Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 45/100

Failure Rate

4.2%

1 terminated/withdrawn out of 24 trials

Success Rate

95.8%

+9.3% vs industry average

Late-Stage Pipeline

8%

2 trials in Phase 3/4

Results Transparency

13%

3 of 23 completed trials have results

Key Signals

3 with results

Enrollment Performance

Analytics

Phase 1
20(83.3%)
Phase 2
2(8.3%)
Phase 3
2(8.3%)
24Total
Phase 1(20)
Phase 2(2)
Phase 3(2)

Activity Timeline

Global Presence

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Clinical Trials (24)

Showing 20 of 24 trials
NCT06059846Phase 3Completed

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)

Role: lead

NCT05496374Phase 2Completed

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

Role: lead

NCT06727136Phase 1Completed

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

Role: lead

NCT04865393Phase 1Completed

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

Role: lead

NCT05856747Phase 1Completed

A Study to Compare Two Bioanalytical Assays for Tebipenem

Role: lead

NCT05955586Phase 1Completed

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.

Role: lead

NCT05966688Phase 1Completed

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

Role: lead

NCT05296382Phase 1Completed

Bioavailability of Tebipenem (SPR994) Crushed Tablet

Role: collaborator

NCT04919954Phase 1Completed

Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Role: collaborator

NCT03788967Phase 3Completed

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)

Role: lead

NCT04553406Phase 2Terminated

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

Role: lead

NCT04868292Phase 1Completed

Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers

Role: lead

NCT04376554Phase 1Completed

Effect of Tebipenem on Normal Human Intestinal Microbiota

Role: lead

NCT04710407Phase 1Completed

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

Role: lead

NCT04178577Phase 1Completed

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

Role: lead

NCT04625855Phase 1Completed

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

Role: lead

NCT04368585Phase 1Completed

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

Role: lead

NCT04421885Phase 1Completed

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

Role: lead

NCT04238195Phase 1Completed

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

Role: lead

NCT03792308Phase 1Completed

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

Role: lead