Eli Lilly Expands Bipolar Disorder Pipeline With New Phase 2 Brenipatide Trial

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

Eli Lilly is advancing its mental health pipeline with a new Phase 2 study called RENEW-Bipolar-1, formally titled “A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder.” The trial aims to see whether adding brenipatide to standard care can delay relapse in adults with bipolar disorder, a key outcome that could support a new treatment option in a large and underserved market.

The study tests brenipatide, an injectable drug given under the skin, used alongside existing standard treatments for bipolar disorder. Two dose levels of brenipatide are being compared against a placebo injection, all on top of usual care, to see whether the drug can help keep symptoms from worsening over time.

This is an interventional Phase 2 trial with randomized assignment to treatment groups. Participants are placed in one of three parallel arms: two different brenipatide doses plus standard care, or placebo plus standard care. The study is double-blind, meaning neither patients nor study doctors know who is receiving brenipatide versus placebo. The main goal is treatment-focused: to measure how long patients can stay stable before symptoms of bipolar disorder return or worsen.

The study includes a screening period of about one month, a treatment period of at least six months, and a follow-up period of about two months. According to the record, the study was first submitted on November 21, 2025, and the most recent update was filed on January 12, 2026, with the status listed as “recruiting.” These dates show the program is active and still enrolling, with key outcome data likely several years away, placing any regulatory or commercial impact in the medium term.

For investors, this update reinforces Lilly’s long-term push into neuroscience, complementing its strong positions in diabetes, obesity, and Alzheimer’s disease. While Phase 2 psychiatric assets rarely move a mega-cap stock on their own, continued progress helps support the pipeline narrative and may modestly boost sentiment among growth-focused holders. If brenipatide shows clear relapse-prevention benefits, it could later compete in a broad bipolar disorder market now served by generic mood stabilizers and atypical antipsychotics from companies like Johnson & Johnson and Otsuka. For now, the main takeaway is that Lilly is actively building optionality in mental health, and the trial’s recruiting status signals ongoing commitment rather than near-term earnings impact.

This Eli Lilly bipolar disorder study is currently ongoing and has been recently updated, with further details available on the ClinicalTrials portal.

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