Infectious Diseases Pipeline

At GSK, our pipeline is focused on unlocking the science of the immune system, human genetics, and advanced technologies to develop vaccines and specialty medicines.

Our products in development progress through three stages: phase I, phase II, and phase III/registrational. Each of these phases allows us to assess the safety and efficacy of our investigational products to eventually provide data to support applications for regulatory approval.

View our ongoing, innovative research with infectious diseases.

Phase 1 Overview

This is the first time a new vaccine or medicine is tested in humans; it will usually be given to a small group of healthy volunteers, or it may be tested on patients who have the condition it is designed to treat. The principal objectives in phase I are to ensure the new vaccine or medicine presents no major safety issues, and to see clear evidence that it can reach the targeted body area and remain there long enough to deliver its potential benefits. We also seek to gain preliminary evidence the vaccine or medicine can offer therapeutic value or help to prevent the disease in question.

View our ongoing, innovative research with infectious diseases.

DISEASE STATES

 
COVID-19

Antiviral Monoclonal Antibody (Vir-7832)

AGILE (Early Phase Platform Trial for COVID-19)

Gonorrhea
No studies exist in this phase
Complicated Urinary Tract Infection

No studies exist in this phase

Uncomplicated Urinary Tract Infection

GSK3882347 (FimH Antagonist)

Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections    

Pulmonary Aspergillosis

No studies exist in this phase

Invasive Candidiasis

No studies exist in this phase

Refractory Fungal Disease

No studies exist in this phase

Complicated Vulvovaginal Candidiasis

No studies exist in this phase

Phase 2 Overview

At this stage, the potential vaccine or medicine is usually tested to understand the effectiveness against the disease it is designed to treat and appropriate dosing levels. The performance of the medicine in one group of patients may be compared against another group of patients receiving a placebo (a treatment that looks the same as the potential new medicine but has no active ingredients) or an existing treatment.

View our ongoing, innovative research with infectious diseases.

DISEASE STATES

 
COVID-19

Antiviral Monoclonal Antibody (Vir-7832)

AGILE (Early Phase Platform Trial for COVID-19)

Gonorrhea
No studies exist in this phase
Complicated Urinary Tract Infection

No studies exist in this phase

Uncomplicated Urinary Tract Infection
No studies exist in this phase
Pulmonary Aspergillosis

Ibrexafungerp

SCYNERGIA: Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis (SCYNERGIA)

Invasive Candidiasis

No studies exist in this phase

Refractory Fungal Disease

No studies exist in this phase

Complicated Vulvovaginal Candidiasis

No studies exist in this phase

Phase 3 Overview

This phase consists of a much larger and potentially longer trial, often involving hundreds or possibly thousands of participants from a range of different countries. The principal objectives in phase III are to demonstrate the safety and effectiveness of the new vaccine or medicine in the typical patient likely to use it; confirm effective dosing levels; identify contraindications; build knowledge of the benefits of the vaccine or medicine and compare them with any risks; and compare results against any currently achieved by existing treatments. Regulators will determine how a new product should be used and which patients should qualify for it based on all the evidence from clinical and pre-clinical studies

View our ongoing, innovative research with infectious diseases.

DISEASE STATES

 
COVID-19

No studies exist in this phase

Gonorrhea

Gepotidacin

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Complicated Urinary Tract Infection

Tebipenem

ADAPT PO: Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Tebipenem Compared to IV Ertapenem in Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis

PIVOT PO: A Study of Oral Tebipenem Pivoxil Hydrobromide Compared to Intravenous Imipenem-Cilastatin in Participants With Complicated Urinary Tract Infection or Acute Pyelonephritis

Uncomplicated Urinary Tract Infection

Gepotidacin

A Study to Evaluate Efficacy and Safety of GEPOTIDACIN in the Treatment of Uncomplicated Urinary Tract Infection

Comparative Study to Evaluate Efficacy and Safety of GEPOTIDACIN to NITROFURANTOIN in Treatment of Uncomplicated Urinary Tract Infection

Pulmonary Aspergillosis

No studies exist in this phase

Invasive Candidiasis

Ibrexafungerp

CARES: Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris

MARIO: A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Refractory Fungal Disease

Ibrexafungerp

FURI: Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

Complicated Vulvovaginal Candidiasis

Ibrexafungerp

VANQUISH: Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis