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A randomized, single-dose, double-blind, parallel-group, Phase 1b inpatient study comparing the safety and efficacy of Omeros' lead oral PDE7 inhibitor to placebo in the treatment of adults with CUD who receive concurrent intravenous cocaine

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Trial Profile

A randomized, single-dose, double-blind, parallel-group, Phase 1b inpatient study comparing the safety and efficacy of Omeros' lead oral PDE7 inhibitor to placebo in the treatment of adults with CUD who receive concurrent intravenous cocaine

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 01 Jun 2025

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At a glance

  • Drugs OMS 527 (Primary) ; Cocaine
  • Indications Cocaine-related disorders
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 15 May 2025 According to Omeros Corporation media release, an enrollment in the study is expected to begin later this year and a readout of data from the study is anticipated late this year or in early 2026.
  • 31 Mar 2025 According to Omeros Corporation media release, ongoing Phase 3 program in PNH, remains on track to readout data late next year.
  • 13 Mar 2025 According to Omeros Corporation media release, the company has received a funding commitment from the National Institute on Drug Abuse (NIDA) for the upcoming year (April 1, 2025 through March 31, 2026) in the amount of $4.02 million, which will fund the Phase 1b clinical trial in patients with CUD to assess OMS527 safety and efficacy, with initial data readout expected in the Q4 2025. Omeros is developing OMS527 for the treatment of CUD at NIDA's direct request.

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