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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
Antiviral Monoclonal Antibody (Vir-7832)
AGILE (Early Phase Platform Trial for COVID-19)
No studies exist in this phase
GSK3882347 (FimH Antagonist)
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
No studies exist in this phase
No studies exist in this phase
No studies exist in this phase
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
Antiviral Monoclonal Antibody (Vir-7832)
AGILE (Early Phase Platform Trial for COVID-19)
No studies exist in this phase
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)
No studies exist in this phase
No studies exist in this phase
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
COMET-TAIL: Intramuscular Sotrovimab (VIR-7831) for Mild/Moderate COVID-19
Gepotidacin
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
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
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
No studies exist in this phase
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
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
Ibrexafungerp
VANQUISH: Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
