TheraRadar

Spero

Pre-Approval PRO BETA
🟡

Slowing Activity

No new clinical trials started in 1-2 years. Monitor for changes in pipeline strategy. Last trial started: 11/20/2024

22
Total Trials
2
Phase 3
2
Phase 2
0
Recruiting
100
Score

Pipeline by Phase

Phase 3
2
Phase 2
2
Phase 1
18

Therapeutic Focus

Healthy Volunteers Acute Pyelonephritis Renal Impairment Urinary Tract Infection Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)

Clinical Trials (22)

NCT06059846 Phase 3 COMPLETED

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Started: 12/21/2023

NCT03788967 Phase 3 COMPLETED

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)

Started: 6/3/2019

NCT05496374 Phase 2 COMPLETED

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Started: 12/14/2022

NCT04553406 Phase 2 TERMINATED

Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Started: 12/3/2020

NCT06727136 Phase 1 COMPLETED

A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants

Started: 11/20/2024

NCT04865393 Phase 1 COMPLETED

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Started: 6/8/2021

NCT05856747 Phase 1 COMPLETED

A Study to Compare Two Bioanalytical Assays for Tebipenem

Started: 5/4/2023

NCT05955586 Phase 1 COMPLETED

A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers.

Started: 8/1/2023

NCT05966688 Phase 1 COMPLETED

A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants

Started: 8/4/2023

NCT04868292 Phase 1 COMPLETED

Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers

Started: 6/3/2021

NCT04376554 Phase 1 COMPLETED

Effect of Tebipenem on Normal Human Intestinal Microbiota

Started: 2/10/2020

NCT04710407 Phase 1 COMPLETED

Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers

Started: 12/7/2020

NCT04178577 Phase 1 COMPLETED

Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function

Started: 12/6/2019

NCT04625855 Phase 1 COMPLETED

Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects

Started: 9/30/2020

NCT04368585 Phase 1 COMPLETED

Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Started: 7/1/2020

NCT04421885 Phase 1 COMPLETED

Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Started: 6/1/2020

NCT04238195 Phase 1 COMPLETED

A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects

Started: 1/19/2020

NCT03792308 Phase 1 COMPLETED

A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers

Started: 12/18/2018

NCT03796910 Phase 1 COMPLETED

A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers

Started: 12/18/2018

NCT03395249 Phase 1 COMPLETED

Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994

Started: 10/20/2017

NCT03376529 Phase 1 COMPLETED

Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741

Started: 11/10/2017

NCT03022175 Phase 1 COMPLETED

A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers

Started: 12/1/2016

Drug Candidates

TBP-PI-HBr Imipenem-cilastatin Dummy Infusion Dummy Tablets Placebo SPR720 500 mg SPR720 1000 mg SPR206 SPR720 Azithromycin
Activity Status: Slowing
Last Trial Started: 11/20/2024
Last Trial Ended: 4/22/2025
Trials (12 months): 0
Completed Trials: 21
Data sourced from ClinicalTrials.gov. This company has no FDA-approved drugs.