Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed psoriasis 1 milestone | |||||
| Filed | US (FDA) | — | psoriasis | 2015-04-23 | “The company submitted ixekizumab to the FDA for the treatment of moderate-to-severe plaque psoriasis.” lilly.com ↗ |
| Filed psoriatic arthritis 1 milestone | |||||
| Filed | EU (EMA) | Taltz | psoriatic arthritis | 2017-11-08 | “Lilly also submitted Taltz to the European Medicines Agency (EMA) for the treatment for adult patients with active PsA.” lilly.com ↗ “Lilly also submitted Taltz to the European Medicines Agency (EMA) for the treatment for adult patients with active PsA.” lilly.com ↗ “Lilly also submitted Taltz to the European Medicines Agency (EMA) for the treatment of adult patients with active PsA.” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | TALTZ | — | 2017-12-01 – 2022-05-04 | fda.gov ↗ |
| Approved | EU (EMA) | Taltz | — | 2016-04-25 | europa.eu ↗ |
| Approved | US (FDA) | TALTZ | — | 2016-03-22 | fda.gov ↗ |
Trials 58
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05030415 | Aug 2021 → Mar 2024 | lichen planopilaris, lichen planus | University of New Mexico | Completed | No outcome recorded |
| Phase 19 trials · 2 met primary | ||||||
| Phase 1 | NCT07200986 | Sep 2025 → Mar 2026 overdue | — | Celltrion | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04259346 | Feb 2020 → Feb 2021 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT03848403 | Jan → Jul 2019 | — | Eli Lilly and Company | Terminated | Met primary |
| Phase 1 | NCT03848416 | Jan → Jun 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03073213 | Apr 2017 → May 2019 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02993471 | Dec 2016 → Nov 2017 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02543918 | Sep → Nov 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01236118 | Dec 2010 → Jan 2013 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01253265 | May 2010 → Dec 2011 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 29 trials · 2 met primary | ||||||
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT05309616 | Feb 2025 → May 2026 | idiopathic subglottic stenosis | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT04589325 | Nov 2022 → Feb 2027 expected | type 1 diabetes mellitus | Göteborg University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04979910 | Aug 2021 → Apr 2024 | major depressive disorder | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT03485976 | May 2018 → Oct 2019 | pityriasis rubra pilaris | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT03099538 | Aug 2017 → Jun 2019 | bullous pemphigoid, pemphigoid | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03137160 | May 2017 → Aug 2018 | pyoderma gangrenosum | Ohio State University | Completed | No outcome recorded |
| Phase 2 | NCT01107457 | Apr 2010 → Jan 2011 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00966875 | Aug 2009 → Mar 2011 | rheumatoid arthritis | Eli Lilly and Company | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06374979 | May → Jun 2025 | guttate psoriasis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 326 trials · 19 met primary | ||||||
| Phase 3 | NCT06588283 | Sep 2024 → Jan 2026 | obesity disorder, psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT06588296 | Sep 2024 → Nov 2025 | obesity disorder, psoriatic arthritis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04527380 | Apr 2021 → Feb 2024 overdue | enthesitis-related juvenile idiopathic arthritis, psoriasis-related juvenile idiopathic arthritis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04724629 | Jan → Mar 2021 | COVID-19 | University of Sao Paulo | Completed | No outcome recorded |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT04285229 | Apr 2020 → Mar 2021 | spondyloarthropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03364309 | Apr 2018 → Jun 2020 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03129100 | May 2017 → May 2020 | spondyloarthropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03073200 | Mar 2017 → Feb 2019 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02757352 | Aug 2016 → Mar 2019 | spondyloarthropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02696785 | May 2016 → Dec 2017 | spondyloarthropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02696798 | Apr 2016 → May 2018 | spondyloarthropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02718898 | Apr 2016 → Feb 2017 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02634801 | Jan → Nov 2016 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02561806 | Oct 2015 → May 2016 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02584855 | Sep 2015 → Oct 2018 | psoriatic arthritis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02513550 | Aug 2015 → Nov 2016 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02387801 | Apr → Sep 2015 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02349295 | Dec 2014 → Sep 2016 | psoriatic arthritis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01870284 | Jul 2014 → Apr 2016 | ankylosing spondylitis | Eli Lilly and Company | Withdrawn | No outcome recorded |
