WebSpero intends to initiate a rolling NDA submission and anticipates completing the NDA submission to the FDA for tebipenem HBr in the second quarter of 2024. The global, randomized, placebo-controlled ADAPT-PO Phase 3 clinical trial evaluated the safety and efficacy of tebipenem HBr in hospitalized adult patients with cUTI or AP. WebDec 28, 2024 · Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) - Full Text View - ClinicalTrials.gov Home Search Results Study …
Tebipenem Trial in Children With Shigellosis - Full Text View ...
WebApr 6, 2024 · April 5, 2024, 9:59 PM · 13 min read. Spero Therapeutics, Inc. (NASDAQ: SPRO) Q4 2024 Earnings Call Transcript March 30, 2024. Operator: Good afternoon, and welcome to Spero Therapeutics Fourth ... WebJun 28, 2024 · The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Spero Therapeutics regarding the New Drug Application (NDA) for … sonic gopher
Tebipenem hydrobromide FDA Approva…
WebApr 6, 2024 · Tebipenem pivoxil hydrobromide is an orally bioavailable carbapenem prodrug that is rapidly converted to the active moiety, tebipenem, by enterocytes. 20 Tebipenem … WebApr 14, 2024 · Tebipenem HBr is an investigational drug in the United States being developed for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis, caused by certain bacteria, in adult patients who have limited treatment options; tebipenem HBr is not U.S. Food and Drug Administration (FDA)-approved. WebSep 22, 2024 · Tebipenem HBr is an investigational drug in the United States being developed for the treatment of cUTI, including pyelonephritis, caused by certain bacteria, … sonic go to the park