Recent Updates
Recently added Catalysts

EDP-323 Dose Regimen 1

Phase 2

RSV Infection | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Last Updated: Oct 7, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

EDP-323 Dose Regimen 1 · 1 trial · 1 indication

Phase 2 1
NCT06170242A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge ModelRSV Infection
COMPLETED142 Analytics
PHASE2COMPLETED
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
RSV Infection
NCT06170242142
Unlock trial analytics

Study Endpoints

Primary Endpoints

Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC)
Day 1 to Day 12

Measured by qRT-PCR in nasal samples.

Secondary Endpoints

qRT-PCR: RSV Peak Viral Load (VLPEAK)
Day 1 to Day 12
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK
Day 1 to Day 12
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity
Day 1 to Day 12
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EDP-323 Arm AEXPERIMENTALSubjects will take EDP-323 Dose 1 orally for 5 days
EDP-323 Arm BEXPERIMENTALSubjects will take EDP-323 Dose 2 orally for 5 days
Placebo Arm CPLACEBO_COMPARATORSubjects will take matching placebo orally for 5 days

Interventions

NameTypeDescription
EDP-323 Dose Regimen 1DRUGEDP-323 capsule
EDP-323 Dose Regimen 2DRUGEDP-323 capsule
PlaceboDRUGPlacebo capsule
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * An informed consent document signed and dated by the subject. * Age 18 to 55 years, inclusive. * In good health with no history of major medical conditions. * A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35kg/m2. Exclusion Criteria: * Pregnant or nu...

Countries:United Kingdom
Unlock Eligibility Criteria

Competitive Landscape -Bacterial Infections 60 trials (matched to "RSV Infection")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
GSK plc Sponsored ADRGSK3PHASE2MenABCWY vaccine
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
Unlock Competitive Intelligence