| Phase 3 | NCT01777191 | Mar 2013 → May 2014 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01695239 | Dec 2012 → Dec 2014 | psoriatic arthritis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01646177 | Jul 2012 → May 2014 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01624233 | Jun 2012 → Sep 2013 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01597245 | May 2012 → Mar 2014 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01474512 | Nov 2011 → Jun 2014 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 411 trials · 2 met primary | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06398106 | Dec 2024 → Mar 2028 expected | psoriasis | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT05855967 | Jun 2023 → Aug 2024 | psoriasis, psoriatic arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT06085079 | Jun 2022 → Dec 2024 | anterior uveitis, intermediate uveitis, panuveitis, posterior uveitis | Massachusetts Eye Research and Surgery Institution | Unknown | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT04537689 | Dec 2020 → Dec 2027 expected | psoriasis | Singapore General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03942042 | Jul 2019 → Jul 2020 | generalized pustular psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT03573323 | Nov 2018 → Jul 2019 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT03151551 | Aug 2017 → Nov 2018 | psoriatic arthritis | Eli Lilly and Company | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT05503875 | Jan 2023 → Dec 2027 expected | psoriasis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT06945107 Comparator | May 2025 → Jun 2026 overdue | psoriasis | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Active not recruiting | No outcome recorded |
| — | NCT07443956 Comparator | Mar 2026 → Feb 2028 expected | obesity disorder, psoriatic arthritis | NHS Greater Glasgow and Clyde | Recruiting | No outcome recorded |
| — | NCT06811558 Comparator | Feb → Dec 2025 overdue | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| — | NCT05042635 Background | Oct 2021 → Sep 2024 | psoriasis | Shanghai Yueyang Integrated Medicine Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Eli Lilly and Company | Results New Phase 3b data on Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) advance understanding of the interconnected immune and metabolic biology in adults with psoriasis and obesity lilly.com ↗
These data showed that when Taltz and Zepbound were used together, changes were observed in more psoriasis disease-associated and metabolic biomarkers compared to Taltz monotherapy. |
| 2026-08-31 | Eli Lilly and Company | Results New Phase 3b data on Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together showed improved and durable efficacy at one year in adults with psoriatic disease and obesity lilly.com ↗
New data show these improvements were maintained or further improved through Week 52, with no new safety concerns identified. |
| 2026-03-28 | Eli Lilly and Company | Results Phase 3b data presented at AAD Annual Meeting show Lilly's Taltz (ixekizumab) plus Zepbound (tirzepatide) delivered superior efficacy for adults with psoriatic arthritis and obesity lilly.com ↗
At the primary endpoint of 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all key secondary endpoints for statistically significant superiority to Taltz monotherapy. |
| 2026-02-18 | Eli Lilly and Company | Results Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with psoriasis and obesity or overweight lilly.com ↗
At 36 weeks, treatment with Taltz and Zepbound met the primary and all key secondary endpoints, delivering superior skin clearance and weight loss versus Taltz monotherapy. |
| 2026-01-08 | Eli Lilly and Company | Results Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with active psoriatic arthritis and obesity or overweight lilly.com ↗
At 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all key secondary endpoints for superiority to Taltz monotherapy. |
| 2021-06-01 | Eli Lilly and Company | Results Taltz® Showed Consistent, Long-Term Improvement in Key Signs and Symptoms of Axial Spondyloarthritis Through Two Years in Phase 3 Study lilly.com ↗
In COAST-Y, Taltz showed consistent and sustained long-term improvements in signs and symptoms, functionality and quality of life in patients with r- and nr-axSpA. |
