Drugs / Lifitegrast
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XIIDRA | — | 2016-07-11 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04792580 | Oct 2022 → Apr 2024 | graft versus host disease | Richard W Yee, MD | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT07040826 | Dec 2022 | dry eye syndrome | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00936520 | Aug 2009 → May 2010 | diabetic macular edema | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00926185 | Aug 2009 → Feb 2010 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00882687 | Apr → May 2009 | eye allergy | Shire | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07111013 | Dec 2025 → Apr 2027 | dry eye syndrome | Bausch & Lomb Incorporated | Withdrawn | No outcome recorded |
| Phase 3 | NCT06879782 | Mar 2024 → Mar 2026 overdue | dry eye syndrome | Lunan Better Pharmaceutical Co., LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT02284516 | Nov 2014 → Oct 2015 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01743729 | Dec 2012 → Oct 2013 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01636206 | Oct 2012 → Mar 2014 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01421498 | Aug 2011 → Apr 2012 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT07560735 | Apr → Sep 2026 expected | dry eye syndrome | Toyos Clinic | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07490535 | Mar → Sep 2026 expected | dry eye syndrome | Pittsburgh Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07025811 | Jul 2025 → Jul 2026 overdue | dry eye syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05505292 | Sep 2022 → May 2023 | dry eye syndrome | State University of New York College of Optometry | Completed | No outcome recorded |
| Phase 4 | NCT04297618 | Jul 2021 → Apr 2024 | dry eye syndrome | University of Waterloo | Completed | No outcome recorded |
| Phase 4 | NCT04669561 | Mar → Aug 2021 | dry eye syndrome | Research Insight LLC | Completed | No outcome recorded |
| Phase 4 | NCT03952481 | Mar → Dec 2021 | dry eye syndrome | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 4 | NCT05045053 | Feb 2021 → Jan 2022 | corneal disorder | Benha University | Unknown | No outcome recorded |
| Phase 4 | NCT03408015 | Jan 2019 | asthenopia, dry eye syndrome | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 4 | NCT03431272 | Nov → Dec 2018 | dry eye syndrome | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 4 | NCT03686878 | Dec 2016 → Jul 2017 | dry eye syndrome | EV Clinical Trials | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04030962 Comparator | Mar 2020 → Mar 2022 | dry eye syndrome | AbbVie | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07128628 Comparator | Oct 2025 → May 2026 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT05102409 Comparator | Sep → Oct 2021 | dry eye syndrome | Aldeyra Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04734197 Comparator | Jan 2021 → Mar 2022 | dry eye syndrome | Surface Ophthalmics, Inc. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT04120987 Comparator | May 2021 → Jun 2022 | dry eye syndrome | Bucci Laser Vision Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT05594745 Comparator | Mar 2021 → Jan 2023 | dry eye syndrome | Tauber Eye Center | Completed | No outcome recorded |
| Phase 4 | NCT04413253 Comparator | Aug 2020 → Apr 2022 | dry eye syndrome | Eye Surgeons of Indiana | Terminated | No outcome recorded |
| Phase 4 | NCT04172961 Comparator | Feb 2020 → Dec 2022 | dry eye syndrome | Toyos Clinic | Unknown | No outcome recorded |
| Phase 4 | NCT03451396 Comparator | Dec 2016 → Feb 2018 | dry eye syndrome | Lifelong Vision Foundation | Completed | No outcome recorded |
Press releases naming this drug 18 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-06-29 | Takeda | Takeda Announces Anticipated Financial Impact from Novartis’ Withdrawal of the Marketing Authorisation Application for Xiidra ® takeda.com ↗ |
| 2019-07-01 | Takeda | Takeda Completes Sale of XIIDRA ® to Novartis takeda.com ↗ |
| 2019-07-01 | Novartis Pharmaceuticals | Novartis successfully completes acquisition of Xiidra®, bolstering ophthalmic portfolio novartis.com ↗ |
| 2019-05-09 | Novartis Pharmaceuticals | Novartis to acquire Xiidra®, expanding front-of-eye portfolio and strengthening leadership in eye care novartis.com ↗ |
| 2018-01-03 | Takeda | Xiidra®* (Lifitegrast Ophthalmic Solution 5%) Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease takeda.com ↗ |
| 2017-08-15 | Takeda | Shire announces submission of lifitegrast Marketing Authorization Application for treatment of dry eye disease in Europe takeda.com ↗ |
| 2016-08-29 | Takeda | Shire’s First Prescription Eye Drop, Xiidra™ (lifitegrast ophthalmic solution) 5% Is Now Available in the U.S. takeda.com ↗ |
| 2016-07-11 | Takeda | FDA Approves Shire’s Xiidra™ (lifitegrast ophthalmic solution) 5% – The Only Treatment Indicated for the Signs and Symptoms of Dry Eye Disease takeda.com ↗ |
| 2016-02-04 | Takeda | U.S. FDA Acknowledges Receipt of Resubmission of Shire’s New Drug Application for Lifitegrast for Dry Eye Disease in Adults takeda.com ↗ |
| 2016-01-25 | Takeda | Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA takeda.com ↗ |
| 2015-10-27 | Takeda | Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease takeda.com ↗ |
| 2015-10-19 | Takeda | Shire Provides Update on Next Steps for Lifitegrast in Light of FDA Complete Response Letter takeda.com ↗ |
| 2015-10-16 | Takeda | Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial takeda.com ↗ |
| 2015-04-09 | Takeda | FDA Grants Priority Review to Lifitegrast NDA for Treatment of Dry Eye Disease in Adults takeda.com ↗ |
| 2015-03-02 | Takeda | Shire Submits Application to the U.S. FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults takeda.com ↗ |
| 2014-05-16 | Takeda | Shire Plans To Submit A New Drug Application To FDA For Lifitegrast For Dry Eye Disease In Adults takeda.com ↗ |
| 2014-04-30 | Takeda | Shire Announces Updates From Phase 3 Clinical Program For Lifitegrast In Adults With Dry Eye Disease takeda.com ↗ |
| 2013-12-05 | Takeda | Shire Reports Top-Line Results On OPUS-2, A Phase 3 Study Investigating The Use Of Lifitegrast (5.0% Ophthalmic Solution) In Adults With Dry Eye Disease takeda.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lifitegrast | “This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution.” NCT06879782 ↗26 |
| Known as | SAR 1118 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00936520 ↗ |
| Known as | Xiidra | “Compare the pharmacokinetic (PK) profiles of Lifitegrast Ophthalmic Solution and Xiidra® in plasma and tears following single-dose administration in healthy subjects.” NCT07040826 ↗7“lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes” NCT03952481 ↗ “Xiidra® (5% lifitegrast ophthalmic solution) dosed once” NCT05102409 ↗ “(Xiidra®) Lifitegrast Ophthalmic Solution 5.0%” NCT07490535 ↗ “Lifitegrast Ophthalmic Solution 5.0% (Xiidra)” NCT07560735 ↗ |
| Action | Inhibit | “a novel integrin antagonist (SAR 1118)” PMID 22330307 ↗ Feb 2012 |
| Modality | Small molecule | “SAR 1118 is a potent and selective small molecule” NCT00936520 ↗ |
| Route | Topical | “SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily” PMID 22330307 ↗ Feb 2012 |