotx Spero Therapeutics Announces Positive Feedback from FDA Pre-Phase 3 Meeting for Oral SPR994 and Submission of IND for SPR994 in cUTI sperotx.com ↗
2018-09-27 Sperotx Spero Announces Positive SPR994 Phase 1 SAD/MAD Final Results sperotx.com ↗
2018-08-28 Sperotx Spero Therapeutics to Present New Data for SPR994 and SPR206 at ESCMID/ASM 2018 Conference sperotx.com ↗
2018-07-16 Sperotx Spero Awarded up to $54 Million by BARDA and DTRA to Support SPR994 Development sperotx.com ↗
2018-07-09 Sperotx Spero Announces Positive Interim Phase 1 SAD/MAD Results for SPR994 sperotx.com ↗
2018-06-05 Sperotx Spero Therapeutics to Present New Preclinical Data for SPR994 at ASM Microbe 2018 sperotx.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SPR994 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03395249 ↗
Known as TBPM-PI-HBr “Tebipenem pivoxil hydrobromide (TBPM-PI-HBr, formerly SPR994) is an orally available prodrug of tebipenem” PMID 31262768 ↗ Aug 2019
Known as Tebipenem pivoxil hydrobromide “Tebipenem pivoxil hydrobromide (TBPM-PI-HBr, formerly SPR994) is an orally available prodrug of tebipenem” PMID 31262768 ↗ Aug 2019
Modality Small molecule “a carbapenem with activity versus multidrug-resistant (MDR) Gram-negative pathogens” PMID 31262768 ↗ Aug 2019
Route Oral “SPR994 is administered in tablet form orally.” NCT03395249 ↗