| 2021-04-23 | Eli Lilly and Company | Results Taltz® Delivers More Cumulative Days with Completely Clear Skin for Adults with Psoriasis Compared to Seven Other Biologics in Novel Network Meta-Analysis lilly.com ↗
Taltz offered patients with psoriasis the greatest number of cumulative days of completely clear skin compared to adalimumab, brodalumab, etanercept, guselkumab, risankizumab, secukinumab and ustekinumab. |
| 2020-10-29 | Eli Lilly and Company | Results New Data at EADV 2020 Confirm Taltz® (ixekizumab) Demonstrates Sustained Long-Term Efficacy in Patients with Psoriasis and Psoriatic Arthritis lilly.com ↗
With Taltz, 83%, 73% and 89% of patients reported complete clearance in scalp, nail and palmoplantar psoriasis, respectively. |
| 2020-06-12 | Eli Lilly and Company | Results Lilly Highlights the Evolution of Its Dermatology Portfolio at Annual American Academy of Dermatology Meeting (AAD) lilly.com ↗
Ixekizumab demonstrated longer medication persistence than other biologics in the treatment of psoriasis patients: Results from IBM MarketScan® database |
| 2020-06-03 | Eli Lilly and Company | Results EULAR 2020: Lilly's Taltz® (ixekizumab) Continues to Show Robust and Consistent Efficacy in Psoriatic Arthritis lilly.com ↗ |
| 2020-06-01 | Eli Lilly and Company | Regulatory Lilly's Taltz® (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA) lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. |
| 2020-03-30 | Eli Lilly and Company | Regulatory Lilly's Taltz® (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis lilly.com ↗
These results and the subsequent FDA approval make a strong case for Taltz as an effective treatment option for doctors to consider for pediatric patients with moderate to severe plaque psoriasis. |
| 2019-11-12 | Eli Lilly and Company | Results ACR 2019: Lilly Presents Positive New Data from COAST-X, a Phase 3 Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis lilly.com ↗ |
| 2019-11-12 | Eli Lilly and Company | Results ACR 2019: Lilly Presents 52-Week Head-to-Head (SPIRIT-H2H) Data from Taltz® (ixekizumab) Versus Humira® (adalimumab) Trial in Psoriatic Arthritis lilly.com ↗
Taltz met the primary and all major secondary endpoints of the study. |
| 2019-10-12 | Eli Lilly and Company | Results Lilly Presents Positive Results for Taltz® (ixekizumab) in Pediatric Patients with Moderate to Severe Plaque Psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress lilly.com ↗
Results from our study indicate that Taltz may have the potential to clear skin and reduce itch in pediatric patients with moderate to severe plaque psoriasis, |
| 2019-10-03 | Eli Lilly and Company | Results New Head-to-Head Data Show Taltz® (ixekizumab) Superiority versus TREMFYA® (guselkumab) in People with Moderate to Severe Plaque Psoriasis lilly.com ↗
Taltz met the primary endpoint of superiority vs. TREMFYA in the proportion of patients with moderate to severe plaque psoriasis achieving complete skin clearance as measured by PASI 100 at Week 12, as well as key secondary endpoints. |
| 2019-08-26 | Eli Lilly and Company | Regulatory Lilly Receives U.S. FDA Approval for Taltz® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). |
| 2019-08-13 | Eli Lilly and Company | Results Lilly Announces Superiority of Taltz® (ixekizumab) versus TREMFYA® (guselkumab) in Delivering Total Skin Clearance at Week 12 in Topline Results from Head-to-Head (IXORA-R) Trial in People Living with Moderate to Severe Plaque Psoriasis lilly.com ↗
At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100. |
| 2019-06-14 | Eli Lilly and Company | Results Lilly Presents Positive Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis at the European Congress of Rheumatology lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study in patients with active psoriatic arthritis (PsA) as a late-breaking abstract at the European Congress of Rheumatology (EULAR) in Madrid, Spain on June 15. |
| 2019-06-11 | Eli Lilly and Company | Results Lilly to Present 5-Year Sustained Efficacy and Safety Results for Taltz® (ixekizumab) in Patients with Plaque Psoriasis at the World Congress of Dermatology lilly.com ↗
Patients with moderate- to severe plaque psoriasis who continued to receive Taltz maintained high levels of skin clearance with no unexpected safety outcomes for up to five years of treatment. |
| 2019-06-06 | Eli Lilly and Company | Results Lilly to Present New Data and Commitment to Patient-Centered Solutions at the Annual European Congress of Rheumatology lilly.com ↗
Ixekizumab Significantly Improves Self-Reported Overall Health as Measured by SF-36 in Patients with Active Ankylosing Spondylitis/Radiographic Axial Spondyloarthritis Naive to Biological Therapy: 52 Week Results of a Phase 3 Trial |
