Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Spero Announces First Patient Visit in Phase 3 PIVOT-PO Trial of Tebipenem H Br
Details : SPR994 (tebipenem pivoxil hydrobromide) is an oral antibiotic in phase 3 trials for treating complicated urinary tract infections, including acute pyelonephritis.
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 02, 2024
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SPR994 is Spero’s novel late-stage development asset, an oral formulation tablet of tebipenem pivoxil hydrobromide, a carbapenem antibiotic of the β-lactam class.
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 31, 2023
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : GSK
Deal Size : $591.0 million
Deal Type : Licensing Agreement
Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr
Details : Under the terms of the agreement, Spero is responsible for the execution and costs of Phase 3 trial of tebipenem HBr (tebipenem pivoxil hydrobromide), an investigational drug, is being developed as the potentially first oral carbapenem antibiotic for the...
Brand Name : Tebipenem HBr
Molecule Type : Small molecule
Upfront Cash : $66.0 million
November 08, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : GSK
Deal Size : $591.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : GSK
Deal Size : $816.0 million
Deal Type : Licensing Agreement
Details : Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission ...
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : $66.0 million
September 22, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : GSK
Deal Size : $816.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection (cUTI), with supportive confirmatory evidence of efficacy could support approval of SPR994 (tebipenem HBr).
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 06, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis.
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 28, 2021
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : HealthCare Royalty Partners
Deal Size : $125.0 million
Deal Type : Financing
Details : Spero intends to use the proceeds from the agreement for launch of tebipenem HBr, for a complicated urinary tract infection (cUTI) indication as well as to support the continued clinical development of SPR720 and SPR206.
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 30, 2021
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : HealthCare Royalty Partners
Deal Size : $125.0 million
Deal Type : Financing
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Spero Therapeutics to Present Data at IDWeek 2021
Details : Presentations will showcase in vitro and in vivo studies of tebipenem HBr for treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) and highlight additional research on the epidemiology and management of cUTI.
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 16, 2021
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis.
Brand Name : SPR994
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 08, 2020
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Phase 3 clinical trial, ADAPT-PO, is evaluating tebipenem HBr for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 05, 2020
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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