Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years

Rhea-AI Summary

Lilly (NYSE: LLY) reported that Omvoh (mirikizumab-mrkz) is the first IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years.

In the LUCENT-3 open-label extension, 63.5% of patients who achieved disease clearance at one year sustained it at four years; 61.3% sustained disease clearance with endoscopic normalization. Long-term safety was consistent with known profiles: 12% serious adverse events and 7% discontinued for adverse events.

Positive

• 63.5% of patients sustained disease clearance from year 1 to year 4
• 61.3% sustained disease clearance with endoscopic normalization at four years
• Reported one UC-related hospitalization and zero UC-related surgeries in the three-year extension
• Omvoh approved in 47 countries and has a U.S. single-injection maintenance regimen

Negative

• 12% of long-term patients reported a serious adverse event
• 7% discontinued treatment due to adverse events
• Analysis of sustained disease clearance was not pre-specified in the protocol

News Market Reaction – LLY

+2.16%

+2.16% Session close to close

In the May 5 session, LLY gained 2.16%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement extends Omvoh’s profile by showing that 63.5% of ulcerative colitis patients who a...

Analysis

This announcement extends Omvoh’s profile by showing that 63.5% of ulcerative colitis patients who achieved disease clearance at one year maintained it through four years, with low UC‑related hospitalizations and surgeries in the extension period. The safety profile remained consistent with prior studies. In context of Lilly’s recent strong Q1 2026 results and active pipeline build, this adds long‑term support to its immunology portfolio. Investors may watch upcoming combination and pediatric trial readouts as the next key inflection points.

Key Figures

Disease clearance durability: 63.5% Stringent clearance durability: 61.3% Disease clearance horizon: 4 years +5 more

8 metrics

Disease clearance durability 63.5% UC patients on Omvoh maintaining disease clearance from year 1 to year 4

Stringent clearance durability 61.3% UC patients maintaining stringent disease clearance with endoscopic normalization to year 4

Disease clearance horizon 4 years Duration of continuous Omvoh treatment with durable disease clearance in LUCENT‑3

UC‑related hospitalizations 1 hospitalization UC‑related hospitalizations during three‑year LUCENT‑3 long‑term extension

UC‑related surgeries 0 surgeries UC‑related surgeries reported during three‑year LUCENT‑3 long‑term extension

Serious adverse events 12% Patients reporting a serious adverse event after one year of Omvoh maintenance entering LUCENT‑3

Discontinuations due to AEs 7% Patients discontinuing Omvoh because of an adverse event in LUCENT‑3

Countries with approval 47 countries Regulatory approvals for Omvoh in UC and Crohn’s disease

Historical Context

5 past events · Latest: May 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 04	Dividend declaration	Positive	+0.5%	Announced $1.73 per share Q2 2026 cash dividend and key dates.
Apr 30	Earnings results	Positive	+9.8%	Reported strong Q1 2026 growth and raised full‑year revenue and EPS guidance.
Apr 27	M&A acquisition	Positive	-1.8%	Agreed to acquire Ajax Therapeutics and its Phase 1 Type II JAK2 inhibitor.
Apr 20	M&A acquisition	Positive	-0.8%	Announced Kelonia acquisition to expand in vivo CAR‑T capabilities and pipeline.
Apr 16	Earnings call notice	Neutral	-0.1%	Confirmed date and webcast details for Q1 2026 earnings call.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

LLY has reacted strongly to major fundamentals (earnings beat) while strategic M&A has occasionally seen short‑term share price softness.

Recent Company History

Over the past few weeks, Eli Lilly reported very strong Q1 2026 results on Apr 30, with revenue of $19.8 billion and raised 2026 guidance, which coincided with a 9.8% gain. Two sizeable acquisitions in late April produced modest negative reactions, suggesting some investor caution around deal spending despite strategic fit. A steady dividend declaration on May 4 and scheduling of the earnings call underscored financial strength. Today’s Omvoh ulcerative colitis durability data extends Lilly’s immunology narrative alongside its cardiometabolic momentum.

Key Terms

ulcerative colitis, interleukin-23p19, histologic remission, endoscopic normalization, +4 more

8 terms

ulcerative colitis medical

"patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh"

A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.

interleukin-23p19 medical

"first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease"

A specific protein subunit that combines with another piece to form interleukin‑23, a signaling molecule the immune system uses to ramp up inflammation; you can think of it as a critical component of an alarm circuit that triggers immune response. It matters to investors because medicines that block this p19 piece can reduce harmful inflammation in conditions like psoriasis and inflammatory bowel disease, making it a major drug target whose clinical and regulatory progress can drive biotech valuations.

histologic remission medical

"Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission."