| 2019-04-22 | Eli Lilly and Company | Results Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis lilly.com ↗
These results provide clinical evidence to support a potential role for Taltz in the treatment of nr-axSpA patients. |
| 2018-12-17 | Eli Lilly and Company | Results Lilly Announces Positive Top-Line Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis lilly.com ↗
In addition, Taltz met the major secondary endpoints. |
| 2018-10-22 | Eli Lilly and Company | Results ACR 2018: Lilly Announces Positive Results for Two Phase 3 Studies of Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) lilly.com ↗
In both studies, Taltz demonstrated a statistically significant and clinically meaningful improvement in proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) over 16 weeks compared to placebo. |
| 2018-06-28 | Eli Lilly and Company | Results Lilly Announces Positive Top-Line Results for Second Phase 3 Study of Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) for TNF Inhibitor-Experienced Patients lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). |
| 2018-05-22 | Eli Lilly and Company | Regulatory Lilly's Taltz® (ixekizumab) Receives the First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for Taltz® (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. |
| 2018-02-19 | Eli Lilly and Company | Results AAD 2018: Treatment with Lilly's Taltz® (ixekizumab) Resulted in Improvement in Impact of Genital Psoriasis on Sexual Activity lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that patients with moderate-to-severe genital psoriasis treated with Taltz® (ixekizumab) reported a greater decrease in the impact of their condition on sexual activity compared to placebo after 12 weeks of treatment. |
| 2018-02-13 | Eli Lilly and Company | Results Lilly Announces Positive Top-Line Phase 3 Results for Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) lilly.com ↗
Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo. |
| 2017-12-01 | Eli Lilly and Company | Regulatory Lilly's Taltz® (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA). |
| 2017-11-08 | Eli Lilly and Company | Results ACR/ARHP 2017: Long-Term Use of Lilly's Taltz® (ixekizumab) Shows Efficacy Improvements in Psoriatic Arthritis for Patients with Prior Inadequate Response or Intolerance to TNF Inhibitors lilly.com ↗
Over the 52-week extension period, the majority of patients treated with Taltz achieved at least a 20-percent improvement in disease activity, as defined by the American College of Rheumatology (ACR 20), the primary endpoint of the study extension. |
| 2017-06-16 | Eli Lilly and Company | Results EULAR 2017: Lilly's Taltz® (ixekizumab) Demonstrated No Progression or Minimal Progression of Radiographic Disease in Patients with Psoriatic Arthritis Through 52 Weeks lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the majority of patients with active psoriatic arthritis (PsA) treated with Taltz® (ixekizumab) exhibited either no progression or minimal progression of radiographic structural joint damage through 52 weeks of treatment. |
| 2017-06-15 | Eli Lilly and Company | Results EULAR 2017: Lilly's Taltz® (ixekizumab) Demonstrated Significant Improvements in Disease Signs and Symptoms at 24 Weeks Among Patients with Active Psoriatic Arthritis Who Had Prior Inadequate Response or Intolerance to TNF Inhibitors lilly.com ↗ |
| 2017-03-04 | Eli Lilly and Company | Results New Head-to-Head Data Shows Significantly Higher Response Rates for Lilly's Taltz® (ixekizumab) Compared to Stelara® (ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis lilly.com ↗ |
| 2016-06-08 | Eli Lilly and Company | Results Studies Demonstrate Lilly's Taltz® (ixekizumab) Maintained or Achieved High Levels of Skin Clearance for Patients with Moderate-to-Severe Plaque Psoriasis through 60 Weeks: Results Published in the New England Journal of Medicine lilly.com ↗
In all three studies, responders to Taltz through 12 weeks demonstrated high levels of skin clearance through 60 weeks. |
| 2016-06-07 | Eli Lilly and Company | Results Results of Clinical and Patient-Reported Outcomes Data for Baricitinib in Patients with Rheumatoid Arthritis to be Presented at Annual European Congress of Rheumatology (EULAR 2016) lilly.com ↗
Ixekizumab Provides Improvements Through 52 Weeks in Physical Function, Quality of Life, and Work Productivity in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis |
| 2016-03-22 | Eli Lilly and Company | Regulatory Lilly's Taltz® (ixekizumab) Receives U.S. FDA Approval for the Treatment of Moderate-to-Severe Plaque Psoriasis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. |
