Drugs / Mirikizumab
Mirikizumab
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Crohn jejunoileitis 4 milestones | |||||
| Filed | US (FDA) | — | Crohn jejunoileitis | 2024-10-14 | “Lilly submitted a supplemental Biologics License Application for mirikizumab in Crohn's disease to the U.S. Food and Drug Administration and European Medicines Agency this year.” lilly.com ↗ “Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Europe, Japan and China.” lilly.com ↗ “Lilly submitted marketing applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Canada, Europe, Japan and China.” lilly.com ↗ “Submission of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease in the U.S. and EU;” lilly.com ↗ |
| Filed | Japan (PMDA) | — | Crohn jejunoileitis | 2024-10-14 | “Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Europe, Japan and China.” lilly.com ↗ “Lilly submitted marketing applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Canada, Europe, Japan and China.” lilly.com ↗ |
| Filed | EU (EMA) | — | Crohn jejunoileitis | 2024-10-14 | “Lilly submitted a supplemental Biologics License Application for mirikizumab in Crohn's disease to the U.S. Food and Drug Administration and European Medicines Agency this year.” lilly.com ↗ “Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Europe, Japan and China.” lilly.com ↗ “Lilly submitted marketing applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Canada, Europe, Japan and China.” lilly.com ↗ “Submission of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease in the U.S. and EU;” lilly.com ↗ |
| Filed | China (NMPA) | — | Crohn jejunoileitis | 2024-10-14 | “Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Europe, Japan and China.” lilly.com ↗ “Lilly submitted marketing applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Canada, Europe, Japan and China.” lilly.com ↗ |
| Filed ulcerative colitis 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | ulcerative colitis | 2023-04-13 | “FDA has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative colitis (UC).” lilly.com ↗ |
| Filed | US (FDA) | — | ulcerative colitis | 2022-04-28 | “Lilly submitted mirikizumab to the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderately-to-severely active ulcerative colitis.” lilly.com ↗ “In the first quarter of 2022, Lilly submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)” lilly.com ↗ |
| Filed | EU (EMA) | — | ulcerative colitis | — | “and a Marketing Authorization Application (MAA) in the European Union for approval of mirikizumab in UC.” lilly.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Omvoh | — | 2023-05-26 | europa.eu ↗ |
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials · 2 met primary | ||||||
| Phase 1 | NCT07446101 | Mar 2026 → Feb 2027 expected | — | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05069896 | Oct 2021 → Jun 2022 | — | Eli Lilly and Company | Completed | Mixed |
| Phase 1 | NCT04607733 | Nov 2020 → May 2021 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT04548219 | Sep 2020 → Jan 2021 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT04137380 | Dec 2019 → Dec 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03886948 | Mar → Oct 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03718884 | Oct 2018 → Oct 2019 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03748940 | Oct 2018 → Jun 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03662100 | Sep 2018 → Jan 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03456713 | Mar → Aug 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03220126 | Jul 2017 → Feb 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03188510 | Jun → Nov 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03053622 | Apr 2017 → Apr 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02568423 | Dec 2015 → Jul 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01947933 | Oct 2013 → Feb 2015 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 27 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07483073 | May 2026 → Jun 2027 expected | Crohn disease, ulcerative colitis | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT07483099 | May 2026 → Jun 2027 expected | Crohn disease | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT06598943 | Oct 2024 → Aug 2026 overdue | ulcerative colitis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04004611 | May 2020 → Mar 2023 | ulcerative colitis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02891226 | Dec 2016 → Dec 2018 | Crohn disease | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02899988 | Sep 2016 → Jun 2017 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02589665 | Dec 2015 → Dec 2017 | ulcerative colitis | Eli Lilly and Company | Completed | Missed primary |
| Phase 314 trials · 5 met primary | ||||||