Histologic remission means that tissue samples examined under a microscope show no signs of active disease after treatment; it’s an objective, lab-based proof that the underlying problem has been erased at the cellular level. Investors care because regulators and doctors often rely on this kind of hard evidence to approve drugs, guide prescriptions and predict long-term outcomes—think of it as inspecting a building’s foundation for cracks rather than just checking the surface paint.

endoscopic normalization medical

"most stringent measure — requiring endoscopic normalization in addition to symptomatic"

Endoscopic normalization is when a physician uses a camera-equipped tube (an endoscope) to inspect the inside of an organ and finds that tissue which was previously inflamed, damaged or abnormal now appears normal. Investors care because this visible, objective sign is often used as a clinical-trial endpoint or treatment goal that can support regulatory approval and wider patient adoption, influencing a therapy’s commercial prospects—like a clear before-and-after photo showing a problem fixed.

open-label extension study medical

"continued treatment in LUCENT-3, an open-label extension study."

An open-label extension study is a follow-on clinical trial where participants continue receiving a treatment and both patients and researchers know what is being given (no blind or placebo). It gathers longer-term safety, tolerability and effectiveness information beyond the initial trial, like turning a short test drive into a longer lease to see how the product performs over time. Investors watch these studies for evidence that a treatment is safe and durable, which can affect regulatory approval, market adoption and sales forecasts.

monoclonal antibody medical

"eltrekibart ... a monoclonal antibody that targets neutrophil-driven inflammation"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

integrin inhibitor medical

"zotemtegrast ... an oral α4β7 integrin inhibitor."

A drug that blocks integrins, which are proteins on cell surfaces that help cells stick to each other and to surrounding tissue. By interfering with that “cell glue,” these medicines can change processes like immune response, blood clotting, or tumor spread; that makes them potential treatments for conditions such as autoimmune disease, thrombosis and some cancers. Investors watch integrin inhibitors because clinical trial results, safety issues, or approval decisions strongly affect a drug’s market potential and company value.

Phase 1 trial medical

"AJ1-11095, a first-in-class, once-daily oral Type II JAK2 inhibitor in a Phase 1 trial"

Phase 1 trial is the first stage of testing a new drug or treatment in humans, focused mainly on safety, tolerability and finding the right dose, usually in a small group of volunteers or patients. For investors it matters because clear safety and dosing results reduce development risk, unlock later, larger trials, and can meaningfully change a biotech’s value and timeline — like a prototype’s maiden test flight that shows whether further investment makes sense.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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In LUCENT-3, more than 60% of patients who achieved disease clearance at one year maintained it after four years of continuous Omvoh treatment

Disease clearance is a high clinical bar in UC requiring simultaneous symptomatic, endoscopic and histologic remission

INDIANAPOLIS, May 5, 2026 /PRNewswire/ -- New long-term data from Eli Lilly and Company (NYSE: LLY) show patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment. In the LUCENT-3 open-label extension study, 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years. These results will be presented at Digestive Disease Week^® (DDW) and represent the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through four years in people with UC.¹

Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission. In real-world studies, achieving disease clearance has been associated with reduced rates of hospitalizations and surgery.^2-3 While previously reported four-year Omvoh data showed durable individual outcomes, this new analysis goes further by evaluating those outcomes together as a composite endpoint, reflecting a higher clinical bar.

"Ulcerative colitis is a lifelong disease, and every person living with the condition deserves a treatment that can deliver strong and durable disease control, not just symptom relief," said Adrienne Brown, executive vice president and president of Lilly Immunology. "Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing."

Durable Disease Clearance in Ulcerative Colitis
Disease clearance was evaluated among patients who achieved clinical remission with Omvoh at one year in the LUCENT-2 maintenance study and continued treatment in LUCENT-3, an open-label extension study. This analysis, which was not pre-specified, showed 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years.^* Even at the most stringent measure — requiring endoscopic normalization in addition to symptomatic and histologic remission — 61.3% of patients who achieved it at one year maintained it through four years.^†

"What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years," said Jean-Frédéric Colombel, M.D., director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. "Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in ulcerative colitis. For a progressive disease like ulcerative colitis, that level of durable remission has the potential to change the long-term course of the disease for patients." 

