Eli Lilly Pushes Into Opioid Use Disorder With New Brenipatide Phase 2 Trial

Eli Lilly And Company (LLY) announced an update on their ongoing clinical study.

The RENEW-Op-1 study, officially titled “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1),” aims to test if Eli Lilly’s brenipatide can safely improve outcomes for people in early recovery from opioid use disorder when added to standard buprenorphine therapy. It targets a large unmet need in addiction care, where better relapse prevention tools could support long-term recovery and expand Lilly’s footprint in neuroscience and addiction treatment.

The main treatment under study is brenipatide (also known as LY3537031), given as a subcutaneous injection and used on top of usual buprenorphine treatment, which is taken under the tongue or in the cheek. The trial compares several doses of brenipatide plus buprenorphine against placebo plus buprenorphine, so the goal is to see whether adding brenipatide can help patients stay in early recovery more effectively than standard care alone.

This is a Phase 2 interventional trial with a randomized, parallel-group design, meaning participants are assigned by chance to different treatment arms that run side by side. The study is double-blind in its main part, so neither patients nor investigators know who gets brenipatide or placebo, and the primary purpose is treatment-focused, aiming to show whether the new drug adds meaningful clinical benefit when layered onto existing opioid use disorder therapy.

The study is listed as “Not yet recruiting,” with initial submission to the registry on Feb. 11, 2026, signaling that sites are being prepared and regulatory and operational steps are still underway. The record was last updated on Feb. 18, 2026, which tells investors this is a fresh entry in Lilly’s pipeline and that key dates such as primary and final completion are still ahead, leaving room for future catalysts once enrollment and data collection are underway.

For investors in LLY, this trial marks an expansion into the opioid use disorder space, a large and politically important market where payers and policymakers are seeking better tools to curb relapse and overdose. While Phase 2 data are years away and will not move near-term earnings, a successful result could support a differentiated addiction franchise, potentially adding a new growth vector alongside Lilly’s core metabolic and neuropsychiatric portfolio and positioning it against emerging efforts in addiction treatment from peers and smaller biotech players.

The RENEW-Op-1 trial of brenipatide in opioid use disorder is an active, updated clinical program, and further operational details and future milestones are available on the ClinicalTrials portal.

To learn more about LLY’s potential, visit the Eli Lilly And Company drug pipeline page.