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EDP-978

Phase 1

Chronic Inducible Urticaria | Small molecule | Dermatology |Enanta Pharmaceuticals, Inc.|Last Updated: Apr 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

EDP-978 · 1 trial · 2 indications

Phase 1 1
NCT07540910A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy AdultsChronic Inducible Urticaria
RECRUITING98 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
Chronic Inducible UrticariaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety measured by adverse events
Up to 8 Days in SAD Cohorts

Secondary Endpoints

Cmax of EDP-978
Up to 5 Days in SAD Cohorts
AUC of EDP-978
Up to 5 Days in SAD Cohorts
Cmax of EDP-938 (FE)
Up to 12 Days in FE SAD Cohort
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EDP-978 SAD CohortsEXPERIMENTALEDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration
EDP-978 MAD CohortsEXPERIMENTALEDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days
EDP-978 SAD Placebo CohortsPLACEBO_COMPARATORMatching placebo, orally, once daily in one single administration
EDP-978 MAD Placebo CohortsPLACEBO_COMPARATORMatching placebo, orally, once daily for 14 days

Interventions

NameTypeDescription
EDP-978DRUGOral administration
PlaceboDRUGPlacebo to match EDP-978, oral administration
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease. * Infection with human i...

Countries:United States
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT07540910primaryCompletionDate: changed
LOWMay 24, 2026NCT07540910studyFirstPostDate: changed
LOWMay 21, 2026NCT07540910NEW_TRIAL: changed
LOWMay 21, 2026NCT07540910NEW_TRIAL: changed

Frequently asked questions about EDP-978

What is EDP-978 used for?

EDP-978 is an investigational small molecule being developed for chronic inducible urticaria, a type of chronic hives triggered by specific physical stimuli. It is also being studied in chronic spontaneous urticaria. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.

What does EDP-978 target?

EDP-978 is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults, with the goal of treating chronic inducible urticaria and chronic spontaneous urticaria.

Who makes EDP-978?

EDP-978 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA. The company is conducting a Phase 1 clinical trial of EDP-978 in the United States.

What phase is EDP-978 in?

EDP-978 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting healthy adult volunteers to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics.

What clinical trials is EDP-978 in?

EDP-978 is being studied in a Phase 1 clinical trial with the identifier NCT07540910. This randomized, double-blind, placebo-controlled trial is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of EDP-978 in healthy adults. The trial is recruiting participants in the United States.

Is EDP-978 the same as any other drug?

EDP-978 is a distinct investigational drug candidate developed by Enanta Pharmaceuticals. No alternative names for EDP-978 have been disclosed. It is being studied specifically for chronic inducible urticaria and chronic spontaneous urticaria.