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Bretisilocin

Phase 1

Undisclosed | Small molecule | Other |AbbVie Inc.|Trials Updated: Sep 30, 2026

Bretisilocin development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Bretisilocin clinical trials

Bretisilocin · 1 trial · 1 indication

Phase 1 1
NCT07604558A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult ParticipantsHealthy Volunteer
COMPLETED26 Analytics
PHASE1COMPLETED
A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Adverse Events
Up to approximately 32 days

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group 1-Bretisilocin-JapaneseEXPERIMENTALParticipants will receive bretisilocin intramuscular (IM) injection on day 1.
Group 1-Bretisilocin-Han ChineseEXPERIMENTALParticipants will receive bretisilocin intramuscular (IM) injection on day 1.
Group 1-Bretisilocin-Non-AsianEXPERIMENTALParticipants will receive bretisilocin intramuscular (IM) injection on day 1.

Interventions

NameTypeDescription
BretisilocinDRUGIntramuscular Injection
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Group 1: Healthy adult Japanese male or female; • Japanese participants must be first-generation Japanese of full Japanese parentage residing outside of Japan for less than 5 years. * Group 2: Healthy adult Han Chinese male or female • Han Chinese participants must be fi...

Countries:United States
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Recent Changes (Last 90 Days)

HIGHSep 30, 2026NCT07604558Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 30, 2026NCT07604558Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMAug 31, 2026NCT07604558Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 31, 2026NCT07604558Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Bretisilocin

What is Bretisilocin?

Bretisilocin is an investigational small molecule being developed by AbbVie Inc. (ticker ABBV). It is in Phase 1 clinical development and has been studied as an intramuscular injection in healthy adult volunteers. Its specific therapeutic indications have not been publicly disclosed.

Who is developing Bretisilocin?

Bretisilocin is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug.

What phase is Bretisilocin in?

Bretisilocin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for the program.

What clinical trials has Bretisilocin been studied in?

Bretisilocin has been evaluated in one completed Phase 1 trial, NCT07604558, titled a study to assess adverse events and how bretisilocin intramuscular injection moves through the body of healthy adult participants. The trial enrolled 26 healthy adult volunteers in the United States and used a controlled design.

How is Bretisilocin administered?

Bretisilocin has been studied as an intramuscular injection. The completed Phase 1 trial, NCT07604558, assessed adverse events and how the intramuscular injection moves through the body of healthy adult participants. It is a small molecule in clinical development.