GlaxoSmithKline (GSK)
NYSE:GSK
Gsk5533524
Neoplasms
Phase I
Recruiting
First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid Tumors
Feb 23, 2026
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Dexamethasone, Carfilzomib, Pomalidomide, Bortezomib, Belantamab Mafodotin, Blenrep
Multiple Myeloma
Phase II
Not Yet Recruiting
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
Nov 10, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does GlaxoSmithKline (GSK) have in its pipeline
GSK is currently developing the following drugs: Gsk5533524, Soc, Gepotidacin, Efimosfermin Alfa. These drug candidates are in various stages of clinical development as the company works toward FDA approval.