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CVL-354

Phase 1

Healthy Participants | Small molecule | Other |AbbVie Inc.|Last Updated: Jul 13, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

CVL-354 · 2 trials · 2 indications

Phase 1 2
NCT05547542Positron Emission Tomography (PET) Trial to Evaluate Target Occupancy of CVL-354 at Kappa and Mu Opioid Receptors in Brain Following Oral DosingOpioid Use Disorder
COMPLETED19 Analytics
NCT05138653A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy ParticipantsHealthy Participants
COMPLETED73 Analytics
PHASE1COMPLETED
Positron Emission Tomography (PET) Trial to Evaluate Target Occupancy of CVL-354 at Kappa and Mu Opioid Receptors in Brain Following Oral Dosing
Opioid Use DisorderUnlock trial analytics
PHASE1COMPLETED
A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
Healthy ParticipantsUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
CVL-354DRUGOral solution/capsule
[11C]-LY2795050DRUGIV injection
[11C]-carfentanilDRUGIV injection
PlaceboDRUGPlacebo matched to CVL-354
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Frequently asked questions about CVL-354

What is CVL-354 used for?

CVL-354 is an investigational small molecule being developed by AbbVie Inc. (ABBV) for opioid use disorder. It has been studied in healthy participants and in a positron emission tomography (PET) trial evaluating target occupancy at kappa and mu opioid receptors in the brain following oral dosing.

What does CVL-354 target?

CVL-354 targets kappa and mu opioid receptors in the brain. A completed Phase 1 positron emission tomography (PET) trial evaluated target occupancy of CVL-354 at these receptors following oral dosing in participants with opioid use disorder.

Who makes CVL-354?

CVL-354 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.

What phase is CVL-354 in?

CVL-354 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in healthy participants and one in participants with opioid use disorder.

What clinical trials is CVL-354 in?

CVL-354 has been studied in two completed Phase 1 trials. NCT05138653 was a single and multiple ascending dose trial in 73 healthy participants. NCT05547542 was a positron emission tomography (PET) trial in 19 participants with opioid use disorder to evaluate target occupancy at kappa and mu opioid receptors.