| Phase 3 | NCT06937099 | Jun 2025 → May 2028 expected | Crohn disease, obesity disorder | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT05509777 | Mar 2024 → Dec 2027 expected | Crohn disease | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT05784246 | Nov 2023 → May 2026 | ulcerative colitis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT05767021 | May 2023 → Aug 2024 | ulcerative colitis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT04844606 | May 2021 → Dec 2030 expected | Crohn disease, ulcerative colitis | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT04469062 | Apr 2021 → Mar 2024 | ulcerative colitis | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04232553 | Jun 2020 → Nov 2024 overdue | Crohn disease | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03926130 | Jul 2019 → Aug 2023 | Crohn disease | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03524092 | Oct 2018 → Nov 2021 | ulcerative colitis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03556202 | Sep 2018 → Feb 2022 | psoriasis | Eli Lilly and Company | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03519945 | Jul 2018 → Mar 2026 overdue | ulcerative colitis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03535194 | Jun 2018 → Mar 2020 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03518086 | Jun 2018 → Jan 2021 | ulcerative colitis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03482011 | Apr 2018 → Mar 2019 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT07612267 | Aug 2026 → Sep 2028 expected | inflammatory bowel disease, lactation disease | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 4 | NCT07659353 | Aug 2026 → Mar 2029 expected | Crohn disease | University Hospital Schleswig-Holstein | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07292012 | May 2026 → Nov 2027 expected | Crohn disease | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Recruiting | No outcome recorded |
| Phase 4 | NCT06997965 | Apr 2026 → Sep 2027 expected | Crohn disease | Alimentiv Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT07235904 | Dec 2025 → Mar 2028 expected | ulcerative colitis | University Hospital Schleswig-Holstein | Recruiting | No outcome recorded |
| Phase 4 | NCT06864403 | Aug 2025 → Apr 2027 expected | pouchitis | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 4 | NCT07059130 | Jul 2025 → Jan 2026 overdue | Crohn disease, ulcerative colitis | Rubix LS | Not yet recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT07186101 Background | Nov 2025 → May 2027 expected | ulcerative colitis | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06937086 Background | Jun 2025 → Apr 2028 expected | obesity disorder, ulcerative colitis | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 4 | NCT07615075 Comparator | Sep 2026 → Sep 2029 expected | schizoaffective disorder, schizophrenia | University of Maryland, Baltimore | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07686757 Comparator | Aug 2026 → Jun 2028 expected | Crohn disease, ulcerative colitis | Specialty Networks Research. | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06626165 Comparator | Jul 2024 → Sep 2025 | ulcerative colitis | Showa Inan General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-05-05 | Eli Lilly and Company | Results Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years lilly.com ↗
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. |
| 2026-02-19 | Eli Lilly and Company | Results Patients with Crohn's disease maintained steroid-free remission for three years with Lilly's Omvoh (mirikizumab-mrkz) lilly.com ↗
New long-term data from Eli Lilly and Company (NYSE: LLY) showed Omvoh (mirikizumab-mrkz) delivered durable efficacy through three years in adults with moderately to severely active Crohn's disease. |
| 2025-10-27 | Eli Lilly and Company | Results Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis lilly.com ↗
New data from Eli Lilly and Company (NYSE: LLY) showed Omvoh-treated patients with moderately to severely active ulcerative colitis (UC) and bowel urgency experienced early improvements in bowel urgency severity, frequency and stool deferral time by Week 12. |
| 2025-10-27 | Eli Lilly and Company | Regulatory Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). |
| 2025-10-07 | Eli Lilly and Company | Results Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive patient outcomes in ulcerative colitis lilly.com ↗
New data from Eli Lilly and Company (NYSE: LLY) showed Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active ulcerative colitis (UC) achieve sustained, long-term outcomes through four years. |
| 2025-02-07 | Eli Lilly and Company | Results Most patients on Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease achieved sustained clinical remission and endoscopic response at two years lilly.com ↗ |
| 2025-01-15 | Eli Lilly and Company | Regulatory FDA approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults. |
| 2024-12-13 | Eli Lilly and Company | Regulatory Lilly's Omvoh® (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease lilly.com ↗ |
| 2024-10-28 | Eli Lilly and Company | Results Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced results from two, multi-year, Phase 3 studies that showed patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease. |
| 2024-10-14 | Eli Lilly and Company | Results Lilly reports one-year histologic outcomes in Phase 3 study of mirikizumab compared to ustekinumab for Crohn's disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced data demonstrating more patients with moderately to severely active Crohn's disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. |
| 2024-05-21 | Eli Lilly and Company | Results More than one-half of patients with Crohn's disease treated with Lilly's mirikizumab achieved clinical remission at one year, including patients with previous biologic failure lilly.com ↗
Mirikizumab patients achieved high rates of combined clinical remission and endoscopic response, two important treatment targets that are difficult to achieve in the same patient, at one year. |