| 2016-03-07 | Eli Lilly and Company | Results Studies Show Ixekizumab Improved Work Productivity for Patients with Moderate-to-Severe Plaque Psoriasis: Results Published in JAMA Dermatology lilly.com ↗
In all three studies, patients treated with ixekizumab reported improved work productivity compared to patients treated with placebo. |
| 2016-03-07 | Eli Lilly and Company | Results Ixekizumab Demonstrates High Levels of Skin Clearance among Patients with Moderate-to-Severe Plaque Psoriasis Who Did Not Respond to Treatment with Etanercept lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that patients with moderate-to-severe plaque psoriasis who did not respond to treatment with etanercept achieved significant improvement in their psoriasis plaques when treated with ixekizumab in a Phase 3 clinical trial. |
| 2016-03-04 | Eli Lilly and Company | Results Ixekizumab Demonstrates Rapid, Clinically Meaningful Improvements as Early as One Week among Patients with Moderate-to-Severe Plaque Psoriasis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that treatment for moderate-to-severe plaque psoriasis with ixekizumab resulted in clinically meaningful improvements as early as one week, compared to patients treated with etanercept or placebo. |
| 2016-02-26 | Eli Lilly and Company | Regulatory Lilly Receives Positive CHMP Opinion for Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis lilly.com ↗
This is the first regulatory step toward approval for ixekizumab in Europe. |
| 2015-11-08 | Eli Lilly and Company | Results Patients Show Significant Improvement in Signs and Symptoms of Psoriatic Arthritis, Less Progression of Structural Joint Damage When Treated with Ixekizumab for 24 Weeks lilly.com ↗ |
| 2015-06-10 | Eli Lilly and Company | Results Studies Show Psoriasis Patients Achieved Significant Levels of Skin Clearance and Improved Quality of Life after 12 Weeks of Ixekizumab Treatment lilly.com ↗
The UNCOVER-2 and UNCOVER-3 clinical studies of more than 2,500 patients found ixekizumab to be statistically superior to etanercept and placebo on all measures of skin clearance. |
| 2015-04-20 | Eli Lilly and Company | Results Lilly's Ixekizumab Met Primary Endpoint in a Phase 3 Study Investigating the Treatment of Psoriatic Arthritis lilly.com ↗
In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements versus placebo in signs and symptoms of active PsA. |
| 2014-08-21 | Eli Lilly and Company | Results Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies lilly.com ↗ |
| 2012-03-28 | Eli Lilly and Company | Results Lilly's Anti-IL-17 Monoclonal Antibody, Ixekizumab, Met Primary Endpoint in Phase II Study in Patients With Chronic Plaque Psoriasis lilly.com ↗
In the 142-subject study, significantly more patients achieved a PASI 75 response in the 150 mg (82 percent), 75 mg (83 percent) and 25 mg (77 percent) ixekizumab groups compared with placebo (8 percent, p < 0.001) at week 12. |
All press releases naming this drug 56 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ixekizumab | “Ixekizumab (Taltz)” NCT07149792 ↗ |
| Known as | IXE | “Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of patients with PsA and patients with...” PMID 37400681 ↗ Jul 20236“This study aimed to evaluate the outcomes of continuous versus interrupted ixekizumab (IXE) treatment and retreatment with IXE after disease worsening in Chinese patients.” PMID 39535685 ↗ Nov 2024 “Ixekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis.” PMID 29116597 ↗ Dec 2017 “Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.” PMID 32415575 ↗ May 2020 “Ixekizumab (IXE), an interleukin-17A inhibitor, has shown efficacy in patients with r-axSpA.” PMID 39509838 ↗ Oct 2024 “Ixekizumab (IXE), a selective interleukin (IL)-17A antagonist” PMID 38814433 ↗ May 2024 “ixekizumab (IXE), an interleukin-17A antagonist” PMID 38332436 ↗ Feb 2024 |
| Known as | LY2439821 | “A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India” NCT05855967 ↗ |
| Known as | Taltz | “using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q2 weeks for 24-weeks.” NCT06085079 ↗ |
| Action | Inhibit | “We evaluated the safety and efficacy of ixekizumab (LY2439821), a humanized anti-interleukin-17 monoclonal antibody, for psoriasis treatment.” PMID 22455413 ↗ Mar 2012 |
| Modality | Monoclonal antibody | “Ixekizumab is a monoclonal antibody that targets IL-17A, a key cytokine in psoriasis pathogenesis.” PMID 25693783 ↗ Feb 2015 |
| Route | Subcutaneous | “Patients were randomized to receive placebo, 10, 25, 75 or 150 mg of ixekizumab injected subcutaneously at weeks 0, 2, 4, 8, 12 and 16.” PMID 25693783 ↗ Feb 2015 |
| Target | IL17A | “Ixekizumab is a monoclonal antibody that targets IL-17A, a key cytokine in psoriasis pathogenesis.” PMID 25693783 ↗ Feb 2015 |