Eli Lilly Advances Brenipatide Into Phase 2 Trials for Opioid Use Disorder and Schizophrenia
Eli Lilly has launched two Phase 2 trials for brenipatide (LY3537031): RENEW-Op-1 for opioid use disorder and RENEW-Scz-1 for schizophrenia. Both are randomized, double-blind, placebo-controlled studies that are not yet recruiting as of February 2026.
Eli Lilly And Company (LLY) has advanced its investigational drug brenipatide (LY3537031) into two separate Phase 2 clinical trials — one targeting opioid use disorder and another targeting schizophrenia. Both studies are listed as "Not yet recruiting," with registrations submitted in February 2026.
The RENEW-Op-1 study is a Phase 2, randomized, double-blind, placebo-controlled trial with a separate open-label cohort designed to evaluate the efficacy and safety of brenipatide as an adjunctive treatment to transmucosal buprenorphine with or without naloxone in early recovery of participants with opioid use disorder. The trial aims to test whether adding brenipatide — given as a subcutaneous injection — to standard buprenorphine therapy can safely improve outcomes for people in early recovery. Several doses of brenipatide plus buprenorphine will be compared against placebo plus buprenorphine. The study was first submitted to the registry on Feb. 11, 2026, and last updated on Feb. 18, 2026.
The RENEW-Scz-1 trial is a separate Phase 2 study testing brenipatide as an add-on treatment for adults with schizophrenia. The goal is to determine whether adding brenipatide to standard care improves symptoms and remains safe over time. The treatment group receives brenipatide as a subcutaneous injection plus standard care drugs, while the control group receives a placebo injection plus the same standard care. The trial includes a one-month screening phase, up to 12 months of treatment, and approximately two months of follow-up, meaning each participant may be involved for around 15 months. The study was first submitted on Feb. 6, 2026, and last updated on Feb. 12, 2026.
Both studies are interventional, randomized, double-blind, and parallel-arm in design. Neither patients nor investigators know who receives brenipatide or placebo. Recruitment has not yet started for either trial, and key dates such as primary and final completion remain ahead.