| 2023-10-26 | Eli Lilly and Company | Regulatory FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. |
| 2023-10-12 | Eli Lilly and Company | Results Lilly's Mirikizumab Helped Patients with Crohn's Disease Achieve Long-Term Remission in Phase 3 Trial lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that mirikizumab (an investigational interleukin-23p19 antagonist) met the co-primary and all major secondary endpoints compared to placebo in VIVID-1, a Phase 3 study evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease. |
| 2023-05-09 | Eli Lilly and Company | Results Lilly Discloses First-in-Class, Interim Phase 2 Data in Pediatric Patients and New Analysis from Phase 3 Program in Adult Patients for Mirikizumab in Ulcerative Colitis lilly.com ↗
The PK, safety and efficacy data were consistent with the adult Phase 3 LUCENT-1 study and support the planned pediatric Phase 3 studies in UC and Crohn's disease starting later this year. |
| 2023-04-13 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative colitis (UC). |
| 2022-05-24 | Eli Lilly and Company | Results Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study lilly.com ↗
Among patients who had responded to 12-week induction treatment with mirikizumab, one-half of patients receiving mirikizumab maintenance treatment (49.9%, n=182/365) achieved clinical remission at one year compared to one-fourth of patients on placebo (25.1%, n=45/179, p<0.001). |
| 2022-02-18 | Eli Lilly and Company | Results Nearly Two-Thirds of Patients Respond to Mirikizumab Treatment at 12 Weeks in Lilly's First-in-Class Ulcerative Colitis Phase 3 LUCENT-1 Study lilly.com ↗
Patients with moderately-to-severely active ulcerative colitis (UC) who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo in Eli Lilly and Company's (NYSE: LLY) pivotal LUCENT-1 Phase 3 study. |
| 2021-12-14 | Eli Lilly and Company | Results Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022 lilly.com ↗
These results build on the positive outcomes from LUCENT-1. |
| 2021-10-01 | Eli Lilly and Company | Results At Week 104, 75% of Patients with Ulcerative Colitis Taking Mirikizumab Maintained Symptomatic Remission in Phase 2 Study lilly.com ↗
Patients taking mirikizumab for their moderately to severely active ulcerative colitis (UC), were in symptomatic remission for up to two years as demonstrated in new results from Eli Lilly and Company's (NYSE: LLY) Phase 2 study. |
| 2021-07-09 | Eli Lilly and Company | Results Mirikizumab Up-Regulates Genes Associated with Mucosal Healing in Ulcerative Colitis for Up to One Year in Phase 2 Study lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced new Phase 2 data showing that gene expression changes induced by mirikizumab in patients with ulcerative colitis (UC) over a 12-week induction treatment were maintained for up to one year. |
| 2021-05-22 | Eli Lilly and Company | Results Mirikizumab Improves Fatigue in Patients with Crohn's Disease in Phase 2 Trial lilly.com ↗
The data from Lilly's Phase 2 study show mirikizumab may help improve fatigue in patients with moderately to severely active Crohn's disease, reinforcing the importance of further study into mirikizumab as a potential treatment for those living with this disease. |
| 2021-03-16 | Eli Lilly and Company | Results Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study lilly.com ↗
In LUCENT-1, mirikizumab met the primary endpoint of clinical remission at Week 12 compared to placebo (p<0.0001). |
| 2020-10-12 | Eli Lilly and Company | Results Mirikizumab Shows Continued Symptom Improvement and Reduction of Intestinal Inflammation in Patients with Crohn's Disease in 52-Week Phase 2 Trial lilly.com ↗ |
| 2020-07-17 | Eli Lilly and Company | Results Lilly's Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis lilly.com ↗
Eli Lilly and Company (NYSE:LLY) announced today that mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of IL23, met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) |
| 2019-05-21 | Eli Lilly and Company | Results Lilly's Mirikizumab Met Primary Endpoint and Key Secondary Endpoints in Phase 2 Study, Including Reductions of Gastrointestinal Lesions lilly.com ↗
Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. |
| 2018-06-05 | Eli Lilly and Company | Results DDW 2018: Patients with Moderate-to-Severe Ulcerative Colitis Achieved Clinical and Endoscopic Remission with Mirikizumab in Phase 2 Trial lilly.com ↗
The results showed that patients treated with mirikizumab achieved significantly greater rates of clinical remission at 12 weeks compared to placebo. |
All press releases naming this drug 27 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mirikizumab | “we are conducting a randomized, double-blind clinical trial of mirikizumab, an FDA-approved monoclonal antibody targeting IL-23, in addition to current antipsychotics, in...” NCT07615075 ↗ |
| Known as | LY3074828 | “A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease” NCT05509777 ↗ |
| Known as | Mirikizumab-mrkz | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990014 ↗ |
| Known as | Omvoh | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990014 ↗ |
| Action | Inhibit | “an Anti-IL-23 Humanized Antibody” NCT01947933 ↗ |
| Modality | Monoclonal antibody | “an Anti-IL-23 Humanized Antibody” NCT01947933 ↗ |
| Route | Intravenous | “mirikizumab, IV” NCT01947933 ↗ |