Recent Updates
Recently added Catalysts

GS-5737

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Gilead Sciences, Inc.|Last Updated: Aug 12, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

GS-5737 · 1 trial · 1 indication

Phase 1 1
NCT01840735Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CFCystic Fibrosis
COMPLETED8 Analytics
PHASE1COMPLETED
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak Plasma Concentration (Cmax) of GS-5737
1 day
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GS-5737ACTIVE_COMPARATORThe GS-5737 85 μg dose is contained in 4 mL of 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline.
PlaceboPLACEBO_COMPARATORThe vehicle (placebo) control contains 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline in 4 mL.

Interventions

NameTypeDescription
GS-5737DRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males or females, ≥ 18 years of age, at Screening * Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria, with at least 1 of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR Abnormal nasal transepitheli...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about GS-5737

What is GS-5737 used for in cystic fibrosis?

GS-5737 is an investigational small molecule being studied for the treatment of cystic fibrosis. It is being developed by Gilead Sciences, Inc. (GILD) and has completed a Phase 1b clinical trial in patients with cystic fibrosis. The drug is not yet approved and remains in clinical development.

Who makes GS-5737?

GS-5737 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker GILD. Gilead is conducting clinical research to evaluate the safety and tolerability of GS-5737 in patients with cystic fibrosis.

What phase is GS-5737 in?

GS-5737 is in Phase 1 clinical development. A Phase 1b trial has been completed, which was designed to assess the safety, tolerability, and pharmacokinetics of the drug in subjects with cystic fibrosis. The drug is investigational and has not received FDA approval.

What clinical trials is GS-5737 in?

GS-5737 has one completed clinical trial, identified as NCT01840735. This was a Phase 1b study titled 'Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF.' The trial enrolled 8 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is GS-5737 the same as remdesivir?

No, GS-5737 is not the same as remdesivir. GS-5737 is being studied for cystic fibrosis, while remdesivir is a different antiviral drug. The two are distinct investigational compounds with different mechanisms and clinical applications.