These findings expand the growing body of long-term data on Omvoh in inflammatory bowel disease (IBD), building on previously disclosed four-year results in UC and three-year results in Crohn's disease, including reduction of serious disease-related complications. In LUCENT-3, one UC-related hospitalization and zero UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension.⁴

The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.⁵ The most common adverse reactions (reported in at least 2% of subjects at a higher frequency than placebo) associated with Omvoh treatment in LUCENT-1 and -2 were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.⁶

Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. In UC, Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (NCT05784246) and Crohn's disease (NCT05509777).

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world. In the U.S., Omvoh is also approved for a single-injection maintenance regimen in UC.

About the LUCENT Clinical Trial Program
Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi).

The randomized, double‑blind, placebo‑controlled LUCENT‑1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT‑2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT‑1.⁵

LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total).

Using a modified non-responder imputation analysis to handle discontinuation and missing data, 49.7% and 42.8% of patients who achieved disease clearance and stringent disease clearance at one year, respectively, sustained it at four years.¹

About Omvoh
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.⁶

Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

Endnotes and References
*Observed cases, post hoc. Symptomatic remission [Mayo stool frequency (SF)=0, or SF=1 with a ≥1-point decrease from baseline, and rectal bleeding=0], and histologic-endoscopic mucosal remission [Histologic remission (Geboes score ≤2B.0) and endoscopic remission (endoscopic subscore [ES] of 0 or 1, excluding friability)].
†Observed cases, post hoc. Symptomatic + histologic remission + endoscopic normalization (ES=0).
¹Magro F, et al. Mirikizumab demonstrates consistent and sustained disease clearance at four years of treatment in patients with moderately to severely active ulcerative colitis. Digestive Disease Week 2026. May 2-5, 2026.
²Andronic AM, et al. J Crohn's Colitis. 2023;17(Supplement_1):i529. https://doi.org/10.1093/ecco-jcc/jjac190.0528
³Pai RK, et al. Expert Rev Gastroenterol Hepatol. 2024;18(1-3):73–87. https://doi.org/10.1080/17474124.2024.2326838
⁴Magro F, et al. J Crohn's Colitis. 2026;20(Suppl 1):jjaf231.1300. https://doi.org/10.1093/ecco-jcc/jjaf231.1300
⁵Sands, B, et al. Mirikizumab provides sustained long-term efficacy up to 4 years of treatment for ulcerative colitis: final results from the LUCENT-3 open-label extension study. 2025 United European Gastroenterology Week. October 4-7, 2025.
⁶Omvoh. Prescribing Information. Lilly USA, LLC.

Indications and Usage for Omvoh^® (mirikizumab-mrkz) (in the United States)
Omvoh is an interleukin-23 antagonist indicated for adults with:

• Moderately to severely active ulcerative colitis
• Moderately to severely active Crohn's disease

Important Safety Information for Omvoh (mirikizumab-mrkz)

CONTRAINDICATIONS

Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.

Infections
Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.

Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.

Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Immunizations
Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.

ADVERSE REACTIONS
Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.

MR HCP ISI CD APP

Click to access provided Prescribing Information and Medication Guide. See Instructions for Use provided with the device.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Refer to:	Kelly Hoffman; kelly.hoffman@lilly.com; 765-736-2555 (Lilly media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)

 

 

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SOURCE Eli Lilly and Company

FAQ

What did Lilly (LLY) report about Omvoh disease clearance at DDW on May 5, 2026?

Omvoh showed durable disease clearance through four years, with 63.5% sustaining it from year 1 to year 4. According to the company, this is the first IL-23p19 to demonstrate four-year durable disease clearance in ulcerative colitis.

How common was sustained endoscopic normalization with Omvoh in the LUCENT-3 data (LLY)?

According to the company, 61.3% of patients who achieved disease clearance at one year maintained it through four years with endoscopic normalization. This measure required simultaneous symptomatic, endoscopic and histologic remission.

What safety outcomes did Lilly (LLY) report for Omvoh over the long term?

Long-term safety was consistent with known profiles: 12% reported serious adverse events and 7% discontinued for adverse events. According to the company, no new safety signals were observed in UC patients.

How might the LUCENT-3 Omvoh results affect Omvoh's regulatory footprint for Lilly (LLY)?

Omvoh is already approved in 47 countries and has a U.S. single-injection maintenance approval. According to the company, four-year durability data reinforce its long-term efficacy case for clinical use.

Was the sustained disease clearance analysis for Omvoh pre-specified in the trial (LLY)?

No — the company describes this sustained disease clearance analysis as not pre-specified. According to the company, the result is a post hoc analysis of patients continuing from LUCENT-2 into LUCENT-3.